Telix’s Gozellix Secures Permanent HCPCS Code, Unlocking U.S. Reimbursement
Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.
- Gozellix granted permanent HCPCS code A9616 by U.S. CMS
- Code effective from 1 October 2025 for Medicare and commercial insurers
- Supports billing, reimbursement, and commercial scale-up in U.S. market
- Advances Telix’s goal to expand access to PSMA PET imaging for prostate cancer
- Step toward Transitional Pass-Through payment status for Gozellix
A Milestone in Prostate Cancer Imaging
Telix Pharmaceuticals Limited, an Australian biopharmaceutical company, announced on 9 July 2025 that its next-generation PSMA PET imaging agent, Gozellix, has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code by the U.S. Centers for Medicare & Medicaid Services (CMS). This development marks a significant regulatory and commercial milestone for Telix as it facilitates provider billing and reimbursement across Medicare and commercial health insurers in the United States.
Effective from 1 October 2025, the HCPCS code A9616 will enable healthcare providers to bill for Gozellix, which is used in PET scans to detect PSMA-positive lesions in men with prostate cancer. This includes patients suspected of metastasis who are candidates for initial definitive therapy, as well as those with biochemical recurrence indicated by elevated prostate-specific antigen (PSA) levels.
Implications for Market Access and Patient Care
Gozellix’s permanent HCPCS code is expected to accelerate its clinical adoption by simplifying reimbursement pathways. Telix highlights that Gozellix’s extended shelf-life and flexible production options overcome logistical challenges that have historically limited access to PSMA PET imaging. By easing reimbursement hurdles, Telix aims to broaden patient access to this precision imaging technology, which is critical for accurate prostate cancer diagnosis and treatment planning.
Kevin Richardson, Telix’s Chief Executive Officer of Precision Medicine, emphasized the importance of this achievement, stating that the HCPCS code is a crucial step toward commercial scale-up in the U.S. and aligns with the company’s mission to improve access to precision medicine imaging regardless of patient location.
Next Steps and Broader Context
Beyond the HCPCS code, Telix is pursuing Transitional Pass-Through (TPT) payment status, which would provide additional reimbursement support during the early commercialisation phase. This status could further enhance Gozellix’s market penetration and revenue potential.
Telix’s portfolio also includes Illuccix, its first-generation PSMA PET imaging agent, which has received approvals in multiple global markets. The company’s ongoing efforts to expand its radiopharmaceutical offerings underscore its commitment to addressing unmet needs in oncology diagnostics.
As Telix moves forward, investors and industry watchers will be closely monitoring the company’s progress in securing TPT status and the subsequent impact on sales and market share in the competitive prostate cancer imaging landscape.
Bottom Line?
With permanent reimbursement coding secured, Telix is poised to accelerate Gozellix’s U.S. rollout, but the path to full commercial success hinges on upcoming payment decisions.
Questions in the middle?
- When will Telix achieve Transitional Pass-Through payment status for Gozellix?
- How quickly will commercial insurers adopt reimbursement for Gozellix following Medicare’s lead?
- What competitive responses might emerge from other PSMA PET imaging providers?
