Biogen’s new Alzheimer’s drug Aduhelm continues to face opposition after its contentious approval from the Food and Drug Administration last month—which the FDA now says should be independently investigated. Some insurers say they won’t pay for the drug, some hospitals say they won’t administer it, and yet more experts say it has no proven benefit and is dramatically overpriced at $56,000 for a year’s supply.
On Thursday, a panel of medical experts convened by the nonprofit Institute for Clinical and Economic Review (ICER) voted 15-to-0 that there is no evidence that Aduhelm provides clinical benefit to patients. The unanimous vote echoes another one from a panel of expert advisors for the Food and Drug Administration who voted last November against FDA approval. Eleven of ten advisors voted that data collected in two identical Phase III clinical trials failed to show the drug is effective, with the remaining advisor voting “uncertain.”
The FDA nevertheless approved the drug June 7, sparking a firestorm of criticism. In an unprecedented move last week, the FDA updated their recommendation for who should receive the drug, significantly narrowing the pool from all Alzheimer’s patients to only those with mild disease. It’s unusual for the FDA to make such a modification so soon after an initial decision and without fresh data to back a change.