UPDATED: Astellas cancer med Xtandi draws fire as U.S. lawmakers demand a pricing hearing

U.S. Department of Health and Human Services (HHS) Secretary Sylvia Burwell recently said that the agency wouldn't take "extraordinary action" against rising drug prices unless the situation called for it. Now lawmakers are holding up Astellas' prostate cancer drug Xtandi as an example--and they're stepping up their campaign to persuade HHS and the National Institutes of Health (NIH) to act.

Rep. Lloyd Doggett (D-TX) and a group of other lawmakers--including Sen. Bernie Sanders (I-VT) and Elijah Cummings (D-MD), who've been leading investigations into pharma pricing--asked Burwell and NIH Director Francis Collins to hold an "open and transparent" public hearing on pricing for Xtandi, the lawmakers wrote in a Monday letter.

"The NIH has a powerful tool to hold drug companies accountable for barriers to access to drugs developed through support of U.S. taxpayers, including price," the lawmakers said, and the agency should use its authority to help improve patients' access to meds.

Back in January, Washington, DC-based nonprofit Knowledge Ecology International (KEI) and Union for Affordable Cancer Treatment (UACT) wrote the NIH to urge the agency to use its "march-in rights" to open up Xtandi to generic competition. Several lawmakers, including Doggett, followed up with a letter backing the idea. The Bayh-Dole Act, a patent reform bill, granted the government powers to skirt patents for pricey drugs developed with federal funding.

But HHS hasn't used this tactic since the law went into effect in 1980. Implementing march-in rights is an "extraordinary remedy" that should only be used in extreme cases, the agency has said. And HHS is only "prepared to use its authority when presented with a case where the statutory criteria are met," Burwell said in response to lawmakers' requests earlier this month.

HHS Secretary Sylvia Burwell

Still, Doggett and his price-fighting brigade aren't going down without a fight. The government can use march-in rights when "action is necessary to alleviate health or safety needs which are not reasonably satisfied" or if a government-funded invention is "not available to the public on reasonable terms," according to laws cited by the reps.

Xtandi meets these requirements, the lawmakers contend. The drug was developed at UCLA through grants from the U.S. Army and NIH. And the drug costs much more in America than it does elsewhere, with a U.S. list price of about $129,000 per treatment course, compared with $39,000 in Sweden and in Astellas' native Japan. "We do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms," the congressional reps said in their note.

Holding a public hearing on Xtandi could be a critical first step in getting the agency to act on pricing. The NIH held a hearing in 2004 to investigate similar issues after getting a march-in request for Abbott Laboratories' ($ABT) anti-HIV drug Norvir. The hearing seemed to pay off, as the company ended up lowering the drug's price for payers, Medicaid and patient assistance programs, the lawmakers pointed out in the letter.

Still, Congress faces an uphill battle in getting the agency to act on drug pricing. The NIH "in 35 years has never agreed with a request for march-in rights, particularly in the context of high drug prices," Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, told FiercePharma in January. And some say that pharma companies are already doing their duty by making patent information available.

But convincing the NIH to use its march-in rights could send an "important signal" to the industy, Kesselheim said. "These are important issues that patients are struggling with. There may be some symbolic importance to more attention to this area."

In the meantime, Astellas is standing by its pricing for Xtandi. "The discussion of XTANDI's price in the KEI petition fails to reflect what payers or patients actually pay for the medicine," the company told FiercePharma in an email.

Last year, about 81% of privately insured patients paid $25 or less out of pocket per month and 79% of Medicare patients paid nothing out of pocket per month for Xtandi, the company said. Astellas also has an assistance program for uninsured or underinsured patients that provides the med free of cost for some individuals who qualify, it said.

- read the letter (PDF)

Editor's note: This story was updated with a statement from Astellas.

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