CMS Boosts Telix’s Gozellix with Key US Reimbursement Win

US Reimbursement Milestone for Gozellix

Telix Pharmaceuticals has achieved a significant regulatory and commercial milestone with the US Centers for Medicare & Medicaid Services (CMS) granting Transitional Pass-Through (TPT) payment status for its next-generation PSMA-PET imaging agent, Gozellix®. This approval enables separate reimbursement for Gozellix under the Hospital Outpatient Prospective Payment System (HOPPS) starting 1 October 2025, a critical step in Telix’s strategy to expand patient access in the lucrative US market.

Alongside the TPT status, Gozellix has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code (A9616), ensuring recognition by CMS and commercial insurers. Notably, patients will avoid the typical 20% coinsurance under this transitional status, reducing out-of-pocket costs and potentially accelerating adoption.

Innovative Imaging Agent with Operational Advantages

Gozellix is designed for PET scanning of PSMA-positive lesions in men with prostate cancer, particularly those with suspected metastasis or biochemical recurrence. What sets Gozellix apart is its longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based agents. These features address longstanding logistical challenges that have limited access to PSMA-PET imaging.

The agent’s formulation supports scalable production via gallium generators or cyclotron-based methods, enhancing scheduling flexibility and throughput for imaging clinics. This production versatility is underpinned by advanced technologies such as the GE FASTlab™ system and Telix’s ARTMS QUANTM Irradiation System®, enabling large-scale manufacturing across commercial and academic centers.

Strategic Implications for Telix

Kevin Richardson, Telix’s CEO of Precision Medicine, highlighted the TPT status as a strong endorsement of Gozellix’s clinical value. With this reimbursement milestone, Telix aims to reduce financial barriers for patients and simplify payment processes for providers, reinforcing its position as the only company with two FDA-approved and reimbursed PSMA-PET imaging products in the US.

This development not only enhances Telix’s commercial footprint but also signals growing acceptance of advanced radiopharmaceutical diagnostics in prostate cancer management. As the US healthcare system increasingly embraces precision medicine, Telix’s innovative imaging agents could become standard tools in prostate cancer diagnosis and treatment planning.

While the announcement stops short of providing detailed financial forecasts, the reimbursement approval is expected to catalyze market uptake and revenue growth. Investors will be watching closely how quickly Gozellix penetrates the market and how competitors respond to this enhanced access.