ORPHAN Cures Act

# ORPHAN Cures Act Summary **What the bill would do:** The ORPHAN Cures Act would modify how the federal government negotiates prices for prescription drugs under Medicare. Specifically, it would expand protections for "orphan drugs"—medications developed to treat rare diseases that affect small patient populations. The bill would exclude time spent developing orphan drugs from the calculation of how long a drug has been on the market, potentially delaying when these drugs become eligible for Medicare price negotiations. It would also remove from price negotiations any orphan drugs approved to treat multiple rare conditions. **Who it affects:** This bill primarily impacts patients with rare diseases, pharmaceutical companies that develop orphan drugs, and Medicare beneficiaries.

Patients with rare conditions may benefit from stronger incentives for drug development, while Medicare's negotiating power for these drugs would be limited. The changes could affect drug prices and availability for both rare disease patients and the broader Medicare population. **Key provisions and status:** The bill excludes orphan drug development time from the "years on market" clock used to determine negotiation eligibility, and extends protections to orphan drugs treating multiple rare diseases. Currently, the bill is in committee and has not yet been voted on by the full Senate.