Legislators call HHS to action on Xtandi march-in rights
More than two dozen lawmakers are putting renewed pressure on the federal government to use its march-in rights to lower the price of prostate cancer drug Xtandi.
The group — led by Sens. Elizabeth Warren (D-MA) and Angus King (I-ME), and Rep. Lloyd Doggett (D-TX) — penned a letter to HHS Secretary Xavier Becerra on Tuesday requesting a “long overdue” public hearing on a petition to lower Xtandi’s price filed by patients more than a year ago. Earlier this month, the petitioners got word that the NIH is still “currently coordinating with HHS to review and assess the information,” according to the letter.
“The Inflation Reduction Act (IRA) has been signed into law and will provide critical relief for Medicare beneficiaries, but there are additional actions – including granting march-in rights for Xtandi – that the administration can take to follow through on its commitment to reduce drug prices for all Americans,” the letter reads.
Xtandi was first approved back in 2012 for late-stage castration-resistant prostate cancer, and has since been awarded new indications in non-metastatic castration-resistant and metastatic castration-sensitive patients. The average wholesale price is more than $189,000 per year, the petitioners wrote to Becerra in November.
The petitioners argue that the federal government should exercise its rights under the Bayh-Dole Act to grant patent licenses for generic manufacturers to produce cheaper versions of the drug, which was developed at UCLA using government funding.
Robert Sachs, one of the prostate cancer patients who submitted the Xtandi march-in petition to NIH, came to be involved after the fall of 2020 when his prostate cancer had metastasized. He was prescribed Xtandi, and said his copays at the time would amount to about $10,000 per year.
“We’re happy if they designate this for a hearing. A public hearing with an independent decision maker, with an opportunity for public participation and let the facts drive the decision,” Sachs, who’s now in remission, tells Endpoints News.
Legislators on Tuesday requested that HHS answer several questions by the end of the month, including whether HHS has procedures in place that govern how officials respond to march-in petitions, and whether the agency has set an internal deadline to respond to the Xtandi petition. They also asked the agency to name the HHS officials involved in the review process.
“You have the power to take on the monopoly abuses of the pharmaceutical industry and the responsibility to ensure Americans have affordable access to the medicines they need,” the letter states.
