CMS Grants Transitional Pass-Through Status for Gozellix

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Stock TELIX Pharmaceuticals Ltd (TLX.ASX)
Release Time 23 Sep 2025, 9:37 a.m.
Price Sensitive Yes
 CMS Grants Transitional Pass-Through Status for Gozellix
Key Points
  • Gozellix granted Transitional Pass-Through (TPT) payment status by CMS
  • Enables separate reimbursement for Gozellix under the Hospital Outpatient Prospective Payment System (HOPPS)
  • Marks a significant milestone in Telix's U.S. commercial strategy
Full Summary

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) 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-PET 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 2025. Additionally, patients are not subject to the 20% patient coinsurance under TPT. 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 imaging. 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 clinics.

Outlook

As the only provider with two FDA-approved and reimbursed products in this class, we are pleased to make PSMA-PET/CT imaging accessible to more patients and providers across the U.S.