LUGPA Policy Update - Medicare Drug Price Negotiation and Xtandi

On January 17, 2025, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the selection of 15 additional drugs covered under Medicare Part D for price negotiations. These negotiations, authorized by the Inflation Reduction Act (IRA), will take place in 2025, with negotiated prices becoming effective in 2027. Among the selected drugs is Xtandi (enzalutamide), a treatment for metastatic castration-resistant prostate cancer (mCRPC).

Implications for Urologists

Xtandi is an important therapy in the management of advanced prostate cancer, a condition commonly treated by urologists. The inclusion of this drug in Medicare’s price negotiation program may affect urology practices and patient care in several ways:

1. Potential for Improved Patient Access:
• Negotiated pricing could lower out-of-pocket costs for Medicare beneficiaries, potentially increasing access to this therapy for patients with prostate cancer.
2. Updates to Prescribing Practices:
• Pricing changes may lead to updated formulary guidelines, requiring urologists to adapt to ensure continued patient access to effective treatments.
3. Practice Management Considerations:
• Lower drug costs could reduce financial barriers for practices managing advanced cancer care, supporting broader treatment availability.
4. Awareness of Potential Challenges:
• Price negotiations might impact manufacturer pricing strategies or drug availability, making it essential for practices to monitor changes in supply chains or coverage policies.

The selected 15 drugs accounted for approximately $41 billion in gross prescription drug costs under Medicare Part D between November 2023 and October 2024, representing about 14% of total Part D costs. Combined with the 10 drugs selected for the first negotiation cycle, these medications represent over a third of gross covered prescription drug costs under Part D. This initiative reflects efforts to reduce drug costs and ensure Medicare’s long-term sustainability.

For groups that have IOD or pharmacies, CMS has issued FAQs for pharmacies and dispensing entities that can be viewed here. 

Next Steps

Negotiations with drug manufacturers will begin in 2025. Urology practices should stay informed about updates to Medicare policies and prepare to address potential changes related to coverage, reimbursement, and patient communication. LUGPA will continue to monitor developments and provide resources to support independent practices in navigating these changes.

For additional information, you can read the full HHS Press Release here and the CMS Fact Sheet here.