Xtandi Petition (filed in 2016, appealed in 2017)

On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes of Health (NIH) and Department of Defense (DoD) asking that they exercise their authority under the Bayh-Dole Act to authorize the generic production of an expensive prostate cancer drug. See: /node/2412

KEI and UACT were asking the NIH use either its royalty-free, non-exclusive license or march-in rights.

On April 22, 2016, Biolyse Pharma offered to sell generic versions of enzalutamide to Medicare and other federal programs for $3 per pill, a discount of about 95 percent compared to the Astellas price of Xtandi to Medicare. See: http://www.keionline.org/node/2480

On June 20, 2016, NIH Director Francis Collins rejected the march-in/royalty free request. See: /node/2603

On April 29, 2017, KEI and UACT appealed the Collins decision HHS Secretary Price. The appeal was rejected by Francis Collins on June 7, 2017. See: http://www.keionline.org/node/2756


Background

Enzalutamide, marketed as Xtandi by the Japanese firm Astellas Pharma, was developed with the support of NIH and DoD grants at the University of California, Los Angeles. Astellas markets Xtandi for over $129,000 per year per patient in the United States, which is over two to four times higher than the price of other high-income, high-GDP countries. The KEI and UACT request asked the NIH to use its march-in or royalty-free rights on Xtandi, citing the comparatively high price of Xtandi in the United States and the failure of Astellas to make the drug available to the public on reasonable terms.

Links to relevant pages on KEI’s website on the request are available below, and this page will be updated with new developments.

  • NIH declines request to use government patent rights to lower price of Xtandi in June 20, 2016 letter from Francis Collins
  • Xtandi 2016 March-In Request
  • Xtandi March-in Request, links to news stories, blogs
  • Bayh-Dole Act and difference between March-In Rights and the world wide royalty free rights in patents
  • Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs
  • 11 Groups Urge NIH to Lower Price of Xtandi, NIH/Army-Funded Prostate Cancer Drug With $129k/Year Price Tag
  • 2017: KEI, UACT Request that Trump Administration Reevaluate Xtandi Petition
  • Rep. Lloyd Doggett keynote address at CAP drug pricing event highlights Xtandi, federal funding of pharmaceutical R&D
  • 56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries
  • Alfred Engelberg and Aaron Kesselheim in Nature on Bayh-Dole royalty free rights in patents, Xtandi case
  • Bicameral letter from 6 Senators and 6 members of the House to NIH
  • NIH acknowledges KEI/UACT request to use royalty-free or march-in rights on Xtandi
  • Biolyse Pharma offers to supply enzalutamide (Xtandi) for $3 per pill to Medicare and developing countries
  • Bloomberg: CVS Will Exclude Xtandi From Formulary in 2017
  • S. Ward Casscells, Pentagon Medical Chief, Praised Army Role in Xtandi Development
  • Congressman Doggett Voices Support for KEI/UACT Petition to NIH on Xtandi
  • Washington Monthly Cover Story Highlights Petition to Lower Price of Xtandi in U.S.
  • Letter to HHS and NIH regarding impact of high prices on cost effectiveness of Xtandi
  • Xtandi patient on Medicare — with supplement — pays $441.97 per month
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