October 9th, 2012
The October 2012 issue of Health Affairs provides an in-depth look at challenges in comparative effectiveness research. To surface issues around communication of research results, the issue includes a hypothetical comparative effectiveness case study of a fictional migraine drug and offers varying commentaries and analyses of the hypothetical case study from the Patient-Centered Outcomes Research Institute (PCORI), the Food and Drug Administration, the pharmaceutical industry, payers, and representatives of patient groups.
These and related articles raise questions about how the research might be applied to decision making across the health care system and the ways it could affect how pharmaceutical companies communicate to both health professionals and the public about competing treatments and options in the future.
Other studies examine additional issues related to comparative effectiveness research as well as topics of interest to the pharmaceutical and medical device industries, insurers, health care providers, and consumers.
The new Health Affairs volume will be discussed at a Thursday, October 11, briefing in Washington DC. The issue has funding support from the National Pharmaceutical Council.
Many comparative effectiveness studies fail to change patient care or clinical practice—and there are clear reasons why. Justin Timbie, health policy researcher at RAND Corporation, and colleagues conducted case studies of the dissemination and adoption of findings from key research studies of the past 10 years and identified five underlying factors that blunt the impact of translation of scientific evidence into health care practice: financial incentives, namely fee-for-service payment; ambiguous study results; inherent biases in the interpretation of results; a failure to design the research for the end user; and limited decision support in patient care settings.
The authors recommend policy changes that will promote greater consensus on the objectives and design of these studies; improve the validity of the guideline development process; and address the perverse financial incentives that slow the translation of evidence.
“We’ve made a significant investment in comparative effectiveness research, but historically, we’ve seen very few studies transform clinical care,” said Timbie. “For PCORI and others to succeed in their missions to improve patient care, the policy community is going to have to take deliberate steps to ensure that these translation barriers are addressed at each stage of the evidence translation process.”
Additional articles in the October issue and their lead authors include:
- The Patient-Centered Outcomes Research Institute Should Focus On High-Impact Problems That Can Be Solved Quickly, Harold C. Sox, associate director for faculty at the Dartmouth Institute for Health Policy and Clinical Practice.
- Reviewing Hypothetical Migraine Studies Using Funding Criteria From The Patient-Centered Outcomes Research Institute, Joe V. Selby, executive director, Patient-Centered Outcomes Research Institute.
- Regulatory Requirements Of The Food And Drug Administration Would Preclude Product Claims Based On Observational Research, Joseph P. Griffin, associate director for policy development, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration.
- Among Other Flaws, Hypothetical Migraine Study Lacks Independent Evaluation And Patient Engagement, Marc Boutin, executive vice president and chief operating officer, National Health Council
- Communication About Results Of Comparative Effectiveness Studies: A Pharmaceutical Industry View, Eleanor M. Perfetto, senior director of reimbursement and regulatory affairs, federal government relations, Pfizer.
- The Hypothetical Migraine Drug Comparative Effectiveness Study: A Payer’s Recommendations For Obtaining More Useful Results, Robert S. Epstein, president and CEO, Epstein French Associates.
Other studies of interest include:
- Almost 95 percent of seniors spending hundreds more on Medicare Part D plans than necessary, Chao Zhou, postdoctoral associate, Department of Health Policy and Management, University of Pittsburgh.
- A low copay (especially a zero copay) for generic statins is the strongest influence on their use and can save Medicare money, John F. Hoadley, health policy analyst and research professor, Georgetown University Health Policy Institute.
- Secondary patents on branded drugs could delay generic HIV antiretroviral competition until at least 2028, Tahir Amin, cofounder and director of intellectual property at the Initiative for Medicines, Access & Knowledge (I-MAK).
- The Food and Drug Administration and the Centers for Medicare and Medicaid Services not meeting the statutory deadline of 180 days for device review or national coverage decisions, Annette Zinn, attorney and consultant specializing in medical device regulation.
- Common arthroscopic knee procedures drop 47 percent in Florida after New England Journal of Medicine articles find them ineffective; could save $82–$138 million if replicated nationally, David Howard, associate professor in the Department of Health Policy and Management, Emory University.
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