Astellas Drops Legal Battle Over Xtandi as Drug’s Pricing Drama Takes an Unexpected Turn

In a surprising twist, Astellas Pharma has chosen to wave the white flag, voluntarily dismissing its legal challenge against the Department of Health and Human Services regarding the Inflation Reduction Act’s contentious drug price negotiation provisions.

In a statement that reverberated through the pharmaceutical world, Astellas made it clear that withdrawing its lawsuit doesn’t signify a change in its core belief. The company staunchly maintains that the current iteration of the Medicare Drug Price Negotiation Program, birthed by the IRA, is not just bad policy but potentially unconstitutional.

Astellas has been a vocal advocate for the argument that the program could upend the competitive dynamics of the market, casting a shadow over future research and development endeavors. The company contends that the IRA’s negotiation provision could further restrict access to life-saving and cost-effective medications for patients.

This legal battle began in July 2023 when Astellas filed its lawsuit, joining the chorus of pharmaceutical companies asserting that the program infringes upon their First Amendment rights by coercing them into agreeing that the government’s defined prices are fair. Additionally, the program essentially compels drug manufacturers to accept government-set prices, which Astellas boldly equates to a “physical taking of property.”

A recent revelation from the Centers for Medicare and Medicaid Services sent shockwaves through the industry. They unveiled the initial list of 10 drugs that would be directly impacted by the negotiation program. Among these critical medications are widely prescribed pharmaceuticals such as BMS’ Eliquis (apixaban), Merck’s Januvia (sitagliptin) for diabetes, and J&J’s Imbruvica (ibrutinib) for blood cancer treatment. Together, these drugs have cost the U.S. government a staggering $50 billion from June 2022 to May 2023.

Notably absent from this list are any medications from Astellas, including their prostate cancer wonder drug, Xtandi (enzalutamide), which carries a hefty price tag of nearly $14,400 for 120 tablets. Interestingly, a 2020 CMS expenditure report revealed a jaw-dropping $2 billion spent on Xtandi. A recent study even predicted that this androgen receptor inhibitor would be among the first wave of Medicare negotiations.

Astellas isn’t alone in this legal saga. Several other pharmaceutical giants have joined the courtroom battle against the HHS, all seeking to thwart the Medicare Drug Price Negotiation Program. The charge was led by Merck, who fired the opening salvo with their lawsuit in June 2023, followed swiftly by BMS. Now, J&J, Boehringer Ingelheim, and AstraZeneca have also entered the legal arena, making this a high-stakes showdown that will shape the future of drug pricing in the United States.

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