Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has announced that the United States Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix (kit for the preparation of gallium-68 (Ga) gozetotide injection), the company’s next-generation PSMA-PET imaging agent for prostate cancer. Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. The company is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe, and Japan.
The TPT designation, effective from 1 October 2025, enables separate reimbursement for Gozellix under the Hospital Outpatient Prospective Payment System (HOPPS). This marks a significant advancement in Telix’s U.S. commercial strategy. Gozellix has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616, ensuring recognition by CMS and commercial health insurers, also effective 1 October 2025. Notably, patients will not be subject to the 20% patient coinsurance under TPT.
Gozellix, after radiolabelling with Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who are suspected of metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. The novel imaging agent offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, helping to overcome logistical barriers that have historically limited access to PSMA-PET imaging.
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, stated that the granting of TPT status for Gozellix is a strong endorsement of the clinical value of the imaging agent. He added that this reimbursement milestone will reduce the out-of-pocket burden for patients, enhance patient access to advanced prostate cancer imaging, and simplify payment for providers, making PSMA-PET/CT imaging more accessible across the U.S.
