Biogen Inc. BIIB, +2.64% shares fell more than 6% in the extended session Tuesday after the Centers for Medicare and Medicaid Services, which oversees the Medicare program, said it plans to cover the biotech’s controversial Alzheimer’s drug Aduhelm and future others like it only in certain instances. CMS’s proposal is that Food and Drug Administration-approved monoclonal antibodies such as Aduhelm and others in its class would be covered for people with Medicare only if they are enrolled in “qualifying clinical trials,” the agency said. The proposed determination is open to public comment for 30 days. If the proposal is finalized, CMS will review each clinical trial submitted to decide whether it meets its criteria. Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services, and other routine costs, CMS said. Aduhelm, the first new treatment for Alzheimer’s in 20 years, was approved by the FDA for the treatment of the neurodegenerative disease in June but its sales have disappointed investors and have been a small portion of what Biogen expected.
