The Centers for Medicare and Medicaid Services has confirmed that it would be limiting its coverage of Biogen's controversial Alzheimer's disease drug, the Washington Post reports.
The Food and Drug Administration approved Biogen's Aduhelm (aducanumab) in June 2021 but questions remained regarding the drug's effectiveness at treating Alzheimer's disease. Biogen had halted trials of the drug following an early analysis that found it did not work as hoped. But a re-analysis then suggested that one trial showed a slowing of cognitive decline among some Alzheimer's disease patients, which prompted the company to seek FDA approval, as Time magazine reported in 2019. The agency then approved the drug despite an outside advisory panel determining that there was not enough evidence supporting its effectiveness. It further approved the drug under its accelerated approval pathway based on surrogate markers, namely that the drug could clear amyloid plaque from the brain, the Post notes.
In January, CMS announced that it would only cover Aduhelm for patients who are enrolled in clinical trials and the agency has now, according to the Post confirmed that approach in a final decision. It adds that CMS said that if FDA approves other upcoming Alzheimer's treatments through the traditional process, the agency would consider broader coverage for those.