US Lawmakers Call for Federal ‘March-in’ Hearings About Xtandi Pricing

Twelve US lawmakers have asked the Obama administration to scrutinize the pricing of the prostate cancer agent enzalutamide and to consider licensing its generic production.

Twelve US lawmakers have asked the Obama administration to scrutinize the pricing of the prostate cancer agent enzalutamide (marketed by Japan-based Astellas as Xtandi) and to consider licensing its generic production.

Enzalutamide, an antiandrogen drug administered to 20,000 US patients in 2015, was developed with federal funding at the University of California Los Angeles. But at more than $129,000 per patient per year, its average US wholesale price tag dwarfs prices in other countries. Enzalutamide sells in Japan and Sweden for $39,000, for example, noted the group of US representatives and senators in a letter to the US Department of Health and Human Services and the National Institutes of Health (NIH). The signatories included presidential candidate Sen. Bernie Sanders.

“When Americans pay for research that results in a safe and effective drug, an unreasonably high cost should not limit their access to it,” the lawmakers’ letter states. “We do not think that charging US residents more than anyone else in the world meets the obligation to make the invention available to US residents on reasonable terms.”

The lawmakers called for the agencies to hold a public hearing to review the drug’s pricing. Their letter cited the government’s “march-in” authority to license generic versions of patented drugs to facilitate reasonable access.

Under the 1980 Bayh-Dole Act, federal agencies have the authority to override patents when doing so “is necessary to alleviate health or safety needs which are not reasonably satisfied” or if a patented invention “is not available to the public on reasonable terms,” the lawmakers wrote. “Price can be a clear barrier to access for consumers, and despite this law being in place for over 35 years, the NIH has never used this broad and powerful authority to protect consumers from excessive prescription drug prices.”

The lawmaker’s letter noted that the NIH’s convening of such a hearing in 2004 led to Abbott Laboratories voluntarily reducing the price of the antiretroviral ritonavir (Norvir).

The lawmakers’ letter follows similar

for the government to exercise its march-in rights to end Astellas’s patent monopoly over enzalutamide.

But enzalutamide’s wholesale prices do not necessarily represent a burden to patients, an Astellas spokesman pointed out.

“During 2015, 81% of privately insured patients paid $25 or less out of pocket per month for Xtandi and 79% of Medicare patients paid nothing out of pocket per month for Xtandi,” Tyler Marciniak told OncoTherapy Network in an e-mail. “For eligible patients who do not have insurance or are underinsured, and have an annual adjusted household income of $100,000 or less, Astellas provides Xtandi for free under the Astellas Access Program; in 2015 over 2,000 men fighting advanced prostate cancer received Xtandi for free.”