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Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals

 
• By Cathy Kelly

Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.

Decision Retains Skepticism About Accelerated Approvals • Source: Alamy

The Centers for Medicare and Medicaid Services has issued a final Medicare Part B national coverage determination for Alzheimer’s drugs that creates a two-tier approach to coverage with evidence development that is dependent on the nature of the US Food and Drug Administration approval.

The final NCD was released on 7 April and goes into effect immediately. The changes in the final decision...

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