Medicare finalizes policy limiting coverage of Biogen Alzheimer’s drug

Medicare won’t pay for Biogen’s new Alzheimer’s drug unless potential patients are enrolled in a clinical trial, the U.S. government said Thursday in a decision that will severely limit the drug’s use.

The final policy, issued by the Centers for Medicare and Medicaid Services, largely confirms a draft proposal released in January, which Biogen and its pharmaceutical industry allies had sought to reverse.

In making its decision, the agency said the clinical trial data supporting the drug, now known as Aduhelm, was insufficient to conclude that the treatment is “reasonable and necessary” – a government standard in cover material.

The policy also applies to other drugs that perform similarly to Biogen’s if, like Aduhlem, they are approved based on an intermediate measure that predicts, but does not prove, clinical benefit.

“We know there’s promising potential with this treatment,” CMS chief medical officer Lee Fleisher said in a call with reporters Thursday. “However, there is currently insufficient evidence of clinical benefit to say that it is reasonably necessary for people on Medicare.”

The final policy opens the door to somewhat less restrictive coverage if an Alzheimer’s drug similar to Aduhelm were to be approved based on a direct measure of clinical benefit. In this case, the CMS would cover the treatment in approved comparative studies, which may collect data through a registry.

The agency’s decision is the latest controversial development for Aduhelm, which received controversial FDA approval last June. Aduhelm is the first drug authorized in the United States to slow the progression of Alzheimer’s disease, rather than temporarily relieve some of its symptoms.

But the evidence Biogen gathered to support its benefits was conflicting and equivocal, raising substantial doubts among doctors and even some FDA officials about whether Aduhelm actually helps patients.

When Biogen first reviewed data from Aduhelm’s two main studies in 2019, it concluded they were likely to fail and halted testing. Months later, however, Biogen re-examined the data and found signs of benefit in one of two trials, which it used to seek approval for Aduhelm.

Independent advisers the FDA later convened strongly criticized Biogen’s results and voted against them.

Ben Fidler contributed reporting.

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