HHS Rejects Bid to Broaden Access to Enzalutamide

Francis Collins

To the dismay of patient advocates, the Department of Health and Human Services (HHS) has turned down a request to override the patent for prostate cancer drug enzalutamide (Xtandi) so that it can be sold to a broader base of patients at a reduced price.

Enzalutamide is one of the higher-end drugs available for fighting cancer, costing upward of $88 per pill (average wholesale) in the United States, leading to contentions that Astellas Pharma is gouging the American public while also placing the drug beyond the reach of many patients with high deductibles or no coverage at all.

The government has never before exercised its “march-in” authority allowed under the Bayh-Dole Act, and patient advocates were hopeful that this time the facts of the case would convince HHS that an exercise of the power was warranted. In its response, the HHS stated that it not only felt that conditions were not met but that no public hearing was called for either. HHS also indicated that the fact that the federal government had partially funded the discovery and development of enzalutamide at US-based institutions did not automatically provide it with authority to intervene in the marketing of the drug, such as by assigning a new manufacturer-distributor to make the product more widely available at lower cost.

“A federal agency that funded an invention has the right . . . to grant a license to a third party if ‘action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time effective steps to achieve practical application of the subject invention in such field of use,’” the HHS wrote in its answer to Knowledge Ecology International (KEI), which was one of the lead groups seeking exercise of march-in authority.

The government agency contended that enzalutamide is currently “broadly available” and that KEI’s own data on sales of the product support that belief by showing that sales have been expanding dramatically and are projected to continue. The advocates failed to provide information “from public sources to suggest that enzalutamide is currently or will be in short supply,” HHS said.

The rejection led to a statement of strong disappointment from KEI. James Love, director of the group, contended that the two page letter from HHS was a profound slight on the 26-page submission originally filed in request of a patent override. Love argued that Francis Collins, director of the National Institutes of Health, an HHS entity, “did not even attempt to deal with the evidence provided in the petition or acknowledge that taxpayers are entitled to protections from excessive pricing.” The group promised that it would soon file an appeal of the decision and that it would make a fresh attempt to request march-in action next year when a new president is sitting in the White House.

Enzalutamide has been a powerful weapon in the fight against metastatic castration resistant prostate cancer, and since 2014 its use has been expanded to front-line treatment with FDA approval. The strength of this medication in fighting cancer is a big reason advocates want to see the price of it reduced; but also, enzalutamide happens to be available only at a substantial premium in the United States whereas in other developed countries it is priced far lower. In Australia, for instance, the US dollar equivalent price is $23.46; and whereas the US wholesale price for a year’s supply ($129,000) is 234% of the per capita income in this country, in Australia it is a substantially lower 53% of per capita income.

For its part, Astellas has said that discount programs are available to help bridge the coverage gap that patients may experience and that it is not realistic to judge the cost of the drug by the information on average wholesale pricing provided by KEI. Patients often pay considerably less, the company said. “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,” the company said, adding that last year 2000 men with prostate cancer received Xtandi for free.