FDA, Medicare And The Future Of Coverage With Evidence Development For Accelerated Approvals
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.
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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.
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.
It's not clear that the proposed revisions and additions to the Centers for Medicare and Medicaid Services’ existing coverage with evidence development study design requirements would address what some experts view as a program failure – the fact that sponsors of the vast majority of technologies subject to CED have not generated the data CMS is looking for.