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.
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FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
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.
Drug Pricing Reforms In US Congress: Legacy Systems vs. Cutting-Edge
A House hearing on bipartisan drug pricing reform bills continues the intense focus on the role of pharmacy benefit managers. But it also shows continued interest in finding ways to make payment systems work for cutting edge gene therapies.