Astellas/Medivation’s Xtandi pricing for prostate cancer faces uncertain NIH hearing, weak 'march-in rights' prospects – experts

07 Apr 2016

Astellas Pharma (TYO:4503)/Medivation's (NASDAQ:MDVN) prostate cancer drug Xtandi (enzalutamide) has drawn debate from Capitol Hill experts on whether the National Institutes of Health (NIH) will hold a hearing to address its price. Most doubted the government agency would weigh in on the controversial topic whilst others said it's possible in an election year.

However, all agreed US lawmakers' call for NIH to invoke "march-in rights" -- that would open up Xtandi's patent to additional licenses -- will also likely remain unheeded. A lack of congressional power to directly restrict drug pricing also underwhelms congressional efforts, they said. The best option for pricing cuts would be media pressure but two experts urged the firms to keep their prices.

Whilst two physicians agreed a reduction in Xtandi's price would be favourable, they noted Xtandi has shown a survival benefit in randomised trials in metastatic prostate cancer and there aren't cheaper generics with comparable efficacy.

In a 28 March letter by 12 Senate and House members to the NIH and the Department of Health and Human Services (HHS), they request the NIH hold a hearing to establish whether march-in criteria can be established for Xtandi. They noted the Bayh-Dole Act gives federal agencies, including the NIH, the authority to license drugs where there are unsatisfied health and safety needs or if the invention is not available to the public on reasonable terms. The lawmakers contend Xtandi's high price, at USD 129k annually, meets march-in criteria. Xtandi was developed with NIH funding.

Additionally the letter stated that Xtandi is sold for USD 39k and USD 30k in Sweden and Canada, respectively. Drug cost differences between US and European countries is not specific to only Xtandi, or even prostate cancer drugs, but is across the board in oncology, said Dr Eleni Efstathiou, associate professor, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.

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