The cost of Enzalutamide (Xtandi) in the United States is being challenged by Knowledge Ecology International (KEI), a public interest advocacy group.  The average US wholesale price of Xtandi in 2015 was $88 per capsule.   That can add up to $129,000 annual cost per man.

There are significant issues related to high costs of treatment. The higher the cost, the more likely that insurance companies will  require pre-authorization to cover the cost of the drug.  That means a man dealing with advanced stage disease is tasked with asking his doctor to spend uncompensated time fighting the insurance company for his treatment.  African American men are particularly at risk, since they experience the highest rate of advanced stage prostate cancer, while experiencing unique and troublesome challenges to access to health care.

Another issue is that Xtandi costs more than twice as much than in most other counties. For example, in Germany, Xtandi cost an average of $36.93 in 2015.

Xtandi was developed with the use of grants from the Department of Defense Prostate Cancer Research Program (DOD PCRP) and the National Institutes of Health (NIH) as well as other federal agencies. “We, the people paid most of the development costs for Xtandi.

KEI along with a group of Democratic congressional members believe that they have a compelling argument for the NIH 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.

KEI has said in a report and in a March 2016 petition given to the US Department of Health and Human Services (HHS) and the NIH, “We are requesting the federal government take steps to address the discriminatory and unfair pricing of Xtandi/enzalutamide by Astellas Pharma, US residents should not have to pay two to four times as much for a cancer drug as residents of other high income countries, particularly when the drug was invented with the support of federal research grants and benefited from other federal research subsidies.” Joining in on the petition were Sens. Elizabeth Warren, Al Franken, Bernard Sanders, and Patrick Leahy, among other elected officials.  They have called for a hearing to investigate the NIH’s reasons for electing not to intervene.

KEI has not reached out to Malecare (as far as we know) or any of our counterparts for dialogue or support for their effort. This strikes us as, at best, curious; we will keep our door open to them.

Astellas provided Malecare with the following statement:
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 high cost of cancer treatment is not limited to Xtandi.  American men pay a higher cost than do men in most other other counties for prostate cancer drugs such as abiriterone (Zytiga), radiun-223 (Xofigo) and sipuleucel-T (Provenge).

See more at: https://web.archive.org/web/20160505200645/http://global.onclive.com:80/publications/oncology-business-news/2016/may-2016/enzalutamide-pricing-debate-goes-to-washington