OBR Daily Commentary

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Off Label

(ASCO Connection Blog) Apr 6, 2011 - What is old, is new again. Off-label use of oncology drugs is common; and has long been the focus of controversy.

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Thomas Marsland, MD (Posted: April 08, 2011)

quotesWith 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. quotes

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Amgen's Xgeva Hits Resistance Over Cost-Benefit Debate

(Morningstar/Dow Jones Newswires) Apr 5, 2011 - Amgen Inc.'s bone-strengthening drug Xgeva, used in cancer patients, is a potential multibillion-dollar product, but questions remain whether the treatment's benefit compared to well-established competition justifies the significantly higher price.

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Thomas Marsland, MD (Posted: April 06, 2011)

quotesHow 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. quotes

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The Model of the Future?

(Wall Street Journal) Mar 28, 2011 - The 2010 health-care law encourages the development of accountable-care organizations as a way to improve care and reduce costs. So what exactly are accountable-care organizations, anyway?

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Thomas Marsland, MD (Posted: March 29, 2011)

quotesThe 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. quotes

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Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

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Howard S. Hochster, MD

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Howard Sandler, MD, MS, FASTRO

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Michael G. King Jr.

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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

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Ted Okon

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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

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William Harwin MD

Florida Cancer Specialists President and Managing Part...

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William McGivney, PhD

National Health Policy Expert...

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Winston Wong, PharmD

President, W-Squared Group...