High Value Health Care

Solve the high cost of Xtandi, treatment for prostate cancer, using “March-In” rights

Federal government is urged to take action on drug prices for key treatment for prostate cancer

Health care

Empty prescription drug bottles
Haley Johnson | Unsplash.com

(UPDATED on Dec. 1, 2022. See note below) 

Original Post – Nov. 18, 2022 –

It’s been one year since four patients living with prostate cancer asked the federal government to use its “March-In” rights to bring down the costs of Xtandi, an expensive but important prostate cancer treatment. We’re still waiting for an answer. PIRG followed up with this request to end the delay and take action now

Xtandi (generic name enzalutamide) was invented at UCLA on grants from the U.S. Army and the National Institutes of Health (NIH). Astellas, which markets Xtandi in the U.S. along with Pfizer, holds an exclusive license to use those patents worldwide. U.S. prostate cancer patients and private and government payers face staggering costs for the drug. In the first quarter of 2021, Xtandi cost Medicaid $149,460 per patient per year. In January of 2022, the U.S. average wholesale price per patient was $189,800 per year compared to costs as much as 80% lower in other countries.

Under the Bayh-Dole Act, to serve the public good, the federal government can “March-In” and license patents to competitors if the drug patents came from research funded by public dollars. Patients petitioned the government to use its power under this law by either demanding more reasonable pricing from Astellas for the drug, or by allowing other drug companies to pay licensing fees to Astellas and compete in the drug marketplace. 

PIRG urged the Department of Health and Human Services (HHS) to respond to the patients’ petition: “This delay has resulted in one more year of federal government programs, health plans and patients living with prostate cancer paying higher prices for this treatment than the rest of the world. We urge you to swiftly make a decision in favor of patients and utilize the power of the federal government under the Bayh-Dole Act to protect the public against ‘unreasonable use of inventions.’” 

UPDATE: (December 1, 2022) The National Institutes of Health (NIH) sent a letter on December 1, 2022 to the patients who sent the original petition to HHS to use the federal government’s rights in the patented inventions for Xtandi, marketed by Astellas. The NIH letter said:  We are currently coordinating with HHS to review and assess.”  


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