The federal government turned down a petition to lower the price of a $129,000 drug used to treat advanced prostate cancer, according to ABC News.
In January, public interest group Knowledge Ecology International petitioned the National Institutes of Health to lower the cost of Xtandi, a drug made by Tokyo-based Astellas Pharma that has a list price of $129,000 a year. Astellas partners with San Francisco-based Medivation to market the drug in the U.S.
Knowledge Ecology, headquartered in Washington, D.C., requested NIH to use its "march-in rights" to break up Astella and Medivation's monopoly before the drug patent expires. The group referenced the Bayh-Dole Act, enacted in 1980, which would allow NIH to give any generic manufacturer a non-exclusive license to make Xtandi and to use its own royalty-free license to manufacture the drug for use by the federal government.
Following NIH's decision to deny the petition, Francis Collins, MD, PhD, director of NIH, stated in a letter to Knowledge Ecology that there was no justification to allow generic drugmakers to produce Xtandi since the drug is not in shortage.
Knowledge Ecology responded to Dr. Collins' letter in a statement saying the NIH did not evaluate evidence that Astellas charges more for Xtandi in the U.S. than in other countries. The group also said the drug's high price limits patient access, places the drug on restrictive formularies, hurts healthcare budgets and requires patients to pay high copays, all justifications for use of NIH's march-in rights.
According to Astellas, many patients with low income or insufficient insurance receive Xtandi for free. About 80 percent of patients covered by Medicare or private insurance pay a monthly copay of $25 or less for the drug, while their health plans pay for the remainder.
Knowledge Ecology plans to appeal the decision to Sylvia Mathews Burwell, the Secretary of Health and Human Services.
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