VBCC_October_100810_Follow ASCO Tabloid 10/12/10 2:34 PM Page 1
OCTOBER 2010 VOL 1 NO 5
www.ValueBasedCancer.com
Breast Cancer Screening Recommendations: Evidence, Fear, and Politics
Adding Comparative Effectiveness to Formulary Evidence WellPoint argues for real-world informational needs An interview with Brian Sweet, RPh, MBA
By Michael K. Gusmano, PhD, and Bradford H. Gray, PhD Dr Gusmano is Research Scholar, The Hastings Center, Garrison, NY, and Adjunct Assistant Professor, Department of Health Policy and Management, Columbia University; Dr Gray is Senior Fellow with the Urban Institute, Washington, DC.
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n November 2009, the US Preventive Services Task Force (USPSTF) published new recommendations about routine breast cancer screening mammography.1 If followed, the new recommendations would substantially reduce the use of the procedure among women aged 40 to 49 years.2 The recommendations were touted by some leading health policy researchers as “rational”3 and “objective.”4 Yet, the positive evaluations were overwhelmed by an avalanche of negative reactions from professional associations, patient advocates, and elected officials from both political parties.5 Within a month, the Senate
agreed by voice vote to an amendment that effectively required the federal government to ignore the Task Force’s recommendations.6 Lessons Learned It is not unprecedented for new practice guidelines to generate powerful opposition. Professional and advocacy opposition, along with financial interests and ideological concerns about government “rationing,” may create barriers to the implementation of comparative effectiveness research (CER) and evidence-based medicine (EBM), Continued on page 12
Guiding Patients Through CostBased Treatment Choices Assistance with a topic not yet on medical school curriculum By Rosemary Frei, MSc
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aving a conversation with patients about the cost benefit of their cancer treatments is difficult, and many clinicians are unprepared for this discussion. Fortunately, however, resources are becoming available to help clinicians aid patients in determining how much they are willing and able to pay for treatments that may cure them—or only buy a few extra weeks of life.
PAF Brochures for Providers and Patients At the annual meeting of the American Society of Clinical Oncology, representatives from the Yu-Ning Wong, MD, MSCE Patient Advocate Continued on page 22
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n May 2010, the health benefits company WellPoint, Inc, announced a policy of using comparative effectiveness research (CER) as part of the firm’s formulary decision-making process. This is not surprising given the emphasis on CER after the dedication of $1.1 billion for these efforts in the American Recovery and Reinvestment Act of 2009, but for WellPoint Chief Pharmacy Officer Brian Sweet, RPh, MBA, this is both a natural development in the company’s evolution as well as a reflection of the times. We were curious to know how the CER formulary policy has played out so far for this early adopter, so we asked Continued on page 7
Accelerated Approval: Good Intentions, Difficult Implementation By Margot J. Fromer
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US Food and Drug Administration (FDA) decision originally set for September 17, 2010, on using bevacizumab (Avastin) in breast cancer has been postponed until December 17, 2010. Although bevacizumab is the first antiangiogenic drug for treating cancer and is the bestselling cancer drug in the world, the FDA Oncologic Drugs Advisory Committee (ODAC) recommended that approval for this indication be revoked in an almost unanimous vote (12-1) at a July 20, 2010, meeting. Accelerated Approval This particular indication was granted in 2008 under the FDA’s accelerated approval (AA) program. Unlike traditional approval, AA is based on a sur-
rogate end point, an indirect or substitute marker representing a clinically meaningful outcome. Progression-free survival is often chosen as the primary end point for AA trials, because it measures a direct effect of treatment. Overall survival (OS), ordinarily the “gold standard” of clinical trials, is increasingly difficult to measure for first-line treatment, because treatments administered after a clinical trial has ended cannot be controlled. The FDA decides whether a particular surrogate end point is acceptable for a clinical trial and generally bases its decision on whether the end point is reasonably likely to predict a real clinical end point. AA is predicated on the condition that Continued on page 5
IN THIS ISSUE Recent highlights from the oncology literature............................................ 9 An interview with David Meltzer, MD, PhD, on the utility of health economics .............................................................. 11 Jason Slotnik considers premarket parallel review ................................... 17 Continuing education for pharmacists on non–small-cell lung cancer....... 24 ©2010 Engage Healthcare Communications, LLC