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Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces that the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET1 imaging agent for prostate cancer.
This designation enables separate reimbursement for Gozellix® under the Hospital Outpatient Prospective Payment System (HOPPS), effective 1 October 2025, and marks a significant milestone in Telix's U.S. commercial strategy. Gozellix® has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 to be recognized by CMS and commercial health insurers, effective 1 October 20252. Additionally, patients are not subject to the 20% patient coinsurance under TPT.
After radiolabelling with 68Ga, Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level3.
Gozellix® is a novel imaging agent offering a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, helping to overcome many of the logistical barriers that have historically limited access to PSMA-PET imaging4. Its innovative formulation enables scalable production, with preparation possible via gallium generators (50mCi and 100mCi) or cyclotron-based methods. This flexibility has the potential to significantly improve efficiency, scheduling flexibility, and throughput for scanning clinics5. Cyclotron production of Gozellix® is supported by the GE FASTlab™6 solid and liquid target production system and Telix's ARTMS QUANTM Irradiation System® (QIS®), the market-leading cyclotron solid target technology, enabling large-scale production across both commercial networks and academic centers.
Posted In: TLX
