Legislators Urge HHS and NIH to Intervene With the Price of Enzalutamide

Twelve members of the US Congress, including Democratic presidential candidate Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD), have signed a letter addressing HHS Secretary Sylvia Matthews Burwell and director of the National Institutes of Health (NIH), Francis Collins, MD, PhD, calling on them to intervene with the current high price of the prostate cancer drug enzalutamide (Xtandi).

Pointing out that high drug prices are access barriers, the letter states, “When Americans pay for research that results in a safe and effective drug, an unreasonably high cost should not limit their access to it.” On this premise, the Congressmen are demanding a public hearing, citing the Bayh-Dole Act of 1980, which the letter states gives federal agencies like the NIH the authority to license a patent when the “action is necessary to alleviate health or safety needs which are not reasonably satisfied” or if the invention is not “available to the public on reasonable terms.”

Enzalutamide was developed by Medivation, in collaboration with the Japanese company, Astellas Pharma. Initially approved in August 2012 by the FDA for the treatment of patients with metastatic castration-resistant prostate cancer who have progressed on docetaxel, the drug subsequently received expanded approval for use in the pre-chemotherapy setting. Priced at $129,000 for the entire course in the United States, the drug is priced at almost one-third that cost in Japan and Sweden ($39,000) and at less than one-fourth the cost in Canada ($30,000).

In their letter, the lawmakers recommend that the government bodies hold a public hearing to openly discuss whether NIH and HHS can invoke their march-in rights to address excessive drug prices. According to Cornell University Law School, march-in rights allow the Federal agency that has funded a project that resulted in an invention to gain a nonexclusive, partially exclusive, or exclusive license for various reasons, including “to alleviate health or safety needs which are not reasonably satisfied.” The drug, developed and patented by the University of California, Los Angeles (UCLA), was licensed to Medivation in 2005. It was recently reported that UCLA will receive $1.14 billion in royalty rights to the drug.

In a response to the letter, a spokesperson for Astellas told the Business Insider, “Xtandi is a standard of care for advanced prostate cancer in the United States and widely available as is evidenced by the 20,000 patients who received it in 2015. 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. 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.”

“The discussion of Xtandi's price in the KEI petition fails to reflect what payers or patients actually pay for the medicine,” the spokesperson added.