CMS issues reimbursement code for PSMA-PET imaging agent Gozellix

The US Centers for Medicare & Medicaid Services (CMS) have issued a permanent Healthcare Common Procedure Coding System (HCPCS) code for Gozellix (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), Telix Pharmaceuticals announced in a news release.¹

The level II code A9616 will be effective starting on October 1, 2025.

Gozellix was approved in the US in March 2025.

According to the company, “The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status.”

“Being granted a HCPCS code marks a significant step forward in Telix’s mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location,” added Kevin Richardson, CEO, Precision Medicine, Telix, in the news release.¹ “It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the US as we bring our next-generation PSMA PET imaging agent to market.”

Gozellix was approved in the US in March 2025.² The agent—after radiolabeling with ⁶⁸Ga—is indicated in patients with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and in patients who have suspected recurrence of prostate cancer based on an elevated serum prostate-specific antigen (PSA) level.

According to the company, Gozellix has a longer shelf life of up to 6 hours and provides an extended distribution profile compared with previously approved gallium-68 (⁶⁸Ga) PSMA-PET imaging agents.

In a prior news release,² Telix noted, “The ability to reliably deliver the product much further from its point of production means Gozellix can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S.” The company believes that this design will further expand the availability, distribution, and scheduling flexibility of PSMA-PET imaging, as these benefits help overcome many of the “logistical barriers that have historically limited access to PSMA-PET imaging.”¹

The approval of Gozellix builds on Telix’s existing imaging portfolio.

In December 2021, the company received FDA approval for Illuccix, a kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and for patients with suspected recurrence based on elevated serum PSA levels.³ An expanded indication of Illuccix was approved in March 2023 to include use in selection of patients with metastatic prostate cancer for PSMA-directed radioligand therapy (¹⁷⁷Lu-PSMA-617).^4 68Ga-PSMA-11 has also received approvals in Canada and Australia.

According to the company, Gozellix “will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs.”

REFERENCES

1. Gozellix receives permanent HCPCS code. News release. Telix Pharmaceuticals Limited. July 10, 2025. Accessed July 15, 2025. https://telixpharma.com/news-views/gozellix-receives-permanent-hcpcs-code/

2. FDA approves new prostate cancer imaging agent Gozellix. News release. Telix Pharmaceuticals Limited. March 20, 2025. Accessed July 15, 2025. https://telixpharma.com/news-views/fda-approves-new-prostate-cancer-imaging-agent-gozellix/

3. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. Telix Pharmaceuticals Limited. December 20, 2021. Accessed July 15, 2025. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix/

4. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals Limited. March 16, 2023. Accessed July 15, 2025. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/