The OBR Blog

April 20, 2012 - 11:04 am Posted in Featured comments0 Comments

A study published in the April 18 issue of the Journal of the American Medical Association found that proton therapy, commonly used although it’s the most expensive way to treat prostate cancer today, didn’t really work any better than intensity-modulated radiation therapy (IMRT), a less expensive form of radiation treatment for men with early-stage prostate cancer. So, “Why would you use proton therapy if you can utilize cheaper modalities to treat the disease?” asked Najeeb Mohideen, MD, Radiation Oncology Associates, Northwest Community Hospital, Arlington Heights, IL, at the recently held ACCC Annual Meeting in Baltimore, MD.

A cost-benefit analysis of newer, high-priced radiation technologies was explored by an expert panel who, in addition to Dr. Mohideen, consisted of William Holden, vice president of cancer services, Christiana Care Health System, Helen F. Graham Cancer Center, Newark, DE; Andre Konski, MD, professor and chair, department of radiation oncology, Wayne State University School of Medicine, and Barbara Ann Karmanos Cancer Center, Detroit, MI; and was moderated by Cliff Goodman, PhD, of The Lewin Group.

Despite proton therapy’s high price tag, Dr. Mohideen did acknowledge that it might be the best option in some cases, such as when treating pediatric cancers. According to statistics, Dr. Mohideen offered that radiation technology made up only 2% of Medicare’s total spend of $83.3 billion in 2010, but that the more expensive radiation technologies were nonetheless on the rise. As an example of the increased utilization, a recent national survey of over 1,600 radiation oncologists found that 65% offered stereotactic body radiotherapy (SBRT) in 2012 whereas only a few cancer centers offered the same technology in 2005. “We’ve seen tremendous advances with high technologies like SBRT,” Dr. Mohideen said, calling the technology a game-changer as far as treating medically inoperable, early-stage lung cancer patients.

But, he emphasized that the clinical evidence needed to support these different radiation technologies is still an area of deficiency. Several reasons cited for that deficiency are that current studies are focused on too small of a patient population or that reports are taken from primarily claims-based Medicare data.

Less is More
Dr. Konski pointed out that the loss in annual dollars for a cancer center treating prostate cancer patients with a full course of radiation therapy compared to a more hypofractionated course based on current Medicare reimbursement rates and two different types of radiation therapy—either IMRT and SBRT—is staggering. In the case of SBRT, the reimbursement resulted in either a loss of $254,000 in revenue for the year (based on technical fees alone) if one patient was treated weekly based on 5 courses of SBRT, or a loss of $325,000 annually if that same patient received only 26 treatments overall or a more hypofractionated treatment regimen.

Dr. Konski also compared the cost effectiveness of treating pancreatic cancer with gemcitabine alone or with a combination of different radiation therapies and produced the following results: A cancer center would lose $12,800 in revenue per patient if that patient were treated with fewer fractions using gemcitabine and SBRT (at a cost of $56,700) versus gemcitabine and IMRT (at a cost of $69,500)—the standard therapy for pancreatic cancer. Great for the provider, Dr. Konski said, but not so good for the revenue stream of a cancer center.

Saving Money With Cyberknife
William Holden discussed the strategy that Graham Cancer Center used to get the go-ahead for the purchase and utilization of the CyberKnife®—a huge $4.7 million capital investment for the institution. “A big part of the strategy was to develop a strong relationship with Blue Cross of Delaware and show that the cost-benefit ratio of treating cancer patients with Cyberknife was cost-effective when done as an outpatient procedure, with no readmissions,” he said. Treating pancreatic patients, for example, was cut by 50% from $80,000; cranial cases showed similar cost-benefit although the cost was not cut in half. Graham is now able to get authorization for patients for Cyberknife treatment from Blue Cross in a single day.

Holden’s advice to cancer centers planning similar start-ups is to “justify your return on investment to financial management and find a champion with the clinical expertise and credibility to push the process through.” Patients benefit from Cyberknife as well, he said, especially in terms of time-savings. For example, lung cancer patients ineligible for surgery who moved to Cyberknife went from having 29 treatments to 5 fractions as outpatients; and prostate cancer patients experienced 5 days of Cyberknife rather than 29 or 30 external beam treatments.

Future Trends
According to Dr. Konski, in contrast to the lost revenue due to the trend towards more hypofractionations, the cost of the newer technology will only increase, Medicare reimbursement rates will remain stagnant or decrease, and cancer centers can’t generally make up the dollars lost in volume since there’s so much competition. And more comparative effectiveness research is sorely needed to accumulate better data on patient outcomes and the cost-benefit of these newer and pricier radiation technologies. “Any payment reform coming down the pike will be looking for excellent quality and excellent outcomes at lower cost,” Dr. Mohideen said.

by Nancy Ciancaglini

April 09, 2012 - 03:04 pm Posted in Featured comments0 Comments

What is threatening cancer care the most these days? The most reflexive answer is the high cost of the drugs. The answer comes up immediately because if patients can’t afford the price tag on the new drugs, then advanced clinical outcomes won’t be achievable. Another answer may be that it is policy, federal or commercial, that is threatening cancer care. But let us not forget about the primary point of contact, the medical oncologist. Maybe the loss of autonomy by the oncologist is the single greatest factor threatening the delivery of quality cancer care today.

In a morning roundtable at the annual NCCN meeting in Hollywood, FL the topic of which cancer stakeholder has the largest role in decision-making was discussed. The title of the roundtable was “Optimal Care for Patients: Who Decides?” and featured: Karen Alban, RN, BSN, OCN, Oncology Nursing Society; Al B. Benson III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University; Nancy Davenport-Ennis, National Patient Advocate Foundation; Scott Gottlieb, MD, American Enterprise Institute; Shari M. Ling, MD, Centers for Medicare & Medicaid Services (CMS); Ray Lynch, CPA, MBA, Huntsman Cancer Hospital; Lee N. Newcomer, MD, MHA, UnitedHealthcare; and David G. Pfister, MD, Memorial Sloan-Kettering Cancer Center. The roundtable was moderated by Clifford Goodman, PhD, of The Lewin Group, as he does every year.

Dr. Goodman set the stage by asking – who is really in charge here? And how might that be changing? With that question as a launching point, Dr. Goodman probed the members of the roundtable to gather the different perspectives and help elucidate how the dynamics between physician and cancer patients are changing.

Karen Alban referred to the treatment team as an “inner circle” because cancer care is not a “one and done” proposition. She points out that cancer care decisions occur over the course of the illness, and the patient often invites multiple inputs over the course of the disease. As might be expected, Ms. Alban provided expertise on what nurses can offer to the patient including acting as a buffer, between the patient and the doctor or other members of the inner circle by educating the patient and the patient’s family, and filling some of the gaps between the patient and their primary care physician and their oncologist.

Dr. Benson added that the first encounter between physician and patient can often be the most important encounter because it establishes tone and future interactions. If the physician can sense that the decision making process is likely to include financial or psychological help the physician can involve those factors immediately and set the tone for what happens over time.

When asked by Dr. Goodman, Nancy Davenport-Ennis told the audience that in 2011 3.5 million consumers called the National Patient Advocate Foundation (NPAF) for information, clearly making them part of the “inner circle”. Ms. Davenport-Ennis says that the tendency to include others in the decision making process is shifting now because years ago decisions were made primarily between the doctor and the patient, but today NPAF hears from patients about the payer, and specifically the type of benefits the consumer has.

Dr. Scott Gottlieb, a fellow at the American Enterprise Institute, an attending physician, and having held roles at CMS and FDA, brings a different perspective to the “who’s in charge here?” discussion. In Dr. Gottlieb’s opinion it depends on the type of coverage – private versus federal insurance. As more practices consolidate into hospitals and we see more capitation agreements as a result, we will see more narrow network types of plans rolled out by insurers. He believes the ACA will likely drive the move toward narrow network plans too.

Similarly, a move toward centralization of decision-making will be seen in the government sector but in this case driven by budgetary constraints and political realities. As Dr. Gottlieb says, “it is a gradual evolution, but there is no doubt the locus is changing.“ CMS wants to get more authority to make more granular decisions about what should and shouldn’t be covered in different contexts, and in the new political environment it will be easier for CMS to get these authorities.

Dr. David Pfister, from MSKCC, says the whole process of cancer care has become much more transparent. Big cancer centers like MSKCC have multi-disciplinary teams impacting on care decisions, and resources like the NCCN guidelines, including the patient guidelines, are important sources of information that impact on decision-making. There is also an increasing list of patient education materials that are having an impact on patient decision-making.

Ms. Davenport-Ennis was asked whether she felt as though there is patient satisfaction that preferences are being heard. She pointed out that it depends on the insurance plan. For example, if a patient is in a high deductible plan with a health savings account and is in a position to fully satisfy the annual amount required in the high deductible plan, he has more autonomy in the decision making process. If patients are in a position to self-pay there is great autonomy and great satisfaction. too But as there is a diverse spectrum of insurance plans, there is less autonomy causing more and more frustration for patients.

Bringing in the payer perspective, Dr. Goodman probed Dr. Newcomer of UnitedHealthcare and Dr. Ling of CMS about who is most responsible for cancer patient care decisions. Dr. Newcomer doesn’t think it is surprising that patients take finances into consideration when making treatment decisions. He points out that there are about as many different insurance coverage plans as there are patients, so it depends on the individual and the plan. “In the fee for service world just about everything gets paid for in one way or the other,” he said.

Dr. Ling says that optimal care is “care that is safe, well coordinated, centered on patients and their families, includes safe transitions from clinic to hospital to outpatient infusion centers, and meets the patient’s goals. Dr. Ling says that Medicare can’t possibly know the individual’s preferences, which is why coverage becomes dependent on evidence of improved outcomes. To determine coverage based on outcomes, CMS has to have a very good data source.

Dr. Benson pointed out that decision-making is increasingly complex as care moves into an era of patient selection based on molecular profiling. He added that we’re a country based on the individual and in the healthcare arena we’re witnessing tension between what the individual wants and what might be best for society as a whole.

The discussion then led toward guidelines, pathways, compliance, and variation in care. Ms. Davenport-Ennis says that she hears more and more patients discussing the pathways and guidelines they are complying with. She says that is a dramatic shift.

Dr. Newcomer related UHC’s experience with community oncology practices and episode-based payments and compliance with guidelines. A few things have been surmised between provider and payer and perhaps most importantly, the fact that there is common interest between parties to identify gaps to improve quality of care by reducing waste. It was also found that everyone wants to incorporate more of the positive advances, like genetic tests that have clinical utility.

Dr. Newcomer shared that compliance to UHC’s physician-chosen guidelines was only about 60%, and that more attention to standardization according to guidelines would reduce variability and waste. Furthermore, guidelines are written to reflect what is known as best care today and it is hard to conceive why there would be a deviation from the best known care.

Dr. Benson followed that point by adding that at the Lurie Comprehensive Cancer Center a guidelines enforcement policy is not in place, but they are incorporating guidelines into training programs and multi-disciplinary tumor conferences. While variation in cancer care is expected at the Cancer Center, use of evidence-based guidelines is presented to assist in treatment decision making.

At this point the discussion progressed to the subject of the Independent Payment Advisory Board (IPAB). Dr. Goodman asked Dr. Gottlieb about the board and Dr. Gottlieb told the audience that IPAB has 15 members who will serve 6 year appointments and they have the mandate to cap the growth rate in Medicare spending.

Dr. Gottlieb elaborated that if Medicare spending is growing at a rate above the Consumer Price Index (CPI), IPAB has to come up with a set of proposals to bring spending back in line with the CPI.

As a result of the IPAB recommendations, Congress has 30 days to come up with alternative proposals to bring spending down or any proposals the IPAB makes will go into effect (and we all know Congress can’t act in 30 days). Dr. Gottlieb described IPAB as a clever way to side-step Congress.

Dr. Gottlieb expects IPAB to identify areas of large expenditure and look for easy ways to cut spending such as move from ASP +6% to ASP +4%, or if price controls (such as VA pricing) are working in one market they’ll move them into another market.

Ms. Davenport-Ennis agreed with Dr. Gottlieb, and added that the end result of IPAB reducing spending is less access to therapies for patients.

As the roundtable concluded, it became increasingly clear that today’s healthcare system is in the midst of an evolutionary shift in terms of delivery of cancer care. External influences are impacting decision-making, and increased information sources combined with impending reductions in spending are making the business of evidence-based medicine increasingly complex.

The outcome of this trend toward including more perspectives in the “inner circle” is that medical oncologists have to spend more of their time coordinating care and managing external dynamics, and thus individualizing care is increasingly difficult and time consuming. When the medical oncologist doesn’t have the autonomy to make therapeutic choices independently, and their job satisfaction goes down accordingly, that may be the real threat to the delivery of quality care.

April 01, 2012 - 05:04 am Posted in Featured comments40 Comments

To the editor:

As someone who covers the biotech universe*, I frankly am appalled that Ms. Huber’s writings have attracted the attention they have in the popular and medical media. The Reuters’ article you posted to your site contains significant misleading statements and does a disservice to readers, medical practitioners, and prostate cancer patients alike.

Insight: New Doubts About Prostate-Cancer Vaccine Provenge
(Reuters) Mar 30, 2012 – Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy.
read article »

Ms. Huber’s specious theory has been and continues to be ridiculed by mainstream immunologists and other scientific thinkers, including none other than Dr. James Gulley, the Director of Clinical Trials at the US National Cancer Institute. As can be seen, for example, in the descriptive material related to Dendreon’s Sipuleucel-T (Provenge) on Wikipedia:

‘This theory was brought up at the CMS Advisory Committee Meeting in November 2010. At that meeting, Dr. James Gulley, Director of Clinical Trials at the National Cancer Institute, dismissed it as follows[15]: “The number of white blood cells that were, the proportion of white blood cells that are removed in terms of the total body white blood cell count is around two percent, so it is not a clinically meaningful amount.” In addition, a recent retrospective analysis of patients on the control arm of the IMPACT trial[16] showed that those treated with salvaged Provenge many months after disease progression had median survival time 23.8 months which was far better than the 11.6 months seen with the pure placebo patients. The median difference between patients on the control arm treated and untreated with salvaged Provenge was a direct contradiction to the Immunodepletion theory.

[15] “An analysis to quantify the overall survival benefit of Sipuleucel-t accounting for the cross-over in the control arm of the IMPACT study“.

‘Lastly, the above same analysis of the control arm of the IMPACT trial showed that the recorded median difference of 4.1 months might have been an underestimation due to the longer life of patients treated with salvaged patients. The presentation[16] stated: “Using the RPSFT model, and assuming that APC8015F (salvaged Provenge) was equally effective as PROVENGE, the median overall survival benefit of PROVENGE in the Phase 3 IMPACT trial was estimated to be 7.8 months, had there been no cross-over to APC8015F (HR=0.60, 95% CI: 0.41, 0.95).”‘

[16] “NCT00779402: Provenge for the Treatment of Hormone Sensitive Prostate Cancer“. US National Institutes of Health.

It must be noted, by the way—and unfortunately, this is either overlooked or ignored by the media—that the Journal of the National Cancer Institute (JNCI) has no relationship whatsoever—NONE—with the United States National Cancer Institute. The JNCI is published by Oxford University Press in England.

As to JNJ’s Zytiga, that drug’s Phase 3 trial was recently stopped because it reached stat sig one of two primary end-points: progression-free survival (PFS). The trial did not reach stat sig on the other primary end point: overall survival (OS). Now, with patients crossing over from the placebo cohort and taking Zytiga, chances are getting slimmer by the day that the trial will reach stat sig on OS. Whether or not Zytiga is approved for pre-chemo PCa patients, then, will depend on the strength of the PFS data and how close the trial comes to achieving stat sig on OS.

Finally, writing in the March 2012 issue of AUA News (p. 42), Dr. Carl A. Olsson had this to say about the paper published by Huber et al. in the JNCI:

“The authors missed the report by Hall et al that “there was no evidence that leukapheresis led to immunodepletion,” citing literature proving that each apheresis removed less than 1% of the total body pool of 1012 lymphocytes and reporting a normal measured cell count after the third apheresis in all men.[3]

“Finally, we are all used to the values of interdisciplinary conferences, which usually combine the experiential qualities of urology, clinical oncology, immunology and other disciplines. However, “healthcare analyst” and “investment management” are talents that appear unseemly in major publications.”

[3] Hall SJ, Klotz L, Pantuck AJ et al: Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. J Urol 2011; 186: 877.

by Theodore J. Cohen, PhD

*Theodore Jerome Cohen, PhD, writes for Seeking Alpha and is a Dendreon Shareholder. He is the author of Death by Wall Street: Rampage of the Bulls. [ed]

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