The OBR Blog

May 15, 2008 - 06:05 pm Posted in Featured comments0 Comments

Today, IMS Health released their predictions for the global oncology industry. According to the forecast, global sales of cancer drugs will grow 12%-15% and reach $75 to $80 billion by 2012, nearly doubling the forecasted growth rate of the global pharmaceutical market (6.4% in 2007). Twelve to fifteen percent growth for the next several years doesn’t jive with the constraints in oncology markets that our industry feels today. There has been remarkable expansion over the last few years (the AWP years?), and in spite of the predicted 12%-15% growth, this industry feels like it is contracting not expanding.

Go west, east, or south of the US. According to IMS, this growth will be driven by the increasing number of cancer patients receiving chemotherapy in Europe, Japan, and North America. Also evidenced is the fact that more patients in emerging markets such as China, Brazil, South Korea, Mexico, India, Turkey, and Russia are getting access to up-to-date targeted therapies. Maybe this explains my instincts. The constraints I feel are real, and the growth that IMS is referring to is coming from ex-US markets.

IMS identifies the following as key dynamics that are influencing the double-digit growth of cancer products through 2012:

• Financial constraints of payers in major markets are leading to increased rigor for selecting targeted therapies – I see, major markets must mean the US. Now this is making sense.
• Improved screening, diagnosis, and access to modern medicines in developing countries – that’s real progress, access being the key in my opinion. Keep it coming.
• New products and combination therapies – of course there is still the tremendous amount of investment and effort to develop new products, some of which may actually make it to market.
• Growth rates for the top markets decrease – finally somebody said it. I knew it didn’t feel like a 12% growth rate here in the US.

Over the next five years, IMS is predicting in its annual forecast that growth will level out due to
• Tapering of current blockbusters – read: Avastin, Herceptin, Gleevec, etc.
• Fewer newer blockbuster medicines – predictive biomarkers may have something to do with this.
• Loss of exclusivity of four oncology products that have annual sales of over $1 billion – inevitable, but let’s get the lawyers on the phone.

IMS also predicts that future growth will be bolstered by the introduction of 25 to 30 new chemical entities between 2008 and 2012. These new entities will help sustain the trend of the expanding patient population being treated with targeted therapies. While many of these new therapies will target the most prevalent tumor types, namely breast and NSCLC, several will focus on late-stage prostate and pancreatic cancers as well as melanoma.

A strong finish. Twenty-five new chemical entities over a five-year period would be excellent progress. So far through ’08 we’ve had two new oncology approvals: Levoleucovorin (not sure if this counts) and Treanda. We’ve got a lot of work to do to get those 25 NCEs on the market, and contributing to predicted growth, by 2012.

Reports like this provoke industry dialogue both pessimistic and optimistic. What does this report invoke in you? In spite of feelings of contraction, the IMS report indicates it is a healthy industry, and the incremental gains found at each ASCO meeting are meaningful for patients, providers, payers, and industry.

May 12, 2008 - 04:05 pm Posted in Featured comments0 Comments

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.

March 11, 2008 - 05:03 pm Posted in Featured comments0 Comments

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.

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March 05, 2008 - 06:03 am Posted in Featured comments0 Comments

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.

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