Medicare Proposes Paying for Comparative Clinical Trials

From today's Integrity in Science Watch:

Medicare may soon begin paying for drugs and devices used in clinical trials that compare the effectiveness of competing FDA-approved therapies.

A draft memo circulated earlier this month by the Center for Medicare and Medicaid Services would reverse a policy that has been in effect since June 2000. Under that policy, the agency pays for the routine physician costs of seniors who participate in clinical trials, but not for the “investigational” drug, device or test, even if it is already FDA-approved and routinely covered by the Medicare outside the clinical trial.

This policy prohibited Medicare from participating in trials comparing competing treatments, which could save taxpayers money by steering seniors to less costly but equally effective medicines and procedures. “We’re proposing a change so that we will be able to participate in these studies,” said Leslye Fitterman, an epidemiologist with CMS’ Coverage and Analysis Group. “We would pay for the drug if (CMS) already pays for it outside the study.”

At stake is the ability of Medicare to generate objective, scientific data for making payment decisions that can save taxpayers money without harming beneficiaries. The issue came up earlier this year when CMS refused to pay

for the routine cost of care for seniors who took part in a National Institutes of Health-sponsored clinical trial comparing two Genentech drugs for macular degeneration (MD). According to the Wall Street Journal, Genentech refused to provide NIH with free drugs, which made the cost of the trial prohibitively expensive for the agency to manage alone. Lucentis, which costs about $2,000 a shot, is already approved for the condition and costs Medicare over $200 million a quarter. Avastin, which is essentially the same drug but is only approved for use against cancer, costs $40 a shot when used for MD. Physicians using Avastin off-label have reported results comparable to Lucentis. A successful government-sponsored test, if published a major peer-reviewed journal, would allow Medicare to pay for the cheaper alternative.

The CMS draft policy should give a boost to legislation co-sponsored by Sen. Hillary Clinton (D-NY) that would create a new federal agency free from conflicts of interest to conduct comparative effectiveness trials. In a recent review in Health Affairs(subscription required), Gail Wilensky, the head CMS in the George H.W. Bush administration, noted that “there is widespread agreement on the attributes that need to be associated with a comparative-effectiveness center: objectivity in the selection of what is studied, credibility in the findings, and independence—from political pressures generated either by government or by private-sector stakeholders.”