CMS Grants Transitional Pass-Through Status for Gozellix

Rhea-AI Summary

Telix Pharmaceuticals (NASDAQ: TLX) has achieved a significant milestone as the U.S. Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer.

The TPT status, effective October 1, 2025, enables separate reimbursement under the Hospital Outpatient Prospective Payment System and eliminates the 20% patient coinsurance. Gozellix® features an extended six-hour shelf life and broader distribution radius compared to existing gallium-based products. The agent can be prepared via both gallium generators and cyclotron-based methods, offering improved efficiency and scheduling flexibility for scanning clinics.

Positive

• TPT status granted by CMS enables separate reimbursement and eliminates 20% patient coinsurance
• Extended 6-hour shelf life and broader distribution radius improve accessibility
• Flexible production methods via both gallium generators and cyclotron-based systems enhance operational efficiency
• Permanent HCPCS Level II code A9616 assigned for recognition by CMS and commercial insurers

Negative

• Risk of image interpretation errors and false results requiring additional clinical correlation
• Performance affected by PSA levels, disease site, and Gleason score
• Potential radiation exposure risks requiring careful handling and patient management

Insights

Healthcare Reimbursement Specialist

CMS granting TPT status for Gozellix significantly improves reimbursement pathway and patient access, boosting Telix's commercial prospects.

The Centers for Medicare & Medicaid Services (CMS) granting Transitional Pass-Through (TPT) payment status for Telix's Gozellix® represents a significant regulatory and commercial milestone. This designation enables separate reimbursement under the Hospital Outpatient Prospective Payment System effective October 1, 2025, which addresses one of the most critical barriers to adoption of advanced diagnostic agents.

The TPT status provides three key financial benefits: 1) separate payment outside of bundled hospital reimbursement, 2) elimination of the 20% patient coinsurance, and 3) assignment of a permanent HCPCS Level II code (A9616) for recognition by CMS and commercial insurers. This trifecta of reimbursement advantages creates a clear payment pathway that will likely accelerate provider adoption.

For context, radiopharmaceutical reimbursement has historically been a major hurdle in nuclear medicine, with many advanced agents struggling to gain market traction despite FDA approval due to inadequate payment structures. The TPT status effectively removes this barrier for Gozellix®, positioning it for broader utilization across the US healthcare system.

From a market perspective, having a reimbursed product with a 6-hour shelf life compared to competing agents with more restrictive logistics requirements gives Telix a significant competitive advantage. The flexibility in production methods (both generator and cyclotron-based) further enhances the product's market potential by making it accessible to various types of imaging facilities with different infrastructure capabilities.

Oncology Imaging Expert

The technical specifications of Gozellix® represent meaningful advancements in PSMA-PET imaging accessibility. The extended shelf life of up to six hours addresses one of the primary logistical challenges in nuclear medicine - the limited useful life of radiopharmaceuticals after preparation. This extension allows imaging centers to schedule patients more efficiently throughout the day and serve larger geographic regions.

The dual production pathway flexibility is particularly valuable from a clinical operations perspective. Gallium-68 has traditionally been produced via generators with limited daily capacity, creating bottlenecks in high-volume centers. The cyclotron production option using both the GE FASTlab™ system and ARTMS QUANTM Irradiation System® enables significantly higher-volume production, potentially allowing centers to scan 5-10× more patients daily compared to generator-only methods.

From a clinical application standpoint, Gozellix® maintains the same diagnostic indications as first-generation PSMA agents - for initial staging of men with suspected metastatic disease and for biochemical recurrence evaluation. The safety profile appears consistent with existing PSMA-PET agents, with minimal adverse reactions reported (<1% incidence of nausea, diarrhea, and dizziness).

As the second FDA-approved PSMA imaging agent from Telix, this represents portfolio expansion rather than an entirely novel capability. However, the operational improvements and reimbursement status combine to potentially expand the addressable market for PSMA-PET imaging, which remains underutilized relative to clinical guidelines recommendations.

MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “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-PET¹ 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 2025². 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) level³.

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 imaging⁴. 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 clinics⁵. 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.

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, United Kingdom, 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. FDA⁷.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook

Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  
Annie Kasparian  
Telix Pharmaceuticals Limited  
Director Investor Relations and Corporate Communications  
Email: annie.kasparian@telixpharma.com 

Media Contact
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

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Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

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©2025 Telix Pharmaceuticals Limited. All rights reserved.

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.
⁷ Telix ASX disclosure 21 March 2025.

FAQ

What is the significance of Gozellix receiving TPT status from CMS?

The TPT status enables separate reimbursement under HOPPS starting October 1, 2025, eliminates 20% patient coinsurance, and improves patient access to advanced prostate cancer imaging.

How does Gozellix differ from existing PSMA-PET imaging agents?

Gozellix offers an extended 6-hour shelf life, broader distribution radius, and flexible production methods via both gallium generators and cyclotron-based systems, improving efficiency and accessibility.

What are the main clinical applications of Gozellix?

Gozellix is indicated for PET scanning of PSMA positive lesions in men with suspected metastatic prostate cancer for initial definitive therapy and those with suspected biochemical recurrence.

What are the key safety considerations for Gozellix?

Key safety considerations include risk of image interpretation errors, radiation exposure, potential hypersensitivity reactions to sulfites, and common side effects like nausea, diarrhea, and dizziness occurring in <1% of patients.

How will Gozellix improve clinical workflow in scanning centers?

Gozellix improves clinical workflow through its extended shelf life, flexible production methods, and enhanced scheduling flexibility, enabling higher patient throughput and improved operational efficiency.