Prescription Drugs Affected by an Expanded Rare Disease Carve-Out from Medicare Price Negotiation

The One Big Beautiful Bill Act (OBBBA) expanded exemptions from Medicare drug price negotiation to include drugs approved for multiple rare diseases and delayed negotiation timelines for drugs first approved for a rare disease. The authors identified 22 drugs, collectively accounting for $18 billion in 2023 Medicare spending, that would be exempted or delayed from negotiation under these new provisions. Congress should consider more targeted approaches, such as setting a higher spending eligibility threshold for rare disease drugs, to preserve savings while maintaining protections for rare disease products.