Astellas Pharma on Wednesday voluntarily dismissed its legal complaint against the Department of Health and Human Services seeking to challenge the Inflation Reduction Act’s drug price negotiation provisions.
In a statement, Astellas said that while it withdrew its lawsuit this “does not change our fundamental belief that in its current form, the Medicare Drug Price Negotiation Program created by the IRA is a bad policy and unconstitutional.”
Astellas has made the case that the program would disrupt the current competitive landscape in the market and might discourage companies from undertaking research and development efforts in the future. In turn, Astellas contends that the IRA’s negotiation provision would make life-saving and low-cost medicines even less available to patients.
The company filed its lawsuit in July 2023. Like other legal complaints, Astellas claimed that the Medicare Drug Price Negotiation Program forces companies to agree that the prices are fair, thereby violating the First Amendment. The program also compels drugmakers to accept government-dictated prices, which Astellas said “amounts to the physical taking of property.”
“These mandated prices deny pharmaceutical manufacturers the adequate, market-driven compensations that they are constitutionally entitled to receive,” the company wrote in a statement at the time of its lawsuit.
Last week, the Centers for Medicare and Medicaid Services released the list of the first 10 drugs that would be affected by the negotiation program. It includes some of the most widely prescribed medications, including BMS’ blood thinner Eliquis (apixaban), Merck’s diabetes drug Januvia (sitagliptin) and J&J’s blood cancer therapy Imbruvica (ibrutinib).
Taken together, these 10 drug products cost the U.S. government around $50 billion from June 2022 to May 2023.
Notably, none of the 10 medicines are from Astellas. Missing from the CMS list is the company’s prostate cancer treatment Xtandi (enzalutamide), which according to Drugs.com costs nearly $14,400 per 120 tablets. In 2020, the CMS spent nearly $2 billion on Xtandi and a recent study published in the Journal of Managed Care and Specialty Pharmacy expected the androgen receptor inhibitor to make it to the first round of Medicare negotiations.
Aside from Astellas, several other pharma companies have filed legal complaints against the HHS, seeking to stop the Medicare Drug Price Negotiation Program. They are led by Merck, who filed the first lawsuit in June 2023, followed by BMS a few days later. J&J, Boehringer Ingelheim and AstraZeneca have all also joined the legal battle.
