As Biopharma Seeks Broader IRA Orphan Exclusion, Study Urges Boosting Savings By Eliminating It
Research takes deep dive into the implications around exempting certain orphan drugs that may qualify for the Inflation Reduction Act’s Medicare price negotiation program, including the effect of the exemption on Medicare spending and the revenue potential of those drugs.
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Rare disease advocates also argue that the Medicare’s government drug price negotiation orphan drug exemption – which only applies when a drug has one orphan designation – will harm other government efforts aimed at more efficient drug development.
As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.
Lilly wants White House Office of Management and Budget to delay final rule until there are regulatory controls against duplicate and diverted discounts. OMB has also held three meetings over past few months with organizations representing 340B providers.