Comparative effectiveness research gets boost with healthcare overhaul law

Pharmaceutical CommercePharmaceutical Commerce - April 2010

PPACA provides $3 billion in funding and creates new Patient-Centered Outcomes Research Institute

Analyzing a drug treatment’s effectiveness—both in terms of cost and clinical outcomes—might be easier to determine now that a fresh influx of federal funds has been earmarked for such research by the Obama administration’s new healthcare law, the Patient Protection and Affordable Care Act (PPACA).

Comparative effectiveness—the study of how one medication or treatment works against another (or against placebo)—garnered attention at the beginning of 2010, when the stimulus bill funded $1.1B worth of studies to be conducted over the next several years. Building on those funds, the signing of PPACA on March 23 adds $3B and creates a new Patient-Centered Outcomes Research Institute, which will specialize in comparative studies of medical treatments.

Cost savings has long been considered the primary goals of such analysis, with head-to-head competition between drugs being a common tactic used to drive down vendor costs. Now, comparative effectiveness research is becoming more prevalent in establishing a product’s clinical value and quality-of-life value for its patients.

The institute will be led by a 19-member board of governors, which, according to final bill text, will include the directors of the Agency for Healthcare Research and Quality and the National Institutes of Health (or their designees).

The US Government Accountability Office’s Comptroller General will appoint the other 17 members, who will represent the following groups:

  • Patient and healthcare consumers (three members)
  • Physicians and providers (five members)
  • Private payers (three members)
  • Pharmaceutical, device and diagnostic manufacturers (three members)
  • Quality improvement or independent health service researchers (one member)
  • Federal and state government (two members)


Among the first items on the institute’s agenda will be “to develop and improve the science and methods of comparative clinical effectiveness research by, not later than 18 months after the establishment of the Institute.”

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