CMS said Jan. 11 it is limiting Medicare coverage of Aduhelm, Biogen's controversial Alzheimer's drug, only to patients who are taking part in clinical trials. While hospitals awaited this guidance from CMS, some conducted reviews of the drug on their own.
Aduhelm is designed to target and eliminate clumps of a toxic protein called beta amyloid that are believed to destroy the brain, according to Biogen. It's the first treatment approved by the FDA to slow cognitive decline from Alzheimer's, as the Alzheimer's drugs the agency previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.
Tim Lynch, PharmD, chief pharmacy officer at MultiCare Health System in Tacoma, Wash., told Becker's the system is "actively monitoring" studies and information regarding Aduhelm and its ability to treat Alzheimer's.
"Our system pharmacy and therapeutics committee determined that despite FDA accelerated approval, there remain questions related to efficacy and long-term outcomes for patients who receive treatment, given the approval was based upon surrogate endpoints (amyloid reduction)," he said.
To evaluate Aduhelm, Yale New Haven (Conn.) Health deployed a "rigorous process," LeeAnn Miller, PharmD, the system's chief pharmacy officer, told Becker's. She said the system formed a panel of experts from its neurology, gerontology, psychiatry, pharmacy and ethics departments to review evidence and discuss the drug's potential application.
The panel discussed conflicting trial results between Biogen's two phase 3 trials, despite the trials being designed nearly identically. Yale New Haven's experts noted the observed benefit in the positive trial was relatively small.
"The potential benefit needing to be balanced against risk of side effects, amyloid-related imaging abnormalities in this case, was also a point of interest, as it was a common finding in both clinical trials," Dr. Miller said of the panel's review.
Both MultiCare and Yale elected to leave Aduhelm off their formularies, but the systems will re-evaluate the drug once post-marketing data becomes available.