Comparative Effectiveness Research (CER) and its Role in New Technology Evaluation

6.15.2010  PRESENTER: G. Scott Gazelle, MD, MPH, PhD, Professor of Radiology, Harvard Medical School (HMS); Professor, Department of Health Policy and Management, Harvard School of Public Health; Director, Partners Radiology, MGH Institute for Technology Assessment and Dana-Farber/Harvard Cancer Center Program in Cancer Outcomes Research Training; Vice Chair for Faculty Development and Associate Vice-Chair for Research, Department of Radiology, Massachusetts General Hospital MODERATOR: Thomas Brady, MD, Director, Cardiovascular Imaging and Intervention and Director, Radiology Research, MGH; LL Robbins Professor of Radiology, HMS; CIMIT Co-Program Leader, Cardiovascular Disease

Forum Summary

As medical advances are made, options for diagnosing and treating diseases are becoming more numerous.  Unfortunately, some of these new tests and therapies do not contribute to improved health, and most are costly.  In 1988, Arnold S. Reiman, then the editor of the New England Journal of Medicine, said, “We can no longer afford to provide health care without knowing more about its successes and failures.  The era of assessment and accountability is dawning at last.” In retrospect, Reiman’s comment was overly optimistic.  Only in the last few years has comparative effectiveness research (CER) been recognized as an important component of medical research. Funding agencies are only beginning to realize that information pertaining to clinical effectiveness alone is not enough to guide efficient allocation of healthcare resources.

The history of federally funded CER in the United States is a relatively short one.  In 2003, the Agency for Healthcare Research and Quality (AHRQ) was authorized to conduct CER and was given a total budget of $300 million.  In 2009, with the passage of the American Reinvestment and Recovery Act, CER became a funding priority.  Funds allocated specifically for CER amounted to $1.1 billion, divided between the AHRQ, the National Institutes of Health (NIH), and the Department of Health and Human Services.  The purpose of this funding was to improve outcomes through the dissemination of evidence-based information, and the Institute of Medicine was mandated to recommend one hundred research areas for priority funding.  In 2010, the Patient Protection and Affordable Care Act created a Patient-Centered Outcomes Research Institute designed to set the agenda for CER in the United States, to provide $500 million of funding, and to disseminate information.  The new institute was prohibited from using dollars per quality-adjusted life year (QALY) as the sole grounds for denying coverage for medical products or procedures.

This prohibition is the result of controversy surrounding the relationship between CER and cost effectiveness analysis (CEA).  CEA is an analytic technique to guide resource allocation under the assumption that resources are limited.  Some people equate CEA with the “rationing” of healthcare whereas others argue that CEA, if used appropriately, is preferable to any other method of dispensing limited healthcare resources.  Researchers engaged in CER have difficulty determining “value” without considering “cost,” but many people feel threatened by the idea of considering “cost” in healthcare.

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