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 per capsule in 2015, enzalutamide can add up to 9,000 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)
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.
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.
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