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.
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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.
Aduhelm Shows Need For More FDA Transparency On Approval Decisions, Surrogate Endpoints, Critics Say
But Center for Drug Evaluation and Research leaders stand their ground at a National Academies meeting, asserting the Phase III data for a different Alzheimer’s drug, Leqembi, are likely to confirm their views on utility of amyloid as a surrogate endpoint.
Accelerated Approval: US FDA Should Explain Why An Ongoing Trial Is Not Required
Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.