Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer, marking a significant milestone in Telix's U.S. commercial strategy [1][2] Group 1: Product and Market Impact - Gozellix® will have separate reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) starting October 1, 2025, and has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 [2] - The TPT status will reduce the out-of-pocket burden for patients and enhance access to advanced prostate cancer imaging [5] - Gozellix® offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, addressing logistical barriers to PSMA-PET imaging [4] Group 2: Production and Technology - The innovative formulation of Gozellix® allows for scalable production via gallium generators or cyclotron-based methods, improving efficiency and scheduling flexibility for scanning clinics [4] - Cyclotron production is supported by GE FASTlab™ and Telix's ARTMS QUANTM Irradiation System® (QIS®), enabling large-scale production across commercial networks and academic centers [4] Group 3: Clinical Application - Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and those with suspected biochemical recurrence based on elevated serum prostate-specific antigen (PSA) levels [3]
CMS Grants Transitional Pass-Through Status for Gozellix