The Future of Aduhelm after CMS Stands its Ground

April 8, 2022

The Centers for Medicare and Medicaid Services (CMS) have held firm with their previous draft guidance to only fund Aduhelm in the context of a clinical trial, much to the chagrin of Biogen and patient groups. This further impacts the drug’s already slim chances for market success. Although the final guidance leaves Aduhelm in the same predicament as before, one small change may open the door for future experimental amyloid-targeting antibody treatment.

According to Angus Liu of Fierce Healthcare, “In a small adjustment from January’s draft guidance, the CMS changed the coverage requirement from “CMS-approved” clinical trials to now allow reimbursement for anti-beta-amyloid antibodies approved under the FDA accelerated approval pathway if a patient is enrolled in an FDA-approved randomized clinical trial or a National Institutes of Health trial. Aduhelm is currently the only drug that fits that description.”