Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals
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.
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FDA, CMS And Accelerated Approval: Flipping The Script
The US Medicare agency’s restrictive coverage policy for Alzheimer’s antibodies is a clear threat to the FDA accelerated approval pathway. Now the payor is going to try a different approach to strengthen the pathway.
UPDATED: US FDA Has People Working At CMS To Help Implement Inflation Reduction Act
The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
Medicare Will Test Payment Model For Accelerated Approvals To ‘Expedite’ Confirmatory Trials
The Center for Medicare and Medicaid Innovation also will develop demonstrations focused on payment arrangements for cell and gene therapy in Medicaid and promoting generic drugs in Medicare Part D.