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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Health policy experts discuss ways Medicare coverage policy may evolve in the coming years and how efforts to smooth the transition between accelerated drug approvals and Medicare reimbursement decisions could play out.
Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.
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.