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

 
• By Cathy Kelly

CMS chief medical officer Lee Fleisher addresses concerns that the Medicare national coverage determination for Alzheimer’s drugs sets a precedent for accelerated approvals. He and the FDA's Janet Woodcock also discuss prospects for closer collaboration on evidence needs pre-approval.

Concerns persist that the Aduhelm decision sets a precedent. • Source: Alamy

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.

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