Stimulus Bill Opens Door to Comparative Effectiveness

February 19, 2009
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research.

Washington, DC (Feb. 19)-Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research. The aim of comparative effectiveness studies is to provide healthcare providers with information about which medical therapies and devices are most effective for patients with a specific health problem. This research goes beyond current requirements that particular treatments be proven to be safe and effective-comparative effectiveness asks whether a particular treatment is also better than other available options.

Pharmaceutical companies have expressed concern that the information may lead insurance companies or the government to deny coverage of more expensive treatments. Some experts, including Helen Evans who recently published a paper with the Heritage Foundation, believe that the government should have not have a major role in comparative effectiveness research or the distribution of its findings. Evans, for example, argues that the private sector should be the primary conductor of comparative effectiveness studies, using the United Kingdom’s system as an example. Many have questioned the UK program’s lack of transparency and “rationing” of healthcare regarding its decisions about drug and treatment coverage. The fact that the program is run under the government-managed healthcare system only adds to the problem.

The US legislation includes supplemental appropriations for fiscal year 2009 to the Department of Health and Human Services (HHS) to carry out the bill’s plans. Funds are specifically designated to the National Institutes of Health and to the Agency for Healthcare Research and Quality. The bill calls for comparative effectiveness efforts that “conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions” and that “encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.”

The bill requests that $1.5 million to go toward a contract with the Institute of Medicine to produce and submit a report to Congress and the HHS Secretary by June 30, 2009, that “includes recommendations on the national priorities for comparative effectiveness research to be conducted or supported with the funds provided…and that considers input from stakeholders.” The bill asks the HHS Secretary to consider recommendations from the report and from the soon-to-be-established 15-member Federal Coordinating Council for Comparative Effectiveness Research.

The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement last week in support of comparative effectiveness research funding and the legislation’s revised language, which supports “patient access and the ability of doctors and patients to choose the treatment that's best for each patient.” PhRMA also noted that it expects the new initiative to be carried out with “real transparency, openness, accountability, and public input in how research priorities are set and how studies are ultimately communicated and conducted.”