NIH refuses to reduce price of $129,000 prostate cancer drug

The National Institutes of Health (NIH) denied a petition to use its “march-in rights” to help lower the cost of Xtandi, a drug used to treat advanced prostate cancer.

The petition had been filed in January by the group Knowledge Ecology International (KEI), asking NIH to use the 1980 Bayh-Dole Act, which allows the federal government some degree of control over patented products developed using federal funding. Using those “march-in rights,” KEI argued NIH could authorize production of a generic version of Xtandi to drive down the cost of the drug.

The drug currently sells in the U.S. for $88.48 per pill, racking up an annual cost of around $129,000.

While Xtandi was developed with the help of federal funding at the University of California Los Angeles, it’s now made by Japanese pharmaceutical manufacturer Astellas Pharma, along with its U.S. partner, Medivation.

In a June 20 letter, NIH Director Francis Collins, MD, PhD, denied KEI’s petition on the basis that because there is no shortage of Xtandi, there’s no reason to authorize generic production.

In response, KEI said Collins didn’t consider the evidence the group presented.

“The two page response by Dr. Collins to KEI and UACT’s 26-page submission was an appalling dereliction of his duty to protect the public from unreasonable use of inventions funded by U.S. taxpayers,” KEI Director James Love said in a statement. “As far as Dr. Collins is concerned, a foreign drug company can charge U.S. residents anything it wants on NIH funded invention, even three or four times as much as in any other country.”

Collins had earlier denied a request by Rep. Lloyd Doggett, D-Texas, for a congressional hearing on Xtandi’s price.

It comes as little surprise NIH would turn down the petition. Since the Bayh-Dole Act was passed in 1980, there have five other attempts to invoke the law for medical technologies. In all five cases, NIH rejected those requests, and its own 2015 study cast doubt on whether it had the authority to use “march-in rights” in the name of lowering costs.

“We found that the existence of march-in rights may select for government research licensees more likely to commercialize the results and that they can be used to extract minor concessions from licensees. But as currently specified in the statute, such march-in rights are unlikely to serve as a counterweight to lower the prices of medical products arising from federally funded research,” the study concluded.

KEI said it will appeal the decision to HHS Secretary Sylvia Burwell and file a new petition next year when a new presidential administration takes over.