Signifying a change from 2007 enrollment trends, small practice oncology groups are enrolling directly in the Medicare Part B competitive acquisition program (CAP), BioScrip and several practices shared with OBR.
In early 2007, the Medicare Part B program’s vendor, BioScrip, reported that oncology scripts were written under the program, but very few oncology practices had signed up. “We had almost 300 internal medicine specialists enrolled in 2006,” said Russell Corvese, a BioScrip administrator. “Many had an oncologist in their practice writing the chemotherapy script.”
In 2008, however, oncologists—including several in the New York City area—enrolled during Medicare’s latest sign-up period, January 1 to February 15, according to BioScrip. This means that some oncologists are choosing to forego buying and billing drugs under the average sales price system (ASP) for their Medicare population and, for the moment, are sending a significant portion of their business to BioScrip.
Across specialties, there are approximately 3000 total physicians enrolled in the CAP. OBR will have an exclusive oncology enrollee breakdown, interviews, and analysis in an upcoming issue.
I attended the “Comparative Effectiveness” themed roundtable at the annual NCCN meeting last week. I’m still not sure what comparative effectiveness means, or what The Hill crowd is planning with it, but I know there are a lot of people who want to discuss it and seem very concerned about it. Someday I hope to know how the Comparative Effectiveness Institute is going to impact on cancer care giving, but until then I’ll keep attending meetings and picking up tidbits pointing me toward the story. When I figure it out we’ll do an article. Sarcasm aside, if this roundtable was about Comparative Effectiveness, I want more. For oncology wonks, this was a great hour spent contemplating the future of the U.S. healthcare system and in particular the future of the oncology industry.
Perhaps there is an underlying problem fundamental to the term Comparative Effectiveness because we don’t even know what Effectiveness truly means. The roundtable began with an attempt at defining Effectiveness as it applies to oncology, and right away we were faced with the problem of Progression Free Survival (PFS). As Dr. Saltz of MSKCC stated very well, Progression Free Survival implies hope because when you throw that word Survival around, you automatically create hope for patients. Does positive PFS correlate to positive Overall Survival? Does a positive PFS deserve to provide hope to patients? Don’t forget that PFS is defined as the period of time patients lived without the cancer getting worse. What does that have to do with survival? And hope?
As you hear more about Comparative Effectiveness, think first about what Effectiveness is. By just offering up one simple word– survival – a can of worms is immediately opened. Optimists can argue that the cancer industry has made incremental but meaningful gains extending the lives of cancer patients, however, cynics can argue that the progress being made isn’t enough and that it is adding too little time to patients’ lives at a very high cost to the healthcare system. If we want to discuss Effectiveness in oncology, we need to be careful with our words, and be prepared to go down a path with wildly differing opinions on what the Effectiveness bar should be.
In a few weeks, NCCN and OBR will be webcasting the full roundtable discussion for those oncology wonks out there who are interested. I think oncologists and industry alike will find it an entertaining, provocative, and worthwhile hour. Stay tuned.
In case you missed it last week, the NIH recently announced that a large-scale, randomized, Phase 3, multi-national study will compare Herceptin® [trastuzumab; Genentech Inc.] head-to-head with Tykerb® [lapatinib; GlaxoSmithKline] in women with early-stage, HER2-positive tumors. The ambitious Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Study (ALTTO) will enroll 8,000 patients in 50 countries across 6 continents with GSK supplying the study drug and providing additional financial support.
The 52-week trial has two different designs depending on whether patients are in stage I or stage II and if they have already been treated with chemotherapy. The 4 treatment arms will consist of either trastuzumab or lapatinib alone, or trastuzumab followed by lapatinib, or the two agents in combination. Did somebody say 8,000 patients in 52 weeks? Congratulations on global cooperation in cancer clinical trials which may mean we could get large randomized study results faster.
The goal of this study is to standardize treatment in early stage breast cancer patients. But unsaid in the media to date, is that this study could leave only one exciting targeted breast cancer drug standing after it is all over. I’m sure GSK/Tykerb is excited to fund this study because they have everything to gain and very little to lose. Of course Genentech/Herceptin has everything to lose. But what are the chances that one drug will prove superior to the other, especially compared to the combination? Very low I’d say. Likely outcome is the two drugs will be used in sequence or combination. Oncologist Dr. Edith Perez of the Mayo Clinic in Jacksonville, Fla. and one of the study’s two lead investigators has already said that the trial will probably show that both drugs, working in concert, are more powerful than either acting on their own. So in that scenario Tykerb will be added and will gain some market share without hurting Herceptin. Everybody’s happy, except insurers.
Whatever the outcome, the point is we’ll have an outcome sooner than usual. That’s something to talk about.
Over the last couple of days we’ve heard a lot about the failure of Nexavar in NSCLC. We’ve heard that as Nexavar’s potential in NSCLC diminishes, Avastin establishes itself as an even more important product for NSCLC patients. At the same time we’re hearing a lot about the looming FDA decision on Avastin in metastatic breast cancer. Maybe it’s too much of a stretch, but I see some sort of connection here.
Nexavar and Avastin are not that dissimilar in terms of mechanism of action. Nexavar is a targeted therapy with two indications that couldn’t meet the overall survival endpoint in NSCLC, and Avastin is a blockbuster targeted therapy with multiple indications that didn’t meet the overall survival endpoint in metastatic breast cancer in their registration study. Maybe the connection is in the study design. So why did Bayer/Onyx include squamous cell patients in their NSCLC study? The Genentech people decided not to include them in the NSCLC registration study for Avastin. If the study was positive Bayer/Onyx would have a population of patients that Avastin doesn’t have, but perhaps that design flaw is responsible for the negative outcome of the study (they say publicly that the squamous cell sub-group had a higher death rate). It doesn’t really matter now except as a learning point for people that design NSCLC clinical trials.
The point is that the roller coaster of cancer drug development couldn’t be in a stranger place today with one targeted therapy failing its registration study and the other a couple of days away from a possible monumental regulatory decision. At the minimum, we will all learn a lot this week about study design, FDA trends, and investment opportunities.
If the FDA decision regarding Avastin for breast cancer is negative, oncologists will have lost access to a great targeted therapy and who knows what will happen with insurers and the 25% market share Avastin already has in metastatic breast cancer. If the FDA decision for Avastin is positive, consider it an admission from the FDA that progression free survival can hold its own and may be equally important as overall survival. That is a precedent which I’m sure the FDA is struggling with.
Nobody in the media is making any predictions, so I’ll open myself up. My prediction is…the FDA will delay their decision on Avastin for 60 days and will wait for more study results, or just use the time to solidify their position. Do you want to make a prediction?