US Medicare Agency Clarifies View Of Accelerated Approval
CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.
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Medicare And Alzheimer’s Drugs: Pressure To Relax Coverage Restrictions Rising Wtih Donanemab Data
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Leqembi Coverage Expansion: US Medicare Head Promises Light Touch On Registry
Medicare is not envisioning an overly burdensome process to fulfill its requirement for a registry as a condition for coverage of ‘fully’ approved beta amyloid Alzheimer’s therapies, the head of the agency tells Congress. Biogen and Eisai still hope to have the registry obligation removed altogether.
Accelerated Approval In The US: It Really Is Rare Outside Of Oncology
Everyone knows that cancer drugs dominate use of the Accelerated Approval pathway by the US FDA. But it is remarkable just how rare a non-cancer AA is.