ORPHAN Cures Act: $8.8 Billion for the Pharmaceutical Industry and Weakened Medicare Negotiation for Patients and Taxpayers

Statement from Mark E. Miller, executive vice president of Health Care at Arnold Ventures on the CBO updated analysis of the ORPHAN Cures Act. 

Washington, D.C. (October 20, 2025)  — The Congressional Budget Office (CBO) released updated scoring for the ORPHAN Cures Act provision included in the 2025 reconciliation act passed earlier this year. Under the new analysis, CBO is projecting the legislation will cost taxpayers and Medicare beneficiaries $8.8 billion over the next decade. This score takes into account the full impact of exempting certain blockbuster, widely-used cancer drugs from Medicare price negotiations — including Keytruda, Opdivo, and Darzalex. These drugs have enjoyed long periods of market exclusivity, have no generic or biosimilar competitors, and are currently driving annual Medicare spending of $6 billion, $2 billion, and $2 billion, respectively. 

“This nearly $9 billion exemption is a giveaway that protects pharmaceutical monopolies and leaves patients and taxpayers on the hook for higher cancer treatment costs. It contradicts the administration’s expressed interest in reducing drug prices and the public’s demand for Congress to act in addressing the high cost of prescription drugs. In fact, more than 3 in 4 voters, and 70% of Trump voters, say it is very important for Congress to take action to reduce the price of prescription drugs.

“Rather than continuing to protect pharmaceutical industry profits, Congress should look to repeal the ORPHAN Cures Act, while also considering the adoption of other policies to reduce wasteful Medicare spending such as that associated with managed care plan upcoding to help close budget gaps. It’s time to stop putting profits ahead of patients.”