Xtandi: 2021-2022 Request to US Department of Health and Human Services to Use the US Government’s Rights in Patents

New: February 23, 2022. UAEM sends letter to HHS and NIH, asking to recuse the NIH technology transfer official, Mark Rohrbaugh, from having any decision-making role in the response to the 2022 petition to march-in and exercise other rights in the patents on the prostate cancer drug Xtandi. (Letter)

New: February 23, 2022. Love, Sachs and Sawyer submit letter to HHS and NIH, with rebuttal of Astellas February 9, 2022 statement. (Letter)

(For a timeline of all events related to this and previous Xtandi cases, please see: keionline.org/xtandi-timeline)

See also: “Xtandi Bayh-Dole Rights Case: Memorandum in Support of Prostate Cancer Patient Petition Asking HHS to Use the US Government’s Rights in Patents to Enable Generic Competition.” January 25, 2020.

Xtandi (enzalutamide) is a treatment for prostate cancer that is currently priced three to five times higher in the United States than it is priced in other high income countries with large economies, such as Japan, Canada, the UK, France, Italy, Germany, Spain or Australia. The most common presentation is a 40 mg capsule or tablet, and the recommended dose is 160 mg per day (4 capsules/tablets).

Prices of Xtandi in the USA
Prices of Xtandi Outside the United States
The US Bayh-Dole Act Public Interest Safeguards
The HHS/NIH March-in Request
What You Can Do
Timeline of Events
Press Coverage
Other Resources


Prices of Xtandi in the USA

Prices in the United States vary depending on the buyer. A single 40 mg capsule can run from $66 on the US Federal Supply Schedule, to more than $100 per capsule. The Drugs.com coupon price as of January 20, 2021 was $13,581.47 for 120 capsules, equal to $113.88 per 40 mg capsules or $165,241 per year (an increase of 5.9 percent from December 2021). The Redbook average wholesale price (WAC) for the fourth quarter of 2021 was $99.32, and one estimated price net of confidential rebates was $88.54. The January 12, 2022 Redbook average wholesale price (AWP) was $130 per 40 mg capsule, or $189,900 per year.

US Prices for 40 mg of Enzalutamide
Price Date Price per unit
USA FSS Jan 19, 2022 $65.91
USA (Average Medicare Part D) 2019 $97.81
Net price per SSR Health estimate 2020: Q4 $88.54
USA (WAC) 2021: Q4 $99.32
USA (Drugs.com), coupon price Jan 20, 2022 $113.88
USA (Redbook), AWP Jan 12, 2022 $130.00

Prices of Xtandi Outside the United States

Outside the United States, the prices of Xtandi are much lower. Among high income countries, prices before discounts have ranged from $21.64 in Japan and $22.30 in Canada to $44.58 in Denmark per capsule.

Astellas, the company that markets Xtandi, is based in Japan. The price in Japan in 2021 was 2354.1 yen for a 40 mg capsule, or $21.64 at current exchange rates, which is 31 percent of the US FSS price, 22 percent of the US WAC price in 2021:Q4, 19 percent of the Drugs.com coupon price in January 2022, and 16 percent of the Jan 2022 Redbook AWP.

Generic versions of enzalutamide are available in some developing countries for as low as $1.72 per capsule. A Canadian generics company has offered to sell enzalutamide to the US Medicare program for $3 per capsule, but the offer was rejected.

The US Bayh-Dole Act Public Interest Safeguards

Xtandi was invented at the University of California-Los Angeles (UCLA) on grants from the US government. There are three patents on Xtandi listed in the FDA “Orange Book,” and all three disclose research funding from the US Army and the National Institutes of Heath (NIH). The funding for the work at UCLA was carried out under the statutory framework of the Bayh-Dole Act. The Bayh-Dole Act has provisions, rarely enforced, to protect the public. These include measures “to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions.” [35 U.S.C. § 200]

Among the most important safeguards in the Bayh-Dole Act relevant to Xtandi are:

1. A “world wide nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world” [35 USC § 202(c)(4)]; and

2. March-in rights [35 U.S.C. § 203], which allow a federal agency “to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances.” This would include, in the case of Xtandi, generic drug manufacturers.

The worldwide paid-up license can be used at any time by the US government, including to acquire generic versions of enzalutamide for federal programs such as the Department of Veterans Affairs (VA), Medicaid or Medicare.

The march-in right is in some ways broader, in that it is not limited to uses “for or on behalf of the United States,” making its use outside of a government program more clear legally, while it is also in other ways more limited, in that the march-in right can only be granted if four grounds are met, each spelled out in the statute, 35 U.S.C. § 203. One key ground for Xtandi is the obligation of a grant recipient or their assignee or licensee to bring the inventions to “practical application.” This is defined in 35 U.S.C. § 201(f) to include an obligation to make the benefits of the inventions “available to the public on reasonable terms.”

The HHS/NIH March-in Request

There is currently a march-in request before the US Department of Health and Human Services asking that the federal government use its rights in the patents on Xtandi to allow generic competition of the treatment. This is the second time that a march-in case has been pursued for Xtandi on the grounds that it is not reasonable to charge US residents more for Xtandi than the price in other high income countries. A 2016 case was rejected by the NIH and the US Department of Defense. Prices for Xtandi were subsequently increased sharply.

The current case involves four prostate cancer patients, Clare Love, David Reed, Robert Sachs, and Eric Sawyer. More recently, Universities Allied for Essential Medicines have asked to join the petition.

HHS has assigned review of the Xtandi march-in request to the NIH, which has indicated that the agency intends to render a decision on whether to move forward the march-in proceedings within a month, approximately by early February 2022.

For an overview of the issue, see the following article in STAT regarding the petition by Robert Sachs (a petitioner of the Xtandi request), Peter Arno, and Kathryn Ardizzone, “Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices?“.


What You Can Do

Please submit comments of support for the Xtandi march-in request as soon as possible (as the NIH will render its decision in the next few weeks).

Comments can be submitted to the NIH Office of Science Policy email box at SciencePolicy@od.nih.gov.

Social Security Works has an open petition to support the Xtandi march-in efforts, sign their petition here.

 


Timeline of Events

(For a timeline of all events related to this and previous Xtandi cases, please see: keionline.org/xtandi-timeline)

November 18, 2021. Robert Sachs and Clare Love petition to the Secretary of Health and Human Services Xavier Becerra asking that HHS grant march-in rights for the patents on the prostate cancer drug enzalutamide.
December 13, 2021. Eric Sawyer petition to the Department of Health and Human Services, asking to join the outstanding march-in petition.

December 23, 2021. Dr. Tara A. Schwetz, Acting Principal Deputy Director of the NIH, emailed acknowledgement of the November 18th request and stated that Secretary Becerra had assigned review of the request to the NIH.

December 23, 2021. Robert Sachs replied to Dr. Schwetz at the NIH restating the request for a hearing on the issue, and asking whom at the NIH would review the petition, and the expected timeline of the process.

January 10, 2022. Dr. Schwetz of the NIH replied to Robert Sachs stating that, “The petition will be reviewed by the NIH Office of the Director, and the review will likely require approximately a month” and asserted that the issue of whether a hearing should be held would follow any decision by the NIH to move forward with the march-in request.

January 14, 2022. Universities Allied for Essential Medicines submitted a request to join the Xtandi march-in petition.

January 19, 2022. Public Citizen submitted a letter asking HHS Secretary Becerra and NIH Acting Principal Deputy Director Schwetz to support the march-in request for Xtandi.

January 25, 2022. KEI drafted a, “Memorandum in support of the petition to HHS to exercise the march-in or paid up royalty right in patents on the prostate drug Xtandi.” The memorandum was submitted to the record for the Xtandi request by petitioner Clare Love.

January 26, 2022. Robert Mermell, a prostate cancer patient, submits a letter of support for the Xtandi request to HHS Secretary Becerra.

February 2, 2022. Harvard academics Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome, and Dr. Michael S. Sinha submitted a letter of support for the Xtandi request to Secretary Becerra and Acting NIH Directory Lawrence Tabak.

February 3, 2022. Xtandi petitioners send a letter to HHS and NIH highlighting that the US government-Pfizer Paxlovid contract contains a reference pricing clause, wherein the US government is entitled to the lowest cost for Paxlovid of the G7 countries + Switzerland, and asking the NIH to use the same or a similar standard to evaluate the Xtandi petition.

February 8, 2022. A dozen members of the House of Representatives, led by Representatives DeFazio and Doggett, sent a letter to HHS Secretary Becerra urging him to follow through with Biden Administration’s commitment to lowering exorbitant prescription drug costs, and to move forward with the Xtandi request. (PDF version)

February 9, 2022. Astellas releases a statement on the Bayh-Dole Act and the petition to exercise march-in and government use rights in the prostate cancer drug Xtandi. KEI provided comments regarding the Astellas claims concerning public and private sector contributions to the development of Xtandi on February 15, 2022.

February 17, 2022. Senators Elizabeth Warren (D-MA) and Angus King (I-ME), and Representative Lloyd Doggett (D-TX) sent a letter to HHS Secretary Becerra urging him to move forward with the Xtandi march-in petition and to consider using the government’s license under Section 202(c)(4) of the Bayh-Dole Act to authorize generic production for government programs.

February 23, 2022. Seventeen organizations and nine individuals signed on to a letter of support for the Xtandi request sent to Secretary Becerra and Acting Director Tabak.

February 23, 2022. UAEM sends letter to HHS and NIH, asking to recuse the NIH technology transfer official, Mark Rohrbaugh, from having any decision-making role in the response to the 2022 petition to march-in and exercise other rights in the patents on the prostate cancer drug Xtandi.

February 23, 2022. Love, Sachs and Sawyer submit a letter to HHS and NIH, with rebuttal of Astellas February 9, 2022 statement.

March 3, 2022. Mark Reisenauer, President of Astellas, publishes an Op-Ed against the use of government rights in Xtandi, repeating claims from the February 9th Astellas statement regarding their investment in the R&D, and neglecting to address the question of why US patients pay 3 to 6 times the price of other high income countries.

Press Coverage

March 25, 2022. Brenda Sandburg. “Xtandi March-In Fight Extended to Paxlovid, Insulin, HIV, Asthma And Hepatitis C Drugs.” Pink Sheet. https://pink.pharmaintelligence.informa.com/PS145924/Xtandi-MarchIn-Fight-Extended-to-Paxlovid-Insulin-HIV-Asthma-And-Hepatitis-C-Drugs

March 18, 2022. Ian Lopez. “Warren Bid to Grab Xtandi Cancer Drug Patents Gets Firm Rebuke (1).” Bloomberg Law. https://news.bloomberglaw.com/health-law-and-business/warren-bid-to-grab-pfizer-cancer-drug-patents-gets-stern-rebuke

February 22, 2022. Fraiser Kansteiner. “March-in campaign on Pfizer’s prostate cancer med Xtandi gets congressional backing. Will it matter?” Fierce Pharma. https://www.fiercepharma.com/pharma/pfizer-s-xtandi-to-face-low-cost-competitors-three-lawmakers-throw-support-behind-march

February 22, 2022. Zachary Brennan. “Democrats urge HHS to ‘march-in’ or enable ‘government-use’ rights to make Xtandi less expensive.” Endpoints News. https://endpts.com/democrats-urge-hhs-to-march-in-or-enable-government-use-rights-to-make-xtandi-less-expensive/

February 20, 2022. Jonathan Cohn. “Here Is How Biden Can Attack High Drug Prices Without Congress.” Huffington Post. https://www.huffpost.com/entry/biden-drug-prices-xtandi-cancer_n_62113cf4e4b0f93b26194783

February 16, 2022. Tiffany Cacy. “Op-ed: US agencies must ensure equitable access to drugs developed with public funds.” The Daily Bruin. https://dailybruin.com/2022/02/16/op-ed-us-agencies-must-ensure-equitable-access-to-drugs-developed-with-public-funds

February 15, 2022. Annalisa Merelli. “Biden’s quest to lower drug prices should start with the prostate medication Xtandi.” Quartz. https://qz.com/2126025/biden-can-easily-cut-the-price-prostate-cancer-drug-xtandi/

February 15, 2022. Nicholas Florko. “The new lightning rod in the fight over high drug prices.” STAT. https://www.statnews.com/2022/02/15/the-new-lightning-rod-in-the-fight-over-high-drug-prices/

February 11, 2022. Charlotte Kilpatrick. “There’s already a law on the books that could lower prescription drug prices — but no one’s using it.” Salon. https://www.salon.com/2022/02/11/theres-already-a-law-on-the-books-that-could-lower-prescription-prices-but-no-ones-using-it/

February 10, 2022. Zachary Brennan. “Marching in again? Latest Xtandi petition raises questions on if NIH has changed its tune” Endpoints News. https://endpts.com/marching-in-again-latest-xtandi-petition-raises-questions-on-if-nih-has-changed-its-tune/

February 10, 2022. Michael Hiltzik. “Column: The government could cut the price of this prostate cancer drug by as much as 80%. Why hasn’t it acted?” Los Angeles Times. https://www.latimes.com/business/story/2022-02-10/xtandi-pricing-prostate-cancer-drug

February 9, 2022. David Dayen. “Biden’s Big Chance to Lower Drug Prices.” The American Prospect. https://prospect.org/health/bidens-big-chance-to-lower-drug-prices/

February 9, 2022. Mari Serebrov. “US lawmakers send Becerra marchin’ orders.” BioWorld. https://www.bioworld.com/articles/515912-us-lawmakers-send-becerra-marchin-orders

February 9, 2022. Alfred B. Engelberg, J.D., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H. “A New Way to Contain Unaffordable Medication Costs — Exercising the Government’s Existing Rights.” The New England Journal of Medicine. DOI: 10.1056/NEJMp2117102

February 9, 2022. Steve Usdin. “NIH poised to decide on march-in petition.” BioCentury. https://www.biocentury.com/article/642208

January 31, 2022. Ed Silverman. “Will the Biden administration approach march-in rights like Trump? Fight over pricey cancer drug offers a test.” STAT. https://www.statnews.com/pharmalot/2022/01/31/biden-trump-patent-cancer-xtandi-pfizer-nih-prostate/

January 26, 2022. Ambika Verma, Tiffany Cacy, and Ernie Powell. “Biden Must Take on Big Pharma Over Cancer Drug That Costs $189,000 Per Year.” Common Dreams. https://www.commondreams.org/views/2022/01/26/biden-must-take-big-pharma-over-cancer-drug-costs-189000-year

January 3, 2022. Peter Arno, Robert Sachs, and Kathryn Ardizzone. “Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices?” STAT. https://www.statnews.com/2022/01/03/march-in-rights-protect-prostate-cancer-patients-from-excessive-drug-prices/

December 15, 2021. Brenda Sandburg. “Xtandi Petition Will Give Biden Administration Chance To Weigh In On Pricing, March-In Rights.” Pink Sheet. https://pink.pharmaintelligence.informa.com/PS145400/Xtandi-Petition-Will-Give-Biden-Administration-Chance-To-Weigh-In-On-Pricing-MarchIn-Rights

Other Resources

Press briefing on the Xtandi march-in request hosted by KEI on December 15, 2021, featuring petitioners and supporters of the march-in petition: https://www.youtube.com/watch?v=KwqUl7NLMXo

KEI Note: Memorandum in support of the petition to HHS to exercise the march-in or paid up royalty right in patents on the prostate drug Xtandi. January 25, 2022.

Previous march-in requests concerning Xtandi: https://www.keionline.org/xtandi

Recent Bayh-Dole Issues: https://www.keionline.org/35432