Medicare Coverage Restrictions For Expensive Drugs: Did Aduhelm Let The Genie Out Of The Bottle?
Payer discomfort with accelerated approvals exploded into the public arena with the Medicare national coverage determination on Aduhelm and similar drugs, and developers worry that the fallout will be far reaching.
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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.
Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.
ALS Drugs: FDA Panel Weighed Less-Than-Ideal Data Against Amylyx’s Ability To Set Postapproval Price
National Institute on Aging’s Brian Traynor questioned whether Amylyx would seek to recoup its money on AMX0035 in 2-3 years, before the Phase III PHOENIX trial completes, or whether pricing would be based on long-term market expectations. NINDS’ Kenneth Fischbeck said Amylyx should reopen US sites in Phase III trial and broaden expanded access instead of seeking approval now.