IRA’s Orphan Drug Exemption Could Lead to More Off-Label Prescribing
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.
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CMS sends a warning to Medicare Part D plans that beneficiaries should have ‘meaningful’ formulary access to drugs with negotiated prices. However, the guidance does not broaden potential exclusions from negotiation for orphan drugs, to the disappointment of stakeholders.
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