Firms Advised To Focus On Comparative Effectiveness Study Methodology

Full article reprinted from "The Gray Sheet" - November 23, 2009

The device industry has a critical role to play as the federal government fine-tunes the methodology it uses for comparative effectiveness research, according to speakers at a recent reimbursement conference hosted by the Medical Device Manufacturers Association in Washington, D.C. Read more...

Firms Advised To Focus On Comparative Effectiveness Study Methodology

Full article reprinted from "The Gray Sheet" - November 23, 2009 

The device industry has a critical role to play as the federal government fine-tunes the methodology it uses for comparative effectiveness research, according to speakers at a recent reimbursement conference hosted by the Medical Device Manufacturers Association in Washington, D.C.

Sean Tunis, director of the Center for Medical Technology Policy, called attention to provisions anticipated to be included in the Senate health reform bill, which was later released Nov. 18, that would create a methodology committee within a Comparative Effectiveness Research Institute.

Such a committee could ultimately define the rules of evidence by which comparative effectiveness research will be done and how new medical technology is compared to alternative treatments.

"It's the work of that committee that you should really be interested in, going forward," Tunis said. Technology firms should not just monitor any rules the committee draws up, he added, but "make sure that you as a community are actually involved with the process."

New methodology standards for comparative effectiveness research could help CMS and private payers accept a wider range of evidence as they conduct systematic reviews for coverage decisions, suggested Steve Phurrough, a medical officer in the Center for Outcomes and Effectiveness at the Agency for Healthcare Research and Quality.

He noted that industry often complains that technology assessments disregard "the best studies." However, until the methodological work is done, said Phurrough, payers will continue to exclude most existing registry and observational data from their systematic review processes.

"It's not the kind of issue where you can take a vote and the majority says, OK, we'll use observational data," Phurrough said.

In the future, Tunis said, the heightened focus on comparative effectiveness research will change the way industry designs its clinical trials, including which outcomes are measured and what comparators are used.

The methodology standards for each technology will determine "what it's going to take to demonstrate that a new technology is, in fact, meaningfully clinically superior to an existing technology," Tunis said.

Industry Given Tips For Upcoming Trials

Some industry executives asked how they should proceed with their clinical trial designs while the standards for comparative effectiveness research methodology remain in flux.

Tunis advised them to remain actively engaged. "It's important not to wait for the methodology committee to come up with the methodologic framework," he said.

For a company currently planning a multi-year clinical trial, Tunis recommended looking at recent tech assessments and examining the critique section for insight on what worked in strong clinical trials and what was missing in the ones deemed not adequately designed. After the review, companies could design their own studies accordingly.

Typically, reviewers of problematic studies have found patients were not representative of real-world ones, settings were not typical of community practice, and comparators were not of greatest interest to clinicians and patients, Tunis said.

Earlier this year, AHRQ hosted a comparative effectiveness methodology conference for researchers, where some argued that large, post-market observational tools can offer better evidence of real-world outcomes than smaller, randomized clinical trials (The Gray Sheet' June 8, 2009).

At the Nov. 10 MDMA meeting, Tunis explained that systematic reviews have historically excluded observational data because "there are well-known, well-recognized and widely shared concerns" about the validity of using observational data to answer questions about comparative effectiveness.

Tunis was optimistic that new methodologies under development, such as propensity scoring and instrumental variables, could increase the value of registries as evidence. But he also warned against "this sort of group hysteria about a rapid-learning health care system where somehow, magically, all of our answers about comparative effectiveness are going to fall effortlessly and inexpensively out of large databases."

- Monica Hogan

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