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The US Centers for Medicare and Medicaid Services, which runs the federal Medicare health insurance plan for elderly people, last month proposed changes to how it pays for clinical trials.
If accepted, the changes would help Medicare compare existing treatments and make scientific and payment decisions that could save money while still providing effective treatment.
Under the current policy, developed in 2000, Medicare pays for certain items and services and for healthcare costs of Medicare beneficiaries who are taking part in clinical trials, but it does not pay for the “investigational” drugs, tests, and devices used in trials even when these drugs, tests, and devices have already been approved by the Food and Drug Administration (FDA). If people were receiving the FDA approved drug, test, or device outside the clinical trial, Medicare would pay for it.
Under the proposed policy Medicare would cover the cost of drugs, devices, and tests already approved by the FDA when they are used in clinical trials. There will be a 30 day consultation period, and the Centers for Medicare and Medicaid Services will publish its decision, called a national coverage determination, 60 days later.
The proposed policy also calls for all studies to register with the clinical trials website (http://clinicaltrials.gov) of the National Institutes of Health (NIH) before enrolment and to publish their results.
The issue was highlighted by the Integrity in Science project of the Center for Science in the Public Interest and an article in the Wall Street Journal (www.WSJ.com, 22 Feb, “Blind ambition: Genentech's big drug for eyes faces a rival”).
The newspaper article reported that the Medicare centres refused to pay the costs of drugs for elderly people taking part in a planned NIH clinical trial comparing two drugs to treat macular degeneration. People in the trial were to be treated with ranibizumab (Lucentis), which costs $2000 (£1000; €1470) an injection, or bevacizumab (Avastin), which costs $40. The drugs, both made by Genentech, are similar. However, ranibizumab is approved by the FDA to treat macular degeneration, but bevacizumab is approved only to treat cancer.
If the cheaper drug proved just as good, Medicare might save $1bn a year, the article said. It reported, “Some say the trial is the first step toward making the US resemble Britain. There the government studies the cost of drugs versus their effectiveness and refuses to pay for those that fail to make the grade.”
Genentech refused to provide drugs or funding for the trial, the Wall Street Journal reported, and because Medicare doesn't pay for the costs of trial drugs that are already approved the trial was prohibitively expensive for the NIH.
The Integrity in Science project said that a successful NIH sponsored trial, if published in a major peer reviewed journal, would allow Medicare to pay for the cheaper drug. The project said that the proposed Medicare policy would help support legislation sponsored by Senator Hillary Clinton to establish a new federal agency free from conflicts of interest to carry out trials comparing the effectiveness of drugs (www.cspinet.org/integrity/watch/index.html).
The proposed new policy can be found at www.cms.hhs.gov.