ORPHAN Cures Act

# ORPHAN Cures Act Summary **What it does:** This bill would change how the Medicare Drug Price Negotiation Program treats "orphan drugs"—medications developed for rare diseases that affect small patient populations. Currently, drugs must be on the market for at least 7 years (or 11 years for certain biologics) before Medicare can negotiate their prices. The bill would exclude the time a drug spent as an orphan drug from this calculation, effectively giving orphan drugs more protection from price negotiation.

It would also expand the exemption to include orphan drugs approved for multiple rare diseases, not just single diseases. **Who it affects:** This primarily benefits pharmaceutical companies developing treatments for rare diseases, as it would delay or prevent Medicare from negotiating lower prices on these medications. Patients with rare diseases and Medicare beneficiaries using these drugs could be affected, as the bill could maintain higher drug prices longer. **Current status:** The bill is in committee and has not yet been voted on by the full House. It was introduced by Representative John Joyce (R-PA) in the 119th Congress.