Wednesday, April 23, 2014

PCORI Head Vows Not To Do Cost-Effectiveness Studies, But Notes Gray Areas

Posted: September 28, 2011

The head of the health reform law's comparative effectiveness research institute waded into the politically charged issue of whether such research will consider costs, pledging that the Patient-Centered Outcomes Research Institute will not do "cost-effectiveness analyses" but cautioning the term "cost analysis" is undefined and said it will be up to patients to determine whether PCORI funnels federal money to research that considers costs in some manner, such as the effect of cost sharing on health outcomes. The institute has received nearly 600 comments on its working definition of PCOR, with drug companies and providers raising strong concerns that its use of the word "value" signals cost analyses will be part of future PCORI studies.

"You can take it to the bank that PCORI will never do a cost-effectiveness analysis," PCORI Executive Director Joe Selby said Wednesday (Sept. 28). But Selby said the institute will listen to what patients want researched, including the possibility of, for instance, whether cost sharing affects adherence to medication regimens, which in turn affects the health of patients. Selby spoke at a conference on PCORI sponsored by the Partnership to Improve Patient Care.

Tony Coelho, chair of Partnership to Improve Patient Care, brought up the matter because his group and others are worried about the word "value" in the working definition of "patient-centered outcomes research." Among the nearly 600 comments that PCORI received on its definition were those from the Center for Medical Technology Policy, which includes former high-ranking CMS officials. CMTP advocated explicitly defining "value" to include cost considerations, arguing that cost may be an important determinant of overall value to patients and an important consideration in health care decision-making. That position rankled Coelho and directly contradicted comments by physicians, drug makers and medical schools, which stated that very inclusion of the word "value" in the definition is a violation of the law.

Shawn Bishop, who helped write the PCORI measure while an adviser to Senate Finance Committee Chair Max Baucus (D-MT), said the law does not authorize cost analyses -- even if patients ask for it. Bishop, who now is at the consultant firm Marwood, added that many lobbyists urged the committee to prohibit all manner of items from comparative effectiveness research (CER). The committee resisted defining comparative effective research by what it is not and instead focused on what the research is. Nevertheless, the committee forbade PCORI from using "dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual's disability) as a threshold to establish what type of health care is cost effective or recommended." (Dollars-per-quality adjusted life year is the metric for most cost-effectiveness analyses.)

But Selby said that cost and clinical outcomes are intertwined, such as with coinsurance and copays. Nevertheless, the problem, he said, is that people use the term "cost analysis," which is undefined. Patients' desires are at the core of PCORI, and if they want cost to somehow factor into research, that's up to them, as long as it's not cost effectiveness.

PCORI is now reviewing the comments it received on the definition of patient-centered outcomes research (PCOR) -- Selby expects there is "nearly 100 percent overlap" between PCOR and CER. PCORI will likely revise the definition, then send the new definition back out for patient groups to review, he said, adding that he hopes to have a final definition this year. That definition will be key as PCORI chooses research projects to fund.

PCORI's methodological committee is expected to issue the standards for measuring clinical outcomes next spring, Selby said. PCORI hopes to have its research priorities out by March, and patients will have a chance to chime in on those priorities in the meantime. PCORI has come up with 10 candidate research priorities based on CER that other entities have done.

PCORI on Wednesday made its first funding announcement. It awarded $26 million in grants for about 40 pilot projects over two years. However, the funding is not for CER. The purpose of the Pilot Projects Grants Program is to inform PCORI's national priorities, collect data for the research agenda, and identify methodology for measuring the outcomes of that research. -- John Wilkerson (This e-mail address is being protected from spambots. You need JavaScript enabled to view it )

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