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(Posted: May 17, 2019)

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Trastuzumab deruxtecan makes Margetixumab clinically irrelevant

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Tomasz M. Beer, MD, FACP (Posted: May 14, 2019)

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While it is undoubtedly exciting to find that more than half of the men with advanced prostate cancer have a genomic alteration which we may be able to match to a drug, this is a very long way indeed from demonstrating a patient benefit. There are countless examples of targeted drugs that yielded little or no benefit in prostate cancer and many other malignancies. This is an important first step, but what is needed next are careful studies that demonstrate what drugs can help which patients based on genomic findings. The routine use of such approaches outside of a clinical trial is not yet warranted with some very specific and not common exceptions. This is not yet an argument for molecularly directed therapy for more than half of our patients.

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Debu Tripathy, MD (Posted: May 08, 2019)

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The development of testing of new antibody-drug conjugates (ADCs, also known as immunoconjugates) is rapidly growing as these agents allow for more cancer cell-specific drug delivery and the use of more potent cytotoxic drugs than can be given by conventional administration. Every such drug has its own "operating characteristics" depending on the antibody/antigen system used, the nature of the linker attaching the antibody to the active drug and the cytotoxic "payload". In the case of trastuzumab deruxtecan, impressive response rates were shown in pretreated patients with HER2+ breast cancer the Phase I setting. Responses nearing 50% were even shown in a separate cohort of patients who had lower HER2 expression in the negative range by conventional definitions. While the results of the Phase II trial have not yet been made public, there is significant enthusiasm as the Phase III registration trials for both HER2+ and HER2-low get off the ground.

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Dean Gesme, MD (Posted: May 08, 2019)

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The expansion of antibody drug conjugates may have more "real world" benefit for our patients than CART cells. We are also in need of expanding our anti-Her2 breast cancer armamentarium and this agent may prove active in IHC 1+ breast cancers as well!

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Debu Tripathy, MD (Posted: May 07, 2019)

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The approval of T-DM1 (ado trastuzumab emtansine) in the adjuvant setting for patients who have residual disease after standard neoadjuvant (pre-operative) therapy for HER2+ breast cancer is a breakthrough for two very important reasons. First, it has a large effect - cutting recurrence risk by 50% in a high-risk group of patients. That alone is a notable achievement. However, in a larger sense, it establishes that pre-operative therapy is not only a treatment that might help shrink breast cancers in order to allow for less aggressive surgery (eg. breast-conserving surgery), but that it is actually a "bioassay" that helps determine which treatment after surgery is most effective. While we have long been using pre-operative therapy as a way to potentially personalize treatment, this is the first actual demonstration that we can put this theory into practice. We are going to see further advances in "precision" medicine by real-time monitoring during treatment to determine what the best next step is for each unique case, and to accelerate the testing of new therapies using this platform. So while the practical result for now is the approval of an established drug in the advanced setting for a new indication in early stage setting - it has much broader implications going forward.

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Tomasz M. Beer, MD, FACP (Posted: May 06, 2019)

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Studies of large populations have inherent limitations in their ability to account for confounders, so it is hard to be sure if hormone therapy really increases risk of dementia. And the story of hormones and dementia in general is complex. Research that directly addresses this question is needed. It is less clear that this information is sufficiently robust to use in treatment discussions and decisions.

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Tomasz M. Beer, MD, FACP (Posted: May 02, 2019)

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The additional of hormonal therapy to radiation in the salvage (rising PSA post prostatectomy setting is the new and impactful change to these practice guidelines. Clinicians should be aware of the potential benefits of adding hormonal therapy in this setting, and of the toxicities.

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Tomasz M. Beer, MD, FACP (Posted: April 29, 2019)

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Darolutamide would be the third androgen receptor inhibitor for non-metastatic castration resistant prostate cancer if it gains approval. The improvement in metastases-free survival with these agents is substantial, although it is too early to know how that effect translates into overall survival results. It is interesting to observe that Priority Review was granted even when two existing agents are already approved in this disease state.

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Tomasz M. Beer (Posted: April 18, 2019)

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Exciting to see the ARCHES clinical trial selected for the plenary session. We learned in February that the trial was positive and showed improvements in progression-free survival from enzalutamide added to hormonal therapy in newly diagnosed metastatic prostate cancer. More information will be helpful in putting these results in context of the previously known benefits of abiraterone and docetaxel in the same setting.

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H. Jack West, MD (Posted: April 12, 2019)

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This new approval is more likely to lead to worse care rather than net benefit. The approval of pembrolizumab for patients with a lower threshold tumor PD-L1 of 1% is based on the KEYNOTE-042 trial being positive against chemo doublet alone in this broader population. However, pembrolizumab was already approved for patients with high PD-L1 of 50% of greater, and that group was the one that drove the positive results of the trial overall, essentially "carrying" the group with tumor PD-L1 1-49%, who did no better with pembro monotherapy than with doublet chemotherapy. The trial was positive despite having favorable results with pembro from the high PD-L1 group diluted by the extremely weak results with pembro monotherapy for the low PD-L1 group.

Some will say that the fact that the first line pembrolizumab arm did just as well in overall survival as doublet chemo means that this now makes pembrolizumab a viable alternative. That might be the case except that the chemo alone arm was not permitted to cross over to immunotherapy upon progression, which has been a well established standard of care for years in patients with advanced NSCLC and who progressed after first line chemotherapy. The first line pembro arm only did as well as a hobbled, substandard of care arm that started with chemo and couldn't get subsequent immunotherapy. On the other hand, every patient who started on pembro could easily transition to chemo later.

Finally, the inclusion of patients with stage III NSCLC who are not able to get chemo/radiation is another concern, since the current standard of care in this setting, chemoradiation followed by durvalumab, is a potentially curative therapy. These were not patients who were the planned subjects of KEYNOTE-042. For patients with stage III NSCLC to receive single agent pembrolizumab rather than chemoradiation would be an egregious affront to our best data-driven standards.

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Ted Okon (Posted: April 11, 2019)

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PBMs are getting more brazen in how they delay and deny cancer patients their oral drugs. Anyone in practice knows that. The Senate Finance hearing was a necessary first step but a lot more needs to be done — especially focusing on how PBMs are adversely impacting patient care.

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Parity of Medicare Reimbursement is needed (Posted: April 11, 2019)

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When the Medicare fee schedule pays the same for clinic-based as well as hospital-based services, that will be a good first step in improving rural access to care. Free-standing satellite oncology clinics cannot remain open when they are forced by CMS to bill as clinic-based operation. It doesn't pay for the drugs. 340(b) doesn't apply to satellite operations, when the "mother ship" institution is not in a 340(b) zip code.

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H. Jack West, MD (Posted: April 11, 2019)

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A disappointing failure, but one that at least leaves the new standard of first line carbo/etoposide/atezolizumab, which showed a survival benefit over chemo alone in the IMpower133 trial, as an uncontested leading approach today. Surprising to see such weak results even for the nivolumab/ipilumumab doublet, but the fact that there's a suggested benefit on the far right end of the curve highlights that there is a subgroup who do well with immunotherapy -- we just need to figure out how to identify them prospectively.

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Howard Sandler, MD, MS, FASTRO (Posted: April 08, 2019)

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Some of the leaders in the US from UCLA and UCSF report on their Ga68 PSMA PET scan results in prostate cancer patients after surgery, after RT or after both. While PSMA PET has not been formally compared with fluciclovine PET, many expect PSMA PET to be superior imaging modality. Hopefully, we'll see some high quality comparison data and hopefully we'll have access to an FDA-cleared PSMA imaging modality soon.

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Howard S. Hochster, MD (Posted: April 08, 2019)

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Thanks to the FDA for this initiative. Underscoring once again that there is nothing "medical" about "medical marijuana," those seeking financial benefit have turned CBD into 21st century snake oil. Claims of its benefit far exceed the small amount of medical evidence for seizures and are based on anecdotal evidence. We need appropriately conducted controlled clinical trials to determine the medical benefits of both marijuana and CBD. Government support and lowering of barriers to conducting this research are necessary.

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Debu Tripathy, MD (Posted: April 06, 2019)

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This label approval of palbociclib for male breast cancer is an example of creativity to address subsets of patients rarely represented in clinical trials, yet for whom it is plausible that the results may not reflect the main study findings. This subsets typically include males (in the field of breast cancer) as well as older patients, pediatric patients or those with varying degrees of organ dysfunction. Small trials used to be required to extend the label to these subsets (although often physicians would just their own judgment, but then may get challenged by insurance companies. This approval is interesting in that it is based on part on new sources of "real-world" data, large data aggregators like Flatiron Health, where outcomes are analyzed based on "big data", including electronic medical records in some cases. We may see more of this - in fact, it is possible that clinical research for some of the less complex diseases will migrate to being primarily conducted in this environment.

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H. Jack West, MD (Posted: April 03, 2019)

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Nice to see further long-term survival data, really in keeping with what we've seen up to now. There are a significant minority of patients who continue to demonstrate prolonged survival far beyond what we'd seen before the era of immune checkpoint inhibitor therapy in advanced NSCLC. That said, the world has shifted to using immunotherapy agents primarily first line in advanced NSCLC. These data don't suggest any change in management or our thinking.

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Tomasz M. Beer, MD, FACP (Posted: April 02, 2019)

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A badly misleading title. This study could not determine if survival is prolonged by the combination. The only thing that this trial can demonstrate is that the combination tested is tolerable and feasible. It will be interesting to see it move beyond phase I. But for now, we know it is feasible.

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Thomas Marsland, MD (Posted: April 01, 2019)

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This particular article hit close to home on two fronts. I can share the author's frustration about primary care since I have recently had to go through the experience of "changing my primary." I received multiple letters from several different entities claiming to be my insurer, completely unclear who the actual insurer is. These letters offer several different panels and availability. Clear as mud as they say. Now also from the side of doctor providing care, I am extremely frustrated by ongoing delays experienced by my patients when I try to refer to another provider for additional insights, and learn that often they are given the "next available " appointment many times months away. Clearly that does not result in good quality care. Usually I can short circuit this with a personal phone call (begging) my colleague to see if they could possibly get my patient is a little sooner (and again to my frustration it usually isn't just one phone call but multiple episodes of phone tag).... texting is somewhat quicker but again often don't have the doc's personal cell and even then am limited by privacy concerns about what I can actually say in a text...)

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Thomas Marsland, MD (Posted: April 01, 2019)

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Although certainly onerous non-competes have been around for a long time. Also over the years I have labored in numerous different programs and systems and they all expect you to "support the team." The critical issues are whether personal compensation becomes a factor in driving referrals. When it does that could ultimately result in reduced access to care for some patients.

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thomas marsland (Posted: April 01, 2019)

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Oral parity has been an issue for a long time. Clearly this needs to be done correctly. We don't want to have the higher patient costs seen on the pharmacy benefit side transitioned to the medical benefit side where most chemotherapy drugs presently reside. Making this more complicated is the move by the administration to consider moving more Part B benefit drugs to the Part D coverage program. How would those moves effect the "parity" issue when Part D becomes the primary coverage for more cancer drugs?

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H. Jack West, MD (Posted: April 01, 2019)

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These data are really obviated by the new standard of carbo/etoposide with atezolizumab as first line treatment for extensive stage SCLC. It is difficult to impossible to see how these data would be relevant with patients with extensive stage SCLC routinely receiving first line atezolizumab. There is no reason to think that subsequent pembrolizumab would have any activity in this setting.

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H. Jack West, MD (Posted: March 25, 2019)

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This was expected based on prior, preliminary presentation of data from this study, though every bit of positive results in small cell lung cancer (SCLC), particularly relapsed SCLC, is very welcome. Lurbinectedin has demonstrated good evidence of activity as a single agent or combined with doxorubicin, though single agent appears to have the better therapeutic index. Still, we await the results of phase III data with lurbinectedin before we can really establish a place for this agent in the management of patients with relapsed SCLC.

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H. Jack West, MD (Posted: March 19, 2019)

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This is an important and appropriate FDA approval. Though the improvement in median overall survival in IMpower133 was a relatively underwhelming 2 months (at least underwhelming by recent standards set with immunotherapy and targeted therapies), the hazard ratio is 0.7, and the beneficiaries have generally achieved prolonged benefit. This approach is a statistically and clinically significant benefit for a broad population with extensive stage SCLC and represents what should be considered the new standard of care, at least until we get a better sense of how to clarify prospectively which patients with extensive stage SCLC are more or less likely to benefit from addition of atezolizumab or another immunotherapy.

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Howard S. Hochster, MD (Posted: March 19, 2019)

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This amazing article should be required reading for all physicians and healthcare administrators. The article explains why all the EHRs are essentially modified billing systems that do not serve the physicians or patients. Every physician spends many uncompensated hours doing notes at home in the evenings and weekends. This is an abuse and is a major factor in burnout. #takebackourtime

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Howard Sandler, MD, MS, FASTRO (Posted: March 19, 2019)

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Prophylactic cranial irradiation (PCI) is generally offered to patients with limited small cell lung cancer but hasn't been offered to non-small cell lung cancers. This prospective randomized study shows that PCI can alter the pattern of failure and has a large impact on the incidence of brain mets (HR = 0.43) but doesn't improve overall survival. Some toxicity has been reported as well. At this point, there would be little rationale for routine use of PCI in non-small cell lung cancer.

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Tomasz M. Beer, MD, FACP (Posted: March 18, 2019)

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This is an interesting and complex finding. First it demonstrates that the relationship between testosterone and prostate cancer is complex - something that is not surprising. Second, it does not question the value of hormonal therapy as the article suggests. Hormonal therapy efficacy is well established - in the right setting. Hormonal therapy is not indicated in low risk localized prostate cancer. Finally, the finding has to be viewed as preliminary. This was not a randomized study. So it is not possible to say that testosterone replacement reduced the risk of relapse. There was not a proper comparison with a randomly selected identical control group. It is possible to say that the relapse rate was low and this is very encouraging. More work is needed in this area.

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William McGivney, PhD (Posted: March 14, 2019)

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Payer Prior Authorization: Intrusion, Disruption and Patient Harm
Is it any surprise that the frequency of payer prior authorizations continues to rise? The arrogance and greed of the payer/MCO industry dominates good sense and dismisses or, more to the point, disses patient well-being. Oftentimes, prior authorization programs are developed and marketed alone or in combination with other intrusive activities to the employer customers. The sale of such programs generates revenue that hits the bottom line of these payers/MCOs. Did you ever wonder why the Claims Cost totals are generally about 85-88% of the reported Medical Costs of a payer. As the oft-quoted Yogi Berra would say: “You could look it up”; although annual Claims costs are not always easily found.
A significant percentage of the Medical Costs minus Claims paid costs proceed to hit the revenue and profit bottom lines of payers/MCOs. In the drug/biologic world of Oncology, about 1% of prescriptions are ultimately denied. The disruption, delay and harm caused by intrusive prior authorization seems of little consequence to payors/MCOs as they forage and, more accurately, ravage the managed care landscape. I could go on and on but my soon-to-be-released book, On the Road to KICK-ASS HealthCare™ will tell the behind-the-scenes story.
One vignette sums up the absurdity of what we tolerate. An endowed professor at a prestigious Medical Center and longtime NCCN Panel Chair tells the story of what we will generously call a “Peer to Peer” discussion on a prior auth disagreement. The internationally respected medical oncologist found out that she/he was speaking with a cardiology nurse from the payer who proceeded to lecture her/him on what the relevant NCCN Guideline recommended. After exhibiting patience, reserve, and restraint, the good doctor informed the payer cardiology nurse that she/he, indeed, was the chairperson of the relevant panel and had been for many years. She/he then educated the cardiology nurse on what the particular NCCN Guideline really said.
This story might be amusing, if not for the fact that behind the enormous waste of time and money was a patient who thought that he/she had traveled the 300 miles to have this world’s leading oncologist determine what was best for her/him; not some script-bound cardiology nurse in some cubicle otherwise removed from the cancer care delivery system.

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Debu Tripathy, MD (Posted: March 12, 2019)

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We will be seeing many more biosimilars approved in the coming years. This term is applied to biological agents since they are not precise chemical structures and therefore cannot be called "identical". By the same token, they may not possess completely equivalent clinical activity and safety. Regulatory agencies do not require the same rigor of testing as a new indication for a biologic agent, but they do have to show "similar" composition, activity and safety. Typically, the clinical endpoint may not have to be as robust (for example statistically non-inferior response as opposed to progression-free survival in the advanced setting, and complete pathological response pre-operatively as opposed to disease-free survival in the early stage setting). Nevertheless, it is general accepted (by some but not all), that these are similar enough to be substituted for the brand name. It is estimated that in the US, this may result in 30-40% drops in prices - maybe not the dramatic effect we would like to see in cancer drug prices, but outside of the US, they might make the difference between large numbers of patients receiving biological drugs vs. not.

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H. Jack West, MD (Posted: March 12, 2019)

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This is an interesting and important finding, but the lack of an overall survival (OS) benefit will mean it should not have any significant clinical impact, since we already have data from Japan that have shown a reproducible improvement in progression-free survival (PFS) that has been quite profound but has thus far failed to translate into an improvement in overall survival. While a substantial improvement in PFS without an improvement in OS sometimes dictates a change in practice, the Japanese data have not led to any appreciable shift in practice since these data became available, generally due to the added cost, the introduction of an IV therapy that requires patients to come to clinic more than they would for oral therapy alone, and some toxicity risk. Because ramucirumab on the RELAY trial essentially just replicates the findings already seen with the erlotinib/bevacizumab combination, it's very difficult to imagine it leading to a different approach based on a very similar trial and agent. We would need to see a significant improvement in OS. Even then, osimertinib has become the first line standard of care, so the leading trial needs to be an anti-angiogenic agent with osimertinib in this setting. An alternative first line approach with considerable interest is that of chemo combined with osimertinib first line, based on the results of the NEJ-009 trial presented at ASCO 2018, which demonstrated not only a significant improvement in PFS and even OS with the combination of carbo/pemetrexed/gefitinib over gefitinib followed by chemo.

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Debu Tripathy, MD (Posted: March 11, 2019)

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This is a notable step forward in breast cancer therapeutics. Making advances, especially in survival, using immunotherapy has been a holy grail despite the long-held belief that the immune system is important in breast cancer when in fact, early immunotherapy trials using checkpoint inhibitors have been disappointing. However, the IMpassion130 trial is clearly positive - testing the addition of the anti PD-L1 antibody atezolizumab to nab-paclitaxel as first line therapy for PD-L1+ (in immune cells) triple negative breast cancer (TNBC). The indication does not specify line of therapy, but does specify the chemotherapy partner and need for PD-L1 testing. There will be a quick succession of results from additional trials - importantly, the KEYNOTE-355 trial testing the addition of pembrolizumab to one of three chemotherapy regimens also in the first line for TNBC is expected to report results later this year. Numerous randomized trials are ongoing (some preliminary already reported) in the neoadjuvant and adjuvant settings for all subsets of breast cancer. So expect an avalanche of data, but most importantly, more options for our patients that will hopefully make differences in survival and with some very long term responses.

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Debu Tripathy, MD (Posted: March 09, 2019)

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Criteria for clinical trials sometimes occupy several pages of a protocol, underscoring how selective they can be by excluding certain age groups, or those with decreased organ function. While some of these may be important for safety reasons, many times they are overly burdensome, especially for when they are intended for patients with refractory cancers who might be expected to have some limitations or physiologic abnormalities. When a new drug is approved, we are finding that the studies upon which the approval was based are so stringent in their eligibility, that "real-world" cohorts or registries must be studied, adding cost and delays in our understanding to true benefit and risk balance of a drug. Efforts to make trials more streamlined and reflective of the target population are welcome.

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Howard Sandler, MD, MS, FASTRO (Posted: March 05, 2019)

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This COG study (of about 350 pediatric ependymoma patients) identified a benefit to RT even in the very young, <3 year old, patients with ependymoma. While RT is clearly risky when given to the very young, tumor recurrence in the posterior fossa is also associated with adverse effects. One could probably argue that carefully delivered posterior fossa RT is less toxic approach if local control can be substantially improved as was apparent in this large COG study. Congratulations to the pediatric brain tumor community.

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H. Jack West, MD (Posted: March 01, 2019)

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We obviously need to see the actual data at the AACR presentation, but this is an important milestone, I expect. Blood-based testing had already gotten a big boost by the paper from Charu Aggarwal and colleagues in JAMA Oncology in ~Oct, 2018, and this presentation will likely bolster confidence among oncologists that blood-based NGS testing is now sufficiently sensitive and established to be used far more broadly.

Significantly, I think this will do a lot to lead to more patients getting NGS testing and greater detection of many targets. The oncologists committed to molecular testing were likely to get it even if it required an additional tissue biopsy -- it was those who were more skeptical or those who didn't want their patients or themselves to deal with the hassle of a tissue biopsy who will now take the path of far less resistance and order a blood-based test they can obtain right in the clinic lab and get their molecular testing that way. And the fact that it comes back a week or more before the tissue NGS test results is a further benefit that has been a significant barrier to broad adoption of NGS testing, at least tissue-based NGS testing, up to this point.

I eagerly await the data, but the abstract strongly suggests that this will be a big year for blood-based NGS testing.

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Dean Gesme, MD (Posted: February 27, 2019)

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BITE technology is extremely exciting! It will be important to see if the first product launches can avoid the extreme complexity and exorbitant total expense that has become a huge impediment to the implementation of CART therapies.

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Howard Sandler, MD, MS, FASTRO (Posted: February 27, 2019)

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Louis Potters and colleagues report out a phase I study of dose escalation for low/intermediate risk prostate cancer using 5 fraction SBRT of 40, 45, and 50 Gy. They didn't detect any increased toxicity with the higher doses although other centers have seen higher doses with 50 Gy in 5 treatments. So far so good, but a small study doesn't have the power to detect a small but meaningful risk of serious late toxicities. I don't expect to see a bunch of relatively rare events with 40 or even 45 Gy but before offering men a more convenient (but so far not more efficacious) treatment, one should be pretty confident about safety.

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Howard S. Hochster, MD (Posted: February 27, 2019)

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Great news for patients with BRCA mutation-related pancreatic cancer. Olaparib maintenance after induction with platinum-based chemotherapy extends time to disease progression (and hopefully, survival). This important study denostrates two key points:
1. Platinum based chemo sensitivity is a marker for PARP inhibitor activity and
2. Patients with BRCA mutation-related pancreatic cancer also can benefit from this class of drugs (previously shown active in breast and ovarian cancers). We now appreciate that BRCA biology is more similar across diseases than different.

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Howard Sandler, MD, MS, FASTRO (Posted: February 22, 2019)

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The PACE (Prostate Advances in Comparative Evidence) trial with two subcomponents: PACE-A and PACE-B is important in prostate cancer radiation and surgical oncology. PACE-B, recently reported some data comparing 'standard, 4-9 week' RT to 'SBRT, 5-fraction' RT, and is showing no difference in acute toxicity. If the tumor control is ultimately shown to be equivalent, then the shorter 5-fraction approach will be widely adopted (adoption is appropriately selective at this point). Results from the highly interesting PACE-A component, comparing surgery to SBRT, (not reported at ASCO GU Cancer Symposium) is eagerly awaited.

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William McGivney, PhD (Posted: February 20, 2019)

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CED for CAR-T: A Better Way to Assure Access to a Very Promising and Very Expensive Treatment
CMS has determined that Medicare will cover CAR-T therapy when such therapy is provided in the context of a clinical study or trial that CMS has approved. For CMS, this is a rare National Coverage Determination (NCD) in cancer care. The policy balances the opportunity and need to make available to patients a very promising new treatment and, at the same time, satisfy the need to collect, analyze and report out on data and evidence that relates to what surely will be an expanding list of tumor type indications and an expanding list of provider-setting types.
Many have likened the introduction of CAR-T therapy to the era of the introduction of high dose chemotherapy with bone marrow or stem cell transplantation. A difference in the CAR-T case is that the FDA has approved CAR-T products based upon some data submission. Further the price tags for CAR-T and HDCT-ABMT/SCT are both very expensive and the eventual total costs of CAR-T will only increase as such costs will include management of very serious side effects in some patients.
Years ago in the early 1990s, I faced the HDCT/ABMT/SCT issue at Aetna. In an invited editorial in the Journal of the National Cancer Institute (McGivney, May, 1992), I proposed the initial thinking around the importance and need for ongoing data collection (Coverage with Evidence Development) to define the therapeutic indices for the various tumor types that HDCT ABMT/SCT would be used for. In return at introduction of a treatment, coverage would be provided at 60-70 centers nationwide to assure widespread access. Without going into great detail, the application of CED to CAR-T will help us avoid the concerns, consternation and conflicts that enveloped the HDCT/ABMT/SCT technology. CED should be applied sparingly but every great once in a while, a very promising, very expensive technology or treatment becomes available that needs to be made available to patients in need but that also needs to have an evidence-based definition of its therapeutic index to evaluate the benefit to be derived by future patients, including those patients with expanded indications. As such, the present Medicare NCD provides access through Medicare coverage as financial support and supports use and access in a very judicious manner for this critically important therapeutic approach.

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Howard S. Hochster, MD (Posted: February 20, 2019)

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Another example of Immunotherapy in GI cancer not living up to the expectations (and hype). Despite some great results in prior single arm trials, the randomized 2nd line study of pembro vs BSC did not reach a HR of 0.78 for OS or PFS - though a positive effect was seen. Not unlike gastric cancer, these drugs have small effects in unselected GI patients and we need better markers for who will benefit (PD-1 expression, IFN signature etc) and better combinations of IO drugs. Sorry state of affairs but we must go back to the drawing board!

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Howard Sandler, MD, MS, FASTRO (Posted: February 19, 2019)

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New guidelines from ASTRO-ASCO recommend moderately hypofractionated radiotherapy for many men with prostate cancer based on multiple high quality randomized trials including an NRG trial: RTOG 0415. Patient reported outcomes from RTOG 0415 further support the safety of the shorter, hypofractionated regimen. The 3 largest, multicenter randomized trials (CHHiP, PROFIT, and 0415) have been practice changing and are providing men with a shorter, more convenient radiotherapy option.

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Tomasz M. Beer, MD, FACP (Posted: February 13, 2019)

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As contemporary hormonal agents are increasingly used earlier in prostate cancer, the need for novel agents in castration resistant disease is increasingly acute. The promising results with LuPSMA could not come at a better time. We will eagerly await the results of the ongoing phase III trials

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William McGivney, PhD (Posted: February 11, 2019)

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Breast Implants; Déjà Vu All Over Again
Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”.
For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage.
The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer.
It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers.

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H. Jack West, MD (Posted: February 08, 2019)

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"Paleo pathology" is cool. Cancer goes back to the Triassic period.

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Tomasz M. Beer, MD, FACP (Posted: February 05, 2019)

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Daralutamide would be the third agent with demonstrated efficacy in non-metastatic castration resistant prostate cancer if the ARAMIS trial yields positive results. Both efficacy and safety data will be of interest and clinicians evaluate a growing stable of options in this disease state where enzalutamide and apalutamide have been approved.

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Tomasz M. Beer, MD, FACP (Posted: January 31, 2019)

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This study confirms one of the major trends in the field: that of intensifying upfront hormonal therapy in newly diagnosed metastatic prostate cancer. We have solid evidence that abiraterone or docetaxel improve outcomes when added to standard hormonal therapy early and now, apparently, similar results are being seen with apalutamide, an androgen receptor blocker. That is good news. We will eagerly await the full results as the magnitude of impact and the post-progression therapy experience of these patients will be an important determinant of how these results are interpreted in context.

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Howard S. Hochster, MD (Posted: January 31, 2019)

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Good argument for tort reform. No surgeon wants to be in court for doing the wrong surgical procedure if an incidental breast cancer is found. Juries and plaintiffs don’t tend to accept guidelines in the face of actual damages to a person.

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H. Jack West, MD (Posted: January 24, 2019)

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We are not privy to the data that the FDA have, but based on the TMB data that are publicly available, I think this is a very appropriate guidance by the FDA. We need more and stronger data to support TMB use for clinical decision-making. First, we need to see a survival benefit by using it; second, we need to see that the survival benefit is predicated on using the TMB test.

I think it is more likely than not that TMB will be a useful biomarker, but not the only one, in a few years. However, the data we've seen from CheckMate-227 are not sufficient to warrant using it.

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Tomasz M. Beer, MD, FACP (Posted: January 23, 2019)

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This is an excellent reminder that genomic testing is fundamentally no different from any other diagnostic intervention. The context of use matters and the authors should be applauded for their work confirming that in low risk patients, this assays should not be used. The speed with which knowledge is growing in this area will challenge us to frequently reassess the value of emerging diagnostics. New development may alter the value balance. But along the way, clinicians should embrace novel diagnostics when they make a valuable contribution and avoid them when they don't.

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Thomas Marsland, MD (Posted: January 22, 2019)

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Financial incentives have and always will drive healthcare. There is no free lunch. This report focuses on treatment practices by physicians depending on the financial incentives. First I strongly believe doctors choose what treatments to recommend depending on what is best for our patients. When efficacy and toxicities are equal then the economics definitely come into play. There are systems where using more expensive therapies are chosen as well as systems where less expensive therapies maybe chosen if there is a financial incentive to do so. Many of the newer models are based on these concepts. Also I would like to point out that that comment about financial incentive clearly applies not just to physicians. Payers also have programs that alter treatment choices due to the economics (prior auths, step therapies, fail first, and more). Gee, bet the PBMs never look at the economics of the treatments they mandate. So let us all agree patients come first and that we need to continue to work to assure that financial incentives work to the benefit of all....

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Howard S. Hochster, MD (Posted: January 22, 2019)

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Another phase 3 trial of Gem-Abraxane with or without your favorite targeted agent. No particular rationale for using BTK inhibitor, ibrutinib, or patient selection for this pathway. And another negative trial without benefit. Let's get smarter.

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H. Jack West, MD (Posted: January 17, 2019)

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This application is based on the results of the IMpower130 trial of first line carbo/nab-paclitaxel with or without atezolizumab in patients with advanced non-squamous NSCLC (disclosure: I am an author on the abstract presented thus far and future publication). The trial is positive for not just an improvement in progression-free survival but also overall survival, which is an achievement. However, I see the limiting factor being that the true comparator in this setting today isn't chemotherapy alone, as was in the trial, but the KEYNOTE-189 combination of carbo/pemetrexed/pembrolizumab in the same setting. Though there can always be an occasion for which an alternative to the carbo/pemetrexed backbone is needed, this chemo regimen and the KEYNOTE-189 combination in general is one that the vast majority of lung cancer specialists and general oncologists alike are very happy to use as their preferred regimen. This will likely relegate the IMpower130 combination being considered here to very, very limited use. There is simply little to no incremental benefit it offers over KEYNOTE-189 in the same setting.

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Howard S. Hochster, MD (Posted: January 15, 2019)

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Another TKI for HCC! We now have 3 agents with variable tolerability profiles. Good news for patients as we have more choices. Now we need more studies on how to incorporate these agents with local therapies including resection, radiation, TACE, TARE and also in combination with immunotherapy. Exciting opportunities.

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Tomasz M. Beer, MD, FACP (Posted: January 14, 2019)

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It is fascinating to see that greater complexity of cancer, typically associated with more aggressive behavior and greater resistance to conventional therapies, may be helpful in immunotherapy responsiveness.

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(Posted: January 13, 2019)

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Outrageous.... There is urgent an need to regulate the drug prices and reign in the greed of the big pharma

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William McGivney, PhD (Posted: January 10, 2019)

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ONLY Invested Over $100 Billion in R and D
A quote in the summary article provided belies the financial investments and contributions of the biopharma industry to the advancement of science and the resultant delivery of new drugs and biologics to the marketplace and, thus, to patients; (even some agents that are clearly game-changers like immuno-therapeutics). The quote is as follows:
“Research and Development is only about 17% of total spending in most large drug companies”.
Dare I say that the use of the adverb “ONLY” might evince a “bias” against the biopharma industry no matter how many billions of dollars that biopharma companies invest in biomedical research (basic and mainly clinical). Being generous let’s look at 2017 for the zenith of federal funding to all 27 of the Institutes, Centers, and Offices of the NIH. Budgeted funding was $33.1 billion. Trying to be scientific and methodologically sound, I looked for the spending by biopharma companies in the same year, 2017, on Research and Development. In an online article by John Carroll in Endpoints on April 24, 2017, the author delineates by company budgeted amounts for R and D in 2017. Being a fan of brevity and “get to the point”, I had to go down the list to ONLY company # 4 to best the NIH’s paltry (synonym for ONLY?) $33 billion by $8 billion with a sum for the 4 companies of $41 Billion invested. If one were to go through the list of the top 15, one would tally ONLY $90 billion invested in R and D. I do believe that there are many more biopharma companies out there to tally but I stopped at ONLY 15.
To what extent would a reduction in drug prices contribute to a proportional (e.g., percent of 17%) reduction in R and D dollar investments? One can ONLY guesstimate!

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Tomasz M. Beer, MD, FACP (Posted: January 10, 2019)

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We must take burnout seriously if we are to retain a robust physician work force. I would offer one observation. The discussion of physician burnout often occurs in a vacuum. We need to recognize that burnout is increasing in many segments of society. It is not a unique ailment limited to the medical profession. And we would be wise to consider the impact of technology, social media, and the resulting 24/7 work cycle on humanity. Many of the changes that we face have emerged rapidly and their full effect is just beginning to be recognized.

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H. Jack West, MD (Posted: December 21, 2018)

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This is an indication that, if approved, most lung cancer specialists won't be eager to support. Though patients with PD-L1 1-49% were included in the KEYNOTE-042 trial that came out positive, the subsets clearly illustrate that the study was positive DESPITE their inclusion, which just diluted the real benefit with pembro in the PD-L1>50% population already known to benefit from pembro over chemo based on the KEYNOTE-024 trial.

And while you could argue that pembro coming out with the same survival as first line chemo in the PD-L1 1-49% group represents a favorable option since patients can do just as well without the side effects of chemo, this isn't really true. The control arm getting first line chemo wasn't permitted to cross over, and only 20% of these patients ever got access to immunotherapy upon progression, which is a clear standard of care that has a consistently proven survival benefit. In other words, first line pembro merely looks comparable to first line chemo in survival for patients with PD-L1 1-49% who received substandard care on the control arm.

First line pembro is a poor option for patients with PD-L1 1-49% who are candidates for chemo/immunotherapy, or arguably even chemo followed by immunotherapy. KEYNOTE-042 should not be interpreted as making first line pembro a compelling option for these patients.

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Tomasz M. Beer, MD, FACP (Posted: December 20, 2018)

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Intensification of therapy for newly diagnosed metastatic prostate cancer has become standard of care as a result of positive results with docetaxel and with abiraterone. It is not unexpected, therefore, that a similar approach with enzalutamide would yield favorable results. We will await eagerly the detailed results to better understand the effect of this combination.

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Ted Okon (Posted: December 18, 2018)

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As I informed Dr. Bach, at least one of his "fact check" statements are not factual. "...McKesson, which owns Texas Oncology (part of US Oncology)" is not correct because the physicians of Texas Oncology own Texas Oncology. It calls into question what other "fact checks" by Dr. Bach are incorrect.

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sheila donnelly (Posted: December 18, 2018)

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not good

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H. Jack West, MD (Posted: December 14, 2018)

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Though the authors and proponents from BMS highlight that the handful of patients who responded to nivo had a longer response rate than was seen with chemo, that's damning with faint praise for a therapy that will cost what nivo does. The vast majority of patients getting nivo for relapsed SCLC don't benefit.

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H. Jack West, MD (Posted: December 14, 2018)

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These data on MYSTIC stave off the executioner for durva or durva/treme in first line treatment of stage IV NSCLC, but I don't think they are favorable enough to call them highly encouraging. The reality today is that the true comparator is no longer doublet chemo alone but chemo with pembrolizumab, with decidedly better outcomes than chemo alone. In this setting, it's hard to conclude that durvalumab measures up even as a lateral move.

And while the TMB gambit provides a post-hoc escape hatch for a growing number of trials that fail on their original prospective design, these results for high TMB patients need not only to be replicated in a prospectively designed trial but need to prove superior to a general approach of chemo/pembro for the PD-L1 0-49% expression population, or pembro monotherapy perhaps for the high PD-L1 subgroup, to reach a tipping point of clear clinical relevance.

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Thomas Marsland, MD (Posted: December 14, 2018)

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Sorry to all my Pharma buddies but it is rare when I get excited when a detail rep come to visit. Today was the exception. The Bayer rep visited today (terrible lunch...) and presented the information on their (and Loxo) new NTRK inhibitor. I had seen the preliminary data at several of the national meetings and indeed they are impressive. It is exciting to see a new targeted drug approved on biology rather than tumor type. Hopefully this is something we will be seeing more of. The other exciting information was the drug support. As the article alludes to, it IS expensive but the program put together by Bayer and Loxo is very innovative and perhaps a model for others. They generously support programs but the best "value" proposition is the approach that the company will pay back if the patient doesn't respond. Wonder if DT is watching?

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Tomasz M. Beer, MD, FACP (Posted: December 13, 2018)

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This is a long term outcome report of an older study. It confirms the previous findings of a benefit of surgery for intermediate risk localized prostate cancer. it does not address the modern practice of active surveillance in low risk patients.

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Tomasz M. Beer, MD, FACP (Posted: December 12, 2018)

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Performance equal to nomograms is certainly encouraging, but what is needed is performance that is better than nomograms. Nomograms are essentially a no cost tool that uses readily available information to calculate probabilities of cancer outcomes. To be successful, imaging needs to improve on the performance of nomograms.

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Tomasz M. Beer, MD, FACP (Posted: December 12, 2018)

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MRI imaging prior to prostate biopsy is emerging as a strategy to reduce unproductive biopsies and increase the diagnosis of clinically significant cancers. NICE approval is an important acknowledgment of the value of this approach.

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Howard S. Hochster, MD (Posted: December 08, 2018)

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Once again, despite our hopes, and the imagination of the public, that a magic-bullet immunotherapy will work globally, we see the limitations of the IO approach. We justify possible activity on the basis of smoking-induced cancers or viral-induced, yet these cancers (like many solid tumors) are not melanoma. The era of continuing to throw anti-PD(L)1 and anti-CTLA4 agents against the wall and seeing what sticks needs to end. Let’s be smarter and try to select the appropriate patients using predictive markers!

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H. Jack West, MD (Posted: December 07, 2018)

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While it's nice to have a new approval, this is also a setting in which the IMpower150 regimen offers nothing beyond what we already have with the KEYNOTE-189 trial regimen of platinum/pemetrexed/pembrolizumab, except alopecia and neuropathy risk. The only real setting in which there is an unmet need now is for those patients with an EGFR mutation or ALK rearrangement who have received and progressed on a prior tyrosine kinase inhibitor -- these patients have been excluded from nearly all of the trials for chemotherapy +/- immunotherapy, but the carbo/paclitaxel/bev/atezo arm was associated with a PFS and OS benefit in EGFR mutation-positive patients at least as strong with addition of atezo to carbo/pac/bev as was seen in the broader population (not as clear that this can be said for ALK-positive patients). Unfortunately, the FDA approval specifically excludes patients with an EGFR mutation or ALK rearrangement, so I anticipate that this approval will (and should) have minimal impact on practice patterns, and we are left with no clear direction on how to approach patients with acquired resistance and EGFR mutation-positive NSCLC.

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Debu Tripathy, MD (Posted: December 05, 2018)

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Very interesting

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H. Jack West, MD (Posted: December 05, 2018)

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This will be an important development for thoracic oncology. The results of the IMpower133 trial, which demonstrated a significant survival benefit with the addition of atezolizumab to standard carbo/etoposide chemo as first line treatment for extensive stage small cell lung cancer (SCLC), were not astonishingly better than chemo, but they are enough that they should change the standard of care. Significant improvements in overall survival, even if not overwhelming, are infrequent enough in oncology in general and SCLC specifically, that we should be eager to adopt them when available. Having this regimen approved will make it far easier to pursue this combination broadly as a new standard of care.

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William Harwin MD (Posted: December 05, 2018)

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Like the data

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H. Jack West, MD (Posted: November 27, 2018)

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This is a big miss. Though even a positive result would need to be weighed for significance relative to the positive results for chemo/atezolizumab in the first line IMpower133 trial, the fact that this trial failed to improve survival compared to placebo in the maintenance setting is a great disappointment, especially on top of the recently reported (though only as a press release thus far) negative result on the CheckMate-331 trial of nivolumab alone vs. 2nd line chemo for relapsed SCLC. This result leads me to be far less inclined to consider either nivo or nivo/ipi as a very compelling option in relapsed SCLC, despite the FDA approval of nivo in this setting (actually 3rd line) earlier this year, or based on the Checkmate-032 phase II trial, which seems in retrospect to be yet another reminder of the power of selection bias. Should the emerging results also cloud our view on the utility of nivolumab +/- ipilimumab in NSCLC? Not enough to counter strong data, but we don't have particularly strong data in first line NSCLC at this time.

These negative results on CheckMate-451 also do not challenge the current concept of integrating immunotherapy into first line treatment for SCLC rather than deferring it as maintenance or 2nd line treatment. Though some are disappointed by the only relatively modestly positive results of IMpower133 with carbo/etoposide +/- atezolizumab, the significant improvement in OS should be sufficient to consider this approach the current standard of care for eligible patients. And the recent results with nivo +/- ipi in SCLC only underscore that significant gains in survival for patients with SCLC are quite hard to come by.

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Howard Sandler, MD, MS, FASTRO (Posted: November 19, 2018)

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It's very challenging to run clinical trials when patients are randomized to very different treatment, such as radiation vs. surgery. LDR brachytherapy has strong data supporting its use but there are limited randomized comparisons. It has been shown to be a relatively low cost monotherapy for prostate cancer but has limited use in the US due to a learning curve and limited practitioner base with expertise. The ASCENDE RT trial suggested a benefit to LDR brachytherapy as a boost when compared to EBRT alone but this finding is somewhat controversial since the study has so far only showed a PSA benefit but not a MFS or OS benefit.

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T Cao (Posted: November 16, 2018)

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It seems too early to approve this drug.

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H. Jack West, MD (Posted: November 16, 2018)

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I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

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H. Jack West, MD (Posted: November 16, 2018)

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I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

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H. Jack West, MD (Posted: November 16, 2018)

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I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

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Thomas Marsland, MD (Posted: November 13, 2018)

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OK so I went into this with an negative attitude but actually to give the devil his due they actually did a good job with this report and program. (I might just point out that their CMO is Roy Beveridge a Med onc... and had I known that before I might have not been quite as much surprised Roy is one sharp fellow...) The program really emphasizes all the components we expect in a good medical home. There multiple studies that show that patient focus medical home programs (including in oncology) can produce savings and good care. Two comments: One of the individuals quoted in the Forbes article mentioned that it isn't about right place, right treatment, right time. But a lot of the saving resulted from reduced hospital admissions and ER visits so clearly place makes a difference. In oncology care clearly right drug and right time have to be a key component to any program. The other point I wanted to emphasize is that under the full value program the practice was responsible for 100% of part B services. Clearly again something like that would not work in the medical oncology setting. All in all though I was impressed with the organization and outcome from the Humana program

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Ted Okon (Posted: November 08, 2018)

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This is yet another mandatory experiment on cancer patient care that is terrible medicine and unconstitutional by using the Medicare Innovation Center to bypass the Congress and existing law. The regulators are now running medicine, and that is both scary and dangerous!

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H. Jack West, MD (Posted: November 06, 2018)

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Lorlatinib has significant activity for ALK+ and ROS+ patients who have even been treated with and progressed on prior TKIs. In fact, lorlatinib is uniquely effective for patients with more refractory ALK+ NSCLC, including good activity in the CNS. It has some toxicity issues ranging from elevated lipids to weight gain to confusion in some patients, but it is an agent we eagerly welcome for the patients who need it.

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H. Jack West, MD (Posted: November 06, 2018)

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Big loss for ACS. Dr. Brawley has been a very respected voice, and his discomfort with ACS decision on fund-raising partnerships will convey a strong message. The stature of the ACS drops with this development.

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Tomasz M. Beer, MD, FACP (Posted: November 05, 2018)

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This study provides an important aggregate assessment of how men weigh survival and adverse effects when diagnosed with prostate cancer. But there is considerable variation between individuals in this regard. We must consider individual values and perspectives in weighing best treatment options.

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H. Jack West, MD (Posted: October 31, 2018)

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A very strong approval that was clearly needed. This regimen became the de facto standard of care after the presentation of the data at ASCO 2018 and represent a clinically as well as statistically significant benefit for patients with advanced squamous NSCLC regardless of tumor PD-L1 expression. This regimen is the consensus recommendation as the optimal regimen today for patients with advanced squamous NSCLC and negative or low PD-L1, and either this or pembrolizumab monotherapy are the strongest choices for the subgroup of patients with squamous NSCLC and high tumor PD-L1 expression.

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Tomasz M. Beer, MD, FACP (Posted: October 26, 2018)

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Cancer hospital ads deserve at least the same scrutiny as other advertising, where deceptive marketing is not OK. Cancer patients are at vulnerable population and need accurate information that can serve as a basis for sound decision making. Anecdotes of exceptional outcomes - particularly when they are exceedingly rare - are not the way to inform patients about where they should get their care.

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Stephen Lillard (Posted: October 25, 2018)

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It’s becoming overwhelming the ad on with the immunotherapy is in biologicals. Need to go forward rapidly and reduced cost.

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H. Jack West, MD (Posted: October 22, 2018)

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Results of IMpower130 are certainly favorable and positive for the carbo/nab-paclitaxel/atezolizumab combination, but I think they are not going to displace carbo/pemetrexed/pembrolizumab as a regimen of choice in this setting based on the KEYNOTE-189 trial. Carbo/pemetrexed is a more commonly used and favored chemotherapy backbone for this population, and the results with IMpower130 cannot be considered superior to those of KEYNOTE-189.

It is notable that the patients with EGFR mutation or ALK+ NSCLC did not appear to benefit from the chemotherapy/immunotherapy combination, supporting the possibility that the benefit seen in this subset of patients in arm B of the IMpower150 trial (receiving carbo/paclitaxel/bevacizumab/atezolizumab) over the control arm of carbo/pac/bev alone may be a function of the inclusion of bevacizumab. We await further data to clarify this hypothesis.

NOTE: I am an author of the IMpower130 abstract/presentation.

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Winston Wong, PharmD (Posted: October 15, 2018)

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This piece is a great example of a pathway program in process. Clinical pathways are not meant to be static. Their goal is to decrease variability and improve quality, however through the learning process, must be updated based upon experience and new learning. Hence every good pathway program must be reviewed and update periodically.

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Winston Wong, PharmD (Posted: October 15, 2018)

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From a payer perspective, I do not think the clinical utility of the liquid biopsy has been show to warrant wide spread coverage. While I am a proponent of the liquid biopsy, I do not think it has gain "prime time" status. It has shown utility in only a few solid tumors, those of which are know to be active cell shedders. It will be interesting to see if payers will pick up coverage of the test.

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Winston Wong, PharmD (Posted: October 15, 2018)

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I have to wonder who the 2 negative votes are, and why did they oppose the bill. I also wonder how deep this regulation will go. If States have already passed similar bills, and the practice is still prevalent, there must be a loophole. Is that Loop hole in the contracting between the pharmacies and the network administrators, or by pharmacy corporate headquarters due to volume purchase agreements? I think there has to be more here than just passing a regulation to open up the lower price gates.

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Winston Wong, PharmD (Posted: October 15, 2018)

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I believe the difficulty here is not so much that a lower dose of drug when taken with a low-fat meal can produce a similar clinical effect, but rather, we are encouraging one to take their medications with food. The lower dose almost becomes a second issue. How many times are we telling patients to take their medication on an empty stomach e.g. antibiotics, biphosphonates? With that aside, in the patients who cannot afford their medication, this is an option. Education on a low-fat meal can serve 2 purposes: 1) offers an affordable option for abiraterone, and 2) promotes a more healthy diet.

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H. Jack West, MD (Posted: October 12, 2018)

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Disappointing result, especially since treatment with either topotecan or amrubicin in relapsed SCLC represents a very low bar for any competing idea. This represents an area where the standard of care is particularly unimpressive, so for nivolumab to have failed to beat chemotherapy here represents a major disappointment. With the positive OS data seen with IMpower133 that added atezolizumab to standard first line chemotherapy in NSCLC, we are likely to see immunotherapy move overwhelmingly into the first line setting, but here nivolumab suffers in comparison by failing to beat even a weak competitor.

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H. Jack West, MD (Posted: October 11, 2018)

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Notably, these results that are coming from academic centers may stem from them having more expertise, more access to newer agents and clinical trials, or some combination of these issues, but selection bias due to differences in the patient populations is always an issue with retrospective database analyses. The patients treated at academic centers have a better performance status and socioeconomic support, including people, funds, and other resources that also contribute to better outcomes. This isn't to say that selection bias explains the difference, but there are many contributing factors, and there is no question that the patients who receive care at academic centers are not the same population as those who don't, and these differences skew toward better results in these patients.

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Tomasz M. Beer, MD, FACP (Posted: October 08, 2018)

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The results of OSPREY 2301 will need to be confirmed, but look quite promising and address one of the important needs in the field of prostate cancer. Improved imaging is essential to improve treatment decisions in early stage prostate cancer, and this approach may finally move us forward in this difficult area where little has changed in decades.

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Tomasz M. Beer, MD, FACP (Posted: September 28, 2018)

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Optimal local therapy for high risk prostate cancer is not known. While this study suggest that surgery + radiation may yield improved outcomes over radiation (+hormonal therapy), population based analyses cannot provide high quality practice defining evidence. Treatment decisions were not made at random and likely incorporated a myriad of patient and tumor factors that patients and physicians consider when choosing therapy. The apparent difference is just as likely to reflect systematic patient selection bias as it is differences in the efficacy between two treatment approaches.

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H. Jack West, MD (Posted: September 28, 2018)

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Dacomitinib clearly has activity for EGFR mutation-positive NSCLC, but I suspect this approval will have very little impact in the already crowded first line landscape. Dacomitinib is clearly superior to gefitinib in both PFS and even OS based on the ARCHER-1050 trial. Osimertinib, however, is now the emerging first line standard of care and is likely to remain so for several reasons:
1) Dacomitinib toxicity is quite challenging, with 66.5% of patients assigned to daco on ARCHER-1050 requiring dose reduction and very high rates of misery-inducing side effects. Osimertinib is generally very well tolerated.
2) ARCHER-1050 excluded patients with known brain metastases, while osimertinib has consistently impressive CNS activity, with a CNS RR of 91% in the FLAURA trial among patients who started with baseline measurable brain mets. CNS control for existing or potential future brain mets is an increasingly significant factor when one option is clearly superior in this regard.
3) Though Pfizer may argue that starting with daco preserves the potential for osimertinib later, only a very small minority of the patients on ARCHER-1050 actually got osimertinib, so we should not presume this will be trivially easy to accomplish for the majority of patients. PFS for first line osi vs. daco is more than 3 months longer with osi.
4) At least among lung cancer experts, but I believe among oncologists in general, Pfizer has had very little presence, while AZ has been heavily marketing and running educational programs. This is a minor factor next to the data, but it is just one more obstacle for Pfizer to overcome. It has shown no interest in developing relationships with oncologists or in cultivating a sense of corporate citizenship by sponsoring educational activities or supporting other valuable programs in the oncology community over many years.

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Thomas Marsland, MD (Posted: September 26, 2018)

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Thanks Lucio - good job. It is hard to believe that there is not a concerted effort to destroy community practice. The sequester cuts represents just another nail in the coffin. If the new proposals in the PFS go forward as presented, community oncology will again face significant revenue reductions, forcing more closings and transitions to hospital based programs ( which is probably the intent). This will ultimately result in less access to care and a higher cost.

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Thomas Marsland, MD (Posted: September 25, 2018)

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How drugs are priced remains a huge black box. There is no question that costs are rising and making it more and more difficult for patients to obtain needed treatments. Although not a big fan of Dr E I do agree that "what the market will bear" plays a large part in that. Clearly research costs are a major component. It is unbelievable how expensive it is to bring a new drug to market. Certainly we need to develop less expensive research designs in the drug approval process. One point not made is the the US pricing is responsible for a large part of drug development costs, with pricing in other markets outside the US covering significantly less of those costs. How much of the cost of a drug comes from marketing is also a complete unknown? How much does direct to consumer marketing really cost and what does it really add for our patients? There are solutions out there. ASCO and others have developed position papers worth reading with some good suggestions on how to help control costs. Hopefully someone is listening.

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Dean Gesme, MD (Posted: September 25, 2018)

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In contrast, chemotherapy initiation in the outpatient setting is being continually delayed due to prior authorization of testing and treatment along with formulary restrictions and now step therapy requirements.

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William McGivney, PhD (Posted: September 25, 2018)

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C-VICER: CVS Embraces ICER
We have reached a very sad time when a major corporation (CVS Health) embraces and is willing to integrate the skewed and obtuse work products of the pedantic ICER into treatment coverage decisions about patients diagnosed with cancer. It is always interesting to see companies willing to limit access while wanting at the same time to have a third party to point the finger at.
Instead of proceeding, I will quote an important article from OBR Green published on October 19, 2016. After reviewing the ICER analysis on Non-Small Cell Lung Cancer, five eminent lung cancer docs stated:
“ICER appears to represent a perspective that is less oriented towards patient benefit than towards motivations that would limit patient access to therapeutic options. ICER’s clinico-economic methods include approaches and metrics that, due to their singular focus on population health, would likely fail patients on an individual clinical needs basis. ICER’s philosophy appears to be similar to that of NICE in the UK, whose limitations placed on drug access have been correlated with lower cancer survival rates in the UK compared to the rest of Western Europe.”
“For us as practicing oncologists and lung cancer researchers, this report has raised serious concerns regarding ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive and unbiased.”
Enough said!

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Tomasz M. Beer, MD, FACP (Posted: September 18, 2018)

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While there is room for a range of views, this is a situation where there must be room for clinical skill and judgment. Skilled clinical assessment and monitoring of cancer status, carried out by an expert oncologist would very likely capture the benefits of abiraterone even if dosed in an alternative fashion. Oncologists do not practice strictly "on label" in any disease. They integrate best available evidence and apply it to each individual patient's unique circumstance. There is no question that the evidence is strongest for conventional food-free dosing, but there is now sufficient evidence to have a through discussion with individual patients about the option of alternative dosing when the economic consequences of not doing so may deny the patient access to the drug altogether.

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Thomas Marsland, MD (Posted: September 18, 2018)

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Delays in accessing the appropriate therapy for patients is a growing problem. Step therapy is just one of another barrier that the payer community is implementing to reduce access to needed drugs. This is especially true when one looks at the entire PBM companies that are rapidly expanding. These programs limit access and delay care. PBMs are a huge black box where transparency is nowhere to be found. Payers use these companies which more and more are part of the payer community itself. How these entities determine which drugs are preferred as part of fail first and step therapies is completely unclear. These organizations are compensated by payers and negotiate discounts and rebates with industry reaping large profits that can drive drug preferences and determine how step therapies are determined. There often is no savings for patients and care is delayed. Adding Part B drugs to this failed system will lead to further care access problems for patients.

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Winston Wong, PharmD (Posted: September 18, 2018)

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Spread pricing has been a revenue generating tool for many years. Even I am surprised by the extent of the spread noted in the piece. I am not sure how spread pricing adds to the pricing stability for a payer, but it definitely contributed to the higher costs.

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William McGivney, PhD (Posted: September 17, 2018)

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“Your First Chance is Your Best Chance”
The title used to be the tagline for some of the advertisements of Memorial Sloan Kettering. CMS has either not heard or dismisses such considerations given the recent announcement to allow Medicare Advantage Plans to enact Step Therapy programs for Part B agents. As quoted in the Forbes article, “Step therapy is controversial. It is the most onerous condition of reimbursement in that it defers certain treatments until a later point in time”. It all just seems to get worse and worse for physician autonomy and patient well-being.
Does CMS not see the distinct possibility in this program of actually increasing the variability of Medicare beneficiaries’ access to therapies given that it is quite likely that MA Plans will have Step Therapy Programs that will differ, one from the other? Will MA Plans deftly handle Part B to Part D stepping processes with a lack of understanding of patient likelihood of non-adherence under Part D. What will implementation of such a Program do to personalized medicine with biomarker-directed care? How long will such step therapy policies delay drugs/biologics for patients in need?
The list of concerns goes on and on!
An NCCN Panel Chair recently told me the story of that person’s latest “peer to peer” discussion with a payer. When the Payer’s cardiology nurse finished misquoting the relevant NCCN Guideline, the Panel Chair told her that she/he was actually the Chair for that Panel and cited the page and line that justified the use of the drug in question.
How will a patient’s first chance be guided with this “most onerous condition of reimbursement” being applied by well-meaning cardiology nurses?

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Tomasz M. Beer, MD, FACP (Posted: September 13, 2018)

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Low sensitivity seen in this trial is a bit of a disappointment. We will need to learn more about this result as the data are fully analyzed, presented, and published. Low sensitivity means that a negative result is not as reassuring for patients as one would have hoped.

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H. Jack West, MD (Posted: September 12, 2018)

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The results of KEYNOTE-042 were positive for an OS benefit of pembro over platinum doublet chemo as first line treatment for patients with tumor PD-L1 expression 1% or higher (about 2/3 of patients), a broadening compared to the established place for pembro as first line treatment for patients with tumor PD-L1 expression 50% or higher (about 30% of patients). However, reviewing how different subgroups did actually demonstrates that the patients in whom pembro was superior was limited to the 50% and higher group that we already treat with first line pembro. The entire trial, including patients with a lower PD-L1 threshold of 20% or 1%, was positive only because the good results were driven by the high PD-L1 group and were favorable enough to still be positive for the trial even after being DILUTED by the lack of benefit for pembro in the lower PD-L1 patient subgroup.

One could argue that the results with pembro in the 1-49% group are comparable for OS as that seen for patients who started with chemo, and pembro is better tolerated, so why not favor it? The answer is because the trial prohibited crossover to pembro upon progression, and only 20% of the patients assigned to first line chemo ever got an immune checkpoint inhibitor off protocol subsequently. This represents an unfair comparison in which pembro only looks comparable to a chemo arm that was severely handicapped by being denied a treatment that is extremely well established as a standard of care as second line treatment with a consistently proven strong survival benefit. In the US, three checkpoint inhibitors are approved and widely used as second line treatment after initial chemotherapy, so the first line pembro arm only comes out looking as good as a first line chemo arm that received what we can only consider overall sub-standard care on the control arm. This isn't just a revisionist view based on current standards, but represents what was a standard of care in the US while this trial was being conducted.

I review the trial results and discuss these issues further in my video here:
http://bit.ly/BMIC38

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Tomasz M. Beer, MD, FACP (Posted: September 10, 2018)

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Intermediate endpoints can speed the delivery of impactful drugs to patients and in prostate cancer, where we now have multiple lines of therapy, it is important that we consider intermediate endpoints because overall survival can be impacted by subsequent therapies and take a long time to measure. But the progression-free survival advantage has to be clear and compelling in quality and magnitude to serve as a robust measure of patient benefit.

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Winston Wong, PharmD (Posted: September 08, 2018)

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While reality demonstrates that these practices do create issues with regards to access and financial toxicity, it is a bit one-sided in that if the PBM is doing their job, there are patient support benefits. The key issue here is that some pharmacies are more efficient and better at providing these services than others. Patient follow-up, compliance and adherence monitoring are among the benefits. No question that there are major disconnects, and fixes are needed. Unfortunately, they are a result of our disjointed health care system.

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Winston Wong, PharmD (Posted: September 08, 2018)

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While there may be some truth that there is a lack of confidence with biosimilar products, I believe that the confidence level is increasing, thus not the reason for the slow uptake in utilization. I believe that the true reason for the slow uptake is due to contracting and rebate levels increasing with the reference product so that there is little motivation for any stakeholder to switch to the biosimilar product. The power of the rebate is so woven into the selection process that unless the biosimilars start to represent more significant deeper discounts than they do today, uptake will continue to be slow.

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Tomasz M. Beer, MD, FACP (Posted: September 07, 2018)

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A thoughtful and careful approach to interpreting results of novel imaging scans is essential. But beyond that, how physicians use the new information also merits careful considerations. Metastases that are only detectable via a high sensitivity scan may not have the same prognostic implications as the presumably higher volume metastases that are detected with conventional imaging. Novel imaging strategies offer opportunity to improve care, but only if deployed with care, thought, and a fair amount of humility.

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Tomasz M. Beer, MD, FACP (Posted: September 06, 2018)

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The most prominent guidelines recommend shared decision making after a thorough discussion about the potential benefits and risks of PSA screening. These recommendations reaffirm this position. Routine screening would imply no particular dialogue and use of screening in all healthy adults, and there is near universal agreement that the available data do not support this. However, the available studies have significant limitations, among the control arms including some screening and importantly the absence of more modern approaches to management of prostate cancer which decouple diagnosis from treatment and include observation. Prostate cancer screening remains a vexing challenge and better tests are needed. For men who chose to be screened, thoughtful and careful consideration of what to do if a cancer is diagnosed is essential.

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Tomasz M. Beer, MD, FACP (Posted: September 05, 2018)

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"Hormone Therapy Can Make Prostate Cancer Worse" is a scary and attention grabbing title. Too bad. The research reported is yielding important understanding about mechanisms of resistance to hormonal therapy. But there is no need to scare people about hormonal therapy. This type of treatment remains the mainstay of managing prostate cancer and the treatment improves survival and outcomes even if ultimately resistance develops. Patients should not be scared away from treatment by this misleading headline.

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Ted Okon (Posted: August 29, 2018)

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Very important analysis conducted by Dr. Lucio Gordan and fellow researchers. Shows the adverse impact that the sequester cut has had on community oncology practices. It's staggering to realize how much these practices have lost. The sequester cut applied to Medicare Part B drugs is illegal, which is why COA is suing the federal government.

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Ted Okon (Posted: August 29, 2018)

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Very good article in the New York Times that explains how the 340B drug discount program has mutated from its intended purpose. The program has become a financial windfall for many hospitals. I simply can't understand why hospitals using the program correctly to help those in need let other hospitals drag down this critical safety net program.

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Dean Gesme, MD (Posted: August 27, 2018)

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We always hear about outrageous costs of health care. Why are we not also outraged at our legal system's outrageous excesses?

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Tomasz M. Beer, MD, FACP (Posted: August 23, 2018)

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Presumably, the amendments to these trials reflect the sponsors's expectation of a larger effect size than originally planned enabling an earlier analysis. One would also note that the landscape for androgen receptor targeting in prostate cancer is increasingly competitive with multiple products on the market and in clinical trials.

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H. Jack West, MD (Posted: August 21, 2018)

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This was an appropriate and not surprising full approval in the wake of the highly positive KEYNOTE-189 trial. Doesn't change much, as we've already had carbo/pem/pembro approved since May, 2017 based on the much smaller & less conclusive KEYNOTE-021g trial, and we've known impressive results of KEYNOTE-189 since mid-April's presentation of the data at AACR and simultaneous publication in NEJM. This has led to broad adoption of this regimen as a clear standard for non-squamous NSCLC.

The inclusion of any platinum, opening up cisplatin as well as the previously specified carboplatin, with pemetrexed and pembrolizumab isn't a major added feature, since the vast majority of US oncologists favor carboplatin in this setting, particularly with KEYNOTE-189 showing a higher incidence of renal toxicity with the chemo/pembro combination than we'd expected.

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Tomasz M. Beer, MD, FACP (Posted: August 16, 2018)

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These Challenge awards are an exceptional selection of projects in prostate cancer research. They share two key attributes: they tackle really important problems in prostate cancer, and they do so with a high degree of innovation.

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Winston Wong, PharmD (Posted: August 13, 2018)

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Specific to cancer care, it will be interesting to see how the discussion plays out with the allowance of so-called "Step-Therapy" and the requirement to cover anything listed in the NCCN guidelines. Will the two be allowed together?

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Winston Wong, PharmD (Posted: August 13, 2018)

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Unfortunately, stories and reports like these are all too common. I have to wonder as I read this. Was the misfortune due to the mis-interpretation of Neulasta Onpro vs. Neupogen? The majority of Neulata is under the medical benefit. I can see the Neupogen being forced through specialty and self-administered. Nevertheless, the timing for responses was poor.

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Winston Wong, PharmD (Posted: August 13, 2018)

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Interesting article. Cites insurers and employers as the revenue hounds. Not entirely true. Yes, these are the true payers, but I would contend that employers don't see a large portion of the rebates. The article states PBM's and Insurers are largely opposed to the elimination of rebate. Why would you be opposed if it did not matter to you. The article implies the PBM's only keep a small percentage and pass on the rest. HUH? This is why we need a more transparent system in place. We can still have the rebates to promote competition, but we also need clear and clean tracking of the dollar flow.

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H. Jack West, MD (Posted: August 08, 2018)

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This doesn't mean that NGS testing is useless, but we must be careful not to oversell it as a miracle. It actually helps relatively few patients beyond standard, limited testing right now, with no improvement in survival in population-based evaluation, at least corrected for other variables.

However, it is a more tissue-efficient way to test for 4-5 or more markers, as we should now be doing for non-squamous NSCLC, and the value of NGS is likely to be a moving target only rising over time. My conclusion is that we should stop over-promising what precision oncology will deliver, but we also shouldn't throw out the baby with the bathwater.

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Tomasz M. Beer, MD, FACP (Posted: August 06, 2018)

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This important discovery is beginning to uncover the mystery of one of the most common translocations in human cancer. The TMPRSS-ERG translocation and related similar translocations are found in about half of all prostate cancer, strongly suggesting that they are important to prostate cancer. But what they do and how to target them has been elusive. The observation that this translocation activates a set of other genes that in turn likely drive prostate cancer may explain not only what it does but suggests that once these carcinogenic effects are established, targeting TMPRSS-ERG itself may not be effective. The downstream effects of the gene are where the action is likely to be in cancer treatment. At the same time, perhaps TMPRSS-ERG itself can be targeted for prevention.

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Tomasz M. Beer, MD, FACP (Posted: July 31, 2018)

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MAO-A was previously shown to be elevated in higher grade prostate cancer and our group previously reported that chemotherapy treatment resulted in elevated MAO-A levels and that MAO-A in turn modulated chemotherapy resistance (PLoS One 2014). The exciting feature is that there are drugs that are available off the shelf that can inhibit MAO-A. The concept needs to be tested.

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Tomasz M. Beer, MD, FACP (Posted: July 27, 2018)

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While this restriction is a result of an unexpected deleterious outcome of a clinical trial of Xofigo in combination with abiraterone, it is worth considering the broader context. In the ALSYMPCA trial, which established Xofigo's role in prostate cancer care, Xofigo was studied in patients with heavily pre-treated, poor prognosis disease. The median survival in the control group was less than 12 months. Since approval, some have advocated for earlier use of the agent, but to date, no level I evidence in support of that has emerged. The EMA action has the effect of focusing European prescribers on patients that more closely resemble those who participated in the registration trial.

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Jeff Patton, M.D. (Posted: July 27, 2018)

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I found this article both fascinating and enlightening. I had not thought of "burnout" in terms of moral injury but it makes total sense. Regulators, bureaucracy and technology have gotten between patients and providers and it is literally sucking the life out of providers. We have to address these issues and a grand scale. Having practiced for 25 years I can say with confidence the experience of providers has deteriorated significantly.

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H. Jack West, MD (Posted: July 25, 2018)

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Nice to see, though not surprising. Brigatinib is a very good second generation ALK inhibitor, at least comparable to if not more efficacious than alectinib, which crushed crizotinib in the ALEX trial that was a head to head comparison of the two. The real question is whether brigatinib will look like a lateral move or possibly meaningfully better than alectinib when we're left to do our cross-trial comparison of ALTA-1 results to those from ALEX.

We'll look forward to seeing the actual results in one of the fall meetings -- not sure if that will be WCLC in Toronto or at ESMO in Munich.

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Tomasz M. Beer, MD, FACP (Posted: July 24, 2018)

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Decoupling treatment from diagnosis is a critical priority in prostate cancer. Low and very low risk patients are appropriate candidates for active surveillance. It is encouraging to see molecular tests emerge that may help identify patients who are at low risk from their disease.

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H. Jack West, MD (Posted: July 20, 2018)

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Very unfortunate and very believable. Some proponents of complementary medicine note that "complementary" is intended to mean that these treatments are given alongside conventional therapies, rather than instead of them, as "alternative" medicines will be. Nevertheless, this work strongly indicts treatment philosophies that are not grounded in clinical evidence and shows that they clearly subtract more than they add for patients with treatable cancers, who are all too often presume that the "medicine" in complementary medicine is actually effective. That is the greater misnomer here, and it leads to net harm to the people gullible enough to pursue it.

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H. Jack West, MD (Posted: July 19, 2018)

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On balance, these data for advanced non-squamous NSCLC compare unfavorably to those of the very similarly designed KEYNOTE-189, another platinum/pemetrexed +/- immunotherapy trial (with placebo on control arm), with IMpower132 showing a significant PFS benefit but failing to demonstrate an OS benefit. This pattern strongly echoes what we saw with IMpower131 vs. KEYNOTE-407 in the setting of advanced squamous NSCLC.

Taken together, pembrolizumab and Merck clearly have the upper hand here, and we would interpret that pembrolizumab is a more efficacious agent. However, I hope to delve more into the practical issue of the actual crossover rates of these two trials to clarify whether a higher crossover on the IMpower trials may contribute to the absence of a significant OS difference. In KEYNOTE-407 and KEYNOTE-189, for instance, crossover was permitted but was still only in the range of 43-50% of eligible patients. If only half of the patients on the chemo only arms of these KEYNOTE trials ever received effective immunotherapy at any point, but a clear majority of the patients on the chemo arms of the IMpower trials received immunotherapy on crossover, it could explain how pembro appears to be conferring a survival benefit not seen with atezolizumab. If no real difference in the crossover rates, then the nod simply needs to go to pembrolizumab for greater efficacy. Regardless, I fear that even if it turns out that crossover rates explain the OS difference more than true drug efficacy, the world may end up failing to care about such details, and rather just punishing Roche for running trials in a way that is better for the participating patients but that undermines their ability to report an OS benefit.

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Winston Wong, PharmD (Posted: July 17, 2018)

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One has to wonder if the move to reimburse new drugs at WAC+3% will be an indicator of the all drugs being reimbursed at ASP +3%. What is unclear is what then is the resultant reimbursement, if there is a change, due to the sequestration removal?

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Winston Wong, PharmD (Posted: July 17, 2018)

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I really have to wonder just how effective transparency laws are, given that there have been transparency laws pass years ago governing the PBM industry, and nothing seemed to change. The easy example is the Pharmacy GAG requirements.

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Dean Gesme, MD (Posted: July 13, 2018)

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CMS action on clinical documentation requirements to reduce redundant and superfluous charting is greatly welcomed by those of us who may now have more time to care for patients as opposed to “buffing the chart” to meet coding requirements.

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Thomas Marsland, MD (Posted: July 11, 2018)

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I absolutely agree with the COA comments. The intent of the 340B program is laudable. We clearly need to make every attempt to improve access to high quality care for those who need economic assistance. Unfortunately there have been multiple abuses of the system that have effected those goals. These abuses have resulted in many providers enriching themselves but using the program to provide drugs for patients with adequate resources. These activities have resulted in the migration of physicians out of private practices to hospital centered programs. This migrations has definitely altered patterns of care which clearly needs to be studied. As you know your ASCO delegation recently was successful in getting a resolution passed at the annual AMA meeting getting AMA support for greater oversight of the 340B program.

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Winston Wong, PharmD (Posted: July 11, 2018)

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The disagreement on how to define "value" goes far beyond that of the Oncologist. I think the most significant statement made was at the very end where the author stated that no one can agreement on what the definition of value is. hence we are all just chasing a concept that is yet to be defined.

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Winston Wong, PharmD (Posted: July 09, 2018)

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The math is simple. Under the proposed agreement, we pay for all doses of the CAR-T, and get refunded the cost when the patient does not fully respond. At worse case, you pay for everyone's dose. On the other side, we pay for everyone's dose. If it does not work, no refund, and we continue treatment with another agent. Who's the winner here? I'm not even sure.

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Winston Wong, PharmD (Posted: July 09, 2018)

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I would challenge anyone to attempt to tell me at the end of the day just what the exact cost of the medication is. Its really becoming a racket with rising prices, only to be countered by rebates and copay cards, and bumped back up by accumulator programs. At the end, the patient gets stuck. Why not just try the more effective drug first?

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Richard Reililng (Posted: July 07, 2018)

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Can't imagine that anyone would find this a surprise. Patients needing pain relief will suffer because of the weak personalities that take narcotics unnecessarily and for less than appropriate reasons. We have tried to fight this in many arenas including the AMA, but the 'bleeding hearts' win the field all the time. Let's hope that our cancer patients get what they need, when they need it, and in the quantity that makes their lives more tolerable in view of their disease processes.

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Tomasz M. Beer, MD (Posted: June 25, 2018)

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Several interesting things about this study. Combination checkpoint inhibition has proven useful in other cancers, but is new to prostate cancer. Patient enrollment using the AR-V7 assays to select highest risk patients is novel and represents the first such study. Finally, the links between DNA repair defects and response extends prior findings and provides new evidence that this relationship may extend beyond microsatellite instability. This regimen is not ready for clinical use, but is of interest for further study.

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Thomas Marsland, MD (Posted: June 22, 2018)

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Gee, I recognize a few of those names.....As you probably can guess from my responses, I tend to binge read my OBR reports....(binge my House of Card series too....). Anyway, some comments on the AMA meeting. AMA as always is a lot of fun. The house of delegates is so diverse with old white dudes like myself mixed with energetic ladies (go Barb...rock star), individuals of all political sides, young docs starting their journey, folks of all racial backgrounds, and people of all sexual identities. We get together and argue the profound and esoteric. The debates are always respectful and we all leave as friends. This year, gun control, opioid issues, physician assistance in dying were hotly debated on the floor. In addition there was the usual alphabet soup of resolutions on MOC, MACRA, and payment resolutions. Our ASCO delegation (EB, RP, SL, KN, MF, ES and yours truly) proposed 5 resolutions. Two were reaffirmed (cancer survivorship care plan, alcohol and cancer). The three in the article were accepted with some amendments. All in all, we were happy with the results. As you know 340B needs a lot of work, and PBMs need some over site too. The electronic transfer of prescribed opioids will make life better for patients and docs. With all this busy agenda we even had time to hit Buddy Guy's House of Blues....(thanks Ray...). So if anyone ever asks what AMA does, the answer is everything. They are a strong voice advocating for our patients and us.....

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Tomasz M. Beer, MD, FACP (Posted: June 21, 2018)

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Increasing availability of molecular tests to risk stratify patients is encouraging. With over-treatment of low risk disease a core challenge in prostate cancer, the use of such tests to increase the proportion of men opting for observation would mean progress. For this to happen, urologists, oncologists, and patients will need to be comfortable trusting the results and acting on them. The tests should only be used when the clinician is willing to act on the result.

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Tomasz M. Beer, MD, FACP (Posted: June 20, 2018)

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With about half of the patients who initially choose active surveillance progressing to definitive therapy, there is an opportunity for low toxicity interventions to reduce the need for more aggressive therapies. While sipuleucel-T was successfully developed for prostate cancer, a number of other vaccine based immunotherapy strategies have not succeeded. This is the first one being deployed in the active surveillance setting.

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Tomasz M. Beer, MD, FACP (Posted: June 20, 2018)

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The choice of Gawande suggest that this venture will set ambitious goals and evaluate health care holistically. Gawande will not be afraid to challenge the status quo and will bring creative and constructive approaches to the challenge of health care cost and quality.

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H. Jack West, MD (Posted: June 07, 2018)

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This work is certainly provocative, but there are several issues that should lead us to be cautious about concluding that this should change practice. Not only was this not a large trial, but the patients in the control arm who received erlotinib alone demonstrated a response rate that was remarkably low for EGFR mutation-positive cancer, about half of what is more commonly seen. There have also been other trials that have been far less impressive but not publicized. Overall, it merits further study but needs validation before being considered a combination approach to pursue outside of an investigational strategy.

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Thomas Marsland, MD (Posted: June 06, 2018)

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So back to the grind stone... in clinic today after and exciting ASCO AM. But as this article suggest there is no free lunch. All of these great exciting life prolonging therapies come at a great cost. The theme of the meeting was personalized care and certainly this offers opportunities to help control the costs but even there with the new (FDA approved) next generation testing we still are often left with many expensive choices for a given patient with really no knowledge of success rates. But there is I think hope on the horizon. I had the chance to meet with a group that is developing highly sophisticated computer programs that can actually predict which of the many mutations noted by the ngs testing will really result in a therapy with a high success rate. (and the flip side avoid those that don't.) The data bases are quite sophisticated and developed from true clinical trial materials. When these types of programs become universally available we really will have the idea of "personalized" therapy come to fruition. Then hopefully these costly treatments will be given to those who truly will benefit.

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Ted Okon (Posted: May 31, 2018)

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It is very disappointing that this Administration would not undo the unconstitutional mistake of the previous Administration applying the sequester cut to Medicare Part B drug reimbursement. This legal action was the last resort of the COA Board.

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H. Jack West, MD (Posted: May 29, 2018)

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Important trial result, positive for both PFS & OS benefit, that confirms benefit of first line chemo-immunotherapy, here with atezolizumab added to carbo/nab-paclitaxel in patients with advanced non-squamous NSCLC, is not specific to a particular chemo backbone or immune checkpoint inhibitor. Instead, it's looking more and more like relatively comparable results will be seen in multiple trials, and we'll have a choice of chemo doublets paired with checkpoint inhibitors.

In that setting, people will gravitate to the chemo regimens they prefer in this setting, and in the US, I think carbo/pemetrexed will be favored for most patients with advanced non-squamous NSCLC. I think with KEYNOTE-021g regimen of carbo/pemetrexed/pembro already FDA approved and KEYNOTE-189 looking so impressive, this will be the default regimen. This means that any new chemo/immunotherapy combination will be reviewed in the context of whether it provides a meaningful incremental benefit over carbo/pem/pembro. I don't think carbo/nab-paclitaxel/atezolizumab can be said to be anything more than a lateral move at best.

The only real caveat I'd offer is the possibility that the story of steroid treatment with chemo/immunotherapy or immunotherapy alone may detract from the benefit of immunotherapy, which some retrospective work has indicated, though the 3 days of premedication with pemetrexed likely wouldn't register as enough to undermine the benefit of immunotherapy, and certainly the highly positive results of the KEYNOTE-189 trial argue against that.

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H. Jack West, MD (Posted: May 25, 2018)

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This finding of a significant OS result was as I would have expected -- with the profound and sustained PFS benefit going out to at least 18 months, as well as a significant benefit with consolidation durvalumab in time to new metastatic disease or death, it was nearly inconceivable that there wouldn't be a significant improvement in OS. What remains to be seen, however, is whether this will be a sustained OS benefit that actually raises the tail of the curve and leads to more patients alive and without disease at 3 and 4 and more years, or whether the year of durvalumab is just delaying the relapse that would otherwise occur in the same proportion of people. In other words, can immunotherapy eradicate the residual disease in people who would otherwise be destined to relapse and die of their cancer, leading to more cures, or is it merely suppressing the disease that will still lead to relapse, just now with enough of a time delay to lead to a transient improvement in survival.

We await not only the data leading to this press release, but also the more longitudinal results of this important trial.

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H. Jack West, MD (Posted: May 24, 2018)

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KEYNOTE-407 was already #2 on my top 5 abstracts in lung cancer for ASCO 2018, behind only the KEYNOTE-042 Plenary Session presentation, but this latest press release now makes it rival KN-042 in significance.

With the new results of a significant PFS and OS benefit on top of the already reported 23% higher objective response rate noted in the abstract, we should expect that this will lead to a timely approval of this combination of carbo/nab-paclitaxel/pembrolizumab for first line treatment of advanced squamous NSCLC, regardless of tumor PD-L1 expression level. The landscape is likely to mirror that for non-squamous NSCLC, where a chemo/immunotherapy combination (carbo/pemetrexed/pembro) is approved regardless of PD-L1 expression, while the leading alternative is pembro monotherapy for patients with high PD-L1 based on KEYNOTE-024, or soon even for those with PD-L1 1% or higher, based on KEYNOTE-042.

So in both squamous and non-squamous NSCLC, it's very likely the leading alternatives will be pembro monotherapy vs. chemo/pembro for those with tumors positive for PD-L1, and chemo/pembro for those whose tumors are PD-L1 negative. IMpower131 will also feature some positive results with carbo/nab-paclitaxel/ataezolizumab, but thus far we know only about a significant PFS benefit. Not only will it need to show a significant OS benefit to compete at all with KEYNOTE-407 results, it will be up against a pembro juggernaut, with multiple positive trials and an increasingly powerful narrative of benefit in many NSCLC trials.

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Thomas Marsland, MD (Posted: May 17, 2018)

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Being still relatively new to the west coast I can comment that the topic of medical marijuana has certainly come up more here than in Florida (although it did come up for discussion there also). I second the comment about the lack of control data. There really is a dearth of clinical studies to support widespread use. With that said there are great anecdotal stories to support benefit from its use. One other problem is the quality control from the production and distribution. How much of the active cannabinoid are present and in what proportions? I did have the opportunity to attend a pain conference last year and there was a presentation on medical marijuana. Indeed there are a number of cannabinoid receptors within the CNS and it certainly would be interesting to see good scientific research looking at efficacy correlated with markers and outcomes. Hopefully this will come one day but until then we will just have to continue to rely on the anecdotal information. It clearly works for some patients.

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H. Jack West, MD (Posted: May 17, 2018)

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It looks like we're going to have data from the IMpower150 trial released in small bits every few months, without any new electrifying developments. Here, the most notable finding is the hazard ratio for OS of 0.54 among patients with an EGFR mutation or ALK rearrangement who received carbo/paclitaxel/bevacizumab + atezolizumab, compared to carbo/pac/bev alone. Patients with liver mets also had the same HR for OS of 0.54 with chemo/bev/atezo.

The reality is that the real comparator for the IMpower150 four-drug regimen is carbo/pemetrexed/pembro (as per KEYNOTE-189), and I think for a broad population, the KEYNOTE-189 regimen is more compelling. However, for patients with an EGFR mutation especially, and to a lesser extent those with an ALK rearrangement, the carbo/pac/bev/atezo regimen deserves to be considered as a compelling option AFTER patients have progressed on initial targeted therapy. Importantly, these patients were to have already received an EGFR or ALK TKI, and the IMpower150 approach should not replace highly effective targeted therapy as first line treatment.

We should expect to see far more work on immunotherapy in patients with a driver mutation. One of the most significant effects of IMpower150 will be that it leads to a re-opening of this question, after the data we had in 2nd line NSCLC led most lung cancer specialists to conclude that checkpoint inhibitors don't have meaningful activity in these patients.

Finally, we need to clarify if the benefit requires bevacizumab, which can be answered by seeing how Arm A of IMpower150 (carbo/pac/atezo, no bev) does. That hasn't been reported yet but can help us understand the contribution of the bev component on Arm B.

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Dean Gesme, MD (Posted: May 16, 2018)

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How does this work? Higher prices in the non-US market are no assurance of lower prices in the US. Are we relying on the altruism that never has existed in capitalist economies??

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William McGivney, PhD (Posted: May 11, 2018)

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Coincidently, I was lecturing last week at the Home of Guideline study, Dartmouth (at the Tuck Business School). I talked about how studies in the 1980s by Drs Wennberg, Zubkoff, and others argued for the establishment of national guidelines. Why? The goal was to diminish the substantial variation of physician practice and recommendations for different reasons in regions across the country.
Thirty years later, we now have a (dare I say) bastardization of that principal as described in this article. Payers, health plans, MCOs, etc. require their own selected and favorite pathways that may differ across each patient frequently in terms of recommended treatments, including preferred treatments. Oncology practices must juggle multiple, disparate recommendations depending on the insurance that a patient may carry or that MCO picked by a payer to manage that patient.
The circumstance of the multiple guideline/pathways recommendations that oncology practices have to juggle belies the concept of a National Guideline that unifies and directs best patient care. Anybody ever hear of the letters NC?

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William McGivney, PhD (Posted: May 11, 2018)

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Payer cost-sharing requirements for patients are an anathema, abomination and disgrace all rolled into one. The current story reiterates, yet again, the issue of seriously ill patients delaying or forgoing needed treatment because of cost-sharing terms in their insurance plan. Cost-sharing is such a nice, euphemistic way to describe what is the abhorrence of this insurer patient-gouging strategy. Indeed, as I am wont to ask, is there still really health insurance that protects seriously ill patients from catastrophic events? If there is, it is “slip, slip sliding away” as commercial payer revenue keeps rising.
The solution is legislation that would eliminate on the private payer side and public payer side cost-sharing arrangements such as deductibles, co-insurance, and co-pays for those diagnosed with and battling serious life-threatening illnesses. A list of such illnesses should be delineated that deserve such protection to assure patient access to necessary therapies.
I developed the Terminal Illness program that Aetna instituted in 1992. To establish a solid patient-oriented and humane piece of legislation is a relatively easy “to do”. Then, we can see who truly stands in support of patients! We should move forward as we seek to serve and treat seriously ill patients in need!

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H. Jack West, MD (Posted: May 07, 2018)

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Though reportedly leading to a statistically significant improvement in overall survival in the IMpower150 trial (per a press release, data yet to be revealed), the carbo/paclitaxel/bevacizumab/atezolizumab combination adds little other than neuropathy and hair loss to the regimen of carbo/pemetrexed/pembrolizumab already approved by the FDA in advanced non-squamous NSCLC. The one finding that was novel and striking about the IMpower150 trial data thus far is that the 14% of patients enrolled who had an EGFR mutation or ALK rearrangement and had progressed on prior targeted therapy demonstrated a relative improvement in PFS with addition of atezolizumab that was every bit as good as that seen in the broader population. In fact, patients with an activating EGFR mutation had a HR for PFS with carbo/pac/bev/atezo of 0.41 relative to carbo/pac/bev alone. This should lead to far greater enthusiasm for using immunotherapy combinations for patients with a driver mutation after they have developed acquired resistance. However, it remains to be seen whether people will favor this particular regimen or possibly extrapolate that this benefit will also be conferred by pembrolizumab added to carbo/pemetrexed.

I think the most important thing the IMpower150 trial will end up doing is changing our perspective on the role of immunotherapy in patients with a driver mutation. We have much more to learn about this question.

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H. Jack West, MD (Posted: May 03, 2018)

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An important result, one more piece of evidence that is at least somewhat supportive of the idea of giving concurrent immune checkpoint inhibitor therapy with first line chemo. This trial is very similar to the IMpower131 trial of carbo/nab-paclitaxel or paclitaxel with atezolizumab or placebo, which has been reported in a press release to be positive for a significant PFS benefit.

We will see more info at ASCO 2018 on these studies. Importantly, however, in a setting in which we're giving up a line of treatment by moving a previously second line approach into first line, seeing more transient, less important endpoints like PFS or especially response rate improve is not nearly as impressive as seeing these potential changes in practice translate to a significant improvement in overall survival. I personally won't favor adding intensity of treatment, cost, and toxicity to the burden of a line of therapy unless it produces an improvement in OS or a dramatic improvement in PFS, such as 6 months or more, ideally without much of an added toxicity burden.

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Thomas Marsland, MD (Posted: May 02, 2018)

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So some thoughts to share upon reading this review.....there is one comment on Flatiron and Bristol using real world data to form a "virtual" control on a small study of Opdivo in esophageal cancer. This is at least somewhat troubling, for several reasons. First, the gold standard still needs to be the randomized prospective trial. Secondly, it is bothersome that the folks who control the data are determining what and how the control arm is being selected. I am also worried about industry collecting and controlling the data and how it is used. Rules for transparency and conflict of interests need to be more clearly defined. Finally, where do the patients and physician fit into all of this? Data are collected via flatiron's EMR which is being used in practices; what control over the data accumulated do the doctors and patients have??? In today's world of mergers, as pharma controls data, insurers, drug distributors, and information companies all start to come together. Where is the transparency and who is looking out for the patients interests?

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Thomas Marsland, MD (Posted: April 24, 2018)

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Clearly the risk for a drug payment bundle could be prohibitive. The variation from practice to practice, or even doc to doc can be significant. Not all cancers were created equal. Even just in breast cancer the differences between someone who treats hormone positive cancer can be dramatically different from someone who treats Her-2 positive or triple neg patients. As one of the authors pointed out the current ICD10 system makes if very difficult to differentiate these sub categories. Historical utilization and risk stratification could be helpful. If someone treats a higher risk population then their "profile" would reflect that and appropriate adjustments could be made. The usage of disease pathways might also make it easier to predict drug cost and bundling. Finally there should be exceptions for outliers. When the DRG system was first introduced to the hospitals, there was a mechanism to deal with outlier populations. Although there really is significant risk there may be a solution if some of these ideas were considered.

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Howard Sandler, MD, MS, FASTRO (Posted: April 24, 2018)

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Interesting experience using focal radiation techniques (with injected radiation) to treat HCC. There are many focal ablative treatments in the liver cancer space including chemoembolization, RFA, cryotherapy, external beam stereotactic radiation approaches. Important for us to improve these techniques as the HCC problem continues to grow! It would be nice to see comparative studies between techniques to help define relative advantages and disadvantages.

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H. Jack West, MD (Posted: April 24, 2018)

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This is a disappointing result, particularly considering how low the bar is to beat third line standard of care in advanced NSCLC, and in the context of so many positive trials of immunotherapy in other lung cancer settings. Moreover, this report should only further lower our expectations for the MYSTIC trial with this combination in first line NSCLC (if that's possible at this point) and I think causes some collateral damage to nivo/ipi as another PD-L1/CTLA-4 inhibitor combination that is "on the bubble" in terms of how to interpret the data thus far.

Perhaps the results would look convincingly more favorable if AZ were to focus on a molecularly defined subset, as BMS morphed the recent CheckMate 227 AACR presentation and publication into a focus on patients with high tumor mutation burden. Regardless, this is unwelcome news for a checkpoint inhibitor strategy several steps behind others in NSCLC.

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H. Jack West, MD (Posted: April 19, 2018)

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This will be a welcome addition to our very limited armamentarium for small cell lung cancer. This is a setting in which topotecan is approved, but I don't think there's another approved agent in oncology less enthusiastically endorsed in practice. It's activity is very marginal, toxicity is significant, particularly if administered as it was actually approved, at a dose that is extremely prone to prohibitive myelosuppression.

Based on these issues, those who treat relapsed small cell lung cancer have eagerly awaited ANY viable alternative. Though only a minority of patients respond well to nivolumab, the same can be said for topotecan, but nivolumab is typically associated with far more manageable and modest toxicities, and there is a real chance for a more sustained benefit than we could ever anticipate with more conventional chemotherapy. Notably, nivolumab is already listed as a leading consideration in the NCCN guidelines, but it would be very welcome to have a formal FDA approval for nivolumab in this setting. We can also look forward to far more clinical data on nivolumab +/- ipilimumab in SCLC in the coming years.

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H. Jack West, MD (Posted: April 19, 2018)

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A long overdue approval that most lung cancer specialists should have come shortly after presentation of the FLAURA trial comparing first line osimertinib to "standard of care" first generation EGFR TKI (either gefitinib or erlotinib) in systemic therapy-naive EGFR mutation-positive NSCLC. The PFS benefit was very substantial (median 18.9 vs. 10.2 mo, HR below 0.5), and osimertinib also has much greater CNS activity to control the risk of future brain mets (quite common in EGFR mutation-positive NSCLC) and also has a more favorable toxicity profile.

Though some oncologists and patients will invariably want to hold out on osimertinib and "save" it as a second line therapy to preserve a backup option, that's an erroneous approach, I would content. If it's reserved for later, a maximum of only 50-60% of patients who develop T790M-positive acquired resistance will qualify for it, and only a limited subset of those patients will actually undergo testing to find it. If osimertinib is used as first line therapy, 100% of eligible patients will receive the benefits from it. If it is reserved for second line, likely well under 50% and more like 30-40% of initially eligible patients will ultimately receive it. Overall, the population will likely to far better by starting with osimertinib.

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H. Jack West, MD (Posted: April 13, 2018)

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This is a very interesting contribution. We know the response rate to first line EGFR TKIs is 70-80%, but not 100%, and we also see wide variability in how long patients go without progression on initial EGFR TKI therapy. Though we have long oversimplified by presuming that patients with an activating EGFR mutation won't have any other relevant mutations, we are beginning to see that additional mutations may contribute to the variability in outcomes we're seeing.

It will be great to see further work from other sources corroborate these observations, but this is very provocative.

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Dean Gesme, MD (Posted: April 13, 2018)

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There is no quicker way to "burn out" physicians than to put them "at risk" for expenses that they cannot reasonably and fairly control -- such as drug prices!

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Thomas Marsland, MD (Posted: April 11, 2018)

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This article really hit home with me. As I have transitioned through my career I've had to deal with many changes in the healthcare system. But the one that pisses me off more than any is the delays in diagnosis and treatments in today's health delivery system. I frequently tell my patients that no cancer grows so fast the 1-2 weeks are critical. BUT in today's world that one to two weeks can easily become six to eight weeks from my ordering studies or treatments till the patient actually receives the service. The bureaucratic hurdles that we providers and patients have to jump through to get the appropriate studies or therapies is criminal. I recently read COA is on the hill
maybe something good may come in this era of less (sic) regulation.....

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H. Jack West, MD (Posted: April 09, 2018)

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**Practice-changing result**!

We obviously need to see the data, but this large phase 3 trial now demonstrates a significant benefit in overall survival for pembrolizumab monotherapy relative to conventional platinum-based doublet chemo as first line therapy for patients with advanced PD-L1 positive (1% or greater PD-L1 expression) squamous or non-squamous NSCLC. Pembro monotherapy has been a preferred standard of care, if not THE irrefutable standard of care, for patients with advanced squamous or non-squamous NSCLC that has 50% or greater PD-L1 expression, which is about 28-30% of patients. These results extend that approach to somewhere in the range of 2/3 of patients with advanced NSCLC.

The leading competition, at least for patients with non-squamous histology, will almost certainly be the concept of chemo/immunotherapy with carbo/pemetrexed/pembrolizumab, as has been shown to be positive for a significant PFS and OS benefit in the phase III KEYNOTE-189 trial being presented at AACR 2018 on 4/16. This was regardless of PD-L1 status so is likely going to be a very compelling option for patients with PD-L1 less than 1%. For those who are PD-L1-positive, pembrolizumab monotherapy would generally be favored based on the tolerability/therapeutic index, but we'll need to see the actual data for both of these trials before drawing firmer conclusions.

Exciting times!

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Winston Wong, PharmD (Posted: April 09, 2018)

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CMS has set the reimbursement for their near normal outpatient rate, thus CMS is treating the CAR-T therapies as an outlier, since the normal hospital reimbursement would be based upon the DRG. Given the co-pay cap, there seems to be little margin for the institution. Need to watch can see what will happen with the additional service reimbursement request.

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Thomas Marsland, MD (Posted: April 06, 2018)

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So again the "value" question....I share my dear friend Ted Okon's comments about sample size of this study. 31 oncologists in a nation of over 5000 medical oncologist is hardly representative. With that said, value is always problematic. Value to whom?? The patient, the payer, the employer, the provider??? Plus the cost is a constantly changing target. Drugs that were considered horribly expensive may be considered a deal when viewed in light of $500,000 Car-T cell therapy. Organized medicine such as NCCN, ASCO and COA have all weighed in with some suggestions on value. Clearly clinical outcomes, quality of life, and cost are all important in the decision process. I always at least briefly discuss cost with the patient and I suspect most oncologist do. Anyway I suspect this issue will be with us for a long time as I don't see pricing coming down soon.

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Ted Okon (Posted: April 05, 2018)

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A total of 31 oncologists and only from academic centers, medical centers, and the VA. No community oncologists. Not representative of anything but 31 random oncologists. Not really research.

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Winston Wong, PharmD (Posted: April 05, 2018)

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Its still comes down to a simple fact. No matter what the cost of a medication is, someone has to pay. Negotiated discounts and copay coupon programs are simply cost shifters, much like the concept of a patient copay.When a discount is issues, someone else is forced to pick up the difference. Even in light of UHC and Aetna declaring that all rebates will be passed on to the member, there is still a discount present. Why not then just charge a lower price?

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Ted Okon (Posted: April 05, 2018)

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Terrible research. Biased sample (not one community oncologist) and making judgements about where oncologists stand on "value" is completely meaningless. Surprised it was published anywhere.

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Winston Wong, PharmD (Posted: April 05, 2018)

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From a payer perspective, the CMS approval for coverage means that reimbursement for medicare and medicaid plans are mandated. This does not mean that coverage for the commercial population is mandated. Coverage for commercial members will be based upon the clinical utility study results. If the tests are specific to a drug, and will predict if a drug will be effective or not, then commercial business will follow suit. This is because the clinical utility of the test is sound. Anything beyond this will be suspect, and will undergo much scrutiny. There still need to be clinical justification for coverage. As I have noted in the past, FDA approved indication based upon genomic profiling results will prove to be a challenge for payers, and so far, that has held true.

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Thomas Marsland, MD (Posted: March 28, 2018)

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This is a good review. The article sums up all the advantages and disadvantages of patient access to clinical data. Early, easy, transparent access are important. The negatives are clearly pointed out. Confusion about path, lab and imaging reports often in very technical wording can be very anxiety provoking for patients. Access to someone who can knowledgeably discuss the finding is critical. This however is often problematic for many reasons. In addition when results are particularly bad I personally do not like having phone discussions; there are somethings that really do need a face to face encounter. This again causes delays and anxiety. As we move through these newer models hopefully these issues will be addressed

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Thomas Marsland, MD (Posted: March 27, 2018)

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Who says you can't teach an old dog new tricks..... I am delighted to see this NCD. In my practice I have been using more and more NGS. These technologies have allowed me to use a much more personalized approach to many patients with difficult to treat tumors. New cancer with an aggressive clinical presentation now have the option of more targeted treatments. Also patients who have been on treatments for a time have additional choices to help control their cancers. This move keeps in step with the evolving trend of thinking of cancers biologically as opposed to anatomically. It is very encouraging to see the payer community more and more accepting of target therapies across tumor types. The wider usage of Foundation One testing will allow wider access to more effective treatments SO Woof, Woof from an old dog.....

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H. Jack West, MD (Posted: March 26, 2018)

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OS data are helpful & important, but today the true comparator is carbo/pemetrexed/pembrolizumab, which is already FDA approved, and for which we will see phase III data in the KEYNOTE-189 trial, reportedly positive for PFS and OS, at AACR on 4/16. Unless the carbo/paclitaxel/bev/atezo data look clearly superior to carbo/pemetrexed/pembro by cross-trial comparison (not statistically valid and not recommended, but inevitable when considering options in real world practice), which I think is very unlikely, clinicians will favor carbo/pemetrexed/pembrolizumab based on familiarity and favorable tolerability. My view is that the carbo/paclitaxel/bevacizumab/atezolizumab combination is a fine option but a lateral move except for adding hair loss and risk of neuropathy. I think other IMpower trials that use atezo with different regimens are going to prove more attractive than ones that saddle it with paclitaxel.

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H. Jack West, MD (Posted: March 23, 2018)

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Obviously a disappointing result, especially in a selected population. Some of my colleagues note that relapsed SCLC is a difficult setting with historically poor results and remain open to rova-T still having a place. I agree that a minority of patients have good responses, but the response rate even in this molecularly selected group was a mere 16%, with a median OS under 6 months, and even a lousy median duration of response of just a few months in the patients who did respond.

In my view, even if this agent is marginally helpful, it isn't close to worth what a new targeted therapy will cost, which is probably an average of at least $10-15K/mo of response that the few responders will experience. I don't think Abbvie or anyone else will have the perseverance or budget to sift through the wreckage and throw good money after bad to develop this further, at least not in this indication.

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Thomas Marsland, MD (Posted: March 21, 2018)

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As a still somewhat new practitioner in California, I have seen a much broader use of "medical marijuana" than what I was used to before. The patients seem more open to its use and at least from my personal experience they do seem to benefit. As the article suggests, my patients use it for a wide variety of reasons including: pain control, anxiety, nausea, appetite, fatigue and malaise. Clearly it works for many. I had the opportunity to attend a pain conference recently and was greatly impressed with research being done on neuro receptors and how there are multiple different cannabinoid receptors. We are now at a point where clinical trials are called for to look at the effectiveness of cannabinoids in a truly clinical manner. Which cannabis products are most effective in individual clinical cases? How does route of administration play into their effectiveness? Just for the record (since recreational marijuana is also legal in CA), my person drug of choice is a good Napa cab.....

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H. Jack West, MD (Posted: March 20, 2018)

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This phase III trial of patients with advanced squamous NSCLC randomizes to first line carbo/paclitaxel/atezolizumab vs. carbo/nab-paclitaxel/atezo vs. carbo/nab-pac alone. The press release notes that carbo/nab-pac/atezo vs. chemo alone shows a significant PFS benefit, OS not significantly superior at this interim analysis.

I'd say this is good but expected based on the trend we've seen that the benefits of chemo/immunotherapy first line are not clearly that regimen-specific. However, while the IMpower150 trial (using carbo/pac/bevacizumab/atezo and shown superior to carbo/pac/bev in advanced non-squamous NSCLC) and this trial show a PFS benefit, we've learned that KEYNOTE-189, of cisplatin or carboplatin with pemetrexed + pembrolizumab or placebo in non-squamous NSCLC, is positive for both PFS and OS (results to be presented at AACR on 4/16). In my opinion, KEYNOTE-189 sets the bar for clear change in practice by achieving an improvement in OS. With greater potential toxicity by giving chemo and immunotherapy together, and with a well-established OS benefit giving sequential immunotherapy in the second line setting, I don't think a PFS benefit alone is sufficient to lead oncologists to embrace a treatment approach that eliminates a line of therapy and is more complex and potentially toxic, especially since squamous NSCLC patients are often older and have significant comorbidities.

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Dean Gesme, MD (Posted: March 19, 2018)

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This NCD creates a bit of a conundrum for commercial insurers; do they follow CMS or try to analyze and promulgate their own rules in this dynamic and turbulent area of oncology? Watch this play out in many and varied ways over the months ahead.

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H. Jack West, MD (Posted: March 15, 2018)

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This presentation of data from KEYNOTE-189, CheckMate-227, IMpower150, and some other trials of immunotherapy combinations in first line advanced NSCLC will be in the same blockbuster session on late Monday morning at AACR. This two hour period will likely have a significant impact on lung cancer practice this year. All eyes interested in the field should be watching around that time.

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Winston Wong, PharmD (Posted: March 15, 2018)

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We are seeing a number of mail-in genetic tests being made available. I doubt that payers will cover the cost of these test, for the reasons noted intros piece. In most cases, the patient will take the results to their doctor, who will mostly rerun the test with a commercially available accepted test. It is this test that the payer will cover simply because the conditions in which the test sample was take is controlled, it is definite that the person being reported on, is the person would actually completed the test, and the results have shown utility and trust. Is 23 and Me just riding the ancestry wave?

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Winston Wong, PharmD (Posted: March 15, 2018)

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This article clearly points out the one area where "charges" has a major impact from a member liability standpoint. Out of Network non-coverage, or even balance billing is the one motivator to drive patients to stay "in Network". Of course, then the uninsured is the most vulnerable, with no coverage at all. However, when services are provided by an in-network provider, charges are meaningless.

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Winston Wong, PharmD (Posted: March 15, 2018)

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The industry is definitely undergoing a major shakeup, and what falls out is anyone's guess. One would think that with the health plan and the PBM being joined at the hip, there would be a more integrated approach to managing patients. This is true of the UHC/Optum fully insured business, although clear improvement in outcomes have not been shown to my knowledge, It will be interesting to watch who becomes the controlling party here in terms of driving the formulary decisions and strategy.

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Thomas Marsland, MD (Posted: March 14, 2018)

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Drug pricing and the costs of medications is clearly an ongoing problem. But as always, this report puts the blame on the oncologist. First and foremost, we the physicians do not control drug prices. That falls on pharma. The margin that oncologist make is really just a very small piece of the overall drug costs. The author picks on two specific drugs in this article, but really fails to look at the total drug revenue to practices. There are many drugs that are actually money losers at the current pricing program. In the end, at least at Medicare reimbursement rates, drugs overall are at best a pass though. The private practice of medical oncology is not a non-profit business, although we compete with non profits who clearly have been shown to make much larger "profits" though the widespread mis-uses of the 340B program (addressed in many other forums). Practices maintain an expensive infrastructure on infusion suites, admixture facilities, and highly trained staff to provide high quality services at what I might point out is less costly than similar hospital-based programs. So yeah I'm not a charity, yes I look at drug prices, but that is needed to keep the doors open. I am anxiously awaiting the new, better system.

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Thomas Marsland, MD (Posted: March 14, 2018)

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So the key question asked in this report is "Who's data is it?" That really is the $64,000 question (gee who remembers that show??). Clearly the potential for big data is tremendous. Real world data can drive clinical decisions making. Which treatments are more effective, less toxic, less costly? Real world data can be used for hypothesis generating clinical trials. Where the waters get muddy is when is data is used by industry to promote marketing and drug usage. Also, there is a huge market for this information by the financial world to promote investing decisions. The economic worth of such information is dramatic. So when large companies such as Roche control this data, how is it limited? Who has access?? What if any economic advantage is there to the patients and physician who are responsible for generating (and owning ???) that data. Clearly there is a need for transparency in this data generation. At a minimum the practices and patients should know when their information is being used in collection or "real world evidence."

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Winston Wong, PharmD (Posted: March 14, 2018)

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It will be interesting to see if payers will reimburse for this test. I doubt that they will, since it is consumer driver, as opposed to provider driven, and time will be needed for payers to gain confidence in the accuracy and reliability of the test, as well as how the information will be handled by the providers. Will the providers simply just turn around an order another test? In additional, with a consumer driven test, can payers even be confident that the test is being used by the same person who purchased the test and would be billing it to the payer. Many questions to be answered.

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Winston Wong, PharmD (Posted: March 13, 2018)

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Hospitals will charge whatever they want to charge. The real question is what are they paid? Medicare reimburses from the DRG. Most payers will pay something based upon the DRG rate. Very few will pay charges, or even a percentage of charges. yes there are some exceptions, but even then, there are limits. So why do we look at the charge numbers?

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H. Jack West, MD (Posted: March 12, 2018)

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We will review these data in comparison to the CheckMate-227 trial results expected to be presented in the next several weeks (which will include positive findings for PFS based on tumor mutational burden, but OS results are reportedly still immature, so we can't expect to see OS data), as well as the rapidly growing collection of data on chemo combined with PD-(L)1 inhibitors, most notably KEYNOTE-189. This trial is also expected to be presented soon (at AACR, I understand) and focuses on the regimen of carbo/pemetrexed/pembrolizumab that already has the major advantages of being FDA approved (based on the phase II KEYNOTE-021g trial) and being the chemo backbone most favored by US-based oncologists for non-squamous NSCLC.

There are certainly opportunities to enter the first line advanced NSCLC setting, especially for squamous NSCLC, but nivolumab/ipilimumab will be the first immunotherapy combination to be broadly discussed and show positive data. The durvalumab/tremelimumab regimen will become a relevant regimen if it demonstrates a significant survival benefit, provided that toxicity isn't prohibitive.

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Jeff Patton, M.D. (Posted: March 07, 2018)

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There are certainly some perverse incentives in medicine but there is a significant literature that community oncologist "who own their own infusion suites" prescribe the same medications even if the financial incentives are removed. There is also published literature, that institutions like the Mayo Clinic that are enrolled in the 340B government discount program where there financial incentives are 40-50% not 6%, prescribe more expensive therapies than their colleagues in the community. Dr. Rajkumar lives in a glass house and should check the facts before impugning others.

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Dean Gesme, MD (Posted: March 07, 2018)

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I respect Dr Rajkumar's clinical expertise but here in MN we have a 2% state drug tax as well as the federal government's 2% sequester; hence ASP plus 6% is totally illusory. The 1.8% net margin is insufficent to cover drug ordering, wastage, bad debt and pharmacy overhead unless they were being subsidized by 340b rebates! Thus 340b rebates may be the real perverse inducement and not "ASP plus 6%".

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H. Jack West, MD (Posted: March 06, 2018)

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With the evidence on immune checkpoint inhibitors in many cancer settings being highly comparable, practical issues like interval between treatments and cost become the leading points of differentiation. An approved four week dosing schedule will lead me to favor this for a larger proportion of my patients moving forward.

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Thomas Marsland, MD (Posted: March 01, 2018)

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Billing and payments for medical services are a complex, confusing world. There are billed charges which have no bearing on reality. Providers, both hospitals and practitioners, often have charges that are astronomical. No one expects to get "billed" charges. Private payers have contracts which define what they will pay for a given service. Patients are responsible for what their policy requires in terms of co-pays and deductibles. Medicare has fixed fee schedules (price controls ??) with patients responsible for 20% of the allowable on the part B side but 20% of charges on the part A side. So this is where this report hits home. In the hospital setting the amount patients pay may very well vary by huge amounts depending on hospital Part A charges. Agree that there clearly needs to be at least more transparency in terms of patients' payment and possibly some legislation to standardized charges for a given procedure or service. All of which really has little to do the the real, true cost of providing these services.

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William McGivney (Posted: February 22, 2018)

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I do not what they call it today, but remember the Buzzwords, “Rapid Heath Learning” (RHL) from about 7 years ago. That term came and went fairly quickly; as such terms are wont to do. There were many terms prior to RHL and I would expect that there are many Buzzword terms still to come.
Getting away from semantical genre to the developing realization from Roche that has sequentially purchased Genentech, Foundation Medicine, other diagnostic entities, and now Flatiron (Flatiron purchased Altos Solutions EMR in 2014), the development and utilization of drugs/biologics will continue the march to the application of:
1. Real World Evidence (RWE or aka data) to expand indications
2. to support drugs/biologics in combination
3. to enhance hypothesis generation to identify new biomarkers for drugs and biologics (old and novel)
4. to develop the innovative drugs and biologics that target newly identified biomarkers

There is more but the strategic path is clear. Questions lurk such as:
1. When will the data source, quality, diversity, quantities, specificity, accuracy, recency etc. be sufficient to support the applications listed above?
2. Is the selected EHR sufficiently operable across systems for centers and larger practices to be happy to participate and provide data?
3. How and will the real owners of data (i.e., patients, providers) participate and share in the next $1.9 billion windfall?
4. What are the missing pieces or upgrades that are still needed?

I do not know but it will be great to watch as “evidence-based medicine”, “outcomes-based decision-making”, “rapid health learning”, etc. actually comes to fruition in the competitive private sector!

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H. Jack West, MD (Posted: February 22, 2018)

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These data are remarkably impressive and are sufficient to lead to a new standard of care. I hope we see an FDA approval to lead to broad testing for TRK and use of larotrectinib being broadly adopted as optimal treatment for these patients.

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H. Jack West, MD (Posted: February 20, 2018)

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Though we haven't yet seen a significant overall survival benefit with maintenance durvalumab after chemo/radiation, I believe the very significant and sustained PFS benefit are extremely likely to be associated with an OS benefit at least at 2 and 3 years out, but may or may not lead to more patients cured. If we see no patients cured and patients can do just as well being "rescued" with immunotherapy upon relapse, and we can spare some patients already cured by chemo/radiation to receive prolonged immunotherapy, there won't be a clear benefit to giving everyone immunotherapy automatically. We will need to see the long-term results of the trial and whether long term OS is better from a year of durvalumab.

In the meantime, we are left considering whether to change our standard based on PFS alone. I think the potential harm to thousands of patients in the next few years, by withholding a therapy that has a significant chance of improving survival, is greater than any harm that could theoretically come from giving durvalumab based on a tremendous PFS benefit, even if it doesn't improve long-term cure rate. Durvalumab will be my standard of care in this setting while we wait for more mature data from the PACIFIC trial.

Please see my video for further thoughts:
http://traffic.libsyn.com/force-cdn/ec/beacon/BMIC-024_Durvalumab_Stage_III_NSCLC_Standard.mp4

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Winston Wong, PharmD (Posted: February 19, 2018)

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I lived through and was part of the payer process for many years. It is not a perfect system. It is a system developed for population health management. Unfortunately, the process for those falling outside of the population is not a smooth process. I venture to say that the time frame referred to here was a couple of years ago when genomic signatures were still up and coming. The mere fact that it was paid for is notable. Unfortunately, dealing with the results is not notable. Hopefully today, the test are more readily paid for and the results are believed.

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Winston Wong, PharmD (Posted: February 19, 2018)

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Once the biosimilars are out on the market here in the US, it will be the first test of how confident the oncology community will be with the use of biosimilars. From a payer perspective, they are not interchangeable, and the Oncologists will have some clout to help drive the market, especially of the financial incentive is not large enough to motivate the switch to the biosimilar.

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H. Jack West, MD (Posted: February 15, 2018)

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On its face, the report that a trial of avelumab vs. docetaxel in chemotherapy-pretreated NSCLC seems surprising unless it's a clearly inferior checkpoint inhibitor to the ones that have already demonstrated positive results and similar efficacy in very similar trials -- namely nivolumab, pembrolizumab, and atezolizumab. We have presumed that these agents are all far more similar than different.

The JAVELIN Lung 200 trial did note that the cross-over of such a higher proportion of patients to subsequent immunotherapy in this trial (26.4% on docetaxel arm, vs. 5.7% on avelumab arm) vs. other ones that have been positive is likely to be a relevant factor that compromised the ability to detect an improvement in OS in the broad study population. Frankly, I think it's disappointing that only just over 25% of patients received access to clearly very effective immunotherapy that has been a standard of care now for a few years. In my clinic, nearly 100% of patients who were ever eligible for a checkpoint inhibitor receive it over the course of their illness. The only question is whether it is delivered first line, second line, or later. And while this trial was conducted in a different time and place, the evidence should lead us to conclude that only 26% of patients receiving immunotherapy is gross under-treatment.

It is also notable that the effects were reportedly greater in those patients with high level PD-L1 expression, as we've generally seen, with a positive survival benefit in that subset.

We will need to see the actual data in an upcoming meeting, but I believe that it is premature to conclude that avelumab is a less effective therapy than the similar checkpoint inhibitors that have been approved in this setting already. I think the results may be most instructive in demonstrating that the timing of immunotherapy is not critical for many/most patients to achieve the same overall survival. In the contemporary practice of treating lung cancer, we should expect and aspire to have nearly all eligible patients receive one of these agents at some point over the course of their disease.

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Winston Wong, PharmD (Posted: February 14, 2018)

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Unfortunately, this is reality. All of these tactics are being used to delay the release of generics. Holding back the reference product is a big thing in the biosimilar world. Recall it was not so far back that we heard of lawsuits files against the innovator companies for paying the generic manufacturer to delay their release. The only thing different today is that with the release of the generic, especially the Revlimid, the generic might not be that less costly. Keep in mind that only a 10% break in cost will support a generic designation.

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Winston Wong, PharmD (Posted: February 14, 2018)

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Medication Therapy Management programs have proven that they can improve patient compliance and adherence. Having a program focused on oral Oncology drugs is needed. My only concern is that for years, MTM programs have been promoted. In the real world, MTM program have failed, especially in the chain pharmacies due to the lack of time available to talk to the patient. Time allocation and productivity measure for the provision of MTM services have not been integrated into the pharmacy workflow. Hence, is frequently neglected. Yes the pharmacist asks if there are any questions. If the patient responds affirmatively, prescription filling slows down, especially if the medication is an oral oncolytic. So while I applaud Walgreens for developing a patient support program, I question if it will actually be put into place on a widespread basis.

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Thomas Marsland, MD (Posted: February 12, 2018)

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YEA!!! Occasionally Congress can get it right. Hey, even a blind squirrel can find an acorn now and then........

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Dean Gesme, MD (Posted: February 11, 2018)

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Increasing transparency in drug pricing and total costs of care attributable to drugs can only serve to foster greater intelligence and insight into the use of pharmaceuticals in the US.

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Thomas Marsland, MD (Posted: February 08, 2018)

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There is a lot beneath the surface in this report. Clearly the major factor in the growth of hospital practices is the 340B program but it is clearly not the only factor. The point is that whether an institution participated before or after 2010, those 340B facilities have a definite competitive advantage over community private practice. Hospitals, whether 340B or not, also have a higher compensation for the exact same service provided under the OPPS compared to the physician fee schedule that private practices bill under. Many also charge a facility fee that private offices cannot. In addition to the expanded revenues afforded hospital centered practices, the bottom line revenues in private practices has deteriorated due to ASP and the multitude of new rules, regs, and other requirements foisted on private practice by the payer communities. The shrinking revenue in private practice has driven doctors to the hospital settings where doctor compensation may be better and there is less hassle with the day to day running of a practice. So as the author suggested it is not solely due to 340B issues that we are seeing the death of private practice but it surely is one of the major drivers. Will be interesting to see how the new reduced payments under the 340B program effect this migration.

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William McGivney, PhD (Posted: February 06, 2018)

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One tweet struck me in this story about the update on Amazon, JP Morgan and Berkshire and it is:
• “I want there to be something to bring healthcare costs down.”
Well, as a whole, general health care costs will never come down as I have written over the years. Healthcare technology innovations are always expensive. Many of these technologies turn out to be add-on interventions (monotherapy going to combination) or make more lines of therapy available by becoming first line (like anti-PD-1s and anti PD-L1s) pushing down previous first line agents to second line and then others to third line, etc. Importantly, our population of potential patients continues to get older.
Actually, the most insightful comment came from Dr. Warren Buffet (honorary MD for my convenience) as the quote focused on working to “check the rise in health costs”. As such, whoever wrote the quote understands that the goal is to check or slow the rate of rise of healthcare expenditures. This is the best that we can hope for and aim for.

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Thomas Marsland, MD (Posted: February 06, 2018)

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So maybe they really are smarter than the rest of us and can provide better care at a lower cost. Certainly these are highly successful, powerful companies and if they really leverage their strengths and resources perhaps they will be able to accomplish their goals. I'm not sure that the "free from profit making" is going to be the answer since there still will be huge costs in providing care. They claim that with the number of employees they can develop "cost effective ways" to deliver care. Gee, the rest of us have never thought of that....Clearly cost and value are hard to define and have different meanings to different stakeholders. As we all struggle to provide more cost effective care I am struct by how much harder it is to deliver good care because of all the rules, regulations, and requirements that delay access to the care patients truly need. One step in the right direction these companies are exploring is to get rid of the hugely expensive middle man, the payer. Payers have large bloated overhead that increase cost of care tremendously. If these successful companies can bring the ability to coordinate care through more efficient information systems which they have used successfully in their other operations, perhaps this will result in a reduction in cost without loss of quality care. If their systems can eliminate many of the problems experienced by doctors and patients who struggle daily with non inter-operative, inefficient information systems, that would certainly go a long ways towards obtaining all our goals of a better health delivery system. So I guess we will find out.

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H. Jack West, MD (Posted: February 05, 2018)

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We’ve eagerly anticipated results from the CheckMate-227 trial, an open-label phase 3 trial of over 2500 patients with advanced NSCLC, either squamous or non-squamous histology, randomized to nivolumab monotherapy or in combination with ipilimumab versus platinum doublet chemotherapy in a comparison of patients with tumors expressing PD-L1 (any level, by the 28-8 pharmDx assay) on part 1a or with tumors expressing no PD-L1 on part 1b. The press release today reflects results for both groups on part 1, noting that there was a significant improvement in progression-free survival (PFS) with nivolumab/ipilimumab (nivo/ipi) compared to platinum doublet chemotherapy in the subset of patients with high tumor mutation burden (TMB) defined as >10 mutations/megabase (mut/MB) on the FoundationOne CDx assay (a liberal threshold capturing approximately 40-45% of patients), though FoundationOne defines high TMB as >20 mut/MB (representing only approximately 13% of patients) (hat tip to Andre Sawyer, Analyst for Equity Research, for noting this point that is easy to overlook). This positive result in patients with high TMB was independent of PD-L1 level. These results are provocative, though we clearly need to see the actual data to get a better sense of the clinical implications. In the meantime, however, we can draw some preliminary conclusions.

First, this result adds momentum to the mounting evidence supporting TMB as a relevant biomarker. It is necessary to add the caveat that this was not a prospectively identified endpoint, as well as the fact that this particular threshold of defining high TMB differently than is done by Foundation Medicine undermines some of the convergence toward clinical utility of TMB if there is no semblance of any consensus. Moreover, we should hope and expect to see subset analyses that define whether the results are far stronger in the much smaller subset with the 20 mut/MB cutoff, with the results in the broader population defined by a 10 mut/MB cutoff diluting the effect but expanding the population to be considered good candidates for nivo/ipi. We should ensure that the lower threshold truly defines the group most likely to benefit from nivolumab/ipilimumab and isn’t being promulgated as a reverse engineered result to maximize eligibility while still defining a population in which the positive result for PFS is maintained.

Second, I consider a positive effect for PFS to be encouraging but insufficient to change practice unless the absolute difference is absolutely remarkable, particularly in the non-squamous patient population. Despite the FDA approval of the carboplatin/pemetrexed/pembrolizumab combination in May, 2017 based on the phase II KEYNOTE-021g trial, I and many other thoracic oncology specialists, as well as general oncologists, have remained unconvinced that the improvement in response rate and PFS with the addition of pembrolizumab to first line chemotherapy should change practice when a sequential approach may well confer the same overall survival (OS). The widening gap between the OS curves with longer follow-up on KEYNOTE-021g has warmed me to this approach as an increasingly compelling option, as has the recently reported positive results for a PFS and OS benefit with addition of pembrolizumab to cisplatin or carboplatin with pemetrexed in the phase III KEYNOTE-189 trial (actual data still awaited). With a regimen that oncologists are comfortable using and that is FDA approved, carboplatin/pemetrexed/pembrolizumab will be the true comparator as we consider nivo/ipi as a challenger.

In contrast, we don’t yet have a first line immunotherapy-based treatment approach for patients with squamous NSCLC who don’t have a tumor with high PD-L1 expression (for which pembrolizumab monotherapy is a clear standard of care and strong option). I think for patients with high PD-L1, pembrolizumab will remain a leading option, and nivo/ipi may emerge as a favorable option compared to doublet chemotherapy for patients with high TMB and low or negative PD-L1. We will need to see the magnitude of benefit and tolerability of nivo/ipi when the actual data are available. In addition, we should expect to see several trials of chemotherapy combined with checkpoint inhibitors in patients with squamous NSCLC that may well be positive for PFS and/or OS in the next 6-12 months. These options will need to be considered alongside nivo/ipi.

Though the dose and schedule of nivo/ipi may well be tolerable for a broad population, it will be critical to see the toxicity profile and compare it not only to a platinum-based doublet but to that expected for other alternatives. I remain concerned that nivo/ipi may be challenging for less selected, potentially older and sicker patients, being treated by oncologists with less support and experience than the trial investigators who have been the main ones gaining experience with this combination up to this point.

Overall, I think this is encouraging for adding further credibility to TMB measurement and potentially nivo/ipi for a selected subset of patients with advanced NSCLC, but I feel these results should definitely not lead us to adopt either TMB or nivo/ipi in clinical practice without far more information.

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Thomas Marsland, MD (Posted: February 01, 2018)

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I think this is a good release. It really is time for a good shout out to NCCN. I would like to thank them for their great work. I find their guidelines a great help. As a community oncologist who sees all types of cancers daily, having a resource like NCCN allows me to feel comfortable treating most cancers. As the article stated, I do visit the site much more frequently. Often the guidelines just reassure me that I am not so out of date as I fear but they do also keep me abreast of rapidly changing treatment protocols in a world where it seems we are often seeing a new drug approval daily. So again thanks NCCN!

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William McGivney, PhD (Posted: January 31, 2018)

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An intriguing announcement was made this morning in that Amazon, Berkshire Hathaway, and JP Morgan will establish a joint venture to reduce health care costs and to improve services for their US employees.

In this “Value” era of evaluation and valuation of health care stakeholder contributions to patient benefit, the establishment of this joint venture by these three industrial behemoths signals the initial recognition of counterpart managed care behemoths’ failures not just in reducing costs but not even substantially restraining the rate of rise of health care expenditures. The real story is that in the Value paradigm, payers and managed care organizations across 25 years have failed and, in their failures, actually have extracted billions of dollars in return from the health care system. Truth be told is that “Value” is lacking in the billions of dollars extracted and generated in redundant, frustrating utilization management programs, formularies, step therapies, precertification requirements, prolonged appeals processes, incomplete and late coverage policies, patient cost-sharing, etc. Please just look at company SEC filings where these words are translated in to dollars. The bottom line is that payers and managed care companies actually have achieved negative (harm) patient benefit both to patients and to self-insured employers.

Self-insured employers, like the three cited, have long suspected that the money paid out for the aforementioned UM programs have been relegated to black holes sucking dollars into them with the impossibility of definitive mapping of where the money went (e.g., medical costs column) and great uncertainty regarding the effects of the programs such dollars funded.

Generally, the “Big 5” commercial insurer stock prices fell 3-5% on Tuesday on the Dow. I guess investors agreed that a techno company, a bank/investment house, and another investment house possibly could manage health care more effectively and efficiently than health insurers, PBMs, SPs, etc. The easiest initial way to cut costs would be to delete the onerous UM and like programs foisted on the system and on clinicians and patients!

Finally, in a somewhat serious ask: Do we really need payer coverage policies with all the available guidelines, pathways etc? Again, as a senior insurer health lawyer said to me as she/he was leaving the company: “The best thing is that I will not have to say any more that Insurer X does not make medical decisions!"

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Ted Okon (Posted: January 29, 2018)

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So great to have community oncology stateside help cancer patients and their medical providers bounce back after the devastating hurricane.

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Ted Okon (Posted: January 29, 2018)

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New study from Avalere Health shows the real impact on hospitals of CMS rebalancing 340B program. Vast majority of hospitals will get a Medicare payment increase, on average. Rural hospitals really benefit. A lot different picture than the one-sided misinformation on this topic.

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Winston Wong, PharmD (Posted: January 28, 2018)

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The benefits, both clinical and financial, of patient navigation programs is slowly being realized. Payers to date have been slow to realize the value of a program like this. Horizon has been on the cutting edge of many program, and this can now add Patient Navigation to their list.

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Winston Wong, PharmD (Posted: January 28, 2018)

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We have been making the same plea for Head-to-Head studies for years. Managed Care has suggested it be part of the FDA approval process, which is what lead to the development of the the CER process. This falls short of being a requirement for the approval process. The FDA position is that they evaluate a medication for efficacy and safety. Cost is not a part of the evaluation, and neither is comparative effectiveness outside of a comparison to a "standard" treatment.

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Howard S. Hochster, MD (Posted: January 22, 2018)

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Great work by Mike Overman and colleagues showing prolonged benefit to Nivo (3 mg,kg) and Ipi (1 mg,kg) given x 4 doses. Median duration of response not yet reached and over one year. This does suggest the combo is more active than single agent Nivo. But randomized trials are needed in this rare MSI-high population. Now possible in the NRG/SWOG COMMIT trial available on CTSU. Please screen your patients early and consider this for first line therapy. After all, MSI-high patients have great responses to chemo also. Order may matter.

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Howard S. Hochster, MD (Posted: January 19, 2018)

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The Keynote-224 is only a phase 2 study of good performance, very well selected HCC patients after sorafenib. But with a 16% response rate and 77% 6-month survival (median survival not yet reached), this is unprecedented good news for HCC patients. Median time on study was 8 months, which could amount to a very meaningful extension of life. The main question is whether these results will be seen with a more real-life patient population. But these data confirm what is seen with nivolumab and show a real benefit compared to other options in HCC (e.g regorafenib after sorafenib).

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Thomas Marsland, MD (Posted: January 18, 2018)

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It will be a while to see how this reduction in the 340B compensation for drugs really plays out. I the article they talk about how the "margin" is used to provide additional services for patients that otherwise would not be available. While this is certainly true that many of the 340 B institutions do provide some additional services they also have rapidly expanded their oncology service line absorbing private practices at an exponential rate. How will the cuts effect that?? Will current programs be cut ??? Will we the physician be forced out or be made to work more for less ??? As private practices have contracted will there even be alternatives for those who may wish to return to a private practice setting. Will hospitals learn to be more efficient as those in private practice were force to do when the ASP pricing went into effect ??? Guess time will tell but it certainly will be interesting to watch

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William McGivney, PhD (Posted: January 17, 2018)

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There are a few of us out there who will remember the famous Abbott and Costello routine that in continuous circular loops keeps begging the question “Yea, but who is on First?”. Practices and Cancer Centers provide care and treatment but also are business centers with each one generally qualifying as a multimillion dollar business.
For businesses, uncertainty is always a negative. Uncertainty in federal regulation, especially in reimbursement processes, measures and requirements, causes confusion and inefficiency in practice planning and management. The moves (e.g., MIPS, OCM) by the federal government to programmatically transition physicians away from fee-for-service practice to Value-based decision-making have been beset by fits and starts with changes that contravene provider side efforts and practice investment in enhancing practice infrastructure and capabilities.
The latest hiccup or, maybe more accurately, eructation in the sequence is exemplified by the MedPAC’s recommendation that the MIPS program be abandoned because the MIPS “system is too burdensome” for physicians and will not lead to improved care. MIPS cuts across therapeutic areas in American Medicine and, thus is not the main focus in Oncology where the OCM continues to evolve. In OCM, practice sentiment is in some situations turning negative with complaints about quality measures that do not relate well to every day practice, government feedback reporting that is confusing, and feelings that one is just checking all the boxes.
In 2006, there were some discussions with CMS about using NCCN Guidelines as a basis for Quality of Care determinations. There were reasons why this NCCN-based process could not be considered for full implementation beyond being a CMS demonstration project for 2006. But now, given present-day back and forths and uncertainty, something built around the NCCN Guidelines deserves serious consideration. At the least, such a system might provide some relief from the policy routine which is becoming farcical to some and unsettling to others who invest hard-earned dollars in capabilities and infrastructure to satisfy evanescent rules and requirements.

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Dean Gesme, MD (Posted: January 16, 2018)

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This call for head to head trials of checkpoint inhibitors is spot on. These trials may be necessary in order to avoid a “commoditization” of this class of drugs by payer/provider interests seeking to reduce excessive treatment costs with immunotherapies given the lack of documented clinically significant differences in efficacy and safety within this class.

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H. Jack West, MD (Posted: January 16, 2018)

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This is a very important result, in keeping with the results of the phase II KEYNOTE-021g trial that led to the FDA approval of the carbo/pemetrexed/pembrolizumab combination that many experts feel was premature, being based on just 123 patients and with only preliminary OS results at the time of the approval. The report of statistically significant positive results for both PFS and OS with initial cisplatin or carboplatin with pemetrexed and concurrent pembrolizumab over the same chemo alone corroborates the KN-021g trial on a larger scale that we really needed to see.

I expect that several other trials that present results this year of various chemo backbones +/- various PD-1/PD-L1 checkpoint inhibitors will also demonstrate a significant benefit at least with PFS and likely many with an OS benefit as well. For patients with non-squamous NSCLC, however, a platinum/pemetrexed combination (overwhelmingly more often carbo than cisplatin in the US) is the preferred chemo combination. Based on this and the existing FDA approval of the KEYNOTE-021g regimen, I believe carbo/pemetrexed with pembrolizumab will be the clear pace-setter for this population. Any competing regimen would need to not just be comparable but would need to be significantly superior to this one in order to provide a real incentive to change from carbo/pemetrexed/pembrolizumab at this point.

That said, there are several important questions that will modulate the level of enthusiasm for this regimen over a sequential approach. Today, the standard of care for the ~30% of patients with high PD-L1 expression (based on 22c3 antibody as companion diagnostic for pembro) is pembrolizumab monotherapy, based on the compelling benefits seen on the KEYNOTE-024 trial, rather than chemo alone. It will be critical to assess whether the results of KEYNOTE-189 are still compelling once that subgroup is removed, because the most relevant question for 2018 is whether patients with low or no PD-L1 expression should receive concurrent chemo/immunotherapy or sequential chemo followed by immunotherapy. Accordingly, the other critical question is whether patients on KEYNOTE-189 who were assigned to initial chemo have a very high crossover rate to subsequent immunotherapy, as they should when 3 checkpoint inhibitors are FDA approved and have a very clear survival benefit in that setting. Though some are complacent and argue that a 60-75% crossover rate to subsequent immunotherapy is sufficient and represents real world challenges, I would contend that those patients who do not receive a checkpoint inhibitor in second line or later have been denied a therapy with proven benefit and have been under-treated by the health care system. More than 95% of my patients who are eligible for a checkpoint inhibitor receive it at some point in their treatment course -- it is absolutely possible. For KEYNOTE-189 to be truly interpretable, we need to see that first line concurrent chemo-immunotherapy is superior to sequential treatment where nearly all patients benefit from both treatment approaches. A lower crossover rate will only demonstrate that 100% of patients receiving immunotherapy is better than only 2/3 of patients receiving it at some point.

Nevertheless, the same could be said for the PARAMOUNT trial's testing of maintenance pemetrexed, which really only demonstrated that the benefit of pemetrexed doesn't max out at 4 cycles, not that it's critical to give maintenance pemetrexed indefinitely. It's a very similar issue here, but we see that our practice patterns in advanced NSCLC have incorporated maintenance pemetrexed as a default because oncologists we will give the heavily marketed message the benefit of the doubt rather than challenge it too critically. I strongly suspect that the evolution of the immunotherapy space in NSCLC will show a similar story and that carbo/pemetrexed/pembrolizumab will be adopted broadly regardless of any lingering questions of whether it is necessarily the best treatment approach for most patients.

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Winston Wong, PharmD (Posted: January 10, 2018)

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Prior to the "Benefit Exchange" individual market, most states had regulations stating minimal, but essential, mandatory benefit coverage for individual and small groups. Due to the high risk pools in this population, cost ratios were high. Payers had to attempt to manage benefits to minimize losses. Some were aggressive and survived. so if we look back, the model was in place insuring access to care. What came about with the exchange market was that the mandatory benefits were expanded benefit, resulting in a high actuarial cost. Hence, the market blew up. Maybe we need to step back in time to evaluate bringing back a model that may have come closer to being affordable.

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Winston Wong, PharmD (Posted: January 10, 2018)

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Annual drug price increases is around 7-9% annually. Negotiated Rebates help to counter these increases, but as Mr Fraizer points out, only a small portion benefits the patients directly. What little actually benefits the patient is negated by increases in copays and coinsurances. So maybe the solution is to do away with rebates entirely and move to a straight list price strategy. Then in order to achieve a coverage status, the competition is then convert to a price war. Price wars to lower cost is cleaner and more transparent than todays world of increasing prices, balanced by PBM negotiations to gain bigger rebates, only to have a good portion to go towards their profit margins, and little benefiting the patient.

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Winston Wong, PharmD (Posted: January 10, 2018)

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Very interesting results. Accurately stated, early analysis of OncoTypeDx showed positive cost effectiveness based upon ideal conditions. There is no argument that real world practices paint a more realistic analysis of cost effectiveness. While early studies did note that a portion of the women determined to have high risk of recurrence opted to skip chemotherapy treatment. They also note, as within this study, that a portion of women determined to have a a low risk of recurrence went on to have chemotherapy. What one needs to question is why did these women opt to undergo chemotherapy treatment. In addition, if chemotherapy was part of the treatment plan, why was the test even completed? Also, if chemotherapy was not a treatment option, why was the test completed. I do not disagree with the findings, as they confirm the findings of early studies (if you dig into the detail). So maybe the true action point here is what can be done to refine the inclusion criteria to run the test in the first place. Maybe tests like OncoTypeDc and Prosigna will become much more cost effective if completed in the appropriate population.

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William McGivney, PhD (Posted: January 04, 2018)

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As new innovative treatments are advancing to market, it is disconcerting to see that standard treatments such as the radiation component of the combination of chemotherapy with radiation are not being accessed by patients due (still) in part to coverage issues with Medicare/Medicaid. This then raises issues about how coverage policy will keep up today (in 2018) with the rapid advances for the treatment of cancers, including SCLC. The findings of this MD Anderson study are not encouraging!
Years ago in moderating a session, I asked the Chief Medical Officer of Medicare, in a half-serious, half-facetious way, if we really needed coverage policy any more as it seemed to be more hindering of access and availability than facilitating. I think today, I would move the question to being 80% serious.
Coincidently, as I was writing this, I was interrupted by a phone call survey regarding my views of the PBM managing my Part D benefit! Needless to say, questions, such as “how helpful the PBM’ was, were met with responses approaching the nadir of appreciation!

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Winston Wong, PharmD (Posted: January 04, 2018)

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All good comments made by ASCO, however, I still an a firm believer that while we continue to focus on the providers prescribing, the Opiate issue is bigger than those whom we are monitoring. Just the other day did we read findings of patients continuing to fill opiate prescriptions after there was no need. Granted a prescription should not have been written for 12 months, but the patient still had a responsibility to not fill the prescription. We also have family members that take the opiate meds from other members of their family. And finally, we ultimately have providers and patients working together to maintain the "habit. So while screening programs and guidelines are a step in the right direction, it is not the comprehensive solution.

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Winston Wong, PharmD (Posted: January 04, 2018)

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Is this a little too late? The average prescription benefit now sees generic dispensing rates in the mid 80's, with the more aggressive plans hitting near 90%. As well, when generics are released, they are being released at a higher cost than what we traditionally are use to. Discounts are not as aggressive these days. Maybe what we need to see is more effort put towards the biosimilar approval process, rather than the analysis paralysis we are now experiencing.

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Winston Wong, PharmD (Posted: January 02, 2018)

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These 7 Key Trends are definitely a continuation of what we have seen through 2017. From a payer perspective, while the decrease in Chemotherapy is balanced by the increase in targeted therapy is technically true, in the end, the patient is receiving some treatment, which is driving cost. We all will have to deal with how to deal with rising cost. Is value-based payments in the future? Probably yes, but not the near future as we all need to determine a methodology to define value and outcomes. Payers will be put into more of a struggle as the number of tumor agnostic tests increases and payers need to modify their payment policies. And finally, patient outcomes and satisfaction will become part of the "value" equation.

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Howard Sandler, MD, MS, FASTRO (Posted: January 02, 2018)

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Interesting concept and interesting that it made it thru small business grant all the way to FDA 510(k) approval. Now comes the real challenging part: Is there a market for a breast-cancer specific radiation treatment device?

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Dean Gesme, MD (Posted: December 20, 2017)

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Tumor heterogeneity is well described but the variability in these NextGen liquid biopsy results seriously calls into question how and when these test results inform best clinical practices for these patients!

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Thomas Marsland, MD (Posted: December 12, 2017)

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So how many part inhibitors do we need, how many check point inhibitors are necessary? Does every company need a "me too" drug. Clearly the cost of pharmaceuticals is a major problem for all of us. One "experiment" that should be considered is including the price of a new drug as part of the approval process. If a new drug in a given class is truly interchangeable, then as part of the value proposition there should be some cost benefits to the payers and patients.

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Thomas Marsland, MD (Posted: December 06, 2017)

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So the glass is half full or half empty. Clearly conveying bad news is never easy but honestly is the best policy. Most patient do appreciate the truth but sometime the messenger is killed. It is difficult to offer hope and realistic expectations. In all of the changes to the idea of patient centered care seems that what patients value most is an open and honest discussion of realistic expectations. These types of discussions often require more time and indeed need to be repeated over a number of visits. Going forward the hope is the system will allow for these types of interactions.

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Howard Sandler, MD, MS, FASTRO (Posted: December 05, 2017)

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PSMA PET and fluciclovine PET are rapidly changing the management of recurrent prostate cancer. Conventional imaging modalities, say bone scan or CT, would only detect recurrences at relatively high PSA levels when local management might be less optimal. However, PET imaging can now detect low volume, low PSA recurrences after surgery that are potentially amenable to local ablation with additional surgery or radiotherapy.

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H. Jack West, MD (Posted: December 04, 2017)

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On balance, I think this is an advance, as I believe that the lack of certainty about coverage is a significant barrier in getting NGS testing. For cancers like lung cancer, where there are already multiple molecular markers that can be tested individually or through NGS with a savings of limited tissue and potentially cost, there is a clear advantage to efficiency of broader testing. It's less clear that NGS is beneficial for a cancer for which there are not several previously identified markers to evaluate for.

Though we might have some concern about mass scaling of a test costing several thousand dollars per test when there are no data demonstrating that this improves patient outcomes, I think there is more potential for harm based on poor decisions resulting from testing. Specifically, some clinicians may impart too much optimism on a treatment recommended based only on preclinical data and a theoretical benefit. These NGS reports include a wide range of possibly beneficial treatments, but that long tail, in order to justify the cost of the test, very often includes treatments of unclear if not frankly dubious benefit. There is the potential for net harm from the suggested targeted therapies, especially if oncologists and patients discard treatment options that are not individualized and therefore less sexy, but they still have well-established efficacy across broad populations. And there is definitely reason to be concerned that the costs of care will rise significantly because many oncologists will have too low a threshold to administer everolimus, at a cost of more than $10,000/month for every tenuously recommended mutation that could be associated with benefit.

Whether broad molecular testing provides a quantum leap in efficacy of treatment or only its cost will depend on how wisely oncologists use the data that will pour in from this testing.

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H. Jack West, MD (Posted: December 01, 2017)

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While reassuring to see that the results in a Chinese population recapitatulate those seen in global phase 3 trials with other populations, these results only provide results I would have presumed to be the case. Reassuring, but it wasn't a question I would have had without these data. I have many Chinese patients and haven't hesitated to treat them with nivolumab in the second line setting based on the results of CheckMate-017 (for squamous NSCLC) and CheckMate-057 (for non-squamous NSCLC).

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Dean Gesme, MD (Posted: November 29, 2017)

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The CMS MIPS program will strongly disfavor oncology practices who must include "buy and bill drugs" in the cost of care provision which is weighed to increase rapidly over the next 3-4 years. APMs may be the only avenue for private practices to maintain "buy and bill" after 2018 unless the MIPS program is changed to remove drug costs from their calculation of MIPS points.

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Heather (Posted: November 19, 2017)

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Thank you for this article. Working for a genetic counseling clinic for cancer patients and providers, we too agree with the idea of, “Oncology tends to lend itself to multidisciplinary care because of the complexity of treatment.” This also helps patients in receiving more personalized treatment plans.

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H. Jack West, MD (Posted: November 14, 2017)

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This is interesting and somewhat helpful for turning a clinical observation at the anecdotal level into retrospective data that actually characterize the frequency of this issue in a clinical population. However, we also need to ask what we do with this information. The report indicates that hyper-progression is seen a little more commonly with immunotherapy than with chemo in advanced NSCLC. However, we can't reliably predict who will demonstrate hyper-progression. The authors find that patients with a higher number of metastatic sites have higher risk, but the absolute difference isn't enough to make this a clinically helpful predictor. Given the clear survival benefit with several immune checkpoint inhibitors over chemo in previously treated NSCLC, this information doesn't/shouldn't dissuade an oncologist from favoring a checkpoint inhibitor based on the far more clear prospective clinical trial data.

That said, it's a valuable starting point for further study of this issue.

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Ted Okon (Posted: November 14, 2017)

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This injunction filed by 3 hospital organizations and 3 hospitals will be interesting to watch. Regardless, 340B hospitals are clearly in the crosshairs of this Administration and Congress. On the other side, the hospitals are fighting mad to retain all the 340B profits available to them. As I have said many times during the past few years, 340B is a financial bubble that has to pop. It is simply not sustainable.

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Thomas Marsland, MD (Posted: November 08, 2017)

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Certainly the original intent of the 340B program is laudable. Throughout the years the program grew and became subject to along list of abuses. Through numerous loop holes this became a vehicle for hospitals to expand costly cancer programs at the expense of more efficient community practices. This ruling is a welcome first step in helping to save the integrity of the program and its transparency. As the article suggests the patients and tax payers will benefit. Hospitals now will have to compete on a more even playing field with private practices and perhaps will learn some of the efficiency community physician had to learn the hard way when the original ASP rule went into effect.

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Dean Gesme, MD (Posted: November 08, 2017)

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DIR fees represent an egregious, morally indefensible and obscure business practice that will push PBMs to the edge of ethical and legal acceptability for patients, providers, regulators, and legislators. Be forewarned!

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H. Jack West, MD (Posted: November 07, 2017)

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The FDA approval for alectinib (Alecensa) as first line treatment for ALK-positive advanced NSCLC is long awaited and should make it a clear standard of care in this setting. The superiority of alectinib over the prior standard of care of crizotinib is remarkable, and alectinib also has highly superior efficacy vs. intracranial progression, which is a common issue in patients with ALK-positive NSCLC. It is also generally quite well tolerated by patients.

Though we still need to learn more about how to best treat patients who develop acquired resistance to alectinib, whether that be with a subsequent ALK inhibitor like brigatinib or lorlatinib (which we hope to see approved in the first half of 2018) or a chemotherapy-based approach, the median PFS for alectinib of over 2 years suggests that we have some time to figure that out.

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H. Jack West, MD (Posted: November 03, 2017)

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Reading the headline, one might get the mistaken impression that this agent showed clinically meaningful results in relevant endpoints. These results are clinically meaningless and are only instructive for showing how garbage results in bogus endpoints can lead to misleadingly positive results.

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Winston Wong, PharmD (Posted: November 02, 2017)

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A change is needed. Currently, there is no incentive to use a biosimilar. End of Story.

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Winston Wong, PharmD (Posted: November 02, 2017)

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There is one subtle, but very real difference in the CVS/Aetna combination when comparing to Anthem, Humana, and UHC. In the latter, the Healthplan owns and drives the PBM. In the former, CVS is purchasing Aetna, so the tides are turned opposite. Should lead to an interesting model development process.

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Winston Wong, PharmD (Posted: November 02, 2017)

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There is no doubt in my mind that pre-certification criteria will become more precise in identifying patients in where there therapies will be used. In the appropriate patient, payers will have a hard time denying coverage.. The trick is to find the appropriate patient. in some respects, it is no different than what we see today with other classes e.g. PCSK9's, but the stakes are higher. We can approve many PCSK9 patient for each CAR-T patient. On the other hand, we will probably see a more definite positive outcome with the CAR-T. Such a dilemma

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Winston Wong, PharmD (Posted: November 02, 2017)

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Educating physician about biosimilars is a big step to help gain confidence that the biosimilar will indeed produce a similar clinical benefit. But will not drive biosimilar utilization to expectations. First, we need to get the approved biosimilars out of court. The legal system is hold the biosimilars hostage. Second, with the current biosimilars only representing a 15-25% discount off the reference product, this is clearly within reach of the reference products to reduce their cost down to near parity. At a near parity cost, why switch. In short, much more than education is needed to drive biosimilar utilization, as as usual, the main factor will be the "$".

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Thomas Marsland, MD (Posted: November 01, 2017)

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Emergency rooms generally are not cancer patients friends. I have found that in routine community practices that if a cancer patients gets to the hospital they are almost routinely admitted. This causes frustrations for the patients and the oncologists. This is normally an after hours happening. Clearly extended office hours as proven in the "come home" project can minimize ER and hospital visits and help reduce the cost of care. Er's often over do testing and once patients are admitted especially to the hospitalist service tend to have extended admissions. Most community cancer practices can handle issues such as dehydration, N&V, diarrhea and pain control as an out patient. The concept of an observational unit is a good starting point but really most of these patients could be stabilized with minimal problems in the ER and then discharged to home with next day follow up in the office.

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H. Jack West, MD (Posted: October 30, 2017)

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At best, this reflects a conclusion from Merck interactions with the EMA that, unlike the US FDA, the EMA would not be persuaded by the favorable results of the phase 2 KEYNOTE-021g trial that enrolled 123 patients. The FDA decision has largely been met by surprise and some derision by many (I would even say most) specialist thoracic oncologists for being a big leap based on a phase 2 trial that, unlike an approval for therapy in a rare mutation population, is in a very common one. Moreover, the arguably premature FDA approval for carbo/pemetrexed/pembrolizumab was given despite the fact that multiple phase 3 trials of chemo vs. chemo/immunotherapy should report results in the next 6-12 months.

A skeptic might suspect that Merck's decision may be related to the company having knowledge of their phase 3 KEYNOTE-189 results not looking as favorable as the KEYNOTE-021g results. Of course, the field of oncology and especially lung cancer is replete with cases of a highly positive phase 2 trial being followed by a clearly negative phase 3 test of the same treatment (figitumumab, onartuzumab, etc.), so this is all too easy to envision.

Certainly, the fact that this was released after 4 PM ET on a Friday designates that was recognized as bad news by the company. Nobody ever waits to releases great news until moments before the weekend starts.

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Thomas Marsland, MD (Posted: October 26, 2017)

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OK so there are days I feel stressed... who doesn't?? But burnout not really. People have asked me when I'm going to retire and I say never... I love what I do. Dealing with oncology patients is indeed challenging. They present with complex issues... medical but also emotional, financial, psycho-social, spiritual and more. It is difficult but rewarding in helping folks get through very difficult times. The stresses and burnout problems for me are much more in dealing with the non-clinical parts of the practice. All the new recording, documenting and regulatory requirements. The EMR's have turned me into the billing, coding, and scheduling person in addition to the care provider. I have been blessed with a loving and supportive family and have always been able to leave the stress of the job at the door when I leave. Balance is important, time for oneself (and family) help me get though all the burnout issues..... a good Napa Cab helps too.....

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Robert Daugherty (Posted: October 24, 2017)

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It's a shame your patients are not illegal immigrants......No driver license, no social security # and most can not speak a word of English. They receive their surgeries, chemotherapy, medications, rooms and even a hospital provided interpreter and in some cases even transportation to and from the hospital. We have US citizens scraping up every dime they have saved, mortgage their homes and some cases having to sell them, pull their kids out of college, canceling their children's weddings and in some cases filing bankruptcy all struggling to pay for cancer treatments. Yet individuals that are in this country illegally get their treatments completely free, Something is wrong with this picture and needs to be stopped. We pay for this one way or the other, don't let anyone tell you illegals do not cost American taxpayer.

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Winston Wong, PharmD (Posted: October 22, 2017)

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It is interesting to see how situations come back around. Recall that Anthem Pharmacy Management once existed, prior to signing on with ESI. Now they are starting up the old strategy again. Whether there is more transparency or not, the one thing that will happen is that Anthem will have greater control of the over all pharmacy strategy.

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Winston Wong, PharmD (Posted: October 19, 2017)

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This study is very similar to the study completed by Peter Bach in 2015. Dr Bach looked at the initial cost of the drug when released, and then tracked cost increases. This study confirms his finding. No matter how you slice and dice the data, the bottom line is that we are still an a time of unsustainable cost increases. The next step is to compare the increases in the US vs. Europe.

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Winston Wong, PharmD (Posted: October 19, 2017)

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From the payer standpoint, there is a belief that smoking cessation programs work to some degree. At one time, it was even a requirement to participate in a program when coverage for smoking cessation products were requested to be covered. However the results were spotty. The success rate was low, driven by the overall member motivation to take the program seriously and successfully complete the program. If we focus on that small piece of the population, the ROI is significant. But looking at it from an overall standpoint, the ROI is not as impressive

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Sasi (Posted: October 19, 2017)

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Who can afford this drug?

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Dean Gesme, MD (Posted: October 18, 2017)

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Rehabilitation and Pre-habilitation are woefully underutilized by oncologists as adjuncts to the treatments which we prescribe. Patients deserve the opportunity to optimize their physical wellbeing in order to maximize quality of life and minimize treatment related toxicities.

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Robert D Orzechowski (Posted: October 16, 2017)

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Thanks, Don, for publicizing this despicable behavior by the upstream entities involved in the drug value chain for cancer patients.
While about 90% of all SP prescriptions are for generics, only about 10% of private oncology practice's dispensing is for generics. Compounding this situation are the delays for drugs and approvals by SPs, which compromise patient care. It is not hard to quantify the significant waste and cost avoidance the community oncology dispensary or pharmacy can capture and thus reduce the cost of care while ensuring high quality, timely, care. Employers who purchase these group health and Rx benefits are unaware of the cost impact they subsidize with the plan designs they buy for employees.

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H. Jack West, MD (Posted: October 10, 2017)

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This is an unfortunate result, in a hard setting to treat. About 20% of patients with advanced NSCLC have a KRAS mutation, making it the most common molecular aberration we see, but also one for which we have no effective targeted therapy. Abemaciclib demonstrated promising activity in earlier phase clinical studies, so this was certainly an important study. However, the fact that patients with a KRAS mutation are well recognized as been especially unlikely to benefit much from EGFR TKI therapy like erlotinib have led some critics to charge that the control arm in this study was receiving what we might interpret as little more than a placebo with side effects.

Nevertheless, there was no difference in overall survival. Despite the improvements in some secondary endpoints and the charge that the control arm did better than expected (which I believe was due to the requirement that patients have failed docetaxel-based chemo, along with most having received an immune checkpoint inhibitor as well, making this a highly selected population for less aggressively paced disease), these results will likely not be enough to make this a viable treatment approach.

Effective treatment for KRAS mutated NSCLC remains a significant unmet need, with insufficient progress marked by this agent and trial.

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H. Jack West, MD (Posted: October 09, 2017)

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The data from FLAURA definitely support a first line approval, and the NCCN has just revised their guidelines in NSCLC to reflect that. The lung cancer community looks forward to a prompt approval of osimertinib in the first line setting. I have several patients in whom I am eager to prescribe osimertinib based on this indication. It can't happen soon enough.

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patrick stagg (Posted: October 08, 2017)

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It was one of the reasons I was happy to retire from the hospital owned practice. Most physicians probably do not see the difference, but our lab charges went from double digits as private practitioners to triple digits. Chemotherapy I did not want to see.

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Thomas Marsland, MD (Posted: October 05, 2017)

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This is an interesting concept. Although this sounds good it may not in the long run hold down drug costs. If a producer knows that 20% (40,50 whatever %) of the treatments are not effective then what is to prevent them from just adding 20% to the initial cost of the drug knowing that they will have to refund that 20%? This indeed is a proposal that should be studied and indeed was discussed in the ASCO white paper on drug costs but is really needed is transparency on how drug prices are developed in the first place.

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Dean Gesme, MD (Posted: October 05, 2017)

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An excellent editorial this past week in JCO authored by Jim Armitage and Dan Longo on this important topic.

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Trish Goldsmith (Posted: October 05, 2017)

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Bill is spot on with respect to his comments and concerns related to the latest iteration of an NCCN product. Over 20 years of work and institutional effort has been devoted to the highly respected NCCN Guidelines and derivative NCCN Drugs and Biologics Compendium.
It is once again disconcerting to see yet another way in which this highly effective and influential effort has devolved. It is also, yet again, another demonstration of the total absence of the patient voice in bringing value to the the delivery and coverage of oncology care in the US.
In addition, it is totally devoid of valuable input from the industry that has and continues to provide NCCN with the vast majority of their vital funding. This funding allows NCCN to continue the good work of those that have devoted tens of thousands of hours to ensure that all patients have access to the best standard of care in oncology.
The voice of patients that count on NCCN and the industry that funds them must be acknowledged and valued.

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Thomas Marsland, MD (Posted: October 04, 2017)

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So clearly less is less..... but less for some maybe more for others. The hospitals have used the 340B program to expand their control of cancer care for years. In the Xcenda report discussed in prior OBR daily's it is noted that 75% of the hospital acquired practices come from those with 340B status. So much for that margin providing indigent care... That report also discusses how hospital centered care costs 60% more than the same care delivered in a private practice setting. This amounts to $90,000 a year more per patient. That report also describes a much greater ER and hospitalization rate by hospital based practice. Community physicians have been under the gun with falling reimbursement for years and that has led to improved quality and efficiency's such as the Come Home Oncology Medical home. Another interesting comment in Moody report points out that patients actually will save $180 million dollars a year. It makes no sense to continue to subsidize hospital programs that result in greater cost of care. Hospitals need to learn to reduce their costs as the doctors in private practice learned to do. The 340B program is broken and abused by hospitals to sustain their margins and inefficiency. The playing field needs to be equalized.

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Thomas Marsland, MD (Posted: October 02, 2017)

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I recently had the opportunity to talk with a group of medical oncologists about MACRA. Many of these physicians are still practicing in small groups or single doctor offices. At the end of the discussion I felt I had to hand out prescriptions for Zolof (a good Napa Cab had already been supplied). They were clearly overwhelmed with the rules and regulations and compliance issues in the new law. These heap additional expenses on already overburdened small practices. This report AGAIN demonstrates the cost efficiency of care delivered in the private practice setting. When physicians control the care delivery, we have continually shown that we can do a better job at cost control than care delivered in a hospital program. Hospitals have a dramatic economic advantage over private practice with things like the 340B pricing and the OPPS. They can give the oncologist greater economic security but at a larger cost for equivalent care. The powers that be must soon understand that the present system is driving doctor out of private practice and that if effort to equalize the reimbursement landscape are not changed there will be no private practices left (I suspect that is their real objective).

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Dean Gesme, MD (Posted: October 02, 2017)

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Early results affirm that this new agent might offer additive benefits in the evolution of serial therapies for castrate resistant prostate cancer.

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H. Jack West, MD (Posted: October 02, 2017)

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Sadly the headline, "DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients with Cancer" leaves out the phrase "with no better accuracy than standard PD-L1 testing". To be clear, if positive, patients have a 45% response, and if negative, it's 15%.

Perhaps a better headline would be "New test NOT helpful, with results neither necessary nor sufficient to predict which patients will benefit from immunotherapy".

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Howard S. Hochster, MD (Posted: October 02, 2017)

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This interesting study from Kurzrock and colleagues looks at circulating tumor DNA (ctDNA) to determine who may benefit from immunotherapy. The study included 69 patients with various diagnoses. With more than 3 mutations detected on the 70-gene panel the response rate was 45% in this group compared with 15% for those with 3 or fewer mutations. Presumably this is closely linked with the calculated "tumor mutation burdern" score. This is a good step in the effort to define the utility of ctDNA which is determined on a blood draw and can be done serially. The title refers to this as "liquid biopsy" though in the old days it was just "phlebotomy" for a blood analysis.

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Jeff Patton (Posted: September 28, 2017)

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We have know for years that the community setting is the lower cost site of care but have been slow perform and publish the studies to prove our case. Congratulations to Dr. Gordan and his collaborators for this publications. Hopefully as we move toward value based reimbursements patient treatment will migrate back to community oncology clinics where the cost of care is lower and patient convenience is better.

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Dean Gesme, MD (Posted: September 26, 2017)

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Lower radiation doses in HPV+ Head & Neck cancer would dramatically reduce toxicity and expense of treating this rapidly increasing virally related malignancy. Potentially practice changing with additional confirmatory data.

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H. Jack West, MD (Posted: September 25, 2017)

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I thought this result might actually have clinical implications until I saw that the randomized trial enrolled 29 patients. It's ridiculous to draw any conclusions from a randomized trial of so few patients. it's interesting and provocative, but it needs adequate follow-up in the form of an appropriately sized phase II trial, or better yet, phase III results.

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Trish Goldsmith (Posted: September 22, 2017)

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Bill is spot on. It is truly sad to see such a wonderful and influential product and the outcome of many years of hard work devolve into its latest iteration. Yet again, another example of a product that is totally devoid of patient input.

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Robin Hutchinson (Posted: September 19, 2017)

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I have to salute FCS for always going above and beyond to care for their patients. There are 47 FCS locations in my territory and Dr. Bustinza is one of the physicians I call on. Dr. Bustinza is such an outstanding physician that it does not surprise me that he and the practice made sure this special gentleman (patient) received the care he needed.

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Howard S. Hochster, MD (Posted: September 15, 2017)

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First approval for a biosimilar in solid tumor usage! This should help bring down the cost of bev by about 1/3. Other bev biosimilars to follow. There is no approval for interchangeability with originator bev, and this must be prescribed specifically using the suffix. But this should be regarded as a step forward for patients and for control of costs. Ironically, Amgen took Novartis to the SCOTUS to delay their roll out of biosimilar filgrastim. Speak to your pharmacy committees!

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H. Jack West, MD (Posted: September 08, 2017)

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The results of the ALUR trial are impressive but not surprising at all. We should expect a second generation ALK inhibitor to be superior to chemotherapy in crizotinib-pretreated ALK-positive patients. The difference is very striking and highly clinically significant in every efficacy endpoint. The efficacy of chemotherapy was rather disappointing overall. But this trial population should not exist for much longer.

Today, with alectinib now becoming the first line therapy of choice for ALK-positive questions, the more relevant question is whether a subsequent alternative second generation ALK inhibitor, such as brigatinib, is a better choice than chemotherapy in alectinib-pretreated patients.

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Thomas Marsland, MD (Posted: September 05, 2017)

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WOW...that is a hunk of change...BUT it would appear that Novartis is at least following some of the suggestions in the recent ASCO paper on drug prices. They would appear to be looking at whether the drug works or not as part of the pricing. In addition they are also considering different pricing for different diseases with different efficacy and hence a somewhat different value proposition. Both approaches suggested in the ASCO report. With that said, $475,000 is still a heck of a lot of money. There is still very much a lack of transparency in how they came up with that number. It is interesting the market was predicting even higher pricing so this number makes them look good. They quote a billion dollars in investment but that is the number quoted for any new drug so why the huge pricing difference for this drug compared to other new innovative cancer therapies. Clearly Novartis has taken some steps toward better drug pricing but no question we still need to do better at controlling new drug costs (some old ones too...)

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Howard (Jack) West, MD (Posted: August 30, 2017)

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FLAURA was added to the meeting and press program after I wrote these comments. We will still need to see whether the PFS benefit is of a magnitude that is worthy of a change in practice, but it's reassuring that the data will be presented at this first large meeting after the press release.

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Thomas Marsland, MD (Posted: August 17, 2017)

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So I actually had the chance to read this article in the Sunday Times while traveling (am usually more of a WSJ guy). I think it raises a number of interesting points. One is the idea of how many drugs in a given category do we really need? Are 20 check point inhibitors really necessary? Yet every company wants to have one of their own. I would respectfully suggest that after the first two or three drugs in a given category, if efficacy is comparable, that cost as part of the value proposition should be considered in the approval process. If it costs less then it should be approved. Clearly one of the issues is that we need to put more patients on trials. In adult community oncology we put as an average only about 5% of patients on trials. We should undertake a national initiative to increase this number significantly. Why not 15% or more??? As the cost of treatments escalates it is even more important that we have the right drug for the right patient at the right time. Only through research and clinical trials will we be able to do that. With that being said we therefore need to make trials more available and easier to use in the community. Trial design looking at alternate marker outcomes for target treatments will result in shorter, less costly trials requiring fewer patients. As I said in one of my other comments, having clinical trials available in my new practice has gone a long way toward making it more fun again.

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H. Jack West, MD (Posted: August 14, 2017)

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It appears that while the PACIFIC trial of durvalumab consolidation after chemoradiation is being presented at ESMO, we won't see data from either the MYSTIC trial (durvalumab/tremelimumab or durvalumab monotherapy vs. chemo doublet first line for advanced NSCLC) or FLAURA (first line osimertinib vs. erlotinib or gefitinib for EGFR mutation-positive advanced NSCLC).

We knew MYSTIC is negative for a PFS benefit, so we should perhaps not be surprised that AZ isn't eager to highlight the results, but I think if there were anything favorable to mitigate the disappointment, they'd have tried to stanch the bleeding by presenting the data. I suspect there will be little to encourage us when AZ ultimately deigns to show us real data.

More notable is the omission of FLAURA from the ESMO program, a trial reported as positive for a significant improvement in the primary endpoint of PFS that could potentially change practice and broaden the indication for osimertinib to include first line treatment if the PFS benefit is substantial enough. Unless AZ just doesn't want to compete for the limelight with the PACIFIC trial that will likely cause a Beatlemania-reminiscent hysteria by both being an immunotherapy and being positive, this suggests that the results aren't as captivating as some would have hoped. As an alternative, the IASLC may have promised the moon and the stars to AZ to postpone presentation of a high-impact trial for the first time at the World Conference on Lung Cancer, but I would have anticipated that AZ should want to get positive results out on a potentially practice-changing therapy to as broad an audience as possible, as quickly as possible.

We'll eventually see what the data show, but I'm disappointed that two of three important lung cancer trials from which we've heard initial results from recent press releases apparently won't be presented at ESMO.

Makes you wonder why they're dragging their feet.

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Winston Wong, PharmD (Posted: August 14, 2017)

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The rationale is pretty simple. The branded drugs are now presenting deep rebate discounts, and bring the net cost to somewhere comparable to the generic/biosimilar. If the cheaper drug was dispensed outright, the only win is the patient paying the lower copay and payer experiences an immediate cost savings. If the more expensive brand is dispensed, the PBM/Payer get the rebate, of which the PBM receives a portion of, and hopefully the piece of the rebate that is passed through to the payer will bring the cost down, if they can even track it. So in essence, that final statement is very true. Someone has to be making money from the deal to make it fly.

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Thomas Marsland, MD (Posted: August 10, 2017)

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So I usually do not even know the exact cost of the drugs. I believe for me and many of us this is a carry over from the days that chemo was a revenue generator for the practice and I did not want to be biased by potential income and wanted to base my treatment recommendations based on the effectiveness and toxicity of the drugs. With that said I am aware of the general expense of the drugs and will often tell patients that the treatment is "expensive." Indeed we do make treatment choice today based on cost, especially in relation to whether the treatment may fall under the medical or pharmacy benefit package. We do have financial counsilors in our practice who can and do have the expertise to make patients aware of the cost of therapies. It really is unrealistic to expect the doc to spend a lot to time talking about drug cost and insurance benefits, things about which we really know every little when our time is much better spent discussing the patient's disease, treatments, and outcomes. The recent NCCN review of patient concept of value confirms that what they really want is time with the physician to discuss their outcomes. Clearly cost is a key piece of the value proposition but it is not the only one and I believe patients are better served discussion cost and coverage with our financial councilors who are better trained to do this than me.

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Thomas Marsland, MD (Posted: August 08, 2017)

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I would tend to agree that the oncologist generally should be the one to deliver long term follow up care. There really are several reasons for this. The patient and the oncologist develop a generally intense relationship during the times of active disease and treatments. The level of trust and communication is often more than that experienced in other settings. Also we in the oncology field tend to be more available to our active patients who many times need to be seen acutely and cannot wait for delayed appointments. These carry over as patients transition into survivorship care. There is just that level of comfort for all parties. In addition it always made my day to see Ms Jones my 20 year breast cancer survivor; it is important for us as the care givers to experience the success stories too. All this is not to say others cannot provide this longer term care but at least for me I would definitely be missing something.....

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Thomas Marsland, MD (Posted: August 08, 2017)

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Thank you Reagan-Udall foundation. One of the really great things to come from my recent move to California (aside from all the great wines...) is the very active research program my new practice has. In all the different Jax practices we had very limited research opportunities. In Petaluma/Santa Rosa the research environment is robust. This group puts 15% of patients on clinical trials much better than the average. It has helped me in my patient management to have access to the newest and best protocols. The R-U Foundation adds another piece to this. I think that we all need to rededicate ourselves to clinical trials and research. It is the only way we will develop the "right drug, right patient, and right time" that will be critical to delivering the quality and value going forward.

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Dean Gesme, MD (Posted: August 07, 2017)

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After a decade with only sorafenib for advanced HCC, it is refreshing to have several promising new targeted drugs and immunotherapies vying for first and second line status in this disease.

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Winston Wong, PharmD (Posted: August 04, 2017)

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The finger pointing between Pharma and the PBM's is looking much like the political arena with regards to ACA. In all reality, both are stockholders and both contribute to the high cost of drugs. The last factor that no one is considering is that whatever, and wherever the price is set at, we will reimburse. That is not the case in Europe, especially in the countries mentioned. In those countries, if the price is too high, the drug is not reimbursed.

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Winston Wong, PharmD (Posted: August 04, 2017)

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The initial release discount of 15% by Pfizer did not spark much uptake, mainly because, in my opinion, a 15% by J&J was well within striking range. Now with a 35% discount on the table, the sandbox should become more stirred up. Not that 35% is not within J&J's range as well, but the payers need to step up to the plate and drive utilization.

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Winston Wong, PharmD (Posted: August 04, 2017)

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Very significant findings, especially if we are looking for "Real-World" evidence. As noted, the need is not only in cancer, but in all diseases. While it is noted that physicians need to do a better job for recruitment, I would surmise that the senior population will usually have not co-morbid conditions that exclude them from the trials, as wells the senior population not being able to handle the rigid controlled monitoring process.

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H. Jack West, MD (Posted: July 31, 2017)

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We have learned from a press release that the PACIFIC trial is positive for a significant improvement in PFS after chemo/radiation for patients with locally advanced, unresectable NSCLC. Because this treatment entails an extra year of IV treatment every two weeks and a cost likely in the range of $180-200K per patient, most experts feel that the PFS benefit should be remarkably long and/or be accompanied by a significant improvement in survival. In this setting, demonstrating a 3-4 month delay in relapse without a survival benefit won't offset the cost in terms of time on treatment for patients or cost to society. The entire lung cancer community looks forward to the presentation of the actual trial data at an upcoming meeting -- I hope at ESMO 2017 (where I will be happy to provide commentary on the detailed findings).

If the PACIFIC trial achieves these criteria, it should rightfully become adopted as a new standard of care in this setting. It would be ideal, however, if we can determine which patients are most or least likely to benefit from this extended treatment so that we can concentrate these extra efforts and costs on the patients who will truly benefit from them.

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H. Jack West, MD (Posted: July 28, 2017)

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It's important to note that while the statistics may well be over-interpreted/misinterpreted to imply that pemetrexed demonstrates meaningfully superior efficacy vs. other partner agents for a platinum in advanced non-squamous NSCLC, I and most of my colleagues who have a particular focus and expertise in thoracic oncologists try to be very judicious in our interpretation of the landscape. Few if any of us would consider pemetrexed to be the clear best choice among the various options, and I don't think any expert would consider alternatives to be a wrong choice. That said, there is near uniformity in favoring carbo/pemetrexed +/- bevacizumab in advanced non-squamous NSCLC not because it's overwhelmingly better but because it's just better enough in its therapeutic index to bubble up to the top. We need to choose one regimen, and for nearly all thoracic oncologists who have a full range of options available, the combination of good if not markedly superior efficacy combined with the favorable side effect profile, convenient schedule, and several other factors make it the best option to nearly all of us, even if not by a wide margin.

That it is expensive, and specifically more expensive than some very inexpensive and perfectly serviceable alternatives is a separate question. The reality of the situation is that few specialists in thoracic oncology are forced to weigh or even carefully consider the question of the incremental value of pemetrexed over other alternatives. Unless that issue becomes prioritized enough for US oncologists to be incentivized to carefully consider the relative costs of agents, we will focus far more on the patient experience and patient/physician satisfaction without feeling compelled to seek a relative bargain option.

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H. Jack West, MD (Posted: July 27, 2017)

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This is an important trial and a potential totally practice-changing result, but its true significance will ultimately depend on whether the PFS difference is not just statistically significantly better but whether the PFS with first line osimertinib is at least 6-7 months, and ideally more like 9-10 months better than gefitinib or erlotinib. Because first line osimertinib means losing a line of therapy for about 50-60% of patients who would test positive for T790M after first line gefitinib or erlotinib and still receive osimertinib second line (with an expected PFS of about 9 months), a PFS benefit of 5.5 months could be statistically significant for PFS benefit but not truly better than sequential therapies.

We will anxiously await the data from the trial, presumably to be presented at ESMO in September. I think the difference could turn out to be more than enough (thinking of the results of the ALEX trial in ALK positive NSCLC as an example), or it may turn out to be statistically superior at an endpoint that still isn't enough. I'll be looking for at least 7 months of PFS benefit (I'd discount from the 9-10 month PFS expected from second line osimertinib because here 100% of patients will receive the benefit, rather than just 50-60%), or an improvement in overall survival when we see the actual data.

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H. Jack West, MD (Posted: July 27, 2017)

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This is a very important negative result, as far too many thoracic oncology experts and financial analysts had already declared immunotherapy combinations as the second coming of the Salk vaccine and the presumed new standard for lung cancer for the future. As I and many other sober-minded people tried to remind everyone, we needed to SEE ACTUAL phase III data before drawing conclusions. As it turns out, this immunotherapy combination of durvalumab/tremelimumab at least, has failed to show a PFS benefit.

While it's remotely possible the IO combination will prove to be significantly better, we heard nothing positive about MYSTIC in this report, so I suspect that there is nothing encouraging to say about it. We haven't yet heard anything about the Checkmate-227 trial of nivolumab/ipilimumab, these agents are similar enough that I think it's very unlikely that another PD-1/CTLA-4 inhibitor will lead to a substantially different result. Moreover, this combination will need to be so much better that it justifies the phenomenally increased cost of the combination, as well as the likely far more challenging toxicity profile.

A sobering dose of reality, but one needed to remind us of the value of not getting too far ahead of the data in our speculation.

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Jeff Patton (Posted: July 19, 2017)

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It certainly appears the hospital lobby is getting their money's worth on the democratic side of the isle, and as per usual inconvenient facts are being ignored or distorted. For anyone that understands anything about business to say that huge government imposed discounts won't be offset with price increases is nonsense. Almost everyone agrees with the original intent of the 340B program but the explosion of the program is out of control. Cruise by your local tax exempt hospital and you will likely see cranes not hospital wing closures.

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john (Posted: June 29, 2017)

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Thank you for catching that error. We have corrected the sentence.

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cate (Posted: June 28, 2017)

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I believe that there is an error in the text. Monarch 2 is in hormone-receptor-positive, HER2-negative breast cancer. The first paragraph in that section says that it is HER2-positive.

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Thomas Marsland, MD (Posted: June 28, 2017)

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What a good looking group. Think I actually recognize a couple of them..... Indeed it was a good meeting. ASCO really is making itself visible at the AMA. We are truly proud of our own Barbara McAneny who was elected president of the AMA. She is a strong voice for community practices. ASCO heads the Cancer Caucus and helps spearhead resolutions that effect cancer care. But more and more it is clear that "our" issues really are issues that impact all of medicine. One can see from the article that MOC, MACRA, opiod abuse and network adequacy are issue effecting not only us but all. What really struct me was the true diversity of our AMA. The House of Delegates has its share of us old white dudes but the mix really is broad based. Doctors of all genders, race, sexual preference, age and political persuasion are represented. Resolutions are hotly debated since clearly such a diverse group has many opinions. The debates are always polite, respectful and comprehensive. The speakers of the house do a great job "herding cats." In the end resolutions are accepted by vote with majority rules. The main driving motivation of all of us there really is we all want the best patient care. Our national leaders could take a good lesson from the AMA House. I would encourage folks to consider joining the AMA. It really does do a good job of addressing issue critical to all of us....

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H. Jack West, MD (Posted: June 23, 2017)

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The approval of the dabrafenib/trametinib combination is significant for potentially tipping the scale clearly in favor of broader genomic NGS testing of lung cancer rather than a more selective approach of individual markers only. With BRAF V600E, a mutation seen in 1-3% of NSCLC, as the 4th clearly actionable marker for which we have an approved targeted therapy, the list of markers for which there is an effective therapy becomes long enough to move a growing population of oncologists off of the fence about NGS testing. This is especially true with effective therapy for MET exon 14 mutations and potentially also RET, HER2, and others looming as additional targets with sufficient treatment options to justify looking for them routinely.

Though patients with BRAF V600E are uncommon, the response rate with this combination is over 60%, and the median progression-free survival is in a range that clearly exceeds that of chemotherapy and should lead us to favor this approach; notably the approval doesn't specify a line of therapy in which this regimen should be pursued. The toxicity of the doublet is a relevant favor, I think particularly with regard to pyrexia. The cost of treatment, with a pair of expensive targeted therapies, is another challenge that could keep it from being eagerly adopted. There is certainly some risk of BRAF V600E becoming a "don't ask, don't tell" marker that isn't invariably looked for by oncologists unless there is a clear expectation/mandate/incentive to do so.

I think that this could be more significant for its implications in broadening the appeal of NGS for lung cancer than any major enthusiasm for dabrafenib/trametinib in BRAF V600E. It could tip the scale toward broad sequencing and at least provide a compelling option to answer the question of what to do if you find this marker.

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Winston Wong, PharmD (Posted: June 20, 2017)

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The article points out the biggest concern associated with the so-called abuse of the 340B program. As noted, the 340B program was intended to provide care to the poor. As such, while the institution requires a 51% discount on medications, the institution can bill the patient's insurer for the normal negotiated amount, thus allowing the institution to use the margin to help subsidize the care provided. Technically, the institution is suppose to bill for medications used for the poor only, but that has expanded to a larger population as noted. This is a pretty accurate description of the abuse that is taking place, which is contributing to the high cost of drugs. There has been talk of tightening the system up for years, but it has yet to happen.

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Thomas Marsland, MD (Posted: June 20, 2017)

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I had the opportunity to sit in on a presentation on OCM at the recent annual meeting in Chicago. It was clear from all the presentations that to transition from the traditional volume based compensation model to one based on value and clinical outcome that a robust IT platform is critical. We need to collect, review, and react on multiple data points in determining quality outcome and cost. The Flatiron program looks to fulfill those requirements. It does not surprise me to see Jeff and Bill leading the way... I would expect nothing less...

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Winston Wong, PharmD (Posted: June 16, 2017)

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There is an infrastructure problem, and the problem is that we need to do a better job to show the trust value of the generic profiling so that it will be paid for. If the tests are covered, the drugs will be used. Next, we need to have more comparative trials between like drug in classes so we definitely will know if one drug is better over another. Finally, we need to rebuild the entire reimbursement system so that pricing is not driven by what the market will accept. Simple changes .... Let's get them done!!

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Winston Wong, PharmD (Posted: June 16, 2017)

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This sounds like the same play innovator manufacturers are playing in the biosimilar world, where the reference product is not being made available to biosimilar companies to conduct their comparative studies. One other point to be made here is was the increase in copay from $42 to $250 due to the price increase solely, or due to a change in the benefit design?

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Thomas Marsland, MD (Posted: June 16, 2017)

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So one of the significant changes in all of the newer compensation models based on value is to include the idea of the what is important to the patient. We have to some extent done that but unfortunately all to often in the more traditional fee for service the patients perspective of what is valuable was not address. Value will change from patient to patient. What is important to a 35 year old mother will be drastically different than what if valuable to an 80 year old gentleman. Another important point is that these discussions have to be ongoing since the patients' definition of value will change as they migrate through the cancer treatment world. Formalizing the patients views as part of the ongoing record is a needed step forward.

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Thomas Marsland, MD (Posted: June 16, 2017)

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So right patient, right drug, right time. But it is not really that easy. As the author suggest more research is needed but in these tumors with rare targetable mutations collecting enough data is difficult. The prospective randomize trial will always be the gold standard but for rare tumors we may well have to rely on pooled real world data. Agree that the infrastructure is not yet in place but a number of programs such as ASCO's Cancer LinQ are being developed. It is critical that all of us participate in this and like programs to assure that we can accumulate sufficient data to help decide who is the right patient; which is the right drug; and when is the right time.

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Jeff Patton (Posted: June 16, 2017)

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Once again COA gets it right. MedPAC is completely out of touch with both the clinical issues and market forces in medicine. We all need to aggressively support COA to represent the interests of us and our patients.

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Winston Wong, PharmD (Posted: June 15, 2017)

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This is a big win for biosimilars. While biosimilars may not be discounted as much as expected, we are still seeing cost savings as rebates arrangements are becoming more aggressive. So now the question is whether the biosimilar manufacturers are ready to begin production sooner.

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Jeff Patton, M.D. (Posted: June 14, 2017)

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This is great news for community oncology. Barbara will be a great champion for us and the value we bring to our patients and our community. Congratulations Barbara!

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Howard S. Hochster, MD (Posted: June 13, 2017)

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A victory for consumers and cost control. SCOTUS overcame lower court considerations and parsed the BPCIA wording to mean that the biosimilar manufacturer does not need to wait 180 days after FDA approval. They can notify the originator company before actual approval. This cuts out the extra 6 month exclusivity Amgen was seeking. Looking forward to
more biosimilar molecules on the market next year.

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john (Posted: June 12, 2017)

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Editor's Note: We are in agreement with your comment and have removed the word "severe" from the sentence.

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Winston Wong, PharmD (Posted: June 12, 2017)

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Very positive for the genomic profiling movement. It goes along with the approval of Keytruda for cancers based upon a genomic result. This will be a challenge for for payers.

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Winston Wong, PharmD (Posted: June 12, 2017)

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The last time I looked up banning DTC ads, the US was only one of two countries that actually allowed advertisement on medications. We have plenty of other things that are banned, so why not DTC ads. think of the billions of dollars that goes into DTC ad, which could either be put back into the system, or used to low prices.

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donsharpe (Posted: June 12, 2017)

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This article contains a severe mistake in the first paragraph. The authors have confused the incidence of all grade adverse events with that of serious adverse events and misstate the following”…as 80% of the Nexavar-recipient patients in the SHARP trial experienced serious adverse events including diarrhea, hand-foot skin reaction and others.” The correct numbers can be found in the NEJM publication (cited as reference #2). Please kindly correct that statement by removing the word “serious” from the sentence.

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H. Jack West, MD (Posted: June 09, 2017)

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CIMA-vax-EGF is the most hype-driven piffle in lung cancer since dichloroacetate. There is staggeringly little evidence to justify the mania around it. It merits study, but it doesn't merit feature stories based on the very marginal data thus far. Everything written about it in the mainstream media is driven by ignorance. True experts in lung cancer roll their eyes over such gullibility and the promotion of so much false hope.

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Dean Gesme, MD (Posted: June 09, 2017)

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Patient Financial Counselors (PFCs) are vital to patient quality of life - they reassure and support our patients every day so that we can minimize financial toxicity from our interventions.

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Ted Okon (Posted: June 09, 2017)

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This seems to be band-aiding the drug price issue, which near the root are the increasing discounts (340B) and rebates (PBMs) that are fueling increasing drug prices. So, where does this approach lead and end? Constantly cutting drug dosages to find the bare minimum needed?

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Howard S. Hochster, MD (Posted: June 09, 2017)

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Another article by Gina Kolata where she dramatizes the situation and misses the key message. This article focuses on the fact that anti-PD1 did not work for most CRC (specifically citing the "failed" drug nivolumab) and how pembro turned it around for MSI-high patients. She brings up the cost and this has become the focus of many tweets on the article.

She misses the most newsworthy fact that this is a groundbreaking approval for the FDA, moving from a histologic indication to a molecular indication. As practicing oncologists, we must stand and applaud the FDA for stepping outside their comfort zone on this one and recognizing the realities of treating such patients.

MSI status now becomes a therapeutic handle rather than a genetic disease-related effect.

Gina Kolata did, however, do a fine job recognizing the key contribution of Dr Luis Diaz here.

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admin (Posted: June 08, 2017)

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Test

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Thomas Marsland, MD (Posted: June 08, 2017)

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This release and the recent FDA activity show that the brave new world has arrived. We are now looking at and treating tumors based on biology as opposed to the old system based on anatomy. Clearly that is not going away anytime soon but at least the approach of treating a tumor based on its biology has finally arrived.

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Winston Wong, PharmD (Posted: June 08, 2017)

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While outcomes based contracting resented to the issue of recovering wasted cost for ineffective therapies, does it really address the high cost to begin with, and addressing the value of the therapy. So the regimen helps the patient achieve therapeutic endpoints, but that does not necessarily translate to a cost effective treatment option. A high cost is still a high cost, even if you hit your endpoints.

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Winston Wong, PharmD (Posted: June 08, 2017)

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Drug importation, let Medicare negotiate rebates, PBM transparency? How long have we heard these options being bounced around. Justifying price increases is a new one, but who is going to determine what is justified and what is not. Then you have all the lobbying that goes on behind closed doors. Will anything ever be put onto the table.?

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Winston Wong, PharmD (Posted: June 08, 2017)

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Fully agree that the data must drive the treatment decision, however, given the growing European experience, should that be taken into account as well? For the time being, we are only looking at "similar" products today, and authorization is still required to exchange a reference product with a biosiilar.

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Winston Wong, PharmD (Posted: June 08, 2017)

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This bold move by the FDA will pose major issues for payers, as payers are site and indication driven. Payers have a hard enough time seeing the clinical utility of any genomic profiling signature, let alone have a drug be based upon. The payers are going to flex in their approach to genomic testing if further approvals like take place, especially given the cost of Keytruda.

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H. Jack West, MD (Posted: June 07, 2017)

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These data with immunotherapy are not definitive, but they certainly represent a promising option and previously treated patients who really have no compelling alternative with any good hint of meaningful benefit. I have one patient with previously treated mesothelioma who have received some benefit from an immune checkpoint inhibitor after she demonstrated progression on prior platinum and pemetrexed chemotherapy, and while she has not demonstrated what would be considered an objective response (mesothelioma is notoriously difficult to assess well on imaging), she has demonstrated ongoing and very prolonged period of stable disease to minor disease shrinkage accompanied by an improvement in her cancer-related symptoms. I certainly do not doubt that she is receiving a very clinically significant benefit from immunotherapy, despite the lack of an objective response. I would not want to put too find a point on the limited data we have available thus far, and especially my single patient experience (I have given an immune checkpoint inhibitor to another 2-3 patients who have not done as well), but I do think that we can and should be encouraged by even limited data showing meaningful clinical activity in a setting in which we have had nothing constructive to offer up to this point.

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H. Jack West, MD (Posted: June 07, 2017)

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The results from the phase 3 AURA3 trial that directly compares osimertinib to chemotherapy in EGFR mutation-positive patients with acquired resistance to an earlier EGFR inhibitorVery clearly demonstrate a significant improvement in disease control with in the CNS with osimertinib. In addition to leading to good disease control in patients with brain metastases, there was even documented activity in a small subset of patients who have leptomeningeal carcinomatosis.

This is emerging as a very significant consideration as we follow and treat these patients longitudinally, as they have a high risk of CNS involvement.Many of us would welcome the opportunity to have EGFR mutation-positive patients receive osimertinib to treat or prevent CNS disease as soon as we could feasibly have him start on it, including ideally in patients who may not have a T790M mutation. Osimertinib emerge as an appropriate first line treatment option for EGFR mutation-positive patients based on the results of the FLAURA trial comparing it to first line gefitinib or erlotinib -- we expect to learn the results from that study as early as this fall.

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Howard S. Hochster, MD (Posted: June 05, 2017)

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It's not the reporting but early intervention by caregivers to deal with symptoms of chemotherapy treatment. An amazing result! This results in fewer hospitalizations and improved survival. We need to up our game and proactively manage symptoms whether by PRO tools or direct contact. Everyone benefits.

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Howard S. Hochster, MD (Posted: June 05, 2017)

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The combined analysis of more than 12000 patients in 6 randomize trial was intended to show a noninferiority of 3 months FOLFOX or CapeOX with 95% confidence. As it turned out the HR = 1.07 with 95%CI = 1.0 to 1.15 for the primary endpoint of 3 yr DFS (or 0.9% absolute difference). This means the we have 95% confidence that the shorter course may be equal as much as 1.8% worse at the most. It seems reasonable to assume these are as equal as possible to define. Also, across subsets of good risk (T3 or N1) 3 months was non-inferior. And CapeOX was more effective and non inferior across the board, though this was not a randomized assignment (physician choice in most studies). We can be comfortable that 3 months of CapeOX (and probably FOLFOX) is as good as 6 months treatment for good risk patients receiving adjuvant therapy.

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Howard S. Hochster, MD (Posted: June 01, 2017)

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It's a big day in drug development as the FDA accepts the concept of a drug use matching the molecular biology and not histologic type. This will benefit the rare patients with Lynch and spontaneous MSI status in endometrial, urothelial, gastric, cholangio and pancreatic cancers. The big questions now are who and when to test. IHC or NGS panel? Early in diagnosis or late? Stay tuned. Perhaps we wil see more broad approvals based on molecular phenotype. But caution is warranted - the BRAF story has played out differently in melanoma and colon cancer.
Test.
Gastric

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Howard S. Hochster, MD (Posted: June 01, 2017)

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Readers beware!! This is a "thought" experiment where a committee of hepatic surgeons decided on resectability of the hepatic metastases based on CT scans from the SIRTEX colon studies. It doesn't mean all the patients would be resectable (many may have occult extra-hepatic disease at time of surgery) and eligibility did NOT require liver only disease. Until actual resection data and survival statistics are presented, this should be regarded as an "in cerebro" experiment only.

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Howard S. Hochster, MD (Posted: June 01, 2017)

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Cost Effecriveness is the charge of NICE. We know about the effectiveness. At what cost has Merck agreed to provide the drug to NHS patients?

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isac i schnirer (Posted: May 26, 2017)

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it's not more resistance to treatment ,but the anti her2 drugs probably don't penetrate well the bbb,including the small molecule .

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H. Jack West, MD (Posted: May 18, 2017)

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In the feeding frenzy that is the business world's hype-driven interpretation of immunotherapy data, the point that the response rate in phase II trials is typically significantly higher than the better established phase III trial data is conveniently overlooked. Could IDO combinations represent a significant improvement? Sure. But docetaxel had a 25% response rate in progressing phase II trials, and carbo/taxol had a 50% response rate as first line treatment in early phase II work, and we all marvel at those crazy numbers when we learn the more sobering reality from far larger clinical trials and greater experience.

This kind of breathless over-reaction to early studies is like a Darwin award of investment. Good luck, guys. Just remember that I told you not to jump off the cliff together, like a sea of lemmings. It's the same reflexive rather than conscious thought-driven process.

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Dean Gesme, MD (Posted: May 17, 2017)

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Watch closely as Amazon may seek to break traditional distribution models in the drug prescibing space!

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Howard S. Hochster, MD (Posted: May 15, 2017)

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Dr Bob Comis was a stolid and long-term leader of the old cooperative group system. He helped lead the transformation to the new NCTN. We will miss his guidance and wisdom. A real loss for our community.

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H. Jack West, MD (Posted: May 12, 2017)

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Though it will be far more important to see this difference translate to a significant improvement in overall survival, this early result based on an interim report is very encouraging and has great potential to finally improve on our longstanding standard of concurrent chemo/radiation in patients with locally advanced NSCLC. Along with needing to clarify whether there is an overall survival advantage, we will need to clarify whether the benefits of durvalumab are seen comparably in patients with squamous and non-squamous NSCLC and across different levels of PD-L1 expression. These results will be among the most anticipated in lung cancer over the next several months.

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sandra (Posted: May 11, 2017)

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Interesting

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H. Jack West, MD (Posted: May 10, 2017)

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This is a weak approval based on disappointingly scant evidence, especially considering that 37 of 123 patients (30%) enrolled had 50% or greater PD-L1 expression and would now be considered as having pembrolizumab monotherapy as standard of care. With the phase III KEYNOTE-189 with the same trial design but larger, and already completed (as well as many other trials of chemo +/- checkpoint inhibitor therapy), it is disappointing that we saw such a rush to judgment. It should be viewed as putting marketing ahead of true evidence. Perhaps the more mature overall survival data (not highlighted in the press release) are more compelling now than at the time of the initial presentation and publication in October, 2016. Unfortunately, I'm afraid we will soon see that the FDA functions merely to rubber stamp marketing efforts with the slightest pretense of evidence to support commercial interests, rather than to offer a critical review of the true value of unfathomably expensive treatments that provide technically positive results on watered down endpoints.

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Thomas Marsland, MD (Posted: May 10, 2017)

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I have been and on again and off again reader of the Economist for a long time. This article reminded me of the quaint old English expression used by my immigrated English relatives who referred to something too expensive as "dear." The point however is on target. The ever rising cost of cancer drugs is unsustainable. The idea of "value based purchasing" is intriguing. But who and how does one decide "how well they work?" Are we looking at clinical outcomes such as response rate, over all survival, or progression free survival ? Where does the patients point of view come into the equasion ? Should we be looking at the cost for total care not just the cost of the drug? (YES) Do they mean basing cost on the efficacy in a specific clnical senario ? Clearly these are complex and valid issues. To make these choice we obviously need lots of data, including clinical outcomes, patient satisfaction, and claims information. Who and how will these data be collected ?? Hopefully some of the next generation of research tools such as Cancer Linq, Flatiron and other will help us decide the right drug, for the right patient, at the right time.

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H. Jack West, MD (Posted: May 10, 2017)

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The clearest point of this manuscript was that this trial showed no hint of the provocative benefit seen with the combination of docetaxel and the MEK inhibitor selumetinib in a prior phase II trial. We can debate potential explanations, and the authors and editorialists offer several hand-waving possibilities, but the only thing we definitely know is that this is yet one more stark example of a very promising phase II trial followed by a stone cold negative phase III trial, as we've seen with figitumumab, onartuzumab, ASA-404, talactoferrin, and a long list of other agents/trials.

I don't know how many times we'll need to see this pattern before we control our hubris in calling a definitive win based on encouraging phase II data. With modest numbers of patients from a very limited number of treating centers, phase II trials are clearly a poor substitute for the broader clinical experience drawn from phase III randomized trials.

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Ted Okon (Posted: May 10, 2017)

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Another company making the right move to control drug prices, especially in cancer. In community oncology we are advancing "value-based" payments for services. The same thing needs to be done for drugs. It's time for those really wanting to advance the quality and affordability of cancer care to step up and innovate.

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Ted Okon (Posted: May 10, 2017)

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Scott Gottlieb is an excellent choice to head the FDA. He has served there before and his prior government experience coupled with his business background provide him with the skill set necessary to modernize the FDA. The comments about his ties to the pharma/bio industry being a negative are absurd and just politics. You want someone who knows the industry from the inside, just like you need a Treasury Secretary who knows Wall Street.

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Winston Wong, PharmD (Posted: May 08, 2017)

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Definitely a very volatile topic. PBMs control a good part of the prescription claims process, but it the back room negotiations with regards to rebate's, etc that require more transparency. However, not everything can be pinned on the PBM. Bottomline is that everyone has a stake, and has contributed to the high prices.

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Richard Goldberg, MD (Posted: May 05, 2017)

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This is a very interesting study that opens the door to prospective investigation of a randomized trial of watch and wait strategy versus surgery in patients with low stage rectal cancers who have complete responses to chemotherapy and radiation. Identifying patients who can be spared the cost and toxicity of triple modality therapy with good outcomes is key.

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Thomas Marsland, MD (Posted: May 04, 2017)

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Hi, all well, settling in in Petaluma. Thought I might comment on this. Data indeed is king. However, there are lots of sites out there that do provide the data. NCCN, Up to Date, to name a couple. CancerLinq, Flatiron, IBM/Watson, and others are also trying to do what is being proposed with Tempus. No question we need real-time data. Things are changing so quickly that even an extremely tech adverse guy like me is running to the cloud (I believe that is where I am going ???) to help me with treatment decisions.

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H. Jack West, MD (Posted: May 04, 2017)

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These results are very provocative, but we need a larger, randomized study to say anything more definitive about whether great activity of chemotherapy after rather than preceding immunotherapy is a reason to change how we typically sequence systemic lung cancer therapies. We will see far more studies of immunotherapy in the first line setting over the next few years, and it will be helpful to assess whether this finding is commonly demonstrated.

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Darla (Posted: May 03, 2017)

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I would be interested to see this.

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H. Jack West, MD (Posted: May 01, 2017)

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The data with brigatinib are strong, as this is an agent that has impressive activity against a broad range of secondary mutations in ALK preclinically, and clinically it is the first second generation ALK inhibitor that demonstrates a median progression-free survival beyond one year. Although the various second generation ALK inhibitors have yet to be compared directly to each other, the results with brigatinib are favorable in cross-trial comparisons. It is also typically well tolerated, though the potential for early pulmonary toxicity in the first few days requires attention and some caution (this is the reason for the escalation from 90 to 180 mg daily after one week).

But the landscape of ALK-positive advanced NSCLC is about to be transformed with the presentation of the results of the global ALEX trial, expected to be at ASCO. This phase III study of alectinib vs. crizotinib in ALK inhibitor-naive patients was recently noted to be positive for a PFS benefit with alectinib, and if it is even half of the demonstrated PFS benefit demonstrated in the smaller and Japanese-only J-ALEX trial reported at ASCO 2016 (Nokihara, A#9008), it should be enough to change practice and make alectinib the first line therapy of choice for ALK-positive NSCLC. That will leave brigatinib likely relegated to post-alectinib, where it may have far less activity than after crizotinib, since brigatinib and alectinib are both second generation ALK inhibitors and may have significant cross-resistance between them.

It's certainly great to have another effective ALK inhibitor available for patients, and we'll need further data to see how brigatinib looks in first line (trial ongoing, vs. crizotinib) as well as its activity after alectinib. We'll also need to keep an eye out for lorlatinib, a third generation ALK inhibitor with activity even after acquired resistance to second generation ALK inhibitor therapy, and other ALK inhibitors in development.

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Howard S. Hochster, MD (Posted: April 27, 2017)

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It is not difficult to imagine that PARP inhibitors, which function through the Homologous Repair pathway, would not add much to standard platinum based therapy in unselected lung cancer and TNBC. What is harder to imagine, is what AbbVie would launch phase 3 trials in unselected patient populations who do not have defined DNA repair defects. We can do better in this era of tumor profiling.

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Howard S. Hochster, MD (Posted: April 26, 2017)

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Fascinating legal wrangling as the Supremes parse the wording of the BPCIA (Biologic Price Competition and Innovation Act). At stake, whether the biosimilar manufacturer must supply the originator company with a copy of their BLA application, and whether an additional 180 day waiting period Is required following actual FDA approval of the biosimilar for the originator to issue patent litigation. This would invalidate notification prior to the formal licensure.
Who knew biosimilars could be so exciting and reach SCOTUS ??

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Winston Wong, PharmD (Posted: April 25, 2017)

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Generally, when a Physician indicates a "Dispensed a Written", on a prescription, it is honored by the health plan and the member pays the branded copay. On the other side of the table, members also ask for the brand out of pure preference, which is what payers are focusing on. Obviously, in this case, if the article is accurate, no DAW code is being recognized.

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Dean Gesme, MD (Posted: April 21, 2017)

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This will only determine how much delay is allowed by the courts and how excessive the legal expenses will be for every new biosimilar to enter the market. If the point is saving money while saving lives, how has our legal system gone so wrong?

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H. Jack West, MD (Posted: April 20, 2017)

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The failure of the phase 3 trial with veliparib combined with chemotherapy is disappointing and yet another reminder of the gulf between promising phase II data and proven benefit in a larger, multicenter phase III trial. This was a large and likely well-conducted study that asked an important question and provided a valuable but humbling answer. Despite recent successes with checkpoint inhibitors and some targeted therapies, it remains quite challenging to generate clinically significant improvements in outcomes in patients with lung cancer.

In the future, trials will increasingly need to focus on more narrow populations as the treatment algorithms incorporate PD-L1 expression and more driver mutations with different standard treatment approaches.

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Winston Wong, PharmD (Posted: April 19, 2017)

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So lets take a different, more cynical approach to the flat trend being observed. Yes, I'll grant that there might be something to the advance utilization management programs. But, should we also take into account that as drug costs increase, so does patient liability, which means maybe trends are flattening because patient cannot afford to pick up their prescriptions, hence no cost is recorded. As well, we are only looking at the prescription benefit side. Much of the sensitivity surrounding drugs cost are under the medical benefit, so are we looking at the entire picture? I think not. Maybe we need to take a step back and look at cost from a much broader view.

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William McGivney, PhD (Posted: April 12, 2017)

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The developers of Value Metric Frameworks continue to struggle to make them relevant and also to make them usable and utilized by a meaningful number of policy-makers and clinicians. In the MedScape article, the key point was made with surprising honesty by ASCO’s Dr. Grubbs who was quoted regarding the ASCO Value Score Framework:
“The organization is working to include cross-trial comparisons”, said Dr Grubbs. "Until we have that, there's going to be limited benefit to this.”
This was an obvious observation made by many when the ASCO Value Score Model was first introduced. Mandating the use of head to head comparator trials as the source of data and other limiting characteristics created a model that once again ended up as confirmation of the saying, “The Perfect is the Enemy of the Good”.
In what I called “The Rush to Value” in my analysis for a journal in July of 2015, organizations and individuals raced to the spotlight for presumptive crowning as “Value Czars” with incompletely thought-out products. Here we are two years later and these products languish. Actually, the one product that still has “legs” is the ICER analytical model. However, any momentum that ICER had was substantially diminished by the results of the 2016 Presidential election.
The pronouncement that many oncologists do not know the price of the drugs that they prescribe continues to amaze me. I submit that this population of docs will not be interested in understanding and reviewing results of the many “Value” Models out there. For the others, a simple statement of Price will probably facilitate the prescriber’s understanding of the Value of what she/he is prescribing.

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H. Jack West, MD (Posted: April 10, 2017)

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In the wake of the highly positive preceding phase II version of this trial in Japanese ALK-positive patients (J-ALEX), we debated whether these results were compelling enough to warrant a change in first line treatment of ALK-positive but ALK inhibitor-naive patients. While that remains debatable, many thoughtful observers of this space have favored waiting until we obtained results from the larger and more demographically/geographically diverse phase III ALEX trial of alectinib vs. crizotinib, which also studied the global standard dose of alectinib (600 mg PO BID) rather than a unique lower dosing (300 mg PO BID) studied in the Japanese only population.

We need to see the data, and I hope and expect that will occur at ASCO 2017 (in either the lung cancer oral abstracts on 6/6/17 or, even better, as part of the Plenary program on 6/4/17). However, now knowing that this trial was positive, as we had expected, these results should be enough to shift alectinib to become the standard of care for first line treatment of advanced ALK-positive NSCLC in the coming months.

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Winston Wong, PharmD (Posted: April 07, 2017)

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A commendable increase of 28 months of survival ... and the overall cost is? Not trying to put a price tag on improved survival but we have to consider the cost of the combination regimen, at least from the patient perspective. As for the difference between the BMS and Merck products, payers believe the difference lies in the study design and the PD-L1 testing.

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Winston Wong, PharmD (Posted: April 02, 2017)

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Agreed that the individual patient may see relief. The bigger picture is that if the individual patient does not pay the higher copay, the cost is spread across the entire insured population in the premium. At the end of the day, the costs are high and someone ends up paying for it.

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William McGivney, PhD (Posted: April 02, 2017)

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As we now rest “comfortably” in the “Valley of Value-Based Policy-Setting and Decision-Making”, it is quite reasonable to evaluate the benefits of providing organizations like AHRQ with half-a-billion dollars a year and compare how such health care dollars might be better (or not) spent. While one is at it, one might as well throw in PCORI to this evaluative and valuation effort. My experiences with AHRQ are based upon my serving as a reviewer for a grant about 12 years ago, a meeting I had with AHRQ folks when I was CEO of a national organization, my experience with the work product of a large contract let by AHRQ, and general tracking of the agency as it changed names through the years. I started to describe those experiences but thought better of heading down that path. In the briefest of my comments (ever), I believe it is a good time to evaluate the products of these agencies and the Value that they might provide.

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Winston Wong, PharmD (Posted: April 02, 2017)

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Ok. So maybe the there was a bit of overexcitement from NantKwest's product. Let's look beyond that and see what the total umbrella of NantHealth is aiming for ... a totally integrated decision support tool, with all of the bells and whistles one could ever imagine or want. In the end, is there an ROI, or will it just be placed alongside of the the other decision support tools, waiting for true clinical utility and an ROI to be proven. IT integration is a powerful tool, and as of yet, we have not achieved it in reality, but at least NantHealth is setting a vision.

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William McGivney, PhD (Posted: March 30, 2017)

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The issue of offering access to “investigational” treatments for serious and life-threatening illnesses is a very difficult issue from a clinical perspective, especially with respect to the provision of a treatment with an ill-defined adverse event profile. However we must remind ourselves that we are talking about people with serious and life-threatening illnesses such as ALS, lung cancer etc.
There are ways to and examples of how the issue has been addressed. Clearly, the FDA has compassionate use guidelines. Further and even better, during the rise of the AIDS epidemic in the 1980s, the FDA produced and finalized the Treatment-IND regulation that made drugs that had shown some early efficacy and had been granted the Treatment-IND designation available to patients with AIDS before FDA approval. The road to finalization of the Treatment-IND was a controversial and a rocky path; but it happened.
In my view the Treatment-IND, pushed by then Commissioner Frank Young, MD, was successful in terms of offering hope to patients, establishing a bridge to possible better drugs, and spurring on innovative research, especially the involvement of smaller biotech companies. The support of the American Medical Association was key and I was fortunate to be the FDA liaison for the AMA at the time and work with Stuart Nightingale, MD Associate Commissioner for Health Affairs at the FDA.
I took the lessons from that experience with me to Aetna in 1991. Six days after joining Aetna as VP Clinical and Coverage Policy, Aetna was on “60 Minutes” for the second time for having denied coverage for high dose chemotherapy/bone marrow transplant. I was charged with addressing the issue of the use of investigational treatments in patients with less than a year to live. The bottom line was the establishment in 1991 of the Aetna “Terminal Illness Policy” whereby investigational treatments, especially HDCT/BMT, were evaluated on an individual patient/beneficiary basis for patients with limited life expectancies. The limit of life expectancy was treated with great flexibility. This program was highly successful and well-respected by patient groups, providers, other payers, employer customers, state legislators, etc. A modified version of this policy still exists at Aetna.
Through it all, I learned one of the commandments for my decision-making in setting coverage policy and making individual patient medical necessity determinations at Aetna:
“The more serious and life-threatening the illness, the lesser degree of certitude about efficacy and the greater risk of harm about treatments that patient, provider and payer should accept.”
This real-world commandment came into decision-making play every day and still does.

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Dean Gesme, MD (Posted: March 27, 2017)

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Speaking from experience as a patient, I would much prefer an MRI of the prostate to investigate an elevated PSA prior to proceeding with an prostate biopsy!

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Fred Pane (Posted: March 27, 2017)

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It isn't President Trump or any other politician/political party that suffers with these issues, it is the American people. Politicians are making decisions for 10 of millions of people and they have the best healthcare in the country. The ACA, a traditional bill which also had a lot of pork belly in it, besides healthcare, was approved without even being read by the politicians we elected. Would you run your business or even home that way? "We will read it later was what the politicians said". Did they read it and make changes before implementation, years after approval? There is no rush to repeal ACA but there is a need to develop a model of healthcare for all citizens of the US, who elect Democrats and Republicans. No one in DC is deserving of their job right now. Meet with your constituents and listen to them. We need to build a better, stronger country. I am commenting, because I did give 60 minutes of input to aides, for two senior senators on ACA and was disappointed to speak with aides, who were going to translate what I said and knew nothing about healthcare, to these two Senators? We pay these people to know what they are voting on. Not to have aides give cleft notes from meetings.

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H. Jack West, MD (Posted: March 24, 2017)

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It's striking that we've needed yet another revision of the NCCN guidelines in NSCLC, but this is a reflection of how rapid the progress has been in the field. Adding PD-L1 expression testing at initial workup, including revised indications for the second line use of the various PD-1 and PD-L1 inhibitors, and including data on the very clear positive results for osimertinib in T790M-positive acquires resistance after first line EGFR Takis -- these are all valuable additions. Whether frustrating or encouraging, additional revisions will likely follow in the coming months, as new data lead to further rapid evolution of our standards of care in advanced NSCLC.

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RMT (Posted: March 23, 2017)

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No proven benefit for protons over IMRT and IGRT for oropharyngeal cancer, so I have no problem with insurance denial.

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Thomas Marsland, MD (Posted: March 20, 2017)

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This report again confirms what we all suspected. That there are indeed significant savings to the "system" when practitioners take the responsibility to direct appropriate care themselves. This as discussed involved standardization of how the practice deals with patients that have "pathways" in place for triage and treatments. Also having expanded access by the patients to the physicians and other caregivers in the practice. No longer is it acceptable to have a recording say "hang up and dial 911" or have the practice on-call person say "go to the ER." WE have to be there for our patients. If we really do this and take responsibility, indeed this can result in reduced costs of care. HOWEVER, there have been numerous examples (Drexel, Wilshire and others) that also clearly show that the costs to the practice are significantly increased. Obviously in any new payment model these increased costs have to be recognized. In addition, these three newer models should be included as potential options for new APM's.

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Oscar (Posted: March 17, 2017)

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I hope the medical community rises up against this horrendous budget and unconscionable "healthcare" act. If anyone has influence over healthcare legislation, it is the medical community. Time to use it.

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Dean Gesme, MD (Posted: March 17, 2017)

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Surely defending our country's medical health warrants expenditures as great as defending our country's borders from immigrants or foreign aggressors!

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H. Jack West, MD (Posted: March 10, 2017)

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We still have more questions than answers about the potential for patients to "hyperprogress" after exposure to immunotherapies, but this has been reported elsewhere (Champiat, Clinical Cancer Res, 2016), and several clinical groups have reported that they have anecdotally noted this phenomenon at their centers, some even noting that they are working on preparing manuscripts that characterize it more fully. This concept will be critical to understand better, especially as immunotherapy moves earlier into and more broadly across treatment paradigms in many cancers.

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Winston Wong, PharmD (Posted: March 09, 2017)

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I am not sure that the consolidated billing for biosimilars is a good idea, mainly because these drugs are not interchangeable. Using a single consolidated J-code will imply that these drugs can be substituted for each other, and they are not. I am also concerned that using the WAC will eventually lead us back to the issue we saw with the inflated AWP.

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Winston Wong, PharmD (Posted: March 09, 2017)

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While I applaud Walgreens for putting together a focused effort in supporting the oncology patient, I am still concerned about the coordination with with oncology practice and their navigation efforts. All practices do not necessarily have medication support monitoring within their four walls, so the Walgreens program is a much needed gap filler. I guess it also goes to state that I hope that the pharmacists are able to dedicate the time to these patient, and not have to be worried about productivity numbers.

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Thomas Marsland, MD (Posted: March 08, 2017)

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Wow.... maybe MedPac actually came up with a couple of good thoughts. This article is definitely worth looking at. They address the ASP issue and rising drug costs by limiting the amount the company may increase the price in a given period of time. This is a dramatic change from the idea that they can control drug costs but reducing the add on (ASP "+") that is the fee to the practice for drug handling. I like the idea of consolidated codes. It clearly has been helpful in the generic world and if done properly should work for biosimilars and even drugs within a give type that have equal efficacy and toxicities. The DVP idea is also one that deserves being looked at (darn, lot of dangling pariticiples today...). This is one way of allowing Medicare to "negotiate" pricing through an intermediary. The proposal removes the outside negotiating vendor from the direct patient billing and issue of drug procurement for the practice that was very problematic in the CAPS program.
Clearly the "administrative" fee would need to be adequate to cover practice expenses on drug handling but we should be open to the idea. It would be interesting if this did then qualify as an APM. It wasn't really clear in the report if that was just an idea or was that a key part of the proposal. The final piece of this article that was very interesting was the discussion of a "virtual" group - a concept I had only very recently heard of ( darn again...). Once more the devil is in the details. Who is in the group??? What metrics are being looked at??? This would go a long way toward being sure that in any performance based payment model that you really are being compared to your peers in terms of quality outcomes and costs. No longer would the oncologist be compared to the internist. Gee maybe MedPac isn't so worthless after all......

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H. Jack West, MD (Posted: March 06, 2017)

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I'm dubious about a 62% specificity. The test doesn't conclusively rule out cancer, nor does it establish what we would consider to be a conclusive diagnosis. being priced aggressively, at 75-80% the cost of a biopsy estimated to cost $15K, I don't think this test will give 75-80% of the value of a biopsy. I am dubious it will emerge as a widely adopted test, at least at the aggressive price point at which it is being offered.

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Winston Wong, PharmD (Posted: March 04, 2017)

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Most health plans require oral oncology agent to be dispensed through their specialty pharmacy program, with the promise by the specialty pharmacy for close monitoring for adverse effects and adherence. The problem, however, is that the oncologists are not kept informed of the patient issues, nor are they informed of a break in therapy. When the oral med is filled by the SP, a major disconnect usually happens. Maybe more effects is needed to provide integrated comprehensive care, as opposed to putting up barriers to oncology practices to stop them from coordinating the care of their patients.

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Dean Gesme, MD (Posted: March 02, 2017)

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Aphinity is expected to be practice changing for Her2 positive early breast cancer patients not already treated with these agents in the neoadjuvant setting. I anticipate this to be a Plenary presentation at ASCO 2017.

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Thomas Marsland, MD (Posted: March 02, 2017)

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Boy are we a mess....... 30% of us are drunks, 20% drug addicts, and another 20% are crazy. Ok so maybe a tad dramatic... but burn out and stress are clearly an issue. I personally don't believe the dealing with dying patients is the most stressful part of practice. Hospice physicians and palliative care doctors didn't seem to have quite the same degree of problems yet they deal with end of life all the time also. For me the biggest stress producer is the constant battle with the regulatory agencies (payers and government) that continually put barriers in place that make good care more difficult. Stress itself is not always a bad thing. It can be a strong motivator for action. For me adequate time off to spend with family is critical. I think that we do need to be sure that as part of any training program that students and fellows are taught the importance of time off and relaxation. At this point think I will retire to the couch with my single malt.

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Thomas Marsland, MD (Posted: March 02, 2017)

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At this point the OCM is the only oncology specific APM available. The article I think clearly points out some of the issues that this and probably any APM presents. The coordination of care, the extra time and effort in patient follow up, and the documentation of "quality" measures really do present a burden on physicians and practices. In the end I do believe the patients get better care but if these programs are to be successful we need to be sure that the extra services provided are recognized and adequately compensated. As an aside one needs to point out that unless the practice accepts the two sided risk model the OCM really doesn't qualify as an APM. This also potentially puts the practices at an additional economic disadvantage as they take on more costs to provide the added services with no guarantee that they will be compensated.

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Richard Goldberg (Posted: March 01, 2017)

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This finding may make us rethink screening guidelines that already call for African Americans to begin screening at age 45 because of that group's propensity for earlier onset disease. Additionally genetic screening for heritable predisposition to colorectal cancer is particularly vital in those with early onset cancer to permit the development of individualized screening recommendations for family members.

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Winston Wong, PharmD (Posted: February 28, 2017)

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This is a 2-edge sword. I an hopeful that we will continue the movement towards value-based care. I am not all together confident that value based care will help justify drug pricing. One can say that NICE already evaluates drugs in this way, and as a result, many drugs are not covered, or are under limited access due to the heavy discounts the manufacturers have offered. If it takes a significant discount to even be reconsidered by NICE, would that not be interpreted that the value is not present under the original pricing. With that said, we all know our pricing is higher here in the US. I think we might have a false hope here.

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Winston Wong, PharmD (Posted: February 28, 2017)

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Pre-existing conditions and lifetime patient maximums are major hot points of concern these days, for good reason. And while the insurance mandate is designed to balance out the risk pool, one has to ask is it enough of a balance. I completely understand the issue of the patient financial burden, but the bigger part of the story lies in the fact that healthcare is expensive, especially in Oncology. If the patient does not have to bear any of the burden because of being an essential benefit, then where will the cost be absorbed? Using the 80/20, or even the 10/90 rule, a lot of insured health folks are needed to really balance out the risk pool.

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Thomas Marsland, MD (Posted: February 16, 2017)

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There is no free lunch (unfortunately). I would like to comment on actually two reports in today's OBR that reference Dr Workman's paper on "how much longer will we put up with $100,000 cancer drugs?" Clearly current drug pricing is unsustainable and if allowed to continue will ultimately result in limitation of access in some form. I am not sure that the idea of using academic centers would really lower the costs of development. There is little data to suggest they can do it more cheaply. The authors talk about partnering with private companies in the development process but clearly these companies are going to be looking for a return.... profit. Perhaps the expected returns may be less than traditional pharma but that remains to be seen. So some concepts that also perhaps need to be explored. I agree that the research process needs to be streamlined. With targeted treatments, as the authors suggested, one may not need the huge, expensive trials that have traditionally been done. It would be useful to look at drug costs in the approval process. If a new drug is not significantly more effective or less toxic then perhaps it should show a cost advantage to get approval. We need more transparency in how drugs are priced. Certainly what the "market will bare" is one large determinant now. How much of the cost is determined by marketing (direct to consumer ???, see prior comments) and not actual development. Allowing negotiations for the cost of drugs by the government would also be big step in controlling pricing. So clearly we need to do a better job of pricing cancer drugs.

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William Harwin MD (Posted: February 15, 2017)

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At Florida Cancer Specialists we have been using DigniCap for several months at 3 of our site and it does appear to be a real advance in preventing alopecia from chemotherapy. I just completed treatment with 6 cycles of TCH + Pertuzumab in a woman with breast cancer with a full head of hair at completion of treatment. The problems with DigniCap are the cost and lack of insurance reimbursement. It may not be fully effective in all patients especially with an Adriamycin regimen.

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H. Jack West, MD (Posted: February 09, 2017)

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What is most remarkable is how many successes we've had with immunotherapies across a wide range of cancers over the past few years. That investors are losing money due to results falling short of expectations is far more a product of the irrationally exuberant, even delusional expectations of many in the financial sector than on the failure in an absolute sense of immunotherapies relative to what should have been realistic expectations for a medical intervention.

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Winston Wong, PharmD (Posted: February 08, 2017)

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Keep in mind that Express Scrips is a PBM, monitoring ambulatory prescription cost. These are mostly self-administered, with some mixing in of medications under the medical benefit. Significant increases were noted in the Oncology and anti infective arena, which are mostly under the medical benefit, hence is not being readily tracked by the PBM. I would surmise that if the overall medical spend was tracked, the level of increase would be higher.

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Winston Wong, PharmD (Posted: February 08, 2017)

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The DIR reporting process was intended to increase the level of transparency throughout the prescription transaction process. As with all good intentions, reality never seemed to occur. It is now a convoluted process that is just as murky as the overall rebate process. The ramifications are far down stream, impacting pharmacies, in addition to the overall cost to the patient and payers. Diplomat Specialty Pharmacy was hit hard last year due to what was called a DIR pullback by a PBM. So much for Transparency.

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H. Jack West, MD (Posted: February 06, 2017)

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It is disingenuous for the media to paint erlotinib (Tarceva) as a completely ineffective and inappropriately marketed drug when what actually happened was that the FDA approval was based on a significant overall survival benefit for erlotinib over supportive care in an unselected population (conducted before we even knew of EGFR mutations), followed by many subset analyses that demonstrated modest but consistent efficacy even in patients with squamous NSCLC (who almost never have EGFR mutations) and those with EGFR wild type. Was it remarkably effective? Not at all. Were oncologists enthusiastic about it? No. But it wasn't until a much later study indicated no significant benefit that one would definitely say that the preponderance of evidence shifted away from treatment of EGFR wild type patients with erlotinib.

In addition, the EGFR mutation test is not perfect. I have had several patients who tested negative for an EGFR mutation on initial workup who later received 2nd or 3rd line erlotinib and enjoyed a spectacular, long-lasting response. In a few cases, later testing showed an EGFR mutation previously missed. Those patients would have almost certainly died years earlier without the benefit of the opportunity to receive erlotinib.

Whether one was actually a proponent of EGFR TKI therapy in EGFR mutation-negative patients or not, it is revisionist history to act as if our current perspective should have been held based on the less extensive evidence available in the past. Moreover, oncologists, patients, and the mass media still regularly sensationalize treatments without a scintilla of evidence outside of a rare case of a patient doing well.

It is the height of hypocrisy for these same oncologists, patients, and mass media to now act indignant that the level of evidence was insufficient to justify using erlotinib, while everyone clamors for off-protocol use of immunotherapy or other new therapies beyond current indications based on wild-eyed optimism and far, far less evidence.

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Thomas Marsland, MD (Posted: February 06, 2017)

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I am no fan of direct to consumer advertising. The article very nicely address a number of the reasons. Clearly no physician would not discuss the use of immune therapy in patients for whom it is indicated. On the other hand no one would order any treatment that isn't efficacious just because the patient saw it on TV. My question that has not been addressed is how much does this advertising add to the cost of the drug. Drug costs today are skyrocketing and although not clear to what degree but large marketing budgets certainly don't help cost controls.

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Winston Wong, PharmD (Posted: February 06, 2017)

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While these penetration numbers are encouraging and impressive, it would be interesting to see the details e.g. what is defined as value based care, and what is the metric that drives the reimbursement. The interest here is that there really is not any accepted standard definition of value-based care. So it could be anything that is not fee-for-service.

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Joan Keit MD (Posted: January 31, 2017)

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It is unethical to advertise cancer drugs to the general public. As a radiation oncologist, I have patients routinely ask me if they can have Optivo because the TV commercial leads them to thing it is the miracle cure. The lay person cannot possibly be able to decide his/her own best cancer therapy. Advertising is a waste of money in an environment where many drugs are already prohibitively expensive.

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Winston Wong, PharmD (Posted: January 31, 2017)

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The issue here is that if the government were to be able to negotiate discounts, it would take a massive overhaul of the current programs. The piece touched on it, but did not specifically state that major changes in the entire system are needed to be able to put radically new programs in place. However with that said, even if discounts could be negotiated with all of the other classes outside of the six protected classes, saving could be realized. Insurance companies do that today. Finally on the topic of transparency, many States have regulations in place. No one knows how to enforce them.

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Thomas Marsland, MD (Posted: January 30, 2017)

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So having the advantage of 35 years of practice has allowed me to see many different models of practice. I have been in a true multispecialty group, a small single specialty group, large corporate models (as being described), a large single specialty practice, and a large cancer focused multidisciplinary practice. The article leads off with a comment about "independent community based providers." My question is: "Is that model viable going forward?" Having watched my market evolve I am very skeptical that even with the power of a large national company that "independent community providers" will be around in the future. Certainly in some markets - yes. However what I have seen is the large hospitals form their own healthcare systems playing hard ball in a way that either you join them or they go out and bring in their own (non independent) oncologists. At best I see community docs as part of carved out joint venture with a local system (all politics are local as is healthcare delivery). Today even with a multidisciplinary cancer focused practice it is hard to provide all of the services: cancer prevention, diagnosis, treatment and support required. Many other specialties and supportive care providers are needed. Hospitals and "systems" are not going to let that business go. As one who grew up in the "buy and bill" days, I am saddened by these changes but we have to adapt and be involved for our patients and ourselves.

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H. Jack West, MD (Posted: January 27, 2017)

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It's not surprising that the second line NSCLC market has shifted away from nivolumab to atezolizumab and pembrolizumab from nivolumab enjoying the overwhelming majority of that market share a year ago. The recent presentation of newer data and subsequent FDA approvals have meant that atezolizumab is now a second line option given on a more convenient every 3 week schedule vs. nivolumab's every 2 week schedule, while both have no requirement for any PD-L1 testing or a threshold level of expression. Even though pembrolizumab requires at least 1% staining for second line use based on the revision of that indication, the new approval of pembrolizumab as first line therapy for high PD-L1 expressors means that the vast majority of NSCLC are now being routinely tested for PD-L1 expression in their initial workup as a standard of care, whereas PD-L1 testing was not previously a necessary step. This means that pembrolizumab, as another every 3 week option, compares favorably as an alternative to atezolizumab for any patients with > or =1% PD-L1 expression.

Finally, though the negative results from Checkmate-026, comparing nivolumab to standard chemotherapy in first line NSCLC, do not speak to the second line setting, it is likely that this has led to somewhat lower enthusiasm toward nivolumab when comparable checkpoint inhibitor options have a more attractive treatment schedule and have not been tainted by negative first line results, at least not yet.

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Winston Wong, PharmD (Posted: January 27, 2017)

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In some respects, maintaining the value-based momentum and smoothing gout the prior authorization process go hand-in-hand. We are putting the decision making process back into the hands of the physicians who are working within the performance and financial parameters benchmarked.

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Winston Wong, PharmD (Posted: January 27, 2017)

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This study provides the rationale for the need to implement patient navigation programs to assist the patient through their journey.

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Dean Gesme, MD (Posted: January 25, 2017)

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A very welcome advance in HCC therapy with lenvatinib dosing which is lower than the initial recommended dosing for radioiodine-resistant well differentiated thyroid cancers. Much greater expense may be an important issue compared to sorafenib. Also the second line role of regorafenib may need some further consideration versus using sorafenib in the second line.

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William McGivney, PhD (Posted: January 25, 2017)

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Support received by organizations from various stakeholders for educational programs and other activities at provider or patient not-for-profits is a valid issue, especially when such an organization(s) might have considerable influence over practice norms and coverage policy.
However, it is always interesting to note the amblyopic view of researchers and the media who focus their efforts only on one side and the easy target. When I was CEO of a major provider organization, I decided to address my limited curiosity by having each grant request (for mainly educational programs) that was sent to a pharma company be also sent (the same grant request) to major payers. One year at our Annual Conference, I was listening to a Panel discussion addressing this issue and was compelled to make a public comment.
The organization had sent over thirty requests for support for educational programs to major payers and we had a uniform answer to all such requests. That answer was “NO”.
I suggest that researchers make sure that they understand the entire system and not close the one eye that should hold a field of vision that includes other stakeholders (e.g., payers) in their quest for veracity.

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H. Jack West, MD (Posted: January 25, 2017)

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My annual family newsletter has higher standards for newsworthiness than a press release saying a trial is ongoing.

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Winston Wong, PharmD (Posted: January 24, 2017)

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Not that I am against the concept of biosimilars, but once a manufacturer meets ALL of the requirements for interchangeability consideration, will the biosimilar still be lower in cost?

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H. Jack West, MD (Posted: January 23, 2017)

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A brilliantly insightful, balanced commentary. Full disclosure: I wrote it.

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Thomas Marsland, MD (Posted: January 23, 2017)

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For every ying there is a yang...... so the ACA may well save some lives but the other side of the coin is also true. I believe that all the added rules and regulations put on us by the ACA often results in treatment delays that could cause lives being lost. The prior auths and pre certs that come the all the low cost Obama care plans certainly cause treatment delays. the degree of ridiculousness cannot be exaggerated.... I actually had to get authorization for a urine analysis the other day. Gosh I must be getting rich ordering UA's. On a more somber note I actually had a patient with a hepatoma that with all the road block thrown up by the insurance company actually took 5 months before she received any treatments at all. Her prognosis was dismal to start but the 5 month delay certainly didn't help. It actually got so bad that I had to go the state insurance commissioner before we had any movement. So as I said just be careful there are always two sides to every story.

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Winston Wong, PharmD (Posted: January 19, 2017)

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There is no doubt in my mind as to what the benefits are for generic profiling, both from Tissue and circulating cells. The ability to identify the cancer type, predict treatment response, and monitor response is priceless. However with that said, as we move into this era of personalize medicine, we still need to keep in mind that the price of the assays may be coming down, but the equipment is still pricey. Hence we still need to identify and assay for the most meaningful genes to report the most useful data that will drive treatment decisions.

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Howard S. Hochster, MD (Posted: January 17, 2017)

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The Supreme Court ruling is important in the coming era of biosimilars. This is an area where the Supremes should be educated on the difference in the approval process for biosimilars versus generics. In the case of biosimilars, the sponsor of the new agent is not only required to support extensive manufacturing data, mechanistic data and composition within tolerable manufacturing bands compared to the originator compound, but they must conduct expensive and time-consuming clinical trials to show clinical equivalence to the originator compound. Biosimilar compounds are named individually with a suffix to the international name so they can be individually distinguished. The extra 180 waiting day for generics should not be extended to biosimilars. They are actual new drugs requiring extensive testing and individual naming.

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Winston Wong, PharmD (Posted: January 16, 2017)

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It maybe the first step, but it is a baby step. We need a replacement to be created, and then the repeal cannot just happen over night. It took many years to get to where we are at. We can't just undo it all overnight.

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Winston Wong, PharmD (Posted: January 11, 2017)

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Sometimes we need to be careful for what we ask for. Allowing Medicare to negotiate price discount may lower costs for Medicare, but on the flip side, if manufacturers are allowed to set their target financial goals, the backside of Medicare discounts is less discounts for the commercial business. So while Medicare cost are blunted, the overall cost of care may not really change all that much.

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H. Jack West, MD (Posted: January 11, 2017)

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I'm not a fan of this approach based on the limited data we have. First, this fining is predicated on a trial with only 123 patients. Though PFS was better with combined chemo and pembrolizumab, there was no difference in overall survival, despite the fact that only 32% of patients assigned to first line chemo had crossed over to get pembrolizumab in the published report (Langer, Lancet Oncol 2016). Moreover, toxicity was clearly greater in the recipients of chemo/pembrolizumab combination. Finally, the concept of maintenance pembrolizumab/pemetrexed indefinitely, with it quite likely that only one of these extremely pricey agents is driving the ongoing benefit but no way to determine which, means that the cost of this treatment is extremely high and buys many patients only the added cumulative toxicity of further treatment with at least one agent that they are not benefiting from significantly.

This is clearly a shrewd marketing move for Merck, trying to broaden their first line claim from 28-30% of the patients, a subset that is particularly likely to benefit from immunotherapy, to the vast majority of NSCLC patients. But it is an assault on the concept of precision medicine that prioritizes corporate interests and squeezes out other companies and agents that have a competing claim in second line.

The key issues are a short term response rate and PFS benefit with far greater net costs, significantly greater toxicity, and no evidence of improved survival, especially if all of the patients assigned to first line chemo were to actually get the checkpoint inhibitor therapy that they should in the second line setting. It is a campaign of marketing interests over refinement of treatment that is truly best for the patient.

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Thomas Marsland, MD (Posted: January 10, 2017)

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Well its a new year but still the same problems. The cost of cancer drugs really is a huge problem. I am glad the misdirected ASP demo project was nixed but the price of new therapies is still an issue that needs to be addressed. We all talk about value and indeed we have made significant strides in helping to define value but the second piece to the value equation is affordability. Even if new agent has value, can we afford it? Not everyone can drive a Rolls. My biggest concern as we move into newer payment models is that they will include bundling and episodes of care that put practices at risk and may force "me" to tell a patient that they cannot have a new treatment because my practice cannot afford it. It makes one wonder if a NICE type program could ever happen here. I certainly would prefer to have the backing of some outside organization that has made the decision that a specific treatment is not "affordable" rather than it being solely based in my specific practice economics. The article also make some very good comments on how much of what we do is still not adequately recognized as valuable in many of the newer compensation models. We need to be sure that future payments do adequately cover our cost for regulatory reporting, care coordination, increased patient access, and many of the other increased services needed to provide a good medical oncology "home".

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Winston Wong, PharmD (Posted: January 10, 2017)

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This presents an interesting question. While I understand the technology and potential ways that the liquid biopsy can be used to monitor tumor response to chemotherapy, will the results be trusted by peer review when the clinical utility of these tests have not yet been established?

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Winston Wong, PharmD (Posted: January 09, 2017)

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Round 2 of the drug pricing circus is beginning. I am pretty sure one thing. It is not the final bill of action that will get us. It will be the backroom deals that are promised to get the bill passed that will be the kicker.

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Winston Wong, PharmD (Posted: January 09, 2017)

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As I see more citations pertaining to the potential uses of the Liquid Biopsy platforms, I can only hope that the clinical utility of sure test will be demonstrated more rapidly that it has taken the general genomic profiling. Granted we need to find the appropriate tumors that the platform can be applied to, but once we identify those tumors, we need to use the technology.

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H. Jack West, MD (Posted: January 06, 2017)

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An important finding from the National Cancer Database, the report by Boffa and colleagues reveals that patients who start adjuvant chemo more than 8 weeks after chemo and even months later follow an improved survival comparable to that seen in patients who received adjuvant chemo starting within the target of 5-7 weeks following surgery, both groups having a superior survival compared to those who undergo surgery alone.

This is valuable to know because the clinical trials of adjuvant chemotherapy for resected NSCLC included patients who are disproportionately younger and more fit than we see in many real world clinics, and many patients experience complications and slower recovery. This leaves us able to consider adjuvant chemo only after a delay, and we have been left with only our judgment about whether that is helpful. Though retrospective, these data help answer that question and corroborate the finding of a benefit of adjuvant chemo in a broader real world clinical experience than studied in prospective trials with arguably non-representative patients, and they also suggest that we should extrapolate the favorable results of early administration of adjuvant chemo for patients who present to us beyond 7 weeks post-op.

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Dean Gesme, MD (Posted: January 04, 2017)

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Providers have a responsibility to fully understand the serious limitations of the tests which we are constantly being enticed to order based on theoretical promises of "patient benefit". We must see through the smoke and mirrors in order to fully comprehend the true state of new developments in order to justify the tests we do and then to correctly inform our treatment recommendations based on those tests.

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Fred Pane (Posted: January 04, 2017)

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I think we all need to realize, that ObamaCare/ACA should have been viewed as a starting point to try and further develop/evolve into a better model. There are pro's and con's to it when you speak to people actually using it. The ACA is a work in progress and needs to be viewed that way, but, it needs input from clinicians, consumers, etc. to evolve, not politicians. Healthcare and payer models continue to evolve and ACA will also.

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H. Jack West, MD (Posted: December 22, 2016)

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Applying artificial intelligence to immunotherapy efforts is like nuclear fission for hype... I hope it doesn't break the internet.

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Sherronda Henderson, MD (Posted: December 13, 2016)

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I am not a robot

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Dean Gesme, MD (Posted: December 10, 2016)

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It is encouraging to see three competing CDK 4/6 inhibitors soon to be available. With the huge potential market consisting of ER + great cancer, it will be a great case study in market pricing --- I.e. competitive capitalism vs collaborative market maintainance.

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H. Jack West, MD (Posted: December 08, 2016)

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Osimertinib was overwhelmingly superior to chemotherapy in terms of both efficacy and tolerability in T790M mutation-positive acquired resistance after initial EGFR TKI therapy.

There should be no question that osimertinib represents the optimal treatment approach here for such patients. Nevertheless, testing rates for EGFR TKI in the setting of acquired resistance remains only 30-40% in the US, far lower than it should be. With osimertinib restricted to T790M-posive patients, it is incumbent on oncologists to look for it, whether in tissue or in plasma followed by tissue if negative by plasma testing. To fail to test for T790M should be considered substandard care.

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H. Jack West, MD (Posted: December 08, 2016)

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Unfortunately, the ASCEND-4 trial had a trial design that essentially guaranteed a positive result, but also an arguably meaningless one. Crizotinib has already been shown to handily beat standard chemo in the PROFILE 1014 trial published by Shaw and colleagues in NEJM (?2015), making crizotinib a clear standard of care over the inferior option of chemo as first line treatment for ALK-positive NSCLC.

Consequently, showing you're better than a known inferior option is really damning with faint praise, especially when ceritinib was associated with very high rates of GI toxicity, including a problematic frequency of grade 3 or higher toxicity.

The fact that the median PFS is 16.6 is impressive relative to chemo, but it's also LESS than we could expect to get from first line crizotinib followed by ANY second generation ALK inhibitor, and both alectinib and brigatinib offer at least comparable efficacy with superior tolerability as 2nd gen ALK inhibitors. The ASCEND-4 trial is only enough to distract us momentarily before realizing ceritinib remains a poor choice with so many other ALK inhibitors available.

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Debu Tripathy, MD (Posted: December 04, 2016)

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These findings are an example of the power of genomic sequencing and bioinformatic analysis - with a small number of cases of testicular cancer, investigators at the Dana-Farber Cancer Institute were able to make two important, but still preliminary observations. One is that reciprocal loss of heterozygosity - that is, the simultaneous loss and gain of different pieces of the chromosome (presumably genes, or regulator of gene expression) can affect resistance to standard chemotherapy. The other (not so novel) is that p53, a well-known "guardian of the genome", is important for treatment responsiveness - many tumors that lose this gene function are more treatment resistant, and the rare hereditary loss of these gene spells risk for multiple cancers at very young ages. Of note, elephants were recently found to have multiple copies of p53 in their genome - perhaps protecting them to a greater extent from cancer).

This is the first step in a new trajectory - using this information to sort out what genes and pathways offer new targets. While we keep hearing about this general theme in publications and grants, the devil is in the details - it is not only about inhibiting one gene or protein, but modulating a multi-dimensional network, and one that probably varies significantly among individual tumors.

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Thomas Marsland, MD (Posted: November 29, 2016)

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Barbara's outstanding work confirms and cements what we have seen with the efforts of Linda Bosserman and John Sprandio. That attention to details, preventive interventions, standardization, and access can dramatically reduce costs of care and improve quality. Unfortunately these models provide many services not traditionally paid for by payers. In addition these added services significantly expand the costs to the practice. In the past those paying the bills have talked the talk but now they must walk the walk. I believe that we are moving in the right direction with many of the newer payment models. Hopefully we can preserve private practice where patients clearly get the most cost effective quality care.

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Thomas Marsland, MD (Posted: November 29, 2016)

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So as we head into the end of an eventful year, I still find that we have much to be thankful for, and much to look forward to in the coming year. I had the opportunity to spend Thanksgiving with a dear friend in the UK who is a leading psychiatric researcher (Ian Goodyear to any who may be interested). We've know each other since our days training together in the 70's. As usual our conversations started out about how one drinks good whiskey and degenerated into healthcare. It would seem that may of the issues are the same on both sides of the pond. They too have access problems with long waits and hard times getting patients needed care. They also have many of the same IT interoperability issues we are experiencing. Good care anywhere requires coordination, integration, and cooperation. I sincerely hope that the part D demo is indeed dead (holding my breath until they lower the coffin..) and that is a good thing but the take home message is that things must change. It cannot be business as usual. We as professionals need to take the lead and advocate for quality and value. Change is unavoidable. Regardless of where and how you drink your whiskey....

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H. Jack West, MD (Posted: November 21, 2016)

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It's important to note that the evidence supports making our clinical decisions far more based on performance status than chronologic age. With the median age of a newly diagnosed patient with lung cancer in the US in the range of 70-71, it's critical for surgeons and those who would potentially refer to surgeons to not dismiss a fit patient's candidacy for surgery based on age alone.

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H. Jack West, MD (Posted: November 18, 2016)

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This is an interesting observation that search terms on lung cancer symptoms are well correlated with subsequent searches for terms consistent with a diagnosis of lung cancer.

I'm not sure whether people will find this nore cool than creepy, that you can identify people highly likely to be diagnosed with lung cancer later, or the basis of search terms alone, but it suggests a potential value in targeting screening efforts in online ads around these search results that could potentially improve survival.

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Thomas Marsland, MD (Posted: November 18, 2016)

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I have heard it said that Data is King.... also GIGO (garbage in, garbage out); with that said it is truly clear that until there is truly an completely integrated system that tracks not only clinical outcomes but also practice costs, and charges any attempt at real health reform, is doomed to fail. The other key piece to this is that for any given patient that these data are available to all the stakeholders. That include patients, payers, and providers. Everyone has to be able to input and extract clinical and economic outcomes if we are to truly have cost effective care. Right patient, right treatment, right time....There are strong forces that are aligned against this interoperability because of their economic dependence on barriers. Fortunately organized medicine associated with some key members of our legislative family are addressing this. Perhaps in the not too distant future we will have a program that provides high quality cost effective care for all (regardless of last night's results - President Trump ????) (hey I voted for him...) (but I'm a right wing wacko).

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Debu Tripathy (Posted: November 17, 2016)

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The power tool of gene editing using the CRISPR (Clustered regularly interspaced short palindromic repeats) system has been used in the lab to generate cells with sculpted genes at a reasonably high fidelity. The ability to study a gene's functions and consequences of loss or gain of function or to even screen the effect of many genes has been greatly facilitated. The controversial use in humans is really an extension of ex-vivo manipulations that have already been in place with engineered cells - most notably chimeric receptor (CAR) T cells, which have yielded impressive results in clinical trials as immunotherapy in hematological malignancies and being reviewed by the FDA for approval. This report from China represents the first application of CRISPR in a human to delete immune checkpoint function and could yield greater and longer term immunotherapy, but also could leave the patient with a permanent auto immune syndrome, or worse, some new and unpredicted phenotype of the immune cell, including malignant transformation. Of course, we will not advance the medical field without taking risks - so the question is not whether to move forward or not, it is a matter of when. Have we carefully maximized the safety, monitoring plan and informed consent process in passing through this new boundary?

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Jeff Patton, M.D. (Posted: November 15, 2016)

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Good for Genentech! The abuse of this program needs to end ASAP. I agree with the author and hope that the new administration will take a close look at this program and bring it back to the initial and laudable intent and away from current abuses.

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Dean Gesme, MD (Posted: November 12, 2016)

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A very welcome addition for the treatment of SCCa of the Head and Neck that can be tolerated by these patients who are often suffering both from their malignancy and the effects of their prior therapies.

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Robert A. Figlin, MD., FACP (Posted: November 04, 2010)

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This long awaited trial performed by the National Cancer Institute demonstrates the benefits of low dose spiral CT scanning in patients at risk for lung cancer when compared to chest x-ray. A 20 percent reduction in mortality allowed the DSMB to stop the trial and inform the results. These results will be presented more formally in a peer reviewed journal but will allow patients at risk to have the promise of an earlier identification of their cancer. Challenges to this effort will be the balanced discussion about the risk of pursuing false positive results that might allow for the additional risks of unnecessary biopsies, surgeries, producing potential morbidity. In balance the results of this long awaited study will change the paradigm for the identification of patients at risk for getting lung cancer by using low dose spiral CT scanning with the hopes of this extending to reducing mortality from lung cancer. These approaches are often best offered by multidisciplinary teams composed of diagnostic and interventional radiologists, thoracic oncologic surgeons, and lung cancer medical oncologists.

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Robert A. Figlin, MD., FACP (Posted: November 19, 2010)

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The current report suggests that Axitinib compared favorably to Sorafenib in a trial in patients with RCCa who had progressed following prior antiangiogenic therapy. Although no specifics were given this trial will form the basis for a future FDA submission of this drug. The kidney cancer research community also awaits the results of a front line trial of Axitinib therapy in previously untreated patients. Axitinib is a "next generation", VEGFr TKI with nanomolar inhibitory concentrations against the targets most important in RCC biology, and if approved will add to the 6 FDA approved drugs over the past 5 years in this disease. The clinical community treating these patients awaits comparative effectiveness studies to place these therapies in context.

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(Posted: November 22, 2010)

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The ongoing shortage of commonly used but older and more cost effective chemotherapy agents represents a major issue for Hem/Onc physicians and their patients. This is particularly true when the illness being treated is a curable malignancy such as Hodgkin or non-Hodgkin lymphoma. The recent shortage of doxorubicin (Adriamycin) is the most difficult example yet of this recent phenomenon. There are no proven equivalent substitutes for doxorubicin for these highly curable patients. It is forcing many oncologists to ration or substitute less proven agents for these patients. The system needs to be modified so that these older agents can still be competitive for companies to make despite being cost effective. Alternatively, a standardized manufacturer that is underwritten by the government must assure there is an adequate supply for these life saving drugs available for our patients.

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Howard S. Hochster, MD (Posted: November 24, 2010)

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For once NICE leads the pack on approval of a new cancer drug. This seems fairly revolutionary for the nation which never believed in paclitaxel for ovarian cancer and the agency that approved oxaliplatin (for reimbursement) only in potentially resectable metastatic colorectal cancer to the liver. Of interest, they are focused more on the high HER-2 expressors, which may be IHC 3+ or FISH high copy number. We are not aware of the analysis presented to NICE and what percent of patients fall into this group. In any case, in the US, few patients fall into this group, but hopefully the FDA will follow suit shortly. ASCO will need to develop the specific testing guidelines (IHC, FISH or both) to match the approval.

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Robert A. Figlin, MD., FACP (Posted: November 29, 2010)

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This decision is just another example that highlights the challenges in drug development. In this case we have a drug Afinitor that has demonstrated clinical efficacy following prior VEGFr TKI therapy in metastatic renal cell carcinoma and is approved for use in the United States and the EU. It is not that the data is being questioned as much as the value added to this patient population of the treatment effects. The medical oncology community (ie: physicians, industry, patient advocate groups, health care providers) will consistently be asked to not only prove a drugs effectiveness using standard metrics of benefit (ie: PFS, OS )but also demonstrate why a health care dollar should be used for this intervention vs another. This is a challenging time for drug development as the clinical trials often ask questions that answer only part of the effectiveness question for a particular therapy. It should be the oncology community at large including all interested parties that set the agenda for what constitutes "effectiveness" when the health care dollar is not unlimited. This announcement today will be just one of the many future similar challenges we all face in caring for our patients.

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(Posted: December 03, 2010)

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The PRIMA study showed a significant improvement in progression-free survival (PFS) with the use of rituximab in a standard maintenance protocol following a rituximab containing induction regimen. At the time of presentation, there was no improvement in overall survival (OS) in the maintenance arm. This result leads to difficult discussions with patients and among Hem/Onc physicians concerning this improvement in the time in remission but no improvement in survival. Is this clinically meaningful? Is it cost effective? NICE evaluates these questions in their decisions for the use of agents whereas cost-effectiveness is not an issue the FDA is charged with evaluating. The use of maintenance rituximab has been adopted by most physicians in the US; however, under new economic scrutiny with bundled payments this might need to be re-evaluated in the future if a therapy only improves PFS and not OS. Hopefully with further follow-up the PRIMA trial will also be positive for OS which will minimize the controversy for the use of maintenance rituximab.

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Howard S. Hochster, MD (Posted: December 16, 2010)

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What criteria should we use to approve the use of new drugs and how do we decide if they are worth the cost? Who should make these decisions? In the US, the FDA approves a drug and CMS is obliged to pay for the on-label use. Some off-label indications may be covered with additional literature. In England, the NICE organization judges cost-effectiveness. I recently applauded their early approval of trastuzumab for some cases of gastric cancer.

Now we see NICE may not be so nice in refusing to pay for the drug in metastatic colon cancer. Of course, this decision only applies to NHS insurance, and the drug is still available in the UK for private payors and those with other insurance. Why this decision? NICE based their decision on the unfortunate results of the Roche 966 trial, one of the largest metastatic CRC trials ever, rather than the pivotal Genentech 2107 trial using IFL as the chemotherapy regimen. The primary endpoint of the 966 trial was to show non-inferiority of CapeOx compared with FOLFOX, and the regimens were indeed equivalent. However in an amendment, 1400 patients were also re-randomized to treatment with or without bevacizumab. In both arms patients treatment was stopped at 6 months, with the development of oxaliplatin neurotoxicity, in the great majority of patients. In this case, the benefit of bevacizumab could not be adequately demonstrated. A second statistical analysis censoring patients 30 days after going off study (rather than using the actual date of progression even for those who stopped treatment) showed much greater effect for bevacizumab, consistent with the hypothesis that the drug was effective as long as it was given.

So, large "well-conducted" trials are not always performed as expected; clinical research often has unanticipated pitfalls. Demonstrating the additive benefit of any biologic in combination with an active chemotherapy regimen is a difficult task, as also seen for bevacizumab in breast cancer, and remains a challenge. Cost-effectiveness is in the eye of the beholder. A bureaucratic view of benefit is certainly different from those on treatment for metastatic cancer. Borderline trial results, even in flawed trials, will be used to keep a lid on costs of cancer treatment.

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(Posted: December 24, 2010)

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As lymphoma research advances, several very important discoveries have identified important proteins or pathways that appear to be more frequent in specific types or subtypes of lymphoma. The MYD88 genetic mutation is a new discovery in the activated B-cell type (ABC) of diffuse large B-cell lymphoma (DLBCL). This subtype is more difficult to treat than other subtypes of DLBCL and identifying potential target areas for novel therapies is an important area of research. The next step after identifying the pathways, proteins, or genetic abnormalities, is to test novel agents that target the specific pathway for treatment in patients with that subtype of lymphoma. Several different clinical trials are using this model now and it is hoped that additional information will be obtained over the next several years to validate this type of target identification. If successful, this targeted therapy could help us to use specific therapies in patients who are predicted to respond to the therapy and to decrease the use of possibly toxic and expensive therapies in those that are not predicted to respond.

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Robert A. Figlin, MD., FACP (Posted: January 03, 2011)

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The approval by the UK to offer Votrient to patients with advanced renal cell carcinoma now allows patients in the UK the option of another antiangiogenic drug targeting the VEGF receptors. This agent has been demonstrated to improve progression free survival when compared to a placebo, and has an acceptable toxicity profile. This announcement also allows for the integration of a comparative effectiveness trial comparing Sutent with Votrient in a completed large scale trial to be reported in the near future. This result is but further evidence that the pharmaceutical industry will be required to demonstrate more than just clinical effectiveness when considering drug development, especially in diseases like renal cell carcinoma where there has been the approval of 6 new agents in less than 5 years.

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Thomas Marsland, MD (Posted: January 06, 2011)

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Most drugs used in clinical oncology are "off label" meaning for non-FDA approved indications. Avastin may yet be a useful drug in breast cancer for selected patients. The key will be in identifying those patients. I hope the payer community does not decide to just deny payment for "all" patients with breast cancer.

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(Posted: January 06, 2011)

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The development of safe and effective biosimilar monoclonal antibodies for patients that are more cost effective should be a priority for improving the health care system. Although these types of agents are available in some other countries, the process for checking the agents to be sure that they are indeed biosimilar needs to be defined further by the FDA. If available, effective, and safe, such agents could provide a good alternative to the original antibody. However, high standards will be necessary to prove the equivalency of any new agents.

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Thomas Marsland, MD (Posted: January 10, 2011)

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The concept of "palliative" care and end-of-life care definitely needs more discussion. We should not be put off by the politicizing of the so-called "death panels." I remember an old professor telling me a long time ago that there is a big difference between prolonging the living and prolonging the dying. We definitely want to do the former but not the latter. Better training and education are critical in help with this. I applaud ASCO's efforts....

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Thomas Marsland, MD (Posted: January 10, 2011)

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I see this as a growing problem. As we transition more and more into "evidence"-based pathways, I become concerned about patients who fall outside of the guidelines. Whose evidence takes precedence??? I have never provided a treatment for which there was at least some evidence, yet today many of these treatments would probably be denied since they may not have been based on the gold standard of randomized Phase III trials. Payers have to understand that not every patient will fit the protocol. I share the concerns that ultimately cost and not patient care will be driving the decision-makers.

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Thomas Marsland, MD (Posted: January 11, 2011)

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It is encouraging to see the payer community recognize the value of continuing to cover Avastin in breast cancer for selected patients. I hope the Medicare carriers make similar decisions.

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Thomas Marsland, MD (Posted: January 12, 2011)

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The author makes a good point. The concept is truly exciting but there is really a dearth of clinical data to support the utility of this. Unfortunately when the public hears of these breakthoughs they often demand access with no good science to tell us what to do with the results.

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Thomas Marsland, MD (Posted: January 12, 2011)

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Early-stage prostate cancer is one of the most challenging problems facing a clinician today. There are many options available: watchful waiting, surgery, radiation therapy. Even within a given discipline there are numerous choices: robotic surgery, open external beam RT, seeds, protons, etc. The problem of which is the correct treatment is also complicated often by incomplete and confusing data as the author points out. Two other variables are also critical. The success and complication rate is extremely dependent on the skill of the physician; those that do more are better skilled and get better success rates. Also, patient selection is crucial. The overall health, vitality and life expectancy are all critical factors in determining what the correct treatment may be for a given patient. More than most diseases, open discussion between the treating doctor and the patient to determine the priorities needs to be key. Each patient is unique.

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(Posted: January 20, 2011)

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The conflict of interest disclosures are an important part in looking at all aspects of a publication or presentation. However, I believe that one needs to look carefully at the types of COI that was disclosed. These large clinical trials would not be able to be done without the direct and/or indirect support of the pharmaceutical companies in supplying the drugs and support for the clinical trial infrastructure needed for the trial. The Hem/Onc physicians who formulate these trials work diligently to design them to answer specific scientific questions. Although a research grant is a disclosure for a COI assessment, it is far different than an author or presentor having stock in a company or taking direct payment from a company. In addition, continuing medical educational talks are scrutinized closely for biased information and although they are often funded by multiple pharma companies, the speakers don't even know which ones. Results of clinical trials that are published are extensively peer reviewed to be sure the information is accurate and scientifically valid. We should all use some common sense about the COI rules with keeping in mind the type and extent of COI associated with the trial.

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Robert A. Figlin, MD., FACP (Posted: January 20, 2011)

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The identification of novel markers and pathways critical to kidney cancer development, progression, and resistance to current therapy, is one of the highest current priorities in kidney cancer research. The current report is further evidence that even clear cell carcinoma, the most common type of renal cell carcinoma, is a heterogeneous disease with additional abnormalities other than what is driven by VHL mutation or hypermethylation. In the clinic we have recognized that not all clear cell RCCa patients respond similarly to currently available therapies. Additionally, recent evidence from the laboratory has suggested that clear cell RCCa may have differing profiles differentially driven by hypoxia inducible factors 1 and 2. It will be important to correlate the current observations with clinical material that might distinguish the clinical behavior of tumors that might harbor both this mutation as well as a VHL abnormality. As with many diseases in cancer we are learning that even those tumors originally described as being driven by a singular molecular abnormality have other biologic distinguishing features. As further evidence of this abnormality emerges strategies to identify patients with this profile, and the generation of specific inhibitors will provide kidney cancer patients with further hope against this difficult disease.

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William Harwin MD (Posted: January 22, 2011)

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This is a timely article and highlights an issue that is on the minds of oncology health care providers in the United States. While third party payers and CMS continue to squeeze community oncology on reimbursement for oncology drugs, there is absolutely no control over both the pricing of new drugs and price increases that pharma continually takes. The disparity in the prices for oncology drugs in the US compared with the rest of the world seems to most unfair for the US healthcare system. Until some controls are put in place, the escalating cost of oncology drugs well above health care inflation will continue unabated.

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(Posted: January 31, 2011)

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These are disappointing results for an old drug that had been rejuvenated ( temporarily). This drug is basically amonafide which was first investigated in a phase 1 trial for AML in 1991. It is a DNA intercalator that maintains activity in the presence of MDR, which is frequently expressed in blasts from patients with secondary AML, the population enrolled on the randomized trial. It was hoped that this would be more effective in combination with ara-C than standard alkylating agents but that was not the case. The primary endpoint was CR, interesting in a pivotal trial where PFS or OS would be expected to be the endpoint. Nevertheless since there were no differences in remission rates in favor of amonafide it is certainly unlikely that PFS or OS would be improved.

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Robert A. Figlin, MD., FACP (Posted: February 01, 2011)

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Biomarker evaluation that can identify those patients most likely to benefit from therapy remains a major challenge in cancer, and more specifically renal cell carcinoma. Despite the current availability of six agents in this disease, four of which target angiogenesis directly, many patients either do not benefit from this approach, or whose benefits are challenged by the side effect profile or the durations of benefit. Biomarkers that could identify the ability to offer a more "personalized" approach to treatment could allow for improvement in the balance between benefit and risk. Biomarkers might also identify mechanisms for resistance that develop in these patients and offer the physician a clearer picture of when to change therapy. Although the trial is designed as a phase 2 exploratory trial, any information that can be obtained from such an approach might enlighten the future designs of trials in this disease.

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Thomas Marsland, MD (Posted: February 04, 2011)

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It often bothers me to see this type of report in the lay press. The general public really has a poor understanding of the concept of risk and benefits. Almost all oncology drugs have the potential for toxic deaths. We have been dealing with this for a long time. Avastin is a great drug and has helped to prolong life for many patients. I would hate to see limits and restrictions put on this drug based on emotional issues. The Avastin lethal side effects (pulmonary hemorrhage, perforation, and the infections discussed were probably more from the cytotoxics) are well-known and documented and with good patient selection really are quite minimal. Certainly frank discussions need to be held with the patients. I hope a good drug doesn't become branded because of this somewhat sensationalist press...

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(Posted: February 09, 2011)

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We now know that based upon genetics and biology, some types of malignancies that appear to be the same are in fact many different subtypes (i.e. Diffuse Large B-cell Lymphoma). This means that small trials of new agents that use less well characterized historical control patients may not be using an adequate comparison. The FDA is now looking back at some of the agents that have been approved over the past few years on an accelerated basis but have not yet completed their confirmatory randomized trial commitments to see if they should continue to be on the market. This is always difficult in rare diseases to get an adequate number of patients on trials for a large randomized trial. This is particularly true in the US where fewer than 3% of cancer patients actually go on clinical trials. A balanced system needs to be done in these rare disorders perhaps with a limited approval time while awaiting the confirmatory trials in a larger patient base. The key to getting the answers is to have more patients on clinical trials as is done in many European countries. This should be encouraged under healthcare and not discouraged as it currently is. As in the past there have been some agreements by insurers on participation in trials as a way to get the treatment. This would encourage the confirmatory tests to be finished in a timely fashion.

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Thomas Marsland, MD (Posted: February 10, 2011)

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The environment is changing. Clearer guidance from Trade Commission and Federal government is certainly needed. The need for physician groups to work together and better coordinate care is truly critical to the success of any meaningful health reform. To do this provider groups need some protection from traditional antitrust provisions. Accountable care organizations and clinically integrated networks offer great opportunities to provide coordinated cost effective care. The concept is to proactively develop and provide quality and cost conscious treatment pathways that require a high degree of communication and coordination amongst providers that historically are not part of one "financially" integrated practice. In the past this may have run afoul of some antitrust issues. To develop these programs we need clear guidance on what is acceptable and what is not.

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William Harwin MD (Posted: February 11, 2011)

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It would be an unfortunate development if the State of Florida reduced funding for the Moffitt Cancer Center. As a practicing oncologist we depend on the resources of Moffitt in referring complicated oncology cases such as bone marrow transplants, liver and pancreas surgery amongst others. It is the combination of community oncology practitioners and tertiary university cancer centers that provides Americans with the finest cancer care delivery system in the world. The Moffitt Cancer Center is the top such center in the State of Florida and the only one with the NCCN designation. With the continued aging of the population we can ill afford reductions in state funding for cancer care.

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Thomas Marsland, MD (Posted: February 16, 2011)

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It is interesting that again we have a "temporary" fix to the problem. What is really needed is a methodology that permanently replaces SGR. By not replacing SGR the hole just keeps getting larger and larger and eventually the piper must be paid. This means that future reductions in the physician fee schedule must keep getting deeper and deeper to cover the dollars paid out in prior years. Although two years seems like a long time (especially in light of the "monthly fixes" we had to endure this past year) it still leaves physicians and practices twisting in the wind unsure of future reimbursements. It becomes extremely difficult to any type of proactive planning when one doesn't know what to expect in terms of future payments. Ultimately patient access is held hostage to these political whims. Doctors will change their practice patterns to adjust to these trends and in the end it is the patients who suffer. As an example we have recently had to stop taking Medicaid patients because of fee reductions. With the new Medicaid fee schedule it would cost our practice more to provide care for these patients than we would be compensated. I fear Medicare is headed in the same direction unless a permanent fix is found.

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Thomas Marsland, MD (Posted: February 16, 2011)

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Wonder if Parker rating makes any difference cab anyone???

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(Posted: February 16, 2011)

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This is very interesting that a subcutaneous formulation of rituximab is being developed compared to the standard IV formulation. Some issues to consider would be what would be the volume of drug that needs to be injected? What are the local toxicities? What about the concern about delayed toxicities when the patient is already long gone out of the office after a subcutaneous slowly released medication? What are the economic consequences of this change? Is this another way to try to extend the patent life of rituximab?

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Robert A. Figlin, MD., FACP (Posted: February 21, 2011)

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Tivozanib is a next generation small molecule targeting the VEGF receptor family of tyrosine kinases. It has the potential to improve upon currently available similar agents because it has nano molar inhibitory concentration (IC 50) against VEGFr 1, 2, and 3, and potentially less off target toxicity because of the kinases that it interferes. It has completed a randomized discontinuation study demonstrating robust clinical activity comparable to currently available agents. A phase 3 trial TIVO -1, has completed accrual comparing Tivozanib with Sorafenib in metastatic RCC patients either previously untreated or treated with a prior cytokine. Results are expected this year. The developing relationship between AVEO and Astellas, is but the next example of a small biotech company developing a targeted agent and the important economic needs to take a drug to the next level. Whether Tivozanib obtains FDA approval and is used by clinicians treating kidney cancer will largely depend upon the results of the phase 3 trial. Comparisons will be made with respect to activity (progression free survival) and toxicity, comparing it to Sunitinib and Pazopanib even though the pivotal trial is against Sorafenib. Additionally a newer agent from Pfizer, Axitinib, is also entering the kidney cancer arena and is being compared to Sorafenib in the second line setting. Ultimately what will be required of this agent in renal cell carcinoma is the demonstration of a therapeutic index that is superior to currently available agents. We do not need agents that are comparable in their activity to currently available agents, but agents that offer this difficult disease new and improved therapeutic alternatives.

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William Harwin MD (Posted: February 18, 2011)

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The ASCO letter in response to the JAMA paper on axillary dissection in breast cancer is very important as a follow up to the JAMA paper. It is helpful in reminding ASCO members that the JAMA study does not apply to all situations (such as mastectomy or palpable axillary adenopathy) and a reminder to use caution in younger breast cancer patients. I find it curious that such a major practice changing paper was not published in the New England Journal of Medicine. It would be of interest to know if it was submitted elsewhere before it was sent to JAMA.

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Thomas Marsland, MD (Posted: February 18, 2011)

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I believe the recent JAMA study is truly significant, however, as so astutely pointed out by the ASCO comment the study may not be universally applicable. Certainly this approach of limited surgery is appropriate for many patients but perhaps not everyone. This type of commentary is often missed in the lay press and often leads the public to misconceptions on what may or may not be appropriate treatments. Lymph node sparing surgery should be considered only for those patients that fit the same criteria as those that were included in the original study.

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(Posted: February 20, 2011)

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Having been the lead site for the US Oncology participants in the trial (US Oncology sites entered almost 100 patients), I have been impressed with the activity of the drug not only in the prostate cancer patients who experienced substantial bone pain relief and bone scan improvement but also in our hepatoma, melanoma and ovarian cancer patients treated here in Las Vegas. There are occasionally "Avastin"-like toxicities which must be watched for and carefully managed. Dose reductions are often needed for the fatigue and lethargy which was reported in over 50% of patients.

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(Posted: February 23, 2011)

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Interestingly, investigators have been trying to target CD19 for close to 20 years. The original approach, through development of antibodies, failed mainly because the antibodies were murine and not humanized; patients, even those with leukemia who are immunosuprressed, rapidly made antibodies to the therapeutic antibody rendering it useless. CD19 is an attractive B cell antigen to target since expression is conserved from pro-B to mature B cells. There are a number of anti-CD19 antibody/toxins currently in trials for lymphoma/CLL/ALL.

This data describes cloning of a novel protein that functioned as a ligand for CD19. Binding of this ligand to CD19 triggered rapid apoptotic cell death in three B-lineage ALL cell lines as well as primary leukemic cells from patients.

The data clearly suggest that this recombiant human protein has potent anti-leukemic activity and could also be used as a targeting molecule to deliver cytotoxic agents.

Although it will be a while before this can enter clinical trials (animal toxicology studies are still needed) this is a potentially exciting new therapeutic approach for B-cell malignancies.

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(Posted: February 24, 2011)

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The good news for England is that NICE, which isn't always so nice, has approved the use of bendamustine for patients with CLL. This drug already has approval in the US with a very broad label. The approval was based on a randomized trial comparing bendamustine to chlorambucil for front-line therapy of CLL. Suprise, surprise, bendamustine was better. It is an alkylating agent with some structural relationship to purine analogs although preclinical data does not show it functioning as a purine analog. Nevertheless it is a very potent alkylating agent that was developed in East Germany. After the fall of the Wall it was mainly used in Germany and Bulgaria so most investigators in both Europe and the US had had little experience with this drug before approval. In the US it has become popular to use it in combination with rituximab and there is certainly a rationale to this. German phase 2 data which was presented at ASH in 2009, suggests that the combination is more effective then single agent bendamustine.

I have notice a trend for front-line usage in the US. I think the reason for this is the tolerability of the regimen; it is definitely less myelosuppressive then FCR. I understand the tendency to use it in older patients where FCR is not an easy regimen to deliver. However I would caution against routine use as front-line therapy in younger, fit patients. That is because there is no published data on time to progression with BR. In additon, FCR had a survival advantage in a randomized trial versus FC. Hepefully the German data will be published soon so we get a better idea on durability of remission. The current German CLL Study Group randomized front-line trial is comparing FCR to BR but it will be some time before data is available from that trial.

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Thomas Marsland, MD (Posted: February 25, 2011)

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You can add my name to the list of physicians who don't believe EMRs have improved efficiency. Our practice has been on an EMR now for three-and-a-half years. The system is still bulky, cumbersome, and not in the least user friendly. It constantly freezes up requiring rebooting and more time. The physician has to change to multiple screens during a patient encounter, each with intrinsic delays. In spite of extended discussions with the engineers, the systems still do not flow easily and are not designed to function in the fashion that physicians work. They are designed by programmers for programmers. All of this could be lived with if the EMRs made data exchange between doctors and practices more efficient, but they do not. All we have done with our EMR is recreate our paper chart in an electronic box. There is perhaps some minimal improvement in office efficiency, but as far as data exchange with other practitioners, the present server-based EMRs are woefully inadequate. There is perhaps some hope on the horizon as newer web- and cloud-based programs become more common. One of the key components to these types of EMRs is their interconnectivity, making information exchange much easier. Hopefully this will be accomplished within my practice lifetime.

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Robert A. Figlin, MD., FACP (Posted: February 24, 2011)

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This abstract was presented at the ASCO GU meeting in Orlando last week. As Dr. Wood's comments, this is likely to be a combination of factors including increased detection with the frequent use of CT/MRI for other reasons finding unsuspected kidney cancer, and possibly a true increase in incidence caused by factors as yet unknown. The alarming observation is that if confirmed to be true and associated with an increase in frequency of this disease, we will be performing more surgeries and having to treat more patients with metastatic disease. Although our success with treatments over the past 5 years has resulted in significant advances, we are still looking for curative treatments for advanced disease patients. With these findings we must commit ourselves to strategies for early detection, which have not yet allowed successful screening approaches, and a better understanding of the cause in this population that might allow for successful interventions.

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(Posted: February 28, 2011)

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The long term followup from the original CALGB trial evaluating fludarabine and rituximab (FR) for frontline CLL has been published showing a respectable median OS of 85 months and median PFS of 42 months. As they have recently presented at ASH in 2010, patients with unmutated VH genes and or poor CG (17p- and 11q-) had significantly worse PFS and OS. No treatment related MDS or AML was observed except in one case where the patient had relapsed and gotten subsequent therapy with FCR. In distinction, the long term data for FCR published by Tam et al in 2008 in JCO showed the actuarial risk of MDS was 2.8% at 6 years. Although this is a minority of patients, the outcome for people developing this disease is quite poor.

A significant and common discussion point among American investigators is whether FCR is better then FR. As of yet, there is no data from randomized trials although the Intergroup study is addressing this question. Clearly the lack of treatment related MDS with FR is an advantage, as well as reduced non-myelosuppresive side effects such as nausea and vomiting etc. The question is whether the apparent increase in efficacy with FCR make those adverse events justifiable. With all the caveats about comparing different clinical trials the results with phase 2 data from FCR (median followup of 6 years) show a median PFS of 72 months (52 months with FCR in the German randomized trial of FCR versus FC with limited followup) and 42 months in the FR trial. Median OS in the phase 2 FCR trial had not been reached with 6 years of follow up, (not reached in the German trial)and median OS with FR was 7 years.

Just as risk adapted strategies are being used more frequently in cancer, one strategy posited by the authors of this article is possibly using FR in low risk patients and FCR in higher risk such as those with 11q deletion. The problem with that is that 11q deletion also defines a group of patients who have significantly shorter PFS with FCR.

There is no doubt that chemoimmunotherapy has markedly improved the outcome for patients with CLL but there is also no doubt that continued improvements, particularly in the high risk groups are urgently needed. The wide array of new drugs that are being tested in clinical trials is encouraging.

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Thomas Marsland, MD (Posted: March 02, 2011)

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Another perfect case of doctors being guilty until proven innocent. Determining the optimal treatment for prostate cancer today is very complicated. There are many options. Surgery (traditional or robotic), Radiation (again with many options - IMRT, Protons, seeds) or Observation. The extent of the disease, patient's age, co-morbid conditions are all important in determining the best choices for a given patient. As we have seen recently from the Urologic meeting extensive research efforts are being undertaken to develop markers which will help decide which patients have aggressive disease and need more intensive therapy, and which patients have less invasive tumors and can safely have a less aggressive approach. Unfortunately the perfect test is still not readily available so I think patients will best benefit from a system where surgeons and radiation oncologists (and perhaps medical oncologists) can work together to coordinate the patient's care. To prohibit practices from providing this type of integrated care between urologist and radiation oncologist does the patient a disservice. Our practice combines urologist, radiation oncologist and medical oncologists. We feel that our patients are given the choices of what therapy (or no therapy) is best for them all provided by one group. Which modality offers the greatest reimbursement is NOT the determining factor in deciding what program is best for a given patient. We provide them all. We have found that by controlling all the aspects of care we can provide better quality and coordination of care. We also have imaging services within our practice (another program vilified by many). We have found that this improves the quality of the diagnostic test since the tests are preformed on the same machines, read by the same board certified radiologist who know what the needs of the oncologist really are and provide back to us in a timely fashion. Yes this generates some revenue for the practice but we also feel that the patient has had a better study. Indeed, as in all professions, there may be some places that perform studies or treatment to maximize profits but I believe that regulators should not place prohibition in place that could prevent the patients from receiving quality coordinated care.

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Howard Sandler, MD, MS, FASTRO (Posted: March 02, 2011)

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This article in the Washington Post highlights an area of interest as we enter an era of health care reform. Specifically, does physician ownership of ancillary services lead to over-utilization of resources? Or, does physician ownership of these services provide easier and better access to care? While urology-ownership of radiotherapy treatment devices has gotten coverage in the lay press (NY Times and now Washington Post), this issue is somewhat generic and applies to imaging tests, such as CT or PET, or ambulatory surgery centers. See, for example, "Physician-ownership of Ambulatory Surgery Centers Linked to Higher Volume of Surgeries" (Hollingsworth JM, et al; Health Aff Millwood; 2010 Apr;29(4):683-9). One question, that I believe remains unanswered, is whether quality of care varies between physician-owned ancillary services and, say, nearby hospital-based services?

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(Posted: March 04, 2011)

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The willingness of patients to undergo extra testing to be in a clinical trial is very dependent on where they are in their cancer journey, where they are cared for, how the physician discusses it with them, and how inconvenienced they are (personally or monetarily). Unfortunately with most patients not being cared for at institutions where cancer clinical trials are performed, it is much more difficult to get the patients into trials. With only 3% of adult cancer patients going on trials, despite in some cases very poor results with standard therapy, we need to re-evaluate this system. It is often pointed out how patients on trials get close follow-up and the opportunity to receive agents years before they are generally available. Yet, most do not take advantage of this opportunity. The clinical trials and regulatory systems need an overhaul.

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Thomas Marsland, MD (Posted: March 07, 2011)

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This is a welcome bill. As the article says, the current ASP formula is flawed. Included in its calculations are the rebates paid to the wholesale distributors for their quick payment of bills to the drug manufacturers. These funds are not in anyway given to the providers. This bill has been proposed before and never passed. Hopefully it will pass this time, but in today's cost-cutting Congress I'm not optimistic.

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Thomas Marsland, MD (Posted: March 09, 2011)

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This certainly is an area of active debate. The key word in this is "routine". The decision to use screening mammography really needs to be individualized recognizing the patient's risk factors. It would be terrible if a patient with high risk was not screened because of this debate.

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Thomas Marsland, MD (Posted: March 10, 2011)

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No question when a new technology is introduced in any clinical setting it is going to be utilized there are two key questions that need to be addressed. There is a wealth of data supporting the use of radical prostectomy in the treatment of prostate cancer. Unfortunately, with a new technology like robotic surgery there are really no "long term" outcome data. Traditionally surgery and radiation have data showing 10-15 year outcomes. This is not available for robotic surgery. (I'm not necessarily saying we need to wait that long before accepting robotics as a viable option.) The second key point is that treatment outcomes very much depend on the experience of the practitioner. There recently was a report I believe in OBR that it took 3,000 robotic surgeries to develop the types of clinical outcomes that are reported in the literature. The same holds true for radiation therapy. The continence and potency results of better than 90% reported with both radiation and robotics are extremely user-dependent....

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Thomas Marsland, MD (Posted: March 10, 2011)

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Avic Roy addresses a truly critical question. How many physicians will continue to be Medicare providers as the reimbursment rates fall. We have recently opted out of Medicaid because reimbursment is less than our cost to provide quality care. There was a recent report (again in OBR ??) on the falling rate of Medicare participation in Texas. To date the numbers are small but...in the end the payer community (private and public) cannot expect physicians to take care of patients when it costs them more money than they receive in payments...

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(Posted: March 17, 2011)

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I am not really sure why this article made it into the NEJM other than it is a large randomized trial in an infrequent patient population, namely AML. The study concludes that there is no benefit to high dose cytarabine (araC), as compared to standard dose in patients with AML, flying in the face of previous data suggesting a benefit, particularly in younger patients where the expected increased toxicity was offset by better outcomes.

The problem with this trial is that all patients got what would be considered high dose araC in one of the two induction cycles, albeit higher dose (2g vs 1g) in the high dose arm. In addition, only two cycles of araC were given in total, unlike what might be more common practice of giving further consolidation with araC. In this trial a third cycle of chemo was not araC-based and importantly, almost 50% of the patients received an autologous or allogeneic transplant.

I would certainly not expect that kind of difference in dosing of araC, particularly given for such a short period of time, followed by subsequent transplant, to have a major impact on long term EFS or OS. And it didn't.

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Robert A. Figlin, MD., FACP (Posted: March 18, 2011)

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The current report is the beginning of a series of clinical trials across many pharmaceutical companies directing therapy at the VEGF receptor pathway while also targeting additional pathways that are thought to be involved in acquired resistance. Unlike the genetic changes that occur in lung cancer for example, that have become resistant to agents like erlotinib with the development of new genetic abnormalities, the resistance to angiogenesis inhibitors is less well understood and only now being tested in the clinic. Targeting the FGF pathway is but one approach to reversing acquired resistance and if compounds like the one described in this report can be delivered safely, promising opportunities exist with diseases like renal cell carcinoma, to further enhance the already important effects for patients from VEGFr TKI's when administered alone.

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Robert A. Figlin, MD., FACP (Posted: March 22, 2011)

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Nephron-sparing surgery should be the standard of care for all patients diagnosed with renal cell carcinoma and anticipating surgical removal. Not all kidney cancers can be removed using this nephron-sparing approach, but patients and physicians alike should be aware of this option and seek out the technical expertise that would allow for a decision prior to surgery. The current report is just the latest in a series of results that supports the adverse health outcomes for people who underwent a radical nephrectomy vs. a nephron-sparing approach. For the patients who either present with metastatic disease or develop metastatic disease upon follow-up, the medical oncologist has the ability to deliver safer systemic therapy when the existing renal function has been maintained. The take-home message from this report for patients is to take the time to seek out the best surgical option before proceeding. It will offer the greatest chance for control of the local cancer while maintaining optimal kidney function and long-term outcomes whether or not the cancer returns.

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Thomas Marsland, MD (Posted: March 22, 2011)

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Self-referral is always a potential problem. There is however a positive side to having ancillary services within the scope of one's practice. It allows for better quality control and integration of those services into the patient's care. We include a number of ancillary services within our practice. This includes imaging, lab, and radiation therapy amongst others. We meet the same standards applied to all the other providers of these services. In addition, we notify the patient of our ownership and provide them with alternatives which they can choose without penalty if they desire. Indeed, this does enhance practice revenue but we also feel it provides better and more coordinated quality care. It is interesting that the groups pushing for this ban are those who also provide these services.

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Thomas Marsland, MD (Posted: March 29, 2011)

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The concept of ACOs is not new. As suggested, this idea has been tried before in the past and for many reasons failed. That doesn't mean that the principles used by ACOs might not succeed this time. However, I am unsure that ACOs as currently designed will be anymore successful this time around. ACOs are actually required by health reform. This model is not just a demonstration project. There are a lot of reasons for concern. First is that the number of patients required to form an ACO is really quite small, only 5,000. This number is really not large enough to offset potential high expenditure cases. To point, Atrius, which seems to have an effective organization, has 700,000 patients. Also in the current proposed models the patients can go outside of the ACO and indeed may not even know they are part of an accountable care organization. How are costs to be controlled when they are outside of the ACO? In the present model, fees are still going to be paid in the usual fee-for-service format which again may work against group savings. It is unclear how outliers will be dealt with. Perhaps the largest hurdle to providing cost effective care in this model is the inability of our current EMRs to interact and communicate, making coordination of care much more problematic. Finally alluded to in the article is the relationship between the hospitals and the physician community. Hospitals make more money on in-patients while physicians try to minimize in- hospital tests and time. The concept is a good one--it is just there are a lot of problems with the model as currently proposed, and I am afraid these problems will ultimately lead to a lack of success.

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Thomas Marsland, MD (Posted: April 06, 2011)

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How much better is good enough??? That is a critical question. At this point we really don't know who is going to answer that question. Will it be the payers, the patients, or the physicians? There are many examples of this out there. Xgeva vs. Zometa is one. Generic paclitaxel vs. nanoparticle paclitaxel is another. As more and more parties push the concept of pathways, I sincerely hope that cost alone doesn't become the primary driver of which therapies are included. I hope organized medicine steps up and helps define what value really is. We need a clearer understanding of when treatments that are marginally better should be included at what cost.

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William Harwin MD (Posted: April 08, 2011)

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Fascinating read. I don't know that it was well known how lopsided all the ODAC votes were against Avastin as far as the risk-benefit ratio. Avastin's use in breast cancer has dropped considerably and Genentech has an uphill climb ahead.

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Thomas Marsland, MD (Posted: April 08, 2011)

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With more grey hairs than my friend and colleague, Dr. Cox, I too remember the "good old days" when off-label usage was much simpler. There is no question that today life is much more complex due to more rules and regulations and most importantly cost. In the past once a drug was approved it was relatively easy to use off-label but indeed there were a lot fewer drugs and the cost of these agents was significantly less. Even in those days however, rarely was a drug used without some evidence to support its use. I remember sitting in on multiple ASCO presentations of definitive, practice-changing paper only to find out that many times the treatment was something I had routinely been doing based on early Phase II data. With the rapidly rising cost of so many of the newer drugs, I do support strong criteria for off-label usage, but this really needs to be clearly defined so that the payer community can more quickly cover off-label indications with less hassle to the practices. The paper cited by Dr. Cox does have some flaws since in the review claims data was used and it can often be difficult to get accurate clinical information from claims data so that their rates of off-label usage could have been overestimated.

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Thomas Marsland, MD (Posted: April 12, 2011)

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I think what we recommend to patients often times is biased by malpractice fears. It is hard to recommend a treatment with higher death rates even if there are fewer long-term complications. However, when making decisions for ourselves, the fear of being sued is not there, and then balancing quality of life and survival come into play more.

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Robert A. Figlin, MD., FACP (Posted: April 12, 2011)

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The recommendation by ODAC today to approve both Sunitinib and Everolimus for the treatment of pancreatic neuroendocrine tumors (NET) is yet another example of how we continue to understand the biology of cancers with drugs that have been approved for other indications. Both Sunitinib and Everolimus received their first approvals in the cancer space for the treatment of metastatic renal cell carcinoma in the first- and second-line respectively. Although not a common disease, there have been few new options for treatment for pancreatic NET until the results of recent trials and the presentation to the FDA that may result in the availability of Sunitinib and Everolimus. They inhibit different pathways and it will be important to understand in what sequence and which agent offers the better opportunity for benefit. It also offers the opportunity for a study of the drugs' comparative effectiveness to help clinicians know what to expect from each agent, and in what sequence.

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Thomas Marsland, MD (Posted: April 14, 2011)

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Hospital owned practices are potentially a problem. Providing care in the hospital generally is more expensive than providing care in the private practice setting. Mayo Clinic and the Kaiser programs are NOT hospital owned. So to use them as models of hospital owned systems is not valid. Kaiser and Mayo are out-patient practices that have hospitals as part of their integrated healthcare delivery systems. THIS model may indeed be more cost effective but it is no question out-patient driven. True hospital owned physicians and hospital driven programs are not cost effective because they use hospital systems to provide ancillary services which cost more than similar services provided by out-patient private practices.

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Thomas Marsland, MD (Posted: April 15, 2011)

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FCCN gets it. Clinical integration and coordination of care is critical to the delivery of high quality cost effective medical care. Many programs rely on the use of "pathways" to standardized care which improves quality and cost control. The true key to making these networks successful is the ability to monitor and exchange data and outcomes. It is encouraging to see high tech programs being used to do this. Many other networks rely on lesser programs and systems based only on claims data that really limit the ability of the group to monitor compliance with pathways and therefore assure persistent quality care and cost effectiveness.

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Thomas Marsland, MD (Posted: April 20, 2011)

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There is a big difference between prolonging the living and prolonging the dying. As an oncologist I have dealt with these decisions on a daily basis for 25 years. The issue should not be framed as one of rationing but more in terms of what is really appropriate care. There comes a time when the issue of quality of life supercedes the issue of "how long." There is no question we can and should do a better job in dealing with end-of-life issues and provide the best appropriate care in all instances. No question this could result in significant savings to the healthcare system in this country, but to address this as "rationing" does everyone a disservice.

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Robert A. Figlin, MD., FACP (Posted: April 20, 2011)

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Renal Cell Carcinoma is a smoking-related disease as one of its risk factors for development. The authors support the observation as seen in other smoking- related diseases (i.e., lung cancer) that patients who do not smoke, or, have stopped smoking, when compared to those who continue to smoke have a better prognosis. The relationship of smoking and the relative aggressiveness of kidney cancer will require further study but this report points out the potential importance of smoking cessation strategies for resected RCCa as is recommended for early-stage lung cancer after resection. Whether these observations apply to all RCCa pathologies or predominantly clear cell RCCa will require additional follow-up.

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Thomas Marsland, MD (Posted: April 27, 2011)

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I had the opportunity to recently attend a Business of Oncology for Pharma sponsored by our state society. One of the biggest issues on the part of the physicians and pharmaceutical community was the idea of access to the docs by industry. With the "sunshine" law and the reporting of even minor gifts (such as lunches for the practices), many practices have stopped this traditional method of information exchanges. We have lost opportunities to understand how new drugs are being used and new indications for old drugs. Also, our back-office business folks have lost opportunities to learn about needed billing and coding information as well as drug replacement and patient assistance programs. To believe that physicians would alter treatment patterns and perhaps not do what is in the patient's best interest for a free pen or lunch is ludicrous. I am glad to see a glimmer of reason return to our elected officials and can only hope others follow suit...

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William Harwin MD (Posted: April 28, 2011)

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This will likely be a blockbuster drug and adds to the growing list of newly approved drugs for advanced prostate cancer such as Jevtana (cabazitaxel) and Provenge (sipuleucel-T). It will be of interest if payers pay close attention to the specifics of the FDA label, namely metastatic castrate resistant prostate cancer patients who have received docetaxel. It is likely over time that the drug will be offered as an option to patients who have not yet received chemotherapy. Prostate cancer, like kidney cancer, has been a rags to riches story with, until recent years, few options in advanced disease. The story of how these new drugs will be used in prostate cancer and in what order remains to be determined.

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(Posted: May 05, 2011)

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This interesting finding parallels other studies and epidemiologic data demonstrating that tumors detected between screening (regardless of whether screening is done yearly or less frequently) tend to be faster growing. These so-called interval cancers are usually discovered by palpation, are higher grade, and also less likely to be hormone responsive. What are the implications for screening and for patients? Younger women are more likely to get aggressive rapidly growing disease, and have dense breasts, making mammographic detection more difficult. In contrast, older women are more likely to have cancers detected by mammogram. Therefore, women of average risk could have several (one to three) mammograms in their 40's, then start annual screening at age 50. This also assumes regular self-examination. Does this mean that we need better screening methods? I would respond that it is not clear, and that the biology of the cancer dictates the manner in which it is diagnosed. Even the best screening tool cannot and should not be used as frequently as would be required to find a sporadic cancer. So, mammograms are important, they detect cancers earlier for the most part, but are more useful in older women. More aggressive cancers tend to be found by palpation; breast exams are still a useful adjunct.

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(Posted: May 04, 2011)

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It is a rare situation where a placebo alone (with no active therapy) would be used in cancer clinical trials against a new therapy in a phase III trial. More commonly the standard of care treatment would be compared to the new therapy in a trial designed to evaluate any additional benefit from the new therapy. One way to evaluate this without bias is to add an inactive drug to the standard of care treatment so that it is blinded against the new therapy in the other arm of the trial. Other optional designs include a cross over design so that the patients in the standard of care arm can cross over to the new drug when the old ones are no longer working. This design is very helpful in helping patients to make the choice to go on the trial. However, if survival is the overall endpoint then this causes some confusion in the end. We owe it to our patients to give them at least the best standard of care for their malignancy.

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Robert A. Figlin, MD., FACP (Posted: May 06, 2011)

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Although I am a co-author on this publication I wanted to take the opportunity to review the implications found in this retrospective study for practicing physicians and the pharmaceutical industry. We have demonstrated that hypertension as defined in this study may be an on target effect of Sunitinib, and as such may be a biomarker of who is likely to benefit. As in all retrospective analysis such as these it will be important for this observation to be validated prospectively. Studies are underway to do just that. If hypertension is a biomarker of benefit we as physicians and the industry that provides us with these molecules must determine their biology and assist the doctor and patient in their best management.Through further investigation will we be able to offer our patients the greatest chance for clinical benefit. Additionally, we can expect that other on target effects formerly thought as "side effects" of the drug may very well be an important indicator of who might benefit. Strategies to modify on target "side effects" must become part of the strategies for drug development in this era of targeted therapy for cancer.

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Thomas Marsland, MD (Posted: May 11, 2011)

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Again, kudos to Dr. Sledge and his very insightful reading of the two articles. The discussion of "value" is always a difficult one. I'm sure the additional 4 months of life would have been very "valuable" to his dad but would that have been valuable to society in general. My hope and prayers are that these types of value decisions are best left to the patients and their doctors, discussed in an open and transparent manner not contaminated by third- party administrative rules and regulations. One can only hope that as additional research unfolds that the mantra of "right drug for the right patient" truly helps in choosing what really is the value for the patient and the society both.

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Thomas Marsland, MD (Posted: May 11, 2011)

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Of all the things in the health care reform bill the IPAB is perhaps the most scary. It puts in place a group of "appointed" individuals who are not responsible to anyone. They have unlimited authority and, taken to the worst case scenario, could result in total price controls. The IPAB is really not subject to any of the other checks and balances other areas of government are. Their potential to impact health care delivery could truly be catastrophic.

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(Posted: May 11, 2011)

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This interesting comment outlines what we now know about differences in recurrence patterns based on tumor biology - with a relatively striking time based variation. The authors suggest that this implies that therapies delivered in the adjuvant setting, specifically chemotherapy, lose effectiveness over time. Indeed we need to understand the natural history of specific cancers, and even more importantly, appropriately individualize therapy to biology. However, patients with early stage breast cancer are living longer now than ever before, and patients with the most aggressive form of cancer are generally free of relapse if they survive without recurrence for 5 years. In contrast, patients with indolent, hormone receptor positive disease experience at least 50% of their relapse risk after 5 years. So, in fact, adjuvant therapy does not 'lose' its effectiveness. Instead, chemotherapy has its greatest impact on cancers likely to recur early. The later relapses may be better controlled by longer duration hormone therapy, perhaps given in sequence or intermittently to reduce development of resistance. Current clinical trial design must take this biologic heterogeneity into account.

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(Posted: May 13, 2011)

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This case sets a very bad example of discrimination against patients with a malignancy. To deprive a currently fit parent the opportunity to spend quality time with her children during their formative years is unthinkable. Even the children did not want to move to be with their father, which should mean something in the law's eyes. I think she should appeal under the Americans with Disabilities Act (ADA) that under normal circumtances she would be given custody as a fit mother or at least joint custody. If they let this go through - what is next for discrimination against patients with cancer?

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Robert A. Figlin, MD., FACP (Posted: May 16, 2011)

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The AUA is concluding its meeting in Washington, DC, with some important observations in the management of renal cell carcinoma. The Fox Chase Group led by Dr. Uzzo continues to help us understand the role of Active Surveillance in people with small renal masses undergoing careful observation. They show us that not all cancers grow quickly or metastasize rapidly. Recommendations for the appropriate management of small renal tumors being followed are suggested. The same group reemphasizes the need for expert urological oncology evaluation in determining the appropriate surgical approach for the resectable patients valuing a discussion about the appropriate nephron-sparing procedure that is right for their situation. The AUA also reports further evidence that kidney cancer is a smoking-related malignancy and also that "agent orange" may in fact cause an increase in kidney cancer incidence.

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(Posted: May 19, 2011)

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This is a very interesting new molecule which is a bispecific single-chain antibody. That bispecificity enables it to target two cells at the same time. In this case it targets CD19, a B-cell antigen present on the ALL cells; it also binds to T-cells which activate them to kill the ALL cells. Twenty-one patients with MRD positivity (strongly correlated with subsequent relapse) were treated and a whopping 16 became MRD negative. Relapse-free survival probability is 78% at a median follow-up of over a year.

This is very encouraging data as relapsed ALL is a dismal disease, probably partly because most frontline regimens use a rotating cocktail of almost every active agent for this disease. Other than the FDA approval of nelarabine a few years ago, which is only approved for the smaller subset of patients with T-ALL, there have been no drugs approved for adult ALL in over 20 years.

This drug is also going to be tested in relapsed ALL and would potentially be amenable to the treatment of any CD19 positive malignancy. Lymphoma and CLL would be other reasonable diseases to investigate, although the current schedule of a 4-week continuous infusion is not too user friendly for more indolent diseases. The company is also working on an alternative formulation that might be easier to administer.

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Thomas Marsland, MD (Posted: May 17, 2011)

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Comparative effectiveness research is something oncologists have done forever. We are constantly comparing one protocol to another to determine which therapy is most effective and least toxic. What has complicated the picture is when cost has been entered into the equation. The health reform currently doesn't allow cost to be included in treatment decision making. Most of us would agree that for truly equal treatments in terms of effectiveness and side effects that using cost to make a treatment decision is not unreasonable. Where again sometime the waters are muddied is when the issue of off label usage is factored into the equation. The Lucentis-Avastin debate does some of this - raising the question of whether Avastin off label would be covered for macular degeration. I would just hope that the whole question of value (benefit for cost) is ultimately decided by the patients and the physicians.

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Thomas Marsland, MD (Posted: May 24, 2011)

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The growing use of oral anti cancer therapies raises a number of interesting and complex questions. As demonstrated by the JOP article the cost is a significant factor for the patients. Their out of pocket expense is usually much greated when they take oral medications covered under the pharmacy benefits rather than intravenous therapy covered by medical benefits. We need to do a better job of helping these patients with financial assistance (which often is available through co-pay foundations) and also in actively monitoring for compliance. These types of activities put additional financial stresses on the practice also. We often employ individuals solely to help patients with financial assistance. Oral anti cancer drugs also require close patient monitoring not only for compliance but also for managing toxicities with no real mechanism to capture these costs. Going forward it is critical that the payer community recognize the value that is being provided by the practice and find some novel way to compensate them for the work that is being done. Finally, the cost of the drugs themselves needs to be closely watched. Hopefully many, if not most, of the newer oral oncolytic will be targeted and use of the "right drug for the right patient" will help to control some of these expenses.

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William Harwin MD (Posted: May 26, 2011)

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We participated in this important clinical trial at FCS and one of our physicians, Dr. Luis Chu, is the fourth author in the NEJM paper. It might be of interest for the readers to know that the FDA as part of their routine regulatory activities closely scrutinized our site as part of their due diligence. I would note that Dr. Mario Eisenberger from John Hopkins (who taught me oncology many years ago at the University of Miami) made an important point in the editorial in the same issue of the NEJM. That is that it would seem reasonable to consider abiraterone not just after docetaxel chemotherapy but also before chemotherapy. For the sake of patients with prostate cancer we can only hope payers don't restrict the drug's use for only patients who have received docetaxel.

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(Posted: June 01, 2011)

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This article summarizes in a large group of patients with CLL what had previously been published but not looked at so systematically. Patients with p53 mutations have a terrible outcome. It is well known that patients with 17p deletions (which are detected by FISH and can be done on the peripheral blood) have a very poor outcome with any standard therapy and that part of the reason for this is the lack of p53 which is needed for cell kill to chemotherapy. Some data had been published that many patients with the deletion also had a mutation of the other allele. This series looked at 520 samples from patients going on a front-line randomized trial. Mutations were found in 7.6% of patients including 76% of those with a 17p deletion and 3% of those without that deletion. This study clearly showed that those with a mutation who didnt have a deletion did quite poorly. OS at 5 years was only 20% ( versus 59% in the others). Although the authors recommend that "analysis of p53 mutations should be performed in patients with CLL who have progressive disease before starting first-line therapy" this test may not be readily available to most clinicians.

However, given the high concordance with 17p mutation I think it would be enough if all physicians would just get a CLL FISH panel (readily available in any commercial lab) at the time of treatment. This is particularly important since there are a number of new molecules in clinical trials, such as the B-cell receptor inhibitors (CAL-101 and PCI32765), that are extremely potent therapies and as of yet, there is no suggestion that patients with 17p deletions do not respond to them. Given the dismal prognosis of patients with 17p deletions/mutations and their failure to respond well to all the currently available treatments, all these patients should be strongly considered for clinical trials and this is the one group where allogeneic transplant in first remission, even if in CR ( albeit unusual), can be considered.

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Thomas Marsland, MD (Posted: June 08, 2011)

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To anyone who was fortunate to attend ASCO's annual meetings it is the best of times and it is the worst of times. One cannot help but be excited about the potential for cancer control that was so obvious at the annual meeting. We currently have over 900 new compounds in clinical development and the meeting presents so many with promise; from the early smaller phase I and II studies to the practice altering phase III presentations. Dr. Sledge in his unique fashion really presented the hope and vision we all share in his presidential address. More than just target therapies, the day of truly personalized cancer care is very close.

The worst of times was also an undercurrent present at the meeting. Is a prolongation of median survival of 2 months really worth $100,000? We really are facing some very difficult choices. I think it is really critical that we as a profession and society be actively involved in helping to define what "value" really is. We cannot abdicate our role to advocate for patient access to high quality cancer care. We must not allow the bureaucrats and accountants to usurp that role and determine patient choices solely on the basis of dollars. Value in the long run is best defined by the patients, families and physicians. The payer community needs to be involved in these policy decisions but cannot be the sole entity making these critical choices.

ASCO is uniquely positioned and up to the job of being that voice and coordinating discussions between all the stakeholders. We also need all of us to stay involved at all levels: local regional and national. The hope is there, we must not let it slip away.

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Howard S. Hochster, MD (Posted: June 11, 2011)

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An interesting way to do research. Take uncontrolled and anonymized insurance data and crunch! We should not be surprised that insurers wish to publish data such as these in order to control physician choice. The problem here is a lack of data on pretreated patients and colon cancer patients who are still in good shape, still want treatment, and have exhausted standard treatments. In that situation I suggest these colon cancer patients be referred for clinical trials (and please do this before they get multiple capecitabine regimens). We also need more trials for this patient population.

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Howard S. Hochster, MD (Posted: June 10, 2011)

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This is not surprising. If one looks at clinical trial results, the same phenomenon is true. In the recent COIN trial of metastatic colon cancer by the MRC, including more than 3000 patients, the median survival was less than 18 months while the US and European trials are showing 24 months median survival. In addition fewer than 30% of patients who were supposed to stop-and-go their chemotherapy actual did. The attitudes in the UK toward treatment for cancer are negative and fewer drugs are approved there. Even for approved drugs, many are not funded by NICE and are therefore not available to most UK patients. Without drug availability survival suffers.

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Thomas Marsland, MD (Posted: June 10, 2011)

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This really is a comment on two articles in today's OBR and a follow-up to my comment from the other day. The first article discusses how the cost of cancer care was discussed at ASCO and the second discusses the poor survival rates of cancer patients in the United Kingdom. These two articles deserve additional comment. Again I laud ASCO for their effort to help introduce the idea of cost and value into the discussion of new treatments. It is critical that our professional societies weigh in on these issues and help the practitioners have open and transparent discussions with their patients on what the "value" of a given treatment truly is. The alternative is what we are seeing in the UK with treatments being rationed and patient survival suffering. I believe that the major offending organization is NICE (National Institute for Clinical Excellence). I don't believe it is because "doctors think the treatments are not worthwhile." This is the perfect example of where we have let a bureaucracy determine what is right for the patient. I have real concerns that the IPAC committee proposed here in the US could result in similar results. At the end of the day, it is the physician with guidance on the definition of treatment value from our professional societies and the patients who should determine where the "value" really lies.

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(Posted: June 09, 2011)

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This interesting article quantifies what physicians are thinking about when making treatment choices for our patients. It is logical that considering toxic therapy in exchange for a longer survival might be an option that physicians and patients may choose. However, the cost of therapy is another issue. Here, I think a balanced look at the cost/benefit ratio is the most important evalaution. Sometimes that benefit might be a prolonged survival. However, if the benefit is comfort and improved quality of life then the cost/benefit ratio might also be balanced toward the beneficial side. There are often less costly alternatives or clinical trials that the patient might benefit from and these should always be considered.

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(Posted: June 11, 2011)

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I had previously commented on this interesting antibody based on data presented from a trial in patients with ALL and MRD positivity. MRD positivity has a strong correlation with subsequent relapse in this disease. The antibody, blinatumomab, is bi-specific, binding to both CD19 on B-cells and CD3 on T- cells, thereby activating the T-cells to kill the B-ALL cells. The MRD trial was a pilot in about 20 patients and was very successful; it has been recently published. The current trial was in patients with ALL and full-blown relapse, rather then just MRD positivity. So the tumor burden in the patients in this trial was much greater and yet the efficacy presented in the first 12 patients is very impressive with responses in 9. Not only did these patients achieve CR or CRi but they were MRD negative after treatment. So this is further confirmation of the potent activity of this agent in ALL. As I had posted previously, it is being developed in lymphoma and could potentially have efficacy in any B-cell disease. The one drawback going into less indolent diseases is that currently this antibody is given as a 30-day continuous infusion, not that user-friendly a schedule. SC formulations are also in development.

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(Posted: June 11, 2011)

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This release is a bit misleading as worded. Standard induction therapy for AML is a regimen referred to as 3 + 7. This is because of the use of 3 days of an anthracycline along with 7 days of cytarabine given at 100mg/m2. Standard consolidation in non-elderly patients is with "high dose" cytarabine. The original high dose cytarabine was 3 g/m2 given q 12 hours. This schedule quickly became unpopular as it was associated with significant cerebellar toxicity likely related to peak concentrations. So how is high dose cytarabine currently given? Well it depends on how many oncologists are in the room since each one likely gives it a slightly different way. Sometimes 3 g is still used, albeit not q 12 hours but many schedules give anywhere from 1-2 grams/m2. This is still a lot more cytarabine than is given in induction and it was shown that higher doses of cytarabine in consolidation were better then the standard dose of 100mg/m2 in a randomized trial. So the point is, patients still benefit from "high dose" cytarabine and it is still needed to cure most patients with AML.

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William Harwin MD (Posted: June 17, 2011)

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This study provides fascinating new information. Personally i was diagnosed with malignant melanoma of the left ear 5 years ago. Fortunately it was a very early lesion and there was no lymph node involvement. I always wondered if exposure in automobiles was a factor in my case and only after my diagnosis did I think to have my car windows tinted.

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Robert A. Figlin, MD., FACP (Posted: June 15, 2011)

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This effort of an immunotherapy approach combined with a standard targeted agent, Sunitinib, will herald a hoped for continuing advance in renal cell carcinoma. We have witnessed many new drug approvals with more to come since December 2005 with the approval of Sorafenib for advanced renal cell carcinoma. Despite these remarkable advances, changing the landscape for both patient and clinician alike, the future goals for patients is further enhanced by asking often difficult scientific questions. Can we take advantage of the small but definite benefits of IL-2 in selected patients by revisiting and combining an immuotherpeutic approach with FDA approved front line therapies? Whether this comes in the form of an off-the-shelf vaccine such as this trial, or a personalized approach taken by others, or agents that modulate the immune system, the exciting new approaches in renal cell carcinoma will most likely come from combining targeted agents with novel immunotherapeutic strategies.

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(Posted: June 18, 2011)

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Peripheral T-cell lymphoma (PTCL) is a very difficult lymphoma to treat, so to have a new drug in the portfolio to treat these patients is especially helpful. With further investigations, combinations of the newly active and traditional agents may be even more beneficial for these patients. Another benefit of some of the newer agents is reduced toxicity over traditional cytotoxic therapies. We still have extensive clinical investigation to do to improve upon the cure rate of PTCL, but the new active agents are the first step.

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Thomas Marsland, MD (Posted: June 21, 2011)

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The article makes some very valid points. There really are no average patients. As we move to an era when everyone wants standardization of treatments, we cannot forget that one size doesn't always fit all. We have to have the flexibility to tailor the therapy to the patient appropriately. As we enter the newer era of personalized medicine we will be challenged to find ways to be sure that patients get the correct care. Usage of target markers and tumor genomics will drive who gets what treatment. In the end, the most cost effective therapy is the right drug for the right patient.

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Thomas Marsland, MD (Posted: June 21, 2011)

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With over 900 new compounds in development and close to half being oral, the issue of coverage for oral drugs is critical. The article raises some very pertinent points that many patients cannot afford the payment for oral drugs which generally are covered under pharmacy benefits as opposed to IV chemo which more often is covered under medical benefits. Recent literature suggests that many patients miss or skip treatments of oral anticancer therapy because of costs. Equalizing coverage is important going forward. The other key piece to this discussion is patient compliance and the fact that the work in providing care for patients on oral drugs is equal to that for patients on IV. In any reform this issue also needs to be addressed. The proposed legislation could help in addressing these issues.

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Robert A. Figlin, MD., FACP (Posted: June 22, 2011)

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That smoking is related to a more aggressive prostate cancer is but one additional risk factor we are finding for some cancers with poorer outcomes. A similar result was recently reported in JCO 2011 for another GU malignancy, renal cell carcinoma. Additionally the benefits of targeted therapy may be reduced in patients who continue to smoke while receiving care. This is also true in lung cancer where smoking alters the metabolism of the EGFr TKI's in patients with advanced disease. Medical oncologists treating patients who continue to smoke while receiving systemic therapy need to become increasingly aware of the negative outcomes associated with this behavior.

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Thomas Marsland, MD (Posted: June 29, 2011)

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It is truly an exciting time in the treatment of prostate cancer. Many of us remember so well when the treatment of castrate resistant prostate cancer consisted of morphine and a hospice referral. We now have a series of treatment alternatives that especially if taken together have the potential to add really meaningful time to a patient's life expectancy. The story reminds me also of the colon cancer story of ten years ago when the addition of a number of new agent took the average life expectancy in metastatic colon cancer from 8 months to almost two years. Cost was also an issue then too. We need to be careful when adding terms like meaningful quality of life years into the equation. We can no longer ignore the cost of therapies but we also cannot ignore the potential being offer by the rapidly expanding treatment options in prostate cancer. Hopefully patients and families with their physicain will continue to have access to this expanding list of new drugs.

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Thomas Marsland, MD (Posted: June 29, 2011)

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yes it is...no it's not...So another paper adding to the "evidence." I think Dr. Love's comment so adequately sums it up - mammography saves lives the question is what is the correct scheduling. The motivation of the groups arguing for less screening certainly is open to question. Is this really just an economic debate? We are constantly being asked to practice "evidence" based medicine yet where does this leave us when there is evidence to support multilpe positions. In the situation where the options are potentially life saving I think we need to err on the side of over doing. The other really key point that is often missed however is that the debate is often about screening in the general population and we need to remember that a patient's individual risk factors really do need to be taken into consideration in the decision tree.

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Robert A. Figlin, MD., FACP (Posted: June 28, 2011)

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Next generation VEGFr targeted therapies carry the hope of an improved therapeutic index when compared to already existing treatment options. Axitinib is one such agent and is being submitted to the FDA for an approval in advanced renal cell carcinoma. The recent presentation at ASCO of the results of the AXIS trial compared Axitinib to Sorafenib in previously treated patients. It demonstrated statistical benefit overall as well as in populations that had received prior cytokines or Sunitinib. Although this trial is the catalyst for submission to the FDA, the community of treating oncologists await the randomized trial in the previously untreated patient population to determine whether this next generation agent may provide additional benefit when compared to other already existing VEGFr TKI's. Ultimately having more agents in renal cell carcinoma is only of value if we are producing more benefit for our patients in the form of longer progression free survivals, better overall survival, while reducing the known side effects of this class of agents. Whether Axitinib offers this opportunity remains to be seen in the further evaluation of this agent.

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(Posted: June 28, 2011)

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The decision for AstraZeneca to stop paying directly for doctors to attend international medical meetings is a good one from the aspect of trying to stop direct influence on the physicians by pharma. However, this will cause a problem for the physician's ongoing medical education. I think a good way to achieve this goal without the potential for conflict of interest would be for the pharmaceutical companies to contribute to a pooled fund to ASCO or ASH that the physicians could apply for a "scholarship" to attend the meetings. This way the companies are still helping with the education, but it is not tied to any one company so that it does not appear that any return is required on the part of the physicians.

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Robert A. Figlin, MD., FACP (Posted: June 29, 2011)

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It is helpful to now know that patients receiving these two targeted agents will respond to flu vaccination and that there is not immunosuppression blocking that response. For Sunitinib this is not a surprise because recent evidence suggests that Sunitinib may improve the immunosuppression associated with cancer through mechanisms controlling T regulatory cells and myeloid derived suppressor cells.

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Robert A. Figlin, MD., FACP (Posted: June 29, 2011)

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The study proposed of TH-302 in combination with Sunitinib in renal cell carcinoma, GIST, and pancreatic neuroendocrine tumors will test the role of a novel agent targeting tumor hypoxia in a phase 1/2 study. Targeting tumor hypoxia in this study must also recognize that the biology of these tumors is distinctively different. Clear Cell RCCa is widely recognized as a disease with genetic control of tumor hypoxia through mechanisms that involve 3p and other chromosomal abnormalities. This is in contrast with GIST and neuroendocrine tumors, where tumor hypoxia is regulated through other mechanisms. It is hoped that in the development of this approach the investigators recognize the inherent biologic differences of the disease they will test in the phase 1 study.

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William Harwin MD (Posted: June 29, 2011)

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The reported allegations against this so called breast cancer charity Coalition Against Breast Cancer (CABC) is an outrage that should be dealt with sternly by New York's Attorney General. The bad publicity underlies the efforts of any number of organizations that raise money for cancer research and assistance for cancer patients. As an oncologist who has participated in Susan Komen, American Cancer Society, and on an annual basis the Pan Massachusetts Challenge bike event I find the alleged actions of the CABC unsettling and offensive to all of us that treat or have been personally impacted by a friend or relative with cancer.

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(Posted: June 29, 2011)

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After a two day hearing with presentations by many supporters of bevacizumab, the FDA came to the same conclusion they had many months ago, when they first recommended withdrawing approval for bevacizumab use in breast cancer. Bevacizumab combined with paclitaxel is still approved for use, until the FDA takes their final action expected this summer.

There are several important issues that have been highlighted by the tremendous controversy surround approval of bevacizumab in the treatment of late stage breast cancer. First, endpoints required for approval seem to be variable depending on the agent added to standard therapy. For example, small benefits have led to approval of chemotherapy agents, despite additional toxicity. The FDA has commented on the lack of survival data, but in order to obtain survival benefit in first-line metastatic trials, we would either need very large studies that would be costly and difficult to complete, or we need to establish a very homogenous population to study. We have already observed significant variations in classifications of tumor biology, and recognize that many novel agents may be most effective in small breast cancer subsets. Our challenge is that we have not yet identified the subsets. The second issue is the extent of data required to confirm initial positive results, and what format confirmatory studies should take to avoid demonstrating clinical benefit not thought to be adequate for final drug approval.

Lastly, this unfortunate ruling does provide a new direction and marching orders for breast oncology; we need to collect tissue in all patients enrolled in novel agent trials, and assign significant resources to identify subpopulations that benefit from specific targeted treatments.

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(Posted: June 30, 2011)

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These results are incredibly important for those with a high risk for the development of lung cancer. With a 20% reduction in lung cancer deaths and 7% reduction in overall mortality, low-dose CT screening for lung cancer will improve survival rates for this difficult disease. The implications of these results will continue to be evaluated, including the cost-effectiveness of lung cancer screening. Patients at high risk for lung cancer should discuss their options with their physicians to make informed decisions regarding individual care.

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Howard Sandler, MD, MS, FASTRO (Posted: July 01, 2011)

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Perhaps not surprisingly, patients are overoptimistic regarding their recovery of sexual function and urine control after radical prostatectomy. This study, which included primarily robotically-assisted surgical procedures, showed that many men had worse function 1 year after surgery than they expected (using an "expectation" quality of life tool administered prior to the surgical procedure. This study reinforces how important it is to fully inform patients prior to medical procedures, but also suggests that when patients are told they have a chance of a complication, many may understand the risk but feel it won't happen to them.

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Howard S. Hochster, MD (Posted: July 05, 2011)

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Been down this road before!

The data presented by Dr. Pirker from Vienna, on the FLEX trial in NSCLC, suggest that H-score (intensity of staining x number of cells) can be helpful as a biomarker of benefit in patients receiving first line chemotherapy (cisplatin and vinorelbine) with cetuximab. To their credit, these investigators stained and analyzed all 1121 patients enrolled. Unfortunately, this study only reported the result of IHC staining, which has been shown to be of no predictive value in colon cancer and is quite subjective. The investigators did not report on any results of other testing and how it may relate to this parameter (FISH for EGFR, Kras mutation, or rash). In fact, the same authors previously published (Lancet Oncology, January 2011), that first cycle rash was a better predictor (HR 0.63 for OS, compared with 0.73 for H-score) with even better survival (15 months median for rash, compared with 12 months for high H-score). IHC has been discredited, but still is in the cetuximab colon cancer label. Let's hope for a more comprehensive analysis before it gains another regulatory imprimature.

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Winston Wong, PharmD (Posted: July 06, 2011)

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This sounds like a technological breakthrough similar to what Abraxane did for Taxol. Since the dose limitation of the medication is due to clinical toxicity, as opposed to a vehicle sensitivity, use of this preparation should be more clinically accepted and signficantly improve outcomes. Let's hope that the manufacturer does not go crazy creating their "premium" price.

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William Harwin MD (Posted: July 07, 2011)

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Second line therapy in small cell lung cancer is often futile and we are badly in need of newer therapies. Amrubicin is a promising agent in small cell lung cancer as well as other malignancies and the small cell indication may be it's path to FDA approval. I have used Amrubicin in other tumor types on clinical trials and found it to be well tolerated. All of us would agree that new therapies for small cell lung cancer are sorely needed.

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Winston Wong, PharmD (Posted: July 07, 2011)

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These finding are interesting from the standpoint that the insertion of a filter is not only costly, but also is an invasive procedure. It would be interesting to conduct additional studies with the other low-molecular weight heparins to determine if the same results are achieved. This would be of significance from the standpoint that each of the different LMWH are dosed differently (ranging from a flat dose to a dose/kg), which had lead some to believe that this is a point of differentiation in terms of clinical benefit. As well, one of the LMWH is now available as a generic product.

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Winston Wong, PharmD (Posted: July 07, 2011)

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As a payor, situations like this are almost a daily occurence. What makes our jobs difficult is that we are dealing with a highly sensitive and emotional disease. The decision to cover, or under what clinical presentation is needed to be covered, is not as black and white as many are lead to believe. For instance, in the case of Provenge, we have an approved FDA indication that is rather subjective with respect to the presence of symptoms. Yes, we are looking at a cost of $93,000 for 4-6 months of survival, but there are other alternatives that produce the same results and are less costly. Provenge may be more appropriate in later lines of treatment.

Avastin is a similar bottom line from the standpoint of cost of therapy, but the clinical relevance is a bit different. While the blanket statement is there, there is no difference in survival when combined with other medications, meaning that Avastin did slow disease progression when combined wiith Taxol. I do not believe there was any similar result when combined wiith other drugs. Thus it does seem prudent to still cover the use of Avastin in situations of progession of advanced metastatic disease.

Bottomline is that , yes, these drugs are expensive. We must strive to bridge a collaboration between payor and physician to maintain the stability of the healthcare system and use these drugs appropriately. Coverage cannot be simply determined upon hitting a cost threshold.

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Thomas Marsland, MD (Posted: July 07, 2011)

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As heartrending as Ms. Morgan's story is I think that in determining the effectiveness of a treatment that we need to remove the emotional component in that decision. Drug effectiveness needs to be determined on the results of appropriate clinical trials. And indeed there may very well be some differences of opinions on the Avastin breast cancer trials but the ultimate decision which is made needs to be based on the evidence, not on the emotional stories of patients who indeed are battling for their lives. In another article reported in OBR they referred to the fact that CMS will continue to cover Avastin for breast cancer patients. This is in keeping with current practice of using drugs for off label indications. Ultimately with the rapidly rising costs of developing therapies it will become more and more critical to develop the predictive markers that will allow us to decide which patients will really benefit from these treatments. Unfortunately such markers do not exist today for Avastin and the ultimate "value" of Avastin for a given patient should be determined by the patient and the physician.

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Howard S. Hochster, MD (Posted: July 14, 2011)

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In that case, I am going bare-foot and wearing no hat when I sunbathe! Thank heavens for such articulate writers. I am now aware of the evil caused by baseball hats (slightly less than the evil caused by baseballs when hit almost to the stands causing spectators to fall over the railings). The writer cleverly left off the by-line so we will never know exactly who authored this inarticulate and misleading headline. Hopefully, in the future they will report on a study instead of an "expert" opinion.

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Winston Wong, PharmD (Posted: July 18, 2011)

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What needs to be noted here is that this will be a "biosimilar" product that will not be interchangable with the innovator product. Hence, from a payor standpoint, it will be treated as another branded product. If history is any indicator, the biosimilar product from Teva will not be drastically discounted. So if Amgen is able to maintain brand loyalty, I doubt there will be a tremendous update of the biosimilar. Just look at the utilization in Europe. Market shares are very low one year after release.

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Winston Wong, PharmD (Posted: July 18, 2011)

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....Not only major job losses, but our costs (3rd party payors) will increase as well as the direct discounts from the manufacturers will dry up.

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Thomas Marsland, MD (Posted: July 19, 2011)

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I find it very interesting that the FDA is trying to streamline its processes. If this results in a lower cost to bring new products to market then the "innovation initiative" will be a success. Ms. Hamburg claims that one of the reasons for this initiative is to provide "timely access" to new technologies. Yet one of the problems we in clinical practice face every day is whether CMS (and other payers) will cover these new technologies. The recent Provenge story is a perfect example of where the FDA approves a novel new drug yet until very recently there remained a question as to whether CMS would cover this. The cost of these new technologies is really the issue and if this new endeavor by the FDA really can streamline the approval process then perhaps that might help keep the cost down on many of these new developments and that truly would be a breakthrough...

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Joseph Bailes, MD (Posted: July 25, 2011)

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Regulatory agencies are concerned about the proliferation of mobile medical applications. As more health professionals rely on these, it is important to review and follow actions that regulatory agencies propose to take. Also, as indicated, manufacturers have gone proactively to the FDA and this will likely continue.

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Winston Wong, PharmD (Posted: July 20, 2011)

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We, the payers, need to be creative to collaborate with these community practices to keep them in business, simply because the alternative is a hospital-based site of service, which will come in at 2-2.5 times the cost.

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Joseph Bailes, MD (Posted: July 25, 2011)

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This study and article raises a very important concern for oncology practices and cancer centers, especially those caring for a large number of medicaid beneficiaries. It is possible some medicaid programs may propose rules as a framework for reimbursing drugs. Also, states can use other data sources and potentially estimate acquisition cost. It is important to contact your state medicaid program to determine plans for drug reimbursement.

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Joseph Bailes, MD (Posted: July 25, 2011)

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Oncology practices and institutions cannot absorb reductions reportedly proposed in the budget negotiations. The resources are needed to maintain state of the art cancer care. Letters and other communications from the cancer community to policymakers stress this and, moreover, reiterate that the cancer care community is united in making certain that resources are available to continue providing care.

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(Posted: July 25, 2011)

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As we are more successful with our oncology treatments, more cancer survivors are alive for years and decades beyond their therapy. Although Hem/Onc physicians have developed excellent guidelines for detecting relapse of the original malignancy, we are not as good at looking for long term complications of therapy and routine healthcare follow up. This is a very important part of keeping survivors healthy and leading a normal lifestyle. Many centers such as ours are developing a specialty in Cancer Survivorship. A primary care physician helps with a thorough evaluation of their healthcare needs during or right after treatment such as physical therapy, nutrition, psychosocial, and physical. Then after therapy and long term, a special follow up plan for the complications and special healthcare screening can be made. This will lead to better satisfaction by patients as well as a healthier society.

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Winston Wong, PharmD (Posted: July 26, 2011)

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Maybe this is the cancer type, and this is the time for a perfect CER study, given all of the recent press about new therapies, added to the old standard therapies. Many treatments........wide scope of costs........outcomes?

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Winston Wong, PharmD (Posted: July 26, 2011)

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While I agree that lower prices will increase access to very effective medication, I would hold my breath to see if the cost of the new generics are really going to cheaper. It is a much more complicated market that one thinks, and lower prices is not a slam dunk.

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Robert A. Figlin, MD., FACP (Posted: July 29, 2011)

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Although we continue to search for relationships either positive or negative for the association of a variable with the development of kidney cancer, after controlling for smoking, diet, and weight, the role of statins could not be conclusively demonstrated to effect kidney cancer development in either a positive or negative way. This trial along with other data does not demonstrate a clear association between statin use and the development of renal cell carcinoma.

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Thomas Marsland, MD (Posted: August 01, 2011)

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This study is certainly interesting. The conclusion however needs to be taken with a grain of salt. The implications for health care economics and potential recommendations should be interperted very carefully. The study was done in Europe where screening is different than in the US. One of the references sited in the reviews in BJM from 2005 talked about the differing survivals between US (89% in the US vs 79% in Europe at 5 years) and Europe in the 80's prior to any of these newer drugs where screening in the US was already well underway and almost non existent in Europe. Also screening in Europe in most of these national programs is offered only every two year which is not the US standard. Also even with coverage the screening rates only increased to 59% of the population in the Netherlands (vs 30% in the period prior to the institution of screening programs) which would seem low by US standards. No question the introduction of newer more effective agents has had a dramatic impact in improved breast cancer survival (and most of us believe biology trumps anatomy) but at this point it is hard to say that screening has not also made a significant contribution and it is very premature to say we need to be cutting back on screening programs.

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Howard Sandler, MD, MS, FASTRO (Posted: July 29, 2011)

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Radiation therapy is a prototypical DNA damaging anti-cancer strategy and modifications of cellular responses to radiation's DNA damage are the goal of many radiation-based laboratory programs. Despite this interest, radiation modifications have tended toward the use of well-established agents along with radiation (think cisplatin and 5FU). Future work is likely to focus more on targeted pathway inhibition plus radiation with a eye towards enhancing the therapeutic ratio by making radiation's effects more tumor-specific.

It is encouraging to see groups, such as the Radiation Oncology department at City of Hope, exploring how p53, radiation, and valproic acid can work together to enhance a radiation-induced, antitumor response. Future work with novel pathway-specific agents should be supported.

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(Posted: July 29, 2011)

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So called Phase IV marketing or "seeding" trials - the term used when already approved pharmaceutical agents go into further large scale testing - can serve a useful purpose if done correctly with proper oversight. Pharmaceutical agents for life threatening diseases are sometimes approved when the patient experience is somewhat limited. Therefore, if done well these expanded trials can be helpful with adding additional information on the agent both for efficacy and safety. However, too often these trials do not have a rigorous scientific design or an adequate plan to obtain the data for analysis. A balance of having an important drug safely available for patients and gathering further information must be maintained. Institutional Review Boards (IRB's) in smaller institutions are often not equipped to follow up on all of these types of trials. Additionally, some trials may be done in offices that are not even covered by IRB's. Therefore, it is important to work with the pharmaceutical industry to maintain a high level of feedback on these trials.

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Richard Goldberg, MD (Posted: August 02, 2011)

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The availability of a molecular signature that differentiates intestinal type from diffuse type gastric cancer using markers other than the visual impression of the reading surgical pathologist would be useful to the clinician. This is especially true if the signatures predict chemoresitance or chemosensitivity to specific agents. This study was done in human gastric cancer cell lines. It needs to be extended by performing the assay in patients and correlated with their response to drug treatment. If the cell line data accurately reflect the situation in patients and predicts drug sensitivity this could be a real step forward in managing patients with these virulent malignacies. The ideal study would be a randomization to standard therapy versus therapy determined by the tumor's individual molecular profile with a comparison of outcomes.

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Joseph Bailes, MD (Posted: August 03, 2011)

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It is true the debt deal spared Medicare from cuts resulting directly of the bill. However, the commission created by the legislation will definitely examine health care spending and cancer care spending as part of that. So, the oncology community must remain vigilant as proposals that could impede access and hamper delivery are likely to reemerge as the discussion progresses.

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(Posted: August 04, 2011)

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This is exciting news for patients with myelofibrosis (MF), a devastating hematologic malignancy for which there is currently no approved therapy. This disease is characterized by marrow fibrosis leading to extramedullary hematopoiesis and development of enormous spleens. Patient presents with severe fatigue, early satiety, weight loss and portal hypertension. QOL is significantly impaired.

Ruxolitinib is a first-in-class JAK-2 inhibitor, a therapy developed after identification of the JAK-2 mutation in 40-60% of patients with this disease (interestingly this mutation is seen in other myeloproliferative diseases, including ET and polycythemia vera).

Ruxolitinib is an oral agent which results in dramatic reduction in splenomegaly with associated improvement in QOL. It does not appear to eradicate the disease as the JAK-2 clone does not significantly change, so very different from the example of targeting the Ph chromosome with imatinib.

The COMFORT trial was an oral presentation at ASH; patients were randomized to ruxolitinib or placebo. The primary endpoint was >35% reduction in spleen volume which occurred in 42% of patients on the drug versus 0.7% of placebo. Thrombocytopenia is the main toxicity.

There is no question that this agent will be approved; there are several other JAK-2 inhibitors in clinical trials but this one will be the first to market.

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Winston Wong, PharmD (Posted: August 04, 2011)

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I agree with the study results, and I would go on to say that this problem is not limited to the Medicare population, especially with the increase in biotech drugs on, and coming to the market.

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Howard Sandler, MD, MS, FASTRO (Posted: August 05, 2011)

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Although the risk of urinary leakage during sexual activity (climacturia) is well-known after radical prostatectomy (see for example Choi JM, et al, J Urol 177:2223-6, 2007), patients are not often informed of the risk pre-operatively. Fortunately, it seems to be a transient phenomenon in most cases and tends to resolve over a year. Use of temporary constriction banding can be employed.

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Howard S. Hochster, MD (Posted: August 08, 2011)

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Dr. Emanuel brings up a major issue with generic drug shortages which has affected all of us and caused some major difficulties for our patients. He uses this issue effectively for some political haymaking. He is not really correct when implying that these manufacturers are not making generic Leucovorin or doxorubicin because they can switch to more lucrative drugs. These are the generic manufacturers who aren't making big bucks on the newly approved agents. The problems have been poor manufacturing practices, explosions which disabled plants and a host of operational difficulties. In fact, Eisai is currently having major manufacturing problems resulting in shortages with the pricey brand name drug, Ontak. I agree that giving companies and physicians more of a margin on dispensing generics might bring usage into a somewhat better balance at a small cost, but the shortage problem is quite a bit more complex.

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Howard S. Hochster, MD (Posted: August 08, 2011)

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At Last! Some responsible news coverage relating to the bizarre return to 19th century popular colonic "cures". Unfortunately the websites promoting colon "cleansing" have been very convincing to a poorly informed public. (See reference to my comments in an editorial as quoted in the Wikipedia article on "mucoid plaque"). This study highlights the never quoted complications of enemas and other means of flushing the colon. This is not surprising given the lack of medical training and unusual particulate matter used. Stick with the mud baths, folks.

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Thomas Marsland, MD (Posted: August 10, 2011)

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As we await the final ruling it is interesting to see the discussion evolve. It varies from calls for hard science to emotional appeals by desperate patients. In the end the jury is still out. The data are conflicting. The confirmatory studies which ODAC used to make its recommendation to pull are different than the initial trial on which the first recommendation was made. The patients and protocols are somewhat different. I agree additional studies are needed. In the interim, regardless of the final FDA determination, Avastin remains available for off-label use supported by continued NCCN guidelines.

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William Harwin MD (Posted: August 08, 2011)

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This was an extremely well written article which has nicely outlined the problems with Provenge. At Florida Cancer Specialists we had to put our use of Provenge on hold earlier this year. Reimbursement from our Medicare carrier was erratic, erroneous, and simply not forthcoming. If a large successful oncology practice that deals regularly with expensive anticancer medications isn't able to provide Provenge, it is not likely that smaller practices can afford to the same. If Dendreon thought urology practices were going to buy and bill for Dendreon at $93,000 per patient, they badly miscalculated. The new CMS policy appears to provide clarity but also had worsened the situation for providers by bundling the infusion payments into the drug payment. This is highly unusual and only worsens the proposition for treating patients with Provenge. The costs of the infusion are not reimbursed, the entire process from the provider standpoint is cumbersome, and it is a risky proposition to purchase this very expensive oncolytic drug with the hope that one gets paid. It is no wonder that sales have been disappointing.

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Thomas Marsland, MD (Posted: August 10, 2011)

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There is no question the types of patients being enrolled into hospice has changed. Cancer is no longer the most common diagnosis. Dementia, COPD, and CHF are now commonly included. We still struggle getting cancer patients into hospice in a timely appropriate fashion. Quality end-of-life care is critical for our cancer patient. Determining a prognosis is difficult enough in a cancer patient but can be even more challenging with some of these more chronic diagnosis. Continued education on palliative end-of-life care is critical to assure appropriate usage. Cost for all aspects of healthcare are rising but we need to be sure that appropriate care is still available.

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Joseph Bailes, MD (Posted: August 11, 2011)

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Since the introduction of the SGR formula in 1997, the issue of appropriate updates in payment for physician services has vexed policymakers and physicians. SGR is widely acknowledged to be a flawed mechanism for reimbursing physician services. However, any proposed replacement for the formula has faced an uphill battle to be advanced because of the estimated cost of "fixing" the SGR. Another proposal linking updates to quality measure reporting is being discussed and floated--we shall see where it goes. This is an issue not easily resolvable and many feel will likely result in another temporary "fix' as 2012 approaches.

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Howard S. Hochster, MD (Posted: August 12, 2011)

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As the author points out correctly, the one randomized trial in colorectal cancer compared surgery with HIPEC plus 5FU chemotherapy to chemotherapy (Mayo Regimen) alone. This is not the ideal trial. Unfortunately, we are seeing the same phenomenon in GI Oncology units as has been seen in radiation oncology. Equipment (in this case the HIPEC perfusion unit) has been purchased so the center can advertise its advanced services. Then the pressue is on to use the equipment for every possible patient. This technique is now being used widely on patients with metastatic colorectal cancer in the absence of adequate prospective trials.

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Richard Goldberg, MD (Posted: August 12, 2011)

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Where and if cytoreductive surgery with intraperitoneal chemotherapy for adenocarcinomas arising in the colon, rectum and appendix belongs in managing patients with intrabdominal recurrence remains controversial. I tend to refer patients with classical mucin producing adenocarcinomas of the appendix that are well differentiated and who have no disease evident outside the pertinoeal cavity, as well as no liver disease. That is a rare situation. However, the use of the technique has crept into the management of the more commonly seen patients with colorectal rather than appendiceal tumors that are not well differentiated. I believe that this aggressive approach is useful in turning the clock back on the clinical syndrome sometimes referred to as "jelly belly" because most of what is in the abdomen is mucous and not tumor and these tumors grow slowly. All too often the paradigm is applied to more aggressive tumors where the recovery time often takes more time off the clock than the surgical procedure puts on it. Whether the heated intraperitoneal chemotherapy makes any additional difference to these patients remains a mystery. We need to develop molecular fingerprints that can be used to sort patients before surgery into those most likely to gain from this approach. Enrollment in clinical trials asking questions about the treatment and the identifying of the biological signposts of who might benefit is critical to refining our knowledge of if and when to employ this tool in an attempt to improve the outcomes for individual patients.

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Winston Wong, PharmD (Posted: August 14, 2011)

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Have the Pharma Guidelines had any impact?

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(Posted: August 15, 2011)

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Advanced Radiation Oncology techniques such as Intensity Modulated Radiation Therapy (IMRT) have shown promise in decreasing short term toxicity from radiation for several malignancies including lymphoma as demonstrated in this analysis. However, like other therapies we need to perform large scale randomized trials to be able to have evidence of improved outcomes such as decreased relapse rates and decreased long term toxicities. Since this will be difficult to do, larger case matched analyses will be needed. As we improve systemic therapies, combinations with IMRT will need to be performed as well.

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Howard Sandler, MD, MS, FASTRO (Posted: August 15, 2011)

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Intensity Modulated Radiation Therapy (IMRT) delivery requires complex technology and meticulous quality assurance that offers the enhanced ability to target tumors with complex geometry that are adjacent to critical structures.

In this work from Fox Chase Cancer Center, the authors describe the relatively non-toxic application of IMRT to lymphomas of the head and neck region, but the technology really shines when applied to nearly all head and neck neoplasms, such as the growing number of HPV-positive, oropharyngeal squamous cell cancers.

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Joseph Bailes, MD (Posted: August 17, 2011)

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FDA approval of this compound with the associated diagnostic test is the direction of drug development. FDA has draft guidance indicating the need for companion diagnostics to be part of regulatory package with the compound. I believe we shall see many, if not most, drugs with companion diagnostics at approval as responding populations are clarified.

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Thomas Marsland, MD (Posted: August 19, 2011)

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Communicating with a terminal patient is always challenging. I still vividly remember one of my first experiences as a fellow when I had to deliver the bad news. It was a disaster. The family was so angry at me that I was destroyed. Why were they so angry with me? I didn't cause his cancer. Now, with over 30 years of delivering "bad news," I think I've come a long way. Experience has taught me talking about death and dying creates a whirlwind of emotions in the patient and family. No two are the same. One needs to be patient, gentle and understanding. There is an art associated with presenting difficult news in a compassionate manner. This can be learned the hard way by experience, but as this article shows, this skill can be refined with appropriate training. I strongly support these types of efforts and believe they need to be a major component of all our training programs. The old maxim of offering cures to some but comfort to all is still paramount.

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Winston Wong, PharmD (Posted: August 19, 2011)

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We have been dealing with shortages for a couple of years now, and the shortages have occurred for some signficant medications. No doubt that standard treatments have been impacted, which leads to the question of the quality of care being provided. I sometimes wonder if the shortages are some part of a bigger strategy to promote alternative regimens.

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Thomas Marsland, MD (Posted: August 23, 2011)

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Drug pricing today is a major issue. The good news is that in the last two years we have seen a number of drugs approved by the FDA. The bad news is that many of these drugs are now pushing into six figures in pricing. This has major impacts on accessibility. Many payers balk at the sticker price and many practices are extremely reluctant to use these agents due to fear of delayed or lack of payment. The prices may very well be justified but how one arrives at those prices is a black box. More transparency and a clearer methodology of how pricing is determined is needed.

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Joseph Bailes, MD (Posted: August 24, 2011)

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This demonstration project is likely to be one of several to examine and study the effects of bundling payments in the Medicare program. Bundling of payments to physicians, hospitals and other providers is viewed as a major way to encourage efficiency. It remains to be proved whether bundling payments for ambulatory specialty services, such as oncology, will be practical or work on a large scale but proposals and demonstrations are likely to be in the future plans for Medicare.

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Thomas Marsland, MD (Posted: August 24, 2011)

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Yes, Virginia, there is a Santa Claus, Easter Bunny and tooth fairy too... Right...lower costs and help doctors and hospitals coordinate care. I'm from the IRS and I'm here to help you...I haven't heard of anything so appealing since the ACO rules...In case you haven't figured it out, I'm somewhat skeptical that this will do anything they claim. First off, what "organizations" are going to be sending out LOI this fall (hospitals maybe ???). How are these organizations going to be structured and who determines how the dollars are distributed across the different stakeholders. The bundling and payment for that bundling is proposed to be determined by CMS and the "providers" again. With whom and which provider does CMS intend to negotiate these bundled payments? In model 4, the hospitals would be responsible for paying the doctors. Another group from whom we, physicians in practice, would have to seek payment in a timely fashion. Even if in this Utopian world we wanted to discuss and coordinate care (which really is and would be a good thing), the vehicles to do this presently do not exist. We do not have a unified EMR/HIT system that would be necessary to accomplish this lofty goal. So with that all said, I guess I won't be running out to sign a LOI anytime soon.

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Howard Sandler, MD, MS, FASTRO (Posted: August 26, 2011)

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The author of the NPR article makes the comment that for treatment of neuroendocrine tumors "every year scores of Americans are sent by their doctors to Europe for long-established treatments that are still unavailable here." Presumably he is referring to PRRT (peptide receptor radionuclide therapy). While this treatment may be "long-established", it still has not been adequately tested in prospective clinical trials. Hopefully, a definitive trial will be performed and then patients and their physicians can make fully informed decisions regarding the benefits and risks of the therapy.

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(Posted: August 26, 2011)

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I have thought that one of the keys to improving clinical trial accrual is using the EMR to identify eligible patients earlier in the process. When a trial is being designed and sites being evaluated, the number of patents realistically eligible for the trial could be measured and then as the trial progresses the EMR should be highlighting the patients as they present so the physician can add as a treatment option for the patient. It is not reasonable that the physician remember the criteria for every protocol in their research program. The EMR vendors need to add and enhance this functionality.

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William Harwin MD (Posted: August 26, 2011)

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This continues to be a major problem. Although there are many obstacles that impede more accruals to clinical trials as a practicing oncologist I think we could all use some help. Patients with newly diagnosed cancer should have the concept of clinical trials introduced to them from the outset. It would help the practicing oncologist if patients at least heard something about the value of clinical trials before they ever saw us. Various organizations including the NCI, pharmaceutical companies, the ACS, Susan Komen, and the NCCN institutions can do a better job promoting and marketing the value of clinical trials to the general public. If we can create a new mindset in the public domain all of us who are interested in clinical trials will have a higher capture rate when we find eligible patients and help improve our unacceptable current percentage of patients enrolled on clinical trials.

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(Posted: August 26, 2011)

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The approval of crizotinib highlights the outstanding progress made bringing effective targeted therapy to patients with non-small cell lung cancer (NSCLC). It has taken less than 5 years from understanding the molecular driver in lung cancer to accelerated approval. Although the ALK translocation is present in a minority of patients, the magnitude of benefit in these individuals is large. Future steps to obtain adequate tissue for molecular evaluations and develop cost effective testing for patients who may benefit are needed. This marks another step forward in understanding the underlying biology of the heterogeneous disease of NSCLC and providing personalized therapy to patients.

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Winston Wong, PharmD (Posted: August 30, 2011)

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So the test runs $1500 as a battery, however what is the consistency of the test results when run by different labs. There needs to be some consistency between labs for us to even start to trust the results. As well, for the 5% that is the target population for Xalkori, comparative effectiveness trial results would be really helpful here with the $115k price tag.

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Winston Wong, PharmD (Posted: August 30, 2011)

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Too bad 5-FU has joined the list of drugs in short supply.....for whatever reason.

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Thomas Marsland, MD (Posted: August 30, 2011)

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I think we need a prospectively randomized study looking at chocolate, red wine or the combination of chocolate with red wine..... personally I like the third arm....

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Winston Wong, PharmD (Posted: September 07, 2011)

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Is it really an increase in the incidence of cancer, or we simply getting better at detection? I suspect it is a little of both.

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Joseph Bailes, MD (Posted: September 07, 2011)

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Texas passed legislation, effective September 1, 2011, which requires mammogram facilities to have their reports contain notice regarding possible need for supplemental breast cancer screening when dense breast tissue is present. This will likely be proposed and effected in other states.

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Winston Wong, PharmD (Posted: September 13, 2011)

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The key statement here is that this is "food for thought". The key question is how great is that increased risk to the general population that takes these medications. My guess is that the increase in risk is very low. The study noted 333 cases of cancer, but what was the population size that was followed? My fear is that primary care physicians will read this headline, and steer their patients off the NSAIDs to other medications, which will then cause other problems. At the end of the day, what have we gained?

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Robert A. Figlin, MD., FACP (Posted: September 13, 2011)

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The risks for developing sporadic renal cell carcinoma remain elusive. Associations with smoking, obesity, exposure to certain chemicals, end stage renal disease, hypertension, and the long-term use of analgesics are the most commonly cited risk factors. Although renal cell carcinoma accounts for only 2-3% of adult malignancies, it continues to increase in frequency. The current publication suggesting that long-term use of NSAIDS is important both because it identifies a population at risk but might also help to understand the mechanisms that are associated with renal cancer development. Patients treated with long-term NSAID use should be alerted to the findings in this article and be advised about the potential long-term risks of such treatments.

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(Posted: September 13, 2011)

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This is a hot topic now in the treatment of ALL. As the article notes, adolescent and young adults (AYA) patients, usually defined as between 15 and 21 years old, have historically done much better when treated on pediatric ALL protocols as opposed to adult protocols. Several of the drugs that are difficult to deliver to adults (high dose steroids, VCR, and asparaginase in particular) are given at higher cumulative doses in pediatric protocols and may account for some of this difference.

But an interesting point is that there are likely to be other relevant and significant patient differences between an 18-year-old treated on a pediatric protocol versus one treated on an adult protocol. The former is likely to still be living at home, be brought in by a parent and have insurance coverage. The latter is much more likely to be an "emancipated teenager", often not living at home and often without insurance and more likely to be noncompliant.

Nevertheless, as of today most people would accept that young patients, and often up to the age of 30, should receive pediatric type regimens. What is not clear is what is the upper age limit of patients that can tolerate such regimens. That is being investigated in clinical trials.

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Winston Wong, PharmD (Posted: September 15, 2011)

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We have definitely seen the cost benefit of the utilization of the OncotypeDx test as a tool. The frustration we have is that we believe the test is under utilized. The reasons for under utilization are numerous, and unfortunately, not always in the best interests of the patients.

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Thomas Marsland, MD (Posted: September 14, 2011)

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This report clearly demonstrates how pricing can dramatically affect access to care on both ends of the scale. On the lower end of the pricing scale, generic drugs are in short supply and they are still very important in the treatment of many cancers with curative intent. The fact of the low profit margin on these drugs is but one factor in the shortages but it is an important factor. (Other reasons include aging production facilities that require more frequent updating and repair; scarcity of raw materials; cumbersome regulatory environments). On the upper end of the drug pricing scale (with prices now running deep into 5 and even 6 figures) the cost is also creating problem with access again to life saving and prolonging drugs. The delays and denials of payment with these agents places a dramatic financial burden on the practices which makes many physicians reluctant to give these drugs. The current pricing system has truly created an access problem for the patients. A more reasonable system with better reimbursements on generic and lower reimbursement on name drugs would be welcome. Transparency on how drugs are priced would greatly aid this effort.

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Winston Wong, PharmD (Posted: September 15, 2011)

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So as it turns out, she admitted that she is neither a scientist, a physician, nor anything related to a clinician. She was merely reporting what someone said to her. Is there really any basis for her opinion?

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Winston Wong, PharmD (Posted: September 15, 2011)

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Is this just a headline? Shouldn't the patient ultimately have the final decision as to the treatment provided after being presented with the treatment options? In many cases, I think the problem really is that the patient is not always presented with the all of the pros and cons of the various treatment options to make an informed decision.

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(Posted: September 15, 2011)

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The physician and follicular lymphoma (FL) patient need to discuss the pros and cons of maintenance rituximab or radioimmunotherapy consolidation on an individual basis. Both have been shown to improve the progression free interval of patients with FL, but there is no overall survival advantage. The pros are that many patients do stay in remission longer and this may psychologically be beneficial. However, on the other side the patient does have to come in for either one extra treatment (RIT) or several additional treatments (rituxmib maintenance) and these treatments could have a small chance of complications or additional side effects or infections. At least at this time, no overall survival benefit can be demonstrated. Another consideration is the cost of the therapy including any co-pay by the patient. Therefore, it is an individual risk/benefit analysis and an overall policy is difficult to specify.

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(Posted: September 22, 2011)

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I believe we will continue to see consolidation in the medical oncology space. We will see additional consolidation of community oncology practices and continued closing of community oncology practices as they seek refuge in larger hospital and integrated health systems due to the continued deterioration of gross margins. The migration to hospitals and health systems has the unintended consequence of actually increasing total costs as community oncology practices provide care at a fraction of the costs associated with health systems.

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Robert A. Figlin, MD., FACP (Posted: September 23, 2011)

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Research in cancer often leads to the benefit for diseases that are not malignant but benefit greatly from the basic science and clinical research efforts of the cancer research community. A prior example would be the use of angiogensis inhibition for macular degeneration. The current example is an unraveling of the biology of a genetic syndrome (tuberous sclerosis complex) that produces benign tumors of the kidney which can be successfully targeted by mTOR inhibition, such as Afinitor. The cancer research community would be well served in informing the public of the benefits to society that cancer research produces in diseases that are not malignant in nature.

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Thomas Marsland, MD (Posted: September 23, 2011)

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It is no surprise that taking care of cancer patients costs more. These patients are usually sicker and require more expensive drugs and technologies to care for them. With that said the article makes a critically important point that with better management we can control those costs to some extent. Our state society hosted a meeting of medical directors and discussions on cost of care quite naturally came up. It surprised me (and maybe it shouldn't) that the largest cost to the payer community was not drugs but hospital costs and that most oncology admissions were NOT for treatment induced toxicity. The primary causes for ER visits and admissions were poor pain control and shortness of breath often in patients no longer on active therapy. The message there clearly is we need to do a much better job in managing symptoms, especially at the end of life. By doing this significant cost saving can be obtained. We are all aware now of numerous studies showing high quality palliative care results in a higher quality of life and perhaps in increased survival at a lower cost. These efforts however are highly labor intensive and the appropriate resources need to be place to support these endeavors.

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(Posted: September 23, 2011)

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This is an important paper. Medical Oncologists are the "quarterback" for driving the care for a larger percentage of cancer patients. If we don't begin to reconize the economic impact of our management decisions, someone else will do it for us. Who better to determine the realative value of the treatments we offer? More care and more expensive care is not necessarily better care.

Jeff Patton, MD
CEO, Tennessee Oncology

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(Posted: September 26, 2011)

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The time to evaluate the "value" equation for new therapies has come. Society may not be able to afford to pay $100k for a therapy that improves progression free survival for only a few months and has no effect on overall survival. These are very difficult discussions and decisions but we do not have unlimited resourses.

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(Posted: September 26, 2011)

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The recent drug shortages for generic drugs are creating a very dangerous situation where the patients and the physicians are caught in the middle. They need the important life saving drugs but with a limited supply of agents, some hospitals are looking toward secondary suppliers for these agents. A concern is always there if the alternative suppliers are legitimate and providing the same quality of agents. This type of activity will take place unless we can deal with the underlying problem which is pricing of generic agents and quality issues. Both short term solutions such as a non-profit agency who leads the manufacturing or importation of the agents, as well as long term solutions such as legislative changes need to be pursued immediately.

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Joseph Bailes, MD (Posted: September 29, 2011)

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The work of the deficit reduction committee in Congress has far reaching implications for medicine and for cancer care. The deficit reduction group is reviewing all proposals that potentially could provide reductions in government spending. So, proposals such as ASP reduction, LCA (least costly alternative) are being discussed. The oncology community must remain engaged, reminding our legislators that cancer care cannot tolerate further reductions. We will not know the outcome of this until November most likely, so continued engagement is necessary to protect our patients.

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