Investment in comparative effectiveness research (CER) is a critical component of U.S. health care reform. There is currently very little objective, third-party data comparing the effectiveness of similar (drug-drug) treatments, medical and pharmacological treatments or different behavioral interventions for a given health problem. Prescribing physicians, pharmacists, patients, and purchasers of health care need evidence to support health care decision-making. Experts agree that CER will reduce unnecessary care, improve outcomes, and ultimately result in cost savings. It is important to note that CER is much broader in scope than just head-to-head comparator drug studies. CER will evaluate varying populations, conditions/diseases and treatment modalities.

The 2009 American Recovery and Reinvestment Act authorized $1.1 billion for CER, including $300 million for the Agency for Healthcare Research and Quality (AHRQ), $400 million for the National Institutes of Health (NIH), and $400 million for the Secretary of Health and Human Services (HHS) to support CER. This same law also created a 15-member Federal Coordinating Council for Comparative Effectiveness Research to consider needs of populations served by federal programs and opportunities to expand on current investments. The Council will provide input on priorities for the $400 million the HHS Secretary will allocate. At the request of Congress, the Institute of Medicine (IOM) will provide input on how to spend the $400 million on research. Here’s an overview of the progress to get CER underway.

HHS Recommends Infrastructure

The HHS-affiliated Council held listening sessions to gather input from diverse stakeholders on priorities and ideas about how CER can empower stakeholders to improve care. The Council’s final report focuses on how HHS can build the infrastructure and tools for the nation to benefit from the research conducted by AHRQ, NIH, and other government agencies. Figure 14 illustrates the infrastructure HHS is recommending.

IOM Report Outlines Initial Priorities

The specific charge to the IOM was to develop a list of high priority research questions for CER. The IOM report, also informed by extensive public input, identifies 100 priority topics reflecting a range of clinical categories, populations to be studied, categories of interventions, and research methodologies. Few topics focus exclusively on comparative research of pharmacologic treatments. Instead, priorities call for comparing the effectiveness of pharmacologic treatment to medical or behavioral interventions. Examples include comparing the effectiveness of:

• Conventional medical management of type 2 diabetes in adolescents and adults, to conventional therapy plus intensive educational programs incorporating support groups and educational resources.
• Different benefit design, utilization management, and cost-sharing strategies in improving health care access and quality in patients with chronic diseases such as cancer, diabetes, and heart disease.
• Treatment strategies for obesity, including bariatric surgery, behavioral interventions, and pharmacologic treatment, on the resolution of obesity-related co-morbidities such as diabetes, hypertension, and musculoskeletal disorders.

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