1. Pink Sheet

IRA’s Orphan Drug Exemption Could Lead to More Off-Label Prescribing

 
• By Sarah Karlin-Smith

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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Rare disease advocates believe IRA will jeopardize filing of supplemental marketing applications for orphan drugs. • Source: Shutterstock

The limited orphan drug exemption in the Inflation Reduction Act’s Medicare price negotiation program could shift more drug use, particularly for rare diseases, into the off-label space and make it more challenging to ensure insurance reimbursement for those products, rare disease advocates worry.

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