Medicare officials said that the federal health insurance program should restrict its coverage of the new Alzheimer’s drug Aduhelm.
Medicare wants the drug to only be covered for patients participating in approved clinical trials, which would greatly limit the number of patients who could use the expensive drug.
Aduhelm is a treatment intended to slow cognitive decline in patients who are suffering from Alzheimer’s. Unlike past medications that treat the symptoms of Alzheimer’s, Aduhelm is supposed to directly treat the illness itself. But whether it works is still being determined.
Aduhelm was controversially approved by the U.S. Food and Drug Administration in June 2021 in a decision that has been criticized by some doctors. Critics say that during clinical trials, the treatment showed significant safety risks, as well as unclear benefits to patients.
The Centers for Medicare and Medicaid Services released a preliminary decision that there remain significant doubts about whether the benefits for patients outweigh safety risks. The CMS said that the decision came from reviews of evidence, as well as the opinions of stakeholders.
The result is that the agency will only provide coverage for patients receiving the drug in randomized controlled trials. The agency’s chief medical officer said that the evidence showed that while there may be huge potential for the treatment, there is also a potential for serious harm.
This includes headaches, dizziness, falls, and even brain bleeding. The agency said that its goal is to protect beneficiaries from harm without knowing the benefits in the Medicare population.
The company that makes the treatment, Biogen, said that the agency’s position denies the daily burden of anyone living with Alzheimer’s and that clinical trial requirements will exclude almost everyone who could benefit from it.
The decision is very unusual and is the first time that the agency has limited Medicare beneficiaries’ access to a drug approved by the FDA in this way.
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