Xtandi is a medicine used to treat advanced prostate cancer sold by Astellas and Pfizer. (1) Xtandi is exorbitantly priced by any measure. The estimated net price of Xtandi in 2020 was $129,000 per year, or close to $90 per capsule. (2) The price of Xtandi is three-to-five times higher in the U.S. than in other high-income countries. In 2020, Astellas and Pfizer made more money selling Xtandi in the U.S. than the rest of the world combined. (3) The year before, Medicare spent more than $1 billion on the drug before rebates. (4) A Canadian manufacturer once offered to sell generic enzalutamide to the U.S. government for $3 per capsule, but the offer was declined. (5)
The originator price poses a barrier to access. For one patient who was briefly placed on the treatment, filing just one prescription cost $625 out-of-pocket. “Drugs like Xtandi force families to focus on and worry about price tags,” he wrote in a submission to HHS. (6) “Please allow American prostate cancer patients the same right to access affordable care as patients around the world.”
The high price of Xtandi also raises concern about health equity. Black Men, in particular, may have disproportionate need for the exorbitantly priced drug, given underlying disparities in prostate cancer mortality and incidence. “Black men have two times the prostate cancer mortality and 60% greater incidence than White men,” one review concluded. (7)
Xtandi was invented at University of California, Los Angeles with U.S. government funding through grants provided by the National Institutes of Health and the U.S. Army. Because the drug was developed through federal grants, the U.S. government retained certain rights, including the right to march-in when underlying taxpayer-funded inventions were not made available on reasonable terms. There are three patents listed in the FDA Orange Book covering Xtandi. (8) All three disclose U.S. government funding.
Table: Xtandi patents
| U.S. Patent Number | Patent Expiration |
| 7,709,517 (9 | 8/13/2027 |
| 8,183,274 (10) | 8/24/2026 |
| 9,126,941 (11) | 5/15026 |
The march-in statute and related definitions in the Bayh-Dole Act plainly state that a failure to make a subject invention’s benefits “available to public on reasonable terms” is a ground for exercising march-in rights. It would strain credulity to suggest that charging triple the price to consumers who paid for the invention of enzalutamide—namely U.S. taxpayers—is “reasonable.” Hence, the U.S. government can march-in and authorize generic competition.
The Biden administration is currently considering a petition filed by prostate cancer patients on enzalutamide. (12) We urge Secretary to move forward with all due haste to authorize generic competition.
(1) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203415s015lbl.pdf
(2) $88.54 per capsule, with 4 capsules required every day. https://www.keionline.org/xtandi2021
(3) https://www.citizen.org/article/united-we-spend-big-pharma-us-international-revenue-report/
(4) Medicare Part D Spending Dashboard.
(5) https://www.statnews.com/pharmalot/2016/04/27/cancer-medicare-xtandi-biolyse-pharma/
(6) https://www.keionline.org/wp-content/uploads/Xtandi-Letter-Mermell-26Jan2022.pdf.
(7) https://www.nature.com/articles/s41391-021-00451-z
(8) There is also a regulatory exclusivity for one indication that expires late this year.
(9) This invention was made with United States Government support under National Institutes of Health SPORE grant number 5 P50 CA092131 and Department of Defense (Army) grant number W81XWH-04-1-0129. The Government has certain rights in the invention.
(10) This invention was made with United States Government support under National Institutes of Health SPORE grant number 5 P50 CA092131and Department of Defense (Army) grant number W81XWH-04-1-0129. The Government has certain rights in the invention.
(12) This invention was made with Government support under Grant No. W81XWH-04-1-0129 awarded by the United States Army, Medical Research and Materiel Command; Grant No. CA092131 awarded by the National Institutes of Health. The Government has certain rights in this invention.
(13) https://www.keionline.org/xtandi2021, https://www.huffpost.com/entry/biden-drug-prices-xtandi-cancer_n_62113cf4e4b0f93b26194783