Comparative Assessment for Medications and Devices: Apples and Oranges?

Abstract

Over the past two decades, there have been multiple attempts by government to fund comparative effectiveness research (CER) in the US. Unfortunately, these efforts have been stymied, typically by Congress refusing to commit the scale of funding necessary to address the magnitude of clinical problems for which such information would influence practice. As a result, to date, the drug and device regulatory approval system has been the primary driver of the type of evidence that is generated to support a product launch. The great majority of evidence generated for regulatory approval could not be construed as comparative effectiveness research. In an unprecedented move, new legislation passed by Congress known as the American Recovery and Reinvestment Act (ARRA) that was aimed at overcoming the economic downturn, includes $1.1 billion dollars to support CER in the US; the size of this budget is orders of magnitude more than has ever been committed to this field. These funds are being distributed via three main routes: the Office of the Secretary of Health and Human Services, the director of the National Institutes of Health, and the Agency for Healthcare Research and Quality. Because of the ongoing debate around what constituted comparative effectiveness research, the ARRA legislation specifically called on the Institute of Medicine (IOM) to define comparative effectiveness and to set CER priorities. Ironically, comparative effectiveness research funds were already flowing out of the National Institutes of Health (NIH) before the IOM published its definition of CER (subsequently published August 4, 2009), or the IOM priority areas established. The IOM Committee working definition of CER is given below: