Gozellix Receives Permanent HCPCS Code
MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA1 PET2 imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).
Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. 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.
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) level.3 With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging.
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “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. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market.”
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA4.
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IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misinterpretation
Image interpretation errors can occur with Gozellix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Gozellix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Gozellix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.
Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.
ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.
DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.
Please note that this information summary is not comprehensive.
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This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
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1 Prostate-specific membrane antigen.
2 Positron emission tomography.
3 Please see full Important Safety Information on corresponding pages.
4 Telix ASX disclosure 21 March 2025.
