Medicare Restrictions On Aduhelm Do Not Signal Broad Concern With Accelerated Approvals – CMS

The US Centers for Medicare and Medicaid Services’ national coverage determination limiting Medicare coverage for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa) to situations when patients are enrolled in a clinical trial should not be read as a sign that the agency is cracking down on drugs cleared through the US Food and Drug Administration’s accelerated approval pathway, CMS chief medical officer Lee Fleisher emphasized.

“Our recent decision should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” Fleisher said 12 April during the Duke-Margolis Inaugural Health Policy Conference....