Comparative effectiveness idea is gaining support in Washington

Some of the contention over the ground rules for the institute, including whether payment could be denied for a drug or other intervention that's found less effective, erupted in a recent Capitol Hill forum for Congressional staff members and others.

Karen Ignagni, head of America's Health Insurance Plans, said that comparative effectiveness findings "should not dictate benefit design. But the idea that we would have this robust research and not pay any attention to it, that makes no sense whatsoever in our view." She noted that the National Eye Institute is doing a head-to-head trial of Avastin (bevacizumab, Genentech) versus Lucentis (ranibizumab, Genentech), for age-related macular degeneration. But Avastin's cost is 50 times less than that of Lucentis. If the current trial happens to show that the two products perform the same function, that would not mean that a health plan would refuse to cover the more expensive one. But, she said, one medication might be put in a higher tier for payment than the other.

Nexon noted that it's possible a comparative effectiveness study will show a product is not safe and effective for a specific use because some products are used off-label and thus have not gone through the Food & Drug Administration's screening for that purpose. In such a case, if a study is conclusive, he said, "Of course, an insurance company should have the ability to deny coverage." In addition, Nexon said, "If you find out from a subsequent study that the FDA made a mistake, and a product that they thought was safe and effective turned out not to be, obviously that should be part of the decision-making."

Nexon noted, for example, that the headlines from CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) funded by the National Institute of Mental Health, said that newer, costlier drugs did not work better than older drugs. But, Nexon asserted, one of the newer drugs did work better, although it had side effects that patients and doctors had to balance. In addition, during the study patients often changed from one drug to another because the first drug did not work well or the effects changed over time. But some state Medicaid programs instituted blanket denials of coverage of the newer drug, said Nexon: "And that is the kind of thing that this can be misused for. And I think it is a real threat to American medical care."

Congress is also grappling with the questions of how the institute should be structured to protect it from undue influence from industry or providers and to give its studies credibility. Other questions are whether it should be funded through both public and private sources and where in the federal structure it should be located.

However, the basic concept has been supported in reports from the Institute of Medicine, the Medicare Payment Advisory Commission, and the Congressional Budget Office.

THE AUTHOR is a writer based in the Washington, D.C., area.