Lessons from Other Countries: CER Process Has To Be Transparent, Fair To Succeed

Washington, DC (September 13, 2010) – The process to use comparative effectiveness research (CER) in the U.S. has to be fair, transparent and responsive to a wide variety of stakeholders in order to be effective, according to a new study funded by the National Pharmaceutical Council (NPC) that examined how similar assessments are done in five other jurisdictions.

The study, which examined health technology assessments (HTA) in Canada, Sweden, Scotland, The Netherlands and Australia, was led by Dr. Adrian Levy of the Department of Community Health and Epidemiology at Dalhousie University in Halifax, Nova Scotia. Publicly-funded HTA has been a feature within other industrialized countries for many years, and may inform the endeavors in the U.S., the authors said. While HTA asks a different question, “Is it worth it?” and often is the main input for health care coverage decisions, CER asks, “Does it work?” and helps to inform the HTA process.  Despite the distinctive features of the U.S. health care system, a review of the HTA systems in other countries may allow insights for the development of CER in the U.S.

Among the study’s key conclusions:

• CER should be responsive to stakeholder needs by minimizing the time to make assessments, maximizing transparency, and using a process that is fair and is conducted with universally agreed-upon standards.
• Unlike other countries in which the HTA process assesses benefits to inform a single payer, the diverse multi-payer system in the U.S. suggests that national efforts here are best focused on generating comparative effectiveness evidence.
• Using CER to identify therapeutic benefit among specific demographic groups (e.g., the elderly or racial and ethnic minorities) and individuals with specific genetic characteristics, disabilities, or multiple conditions may be difficult to achieve because few randomized trials can really detect differences, and thus such studies are rare. 

The study was published today in the journal Pharmacoeconomics. Its conclusions build on a review funded by NPC which looked at the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) to assess implications for publicly funded CER in the U.S. The study also comes at a time when the U.S. is in the process of implementing a new CER entity, the Patient-Centered Outcomes Research Institute (PCORI), and naming a Board of Governors to oversee it.

“As the U.S. moves forward with establishing PCORI, lessons from other countries can and should inform how publicly funded CER is conducted in the U.S.,” said NPC President Dan Leonard. “NPC will continue to fund research designed to help policymakers make the most appropriate decisions regarding CER as this new enterprise is built out so health care providers and patients can benefit from improved decision making.”

NPC also has developed a CER Toolkit that provides an overview of CER definitions, its history, NPC’s key considerations for CER, and the CER provisions included in the Patient Protection and Affordable Care Act. The toolkit is available in the issues section of NPC’s website, www.npcnow.org, under “comparative effectiveness research.”

About the National Pharmaceutical Council

NPC’s overarching mission is to sponsor and conduct scientific analyses of the appropriate use of biopharmaceuticals and the clinical and economic value of innovation. The organization’s strategic focus is on evidence-based medicine (EBM) for health care decision-making, to ensure that patients have access to high-quality care. NPC was established in 1953 and is supported by the nation’s major research-based pharmaceutical companies. For more information, visit www.npcnow.org.

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