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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Medicare Payment Caps For Part B Drugs With Accelerated Approvals Endorsed By MedPAC
Recommendation meant to drive completion of confirmatory trials for accelerated approvals will be forwarded to Congress. Medicare Payment Advisory Commission also recommends allowing Part B to use reference pricing and to adjust ASP payment add-ons for providers.
Medicare CED Update Targets Study ‘Efficiency,’ But May Not Ease Data Collection Burden
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.
Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever
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.