Commercial payers have been complaining for years that new drugs are being approved by the US Food and Drug Administration with less efficacy information than previously required. Now the Centers for Medicare and Medicaid Services has brought that point of view to the public’s attention in a big way, with a high-profile Medicare coverage policy that has dramatically impaired the commercial future of Biogen, Inc.’s Aduhelm and threatens several drugs in development, too.
Released on 7 April, the final NCD imposes coverage with evidence development (CED) requirements on all amyloid-directed monoclonal antibodies for...
