March-in campaign on Pfizer's prostate cancer med Xtandi gets congressional backing. Will it matter?

Three lawmakers have thrown their support behind a plan that could empower the National Institutes of Health (NIH) to supply cheaper versions of Pfizer and Astellas' prostate cancer drug Xtandi—but will the campaign spur actual change?

In a letter sent Tuesday, U.S. Senators Elizabeth Warren, D-Massachusetts, and Angus King, I-Maine, plus Congressman Lloyd Doggett, D-Texas, pressed Department of Health and Human Services (HHS) secretary Xavier Becerra to move forward with the march-in petition submitted for Xtandi, also known as enzalutamide. Specifically, the lawmakers want Becerra to hold a public hearing to let petitioners and patent-holders lay out their arguments and evidence.

While the march-in campaign around Xtandi now boasts some congressional support, history suggests it's unlikely the NIH will act on its march-in rights and allow cheaper competition to the pricey cancer drug. The federal government has never exercised march-in rights.

The rights allow the government to grant patent licenses to other parties—or take licenses for themselves—if taxpayer funding helped in the patent owner’s research and development process, UpCounsel explains. Established in the Bayh-Dole Act of 1980, the rights, in theory, can help introduce competition and lower prices for consumers, the lawmakers said in a release.

The HHS shot down a similar petition in 2016, but said it was “prepared to use its authority when presented with a case where the statutory criteria are met,” then-HHS Secretary Sylvia Burwell said at the time. 

As for Xtandi, the drug was developed at the University of California, Los Angeles, with some serious financial support from the Pentagon and the NIH, The Lost Angeles Times reports. UCLA sold its rights to the med in 2016.

“Exercising the government’s march-in rights for Xtandi will dramatically lower the price of this life-saving drug for millions of Americans,” the trio of lawmakers wrote in Tuesday’s letter.

Despite Xtandi’s taxpayer provenance, “the drug can cost Americans as much as six times what it costs individuals in other high-income countries,” the lawmakers pointed out. The average wholesale price for one Xtandi capsule in the U.S. is $130, versus just $20 per capsule in Japan, the lawmakers added, citing data from Knowledge Ecology International. A year’s worth of Xtandi in the U.S. costs nearly $160,000 more than the drug’s price in Japan, they added.

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The HHS has telegraphed plans to respond to the march-in request as early as this month, The Los Angeles Times reports. That could come in the form of an approval or rejection of the petition, or the scheduling of hearings on the request.

Military veteran Clare Love and former MIT computer scientist David Reed, Ph.D.—both of whom have been diagnosed with prostate cancer—sent their march-in petition to the Department of Defense back in 2019.

“The price of Xtandi in the United States is more than four times the median price in the seven high-income countries identified by the U.S. Senate Armed Services Committee in 2017 to be used to determine if the U.S price on a Department of Defense (DoD)-funded drug is reasonable,” the petitioners wrote in their letter. “The price in the U.S. is five times the reimbursed price in Japan, where Astellas is headquartered,” they added.

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Love and Reed recently re-submitted their petition to HHS after not receiving a response, Endpoints News recently reported. As a result, NIH said it would complete its second review of the march-in for Xtandi in February.

In the U.S., where Pfizer markets Xtandi, the drug generated a little more than $1 billion for full-year 2020, the company said in its annual report published last year.