The US Centers for Medicare and Medicaid Services will only cover Biogen's controversial Alzheimer's disease drug Aduhelm for patients who are enrolled in clinical trials, the Washington Post reports.
The Food and Drug Administration approved aducanumab (Biogen's Aduhelm) in June 2021, despite questions over whether the treatment slowed cognitive decline in Alzheimer's disease patients and concerns regarding the drug's high cost — Biogen initially announced a $56,000-a-year list price for Aduhelm, though, it announced in December it was dropping the price by about half.
Though an FDA advisory panel recommended against approval, the Post notes FDA still approved the drug based on the finding that it reduced brain amyloid levels and argued there was "reasonable likelihood" this would benefit patients. Since its clinical benefit is unclear, some health insurers have said they would not cover the drug and some medical centers have said they would not administer it.
As the Post notes, many private insurers follow the lead of CMS, making this new announcement "make or break" for Aduhelm. Under its new draft policy, Medicare would only cover aducanumab and other approved monoclonal antibodies that target amyloid in the context of a clinical trial. Aducanumab, CMS notes, is the only such approved monoclonal therapy.