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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As with many rare diseases, a clear natural history would make deciphering the data easier, but for now what Sarepta characterizes as stabilization is seen by FDA reviewers as expected improvement based on previous measures of disease progression at younger ages.
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.