Telix Pharmaceuticals Limited (TLX), a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, has announced that its next-generation PSMA-PET imaging agent, Gozellix, has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS). This code, A9616, will be recognised by CMS and commercial health insurers for reimbursement of Gozellix, effective from 1 October 2025.
The assignment of the permanent HCPCS Level II code is a significant step toward receiving Transitional Pass-Through (TPT) payment status and supporting provider billing and reimbursement for Gozellix. Gozellix, after radiolabelling with gallium-68, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer. This includes those with suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level.
Telix believes that receiving the HCPCS code will support clinical adoption of Gozellix and expand access to PSMA PET imaging. Gozellix overcomes logistical barriers that have historically limited access to PSMA-PET imaging thanks to its extended shelf-life and flexible production options.
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, stated that this code marks a significant step forward in Telix’s mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location, and an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S.
