Xtandi 2016 March-In Request

Today Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) petitioned the Department of Health and Human Services, the Department of Defense, and the National Institutes of Health, asking that they exercise either their royalty-free, non-exclusive license or federal "march-in" rights to end the monopoly on an expensive prostate cancer drug, enzalutamide, marketed as Xtandi by Astellas, a Japanese pharmaceutical company.

Xtandi was invented at UCLA on federal grants from the NIH and DoD.

The basis of the request is that the price of Xtandi is 2 to 4 times higher in the U.S. than in other high income countries, and that the "march-in" provisions in the Bayh-Dole Act should be used to protect U.S. consumers from excessive prices.

The average wholesale price (AWP) for Xtandi is $88.48 per capsule in the U.S., more than three times the price Astellas charges in Japan and more than four times the price in Canada.

Attached to this blog post is a pdf of the request, and of the press release.

Press Coverage

Ed Silverman, "Taxpayer money helped create this cancer drug. Should we be able to force the price down?," Pharmalot, Stat News, Boston Globe, Jan. 14, 2016.

Carolyn Y. Johnson, "Taxpayers helped fund this $129,000 cancer drug. Should the government help cut the price?," Washington Post, Jan. 14, 2016.

Emily Wasserman, "NIH and HHS get 'march-in' request for Astellas' Xtandi," FiercePharma, Jan. 14, 2016.

Russia Today, "Patient advocates petition US gov’t to lower cost of $129K cancer drug partly funded by taxpayers," Jan. 15, 2016.

AttachmentSize
Xtandi-March-In-Request-Letter-14Jan2016.pdf769.8 KB
Xtandi-Press-Release.pdf260.5 KB