Comparative Effectiveness Shaped without Much Industry Input

Lindsey Rooney

August 1, 2009

4 Min Read
Comparative Effectiveness Shaped without Much Industry Input

News Trends

First-Quartile Priorities

When creating priorities, IOM divided a list of 100 research topics into four quartiles. The first quartile is considered the highest priority group. The topics are not ranked within each quartile. Some of the first-quartile priorities include comparing the effectiveness of: • Different treatments for atrial fibrillation. • Different treatments for hearing loss in children and adults. • Strategies to reduce healthcare-associated infections. • Management strategies for localized prostate cancer. • Imaging technologies in diagnosing, staging, and monitoring patients with cancer. • Film-screen or digital mammography alone and mammography plus MRI in community practice–based screening for breast cancer.

To help mold the direction of comparative effectiveness research (CER), a committee of the Institute of Medicine (IOM) has created a list of 100 healthcare priorities. Congress requested these priorities from IOM through the American Recovery and Reinvestiment Act (ARRA)—legislation that appropriated $1.1 billion to accelerate CER.

A summary of the IOM's report states that the information required to make decisions about healthcare treatment is too often “incomplete or unavailable, resulting in more than half of treatments delivered today without clear evidence of effectiveness.”
In an effort to advance CER and overcome this lack of information, the panel attempted to collect stakeholder input to develop a list of research topics to be funded by ARRA. According to the committee, it made more than 20,000 solicitations to stakeholders. It says that it received input from direct mail, a Web-based questionnaire, and a public session that was attended by 54 people in Washington, DC.
Despite this initiative to reach industry, the response rate was low. “Industry-nominated topics were around 2% of the total” submissions received, says Harold C. Sox, MD, cochairman of the IOM panel and editor of the The Annals of Internal Medicine.
However, Sox doesn't think this lack of input necessarily subtracts from the panel's list of priorities. “It's possible that more industry participation might have added some topics that the committee would have ranked in the top 100,” Sox says. “Still the committee felt that every one of the 100 topics was important to study.”
Susan Bartlett Foote, a professor in the Division of Health Policy and Management at the University of Minnesota and a previous member of a CMS Medicare Coverage Advisory Committee, speculates that the industry's silence could be due to a lack of support for CER. “I think the device industry as a whole is trying to lie low on the issue and let the Republicans tank the effort,” she says.

Breaking Down the Priority List

24Priorities affect special populations. 29Research areas are included. 49Priorities were determined to be best evaluated through the use of RCTs.* *Randomized controlled trials in which patients are randomly assigned to different interventions.

With or without industry influence, Foote doesn't think the 100 priorities will have much of an effect in Congress. Most politicians are dug in on their position on CER, and “I don't think the report will change anyone's mind,” she says.
Industry group AdvaMed has shown a favorable response, although it says it is still reviewing IOM's report. “AdvaMed supports the use of CER to help guide and inform clinical decision making,” says David Nexon, senior executive vice president of AdvaMed. “It seems that IOM also supports CER to be used in this manner.”
The next step for the report is unclear. Sox says that his panel briefed some House and Senate members, but he doesn't know whether any congressional hearings will be held regarding the priorities. He says that he would prefer that the report help establish a national CER program with stable funding. But even if this is accomplished, he realizes that the program will face obstacles. Deciding industry's role in the governance of the program would be difficult, he says, as well as “fulfilling the high expectations of CER supporters while answering the objections of CER detractors.”Copyright ©2009 Medical Device & Diagnostic Industry

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