Astellas Drops Lawsuit Against HHS Following Exclusion of Xtandi from Drug Price Negotiation List

Astellas has canceled its lawsuit against the U.S. Department of Health and Human Services (HHS) after its prostate cancer drug, Xtandi, was not included in the initial list of drugs to face price negotiations in 2026. Astellas previously sued HHS over the Medicare Drug Price Negotiation Program, arguing it would disrupt the competitive marketplace and diminish the availability of new drugs. Xtandi, which cost Medicare nearly $2 billion in 2020, is currently priced at around $180,000 annually. Efforts to reduce its price, such as a request to use “march-in rights,” have been unsuccessful as it is deemed ineffective due to lengthy administrative processes and remaining patent life.

Why You Should Care:

• The case represents a development in the ongoing discussion about drug pricing in the U.S., particularly concerning patients, healthcare providers, and pharmaceutical companies. Astellas’ decision to drop the lawsuit suggests a possible decrease in tensions around the price negotiation program, although the company still expresses concern.
• The case highlights the challenge faced by patients in affording high-cost drugs. Despite significant Medicare spending, the cost of Xtandi remains high for individuals, underscoring the barriers to access to vital treatments.
• The case brings attention to the debate around policies like the ‘march-in rights,’ which could lower drug prices but, in reality, face multiple hurdles, such as lengthy procedures and patent issues. This debate continues to be a subject of discussion for policymakers, healthcare providers, and patient advocacy groups.

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