Leonard Saltz, MD
It’s no secret to oncologists that enzalutamide (Xtandi) is not only a potent drug in combating prostate cancer but also an expensive one. With an average US wholesale price of $88 per capsule in 2015, enzalutamide can add up to $129,000 in a year’s time for just one patient. This heightens the likelihood of pre-authorization requirements and cost-sharing arrangements that may be financially burdensome, ruinous, or simply impossible to meet (Figure 1)
In fact, the prices charged for enzalutamide in the United States are more than twice what they are in the next highest country, Germany, where a capsule of the drug cost an average of $36.93 last year. Even in other countries where it is priced a bit lower, enzalutamide is considered expensive; but in the United States, some are rankled that Americans have to pay more for a drug that was developed in this country largely with the use of grants from the National Institutes of Health (NIH) and other federal agencies (Figures 2, 3)
Figure 1: Higher Formulary Tiers Can Mean Higher Co-Pays and Restricted Access for Xtandi
Source: Knowledge Ecology International
Knowledge Ecology International (KEI), a public interest advocacy group, said in a report that enzalutamide pricing is particularly hard on economically disadvantaged African Americans in the United States, as they have statistically higher chances of having prostate cancer and would find it more difficult to afford treatment. For these reasons, KEI and a group of Democratic congressional members believe that they have a compelling argument for the NIH to initiate a first-time exercise of its power to override a drug patent on the grounds of “non-use and unreasonable use of an invention.” Such a right to do so is granted under the 1980 Bayh-Dole Act, which allowed industry to capitalize on and direct the use of innovations while allowing the government to intervene when the health and safety needs of the population are not being met. Such a “march-in” order to appoint a lower-cost provider has never been tried by the NIH.
“We are requesting the federal government take steps to address the discriminatory and unfair pricing of Xtandi/enzalutamide by Astellas Pharma,” KEI said in a report that accompanied a March petition to the US Department of Health and Human Services (HHS) and the NIH. “US residents should not have to pay two to four times as much for a cancer drug as residents of other highincome countries, particularly when the drug was invented with the support of federal research grants and benefited from other federal research subsidies.”
Sens. Elizabeth Warren, Al Franken, Bernard Sanders, and Patrick Leahy, among other elected officials, have joined in signing the petition, which calls for a hearing to investigate the NIH’s reasons for electing not to intervene.
Figure 2: Cost of Xtandi 40mg capsule/tab in US and 13 High Income Countries
Source: Knowledge Ecology International.
Developed at the University of California at Los Angeles (UCLA), Xtandi is an oral medication that inhibits the androgen receptor, which drives prostate cancer progression. In a phase III clinical study of patients previously treated with chemotherapy, Xtandi reduced the risk of death by 37 percent and increased median survival by 4.8 months, compared to instances where subjects took a placebo. In a separate phase III clinical study of patients not previously treated with chemotherapy, Xtandi reduced the risk of death by 23 percent and increased median survival by 4 months.