CMS Grants Transitional Pass-Through Status for Gozellix
Melbourne (Australia) and Indianapolis, IN (U.S) | 23 September 2025
Telix 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[1] 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[2]. Additionally, patients are not subject to the 20% patient coinsurance under TPT.
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].
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[4]. 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[5]. Cyclotron production of Gozellix® is supported by the GE FASTlab™[6] solid and liquid target production system and Telix’s ARTMS QUANTM Irradiation System® (QIS®), the market-leading cyclotron solid target technology, enabling large-scale production across both commercial networks and academic centers.
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “Granting TPT status for Gozellix is a strong endorsement of the clinical value of our next-generation imaging agent. Gozellix is already available nationally, and this reimbursement milestone will reduce the out-of-pocket burden for patients, enhance patient access to advanced prostate cancer imaging and simplify payment for providers. 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.”
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 to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
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 is not comprehensive.
Please see the Full Prescribing Information here.
You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.emailing pharmacovigilance@telixpharma.com.
[1] Imaging of prostate-specific membrane antigen with positron emission tomography.
[2] Telix ASX disclosure 9 July 2025.
[3] Gozellix® prescribing information.
[4] Data on file.
[5] Gozellix® prescribing information. Data on file.
[6] FASTlab is a trademark of GE Healthcare and its affiliates.