Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has announced a new payment structure for specialized diagnostic radiopharmaceuticals, allowing separate payments for these agents in the hospital outpatient setting, which will enhance patient access to advanced imaging technologies [1][3][6] Group 1: Payment Structure Changes - Starting in 2025, the Hospital Outpatient Prospective Payment System (OPPS) will reimburse specialized diagnostic radiopharmaceuticals based on Mean Unit Cost (MUC) for those exceeding a daily cost threshold of US$630 [2] - This new rule will ensure consistent reimbursement for Medicare Fee for Service patients after the expiration of pass-through status, allowing purchasing decisions to be based on clinical utility rather than reimbursement structures [3] Group 2: Impact on Telix Pharmaceuticals - The new payment rule will apply to Telix's lead product, Illuccix®, after its pass-through status expires on July 1, 2025, and will also extend to other investigational agents in its pipeline if approved [4] - If TLX007-CDx is approved, Telix will be the only company with two PSMA-PET imaging agents available, potentially increasing its market reach and providing more options for patients [5] Group 3: Industry Implications - The decision by CMS is expected to promote further investment in the development of new imaging agents, providing a clearer commercial pathway for companies like Telix to recover their innovation costs [6] - The change in reimbursement policy is anticipated to enhance access to advanced imaging agents, which are crucial for informed treatment decisions in oncology [6]
Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals