The U.S. won’t step in to slash the price of Pfizer and Astellas’ pricey prostate cancer med Xtandi, drawing the ire of patent experts and lawmakers alike.
The most recent decision comes after a trio of U.S. senators last year pressed Department of Health and Human Services (HHS) Secretary Xavier Becerra to move forward with the march-in campaign for Xtandi, also known as enzalutamide.
The march-in authority allows the government to grant patent licenses to other parties—or scoop up licenses for themselves—if taxpayer funding underpinned the patent owner’s research and development process. The authority was carved out in the Bayh-Dole Act of 1980, and, in theory, it could help introduce competition and lower prices for consumers.
March-in rights have never been used in practice.
In its rejection, the NIH said it shared the petitioners' concerns about high drug prices, but that it had also determined Xtandi was “widely available to the public on the market.”
What’s more, given the drug’s remaining patent life and “lengthy administrative process involved for a march-in proceeding,” NIH figures the march-in authority wouldn’t be an effective means of lowering Xtandi’s price.
The drug, which won approval back in 2012, has a wholesale cost of around $160,000 to $180,000 per patient each year, according to online sources.
Meanwhile, the march-in rejection is already garnering serious pushback.
Sen. Bernie Sanders, I-Vermont, said he was “extremely disappointed” by the petition snub. He noted patients can buy Xtandi in Canada for a fraction of its U.S. price and railed against Astellas’ history of price hikes, which have pumped up the cost of Xtandi by more than 75% in the U.S.
“How many prostate cancer patients will die because they cannot afford this unacceptable price?” Sanders asked.
Sanders also invoked his authority as chairman of the Senate’s Health, Education, Labor and Pensions Committee, promising to do “everything [he] can to take on the greed of the pharmaceutical industry and make sure that drugs that are developed with U.S. taxpayer money are sold here at a reasonable price.”
Xtandi was developed at the University of California, Los Angeles (UCLA) and was fueled by some serious cash from the Pentagon and the NIH, the Los Angeles Times reported last year. UCLA sold its rights to the med in 2016.
Aside from Sanders, Rep. Lloyd Doggett, D-Texas, said in a statement the Biden administration had “missed yet another opportunity to do something meaningful to lower prescription drug costs and protect taxpayer investments.”
James Love, a patent expert and march-in rights advocate who serves as director of Knowledge Ecology International, said over email that he was “pretty sure there will be an administrative appeal, given how the NIH dealt with this.”
“I don't think the White House would have had the audacity to reject this given all of Biden's speeches about drug pricing if they did not have a recent victory on insulin,” Love told Fierce Pharma. He added that the situation is “not really over yet” because the HHS must “at some point” deal with the true issue, which he defined as price discrimination.
While the rejection comes as a blow to advocates for lower drug prices, the government said it's open to future march-in petitions. Tuesday, HHS and the U.S. Department of Commerce said it would take a “whole-of-government approach” to review the march-in authority. As part of the effort, HHS said it will convene a workshop this year to “further refine” cases where march-in authority might be appropriate.