New York – With the high cost of prescription drugs in the United States a continuing public and political hot button, several lawmakers went on record this week targeting the expensive prostate cancer drug Xtandi (enzalutamide).

The drug, marketed by Medivation Inc. and Astellas Pharma Inc., is used to treat advanced forms of the cancer that no longer responds to hormone therapies or surgical treatments that lower testosterone, and has spread to other parts of the body.

Reps. Lloyd Doggett (D-TX) and Peter Welch (D-VT) joined Vermont’s Sen. Bernie Sanders in calling on the National Institutes of Health and the U.S. Department of Health and Human Services to take action aimed at cutting the cost of Xtandi.

At least nine other lawmakers, all Democrats, also signed the request. The group claims the drug was developed at the University of California, Los Angeles, through taxpayer-supported research grants.

The lawmakers are asking for public hearings to be held since the drug costs $129,000 in the U.S. for a one-year course of treatment while it sells for less than a third of the that price in Sweden and less than a quarter of the cost in Canada. The estimated U.S. wholesale cost of Xtandi is $88.48 per 40 mg unit, which is taken four times a day. In contrast, Xtandi reportedly costs about $20 per unit in Canada.

In a press statement following the lawmakers’ request, an Astellas spokesperson said that 81 percent of privately insured patients last year paid $25 or less per month out of pocket for the drug and 79 percent of Medicare patients paid nothing out of pocket.

Eligible patients without insurance and those underinsured with adjusted household income of $100,000 or less can receive the drug free of charge under the company’s “Access Program,” according to the Astellas press statement.

In January, the non-profit organization Knowledge Ecology International joined the non-profit Union for Affordable Cancer Treatment in calling on the federal government to adopt a policy to “use its royalty free rights, or grant licenses under federal ‘march-in rights,’ when prices in the United States are excessive, and/or higher than they are in high income foreign countries, and to apply that policy in this case on patents on (Xtandi).”

The non-profits at the time claimed such an approach would be in accord with the objective of the Bayh-Dole Act, adopted in 1980, “to protect the public against nonuse and the unreasonable use of inventories.”

The controversial march-in rights under Bayh-Dole allows federal funding agencies to potentially ignore the exclusivity of patents awarded under the act and grant additional licenses to other “reasonable” applicants.

While Bayh-Dole was passed to allow non-profits and others to retain patent ownership of inventions developed using federal funding, the act also grants federal agencies the right to license patents in cases where it’s deemed necessary “to alleviate health and safety needs which are not being reasonably satisfied (or) to the public on reasonable terms.”

There was no word on whether the federal government would consider such action in the case of Xtandi.

In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize Xtandi in the U.S., while Astellas was given responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the drug outside the U.S.

(Sources: Medivation Inc., Astellas Pharma Inc., Knowledge Ecology International, Associated Press) 

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