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

08 Apr 2022

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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EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

11 Jul 2025

• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

11 Jul 2025

• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.