FDA Approves Gozellix, a PSMA PET Preparation Agent

- The key operational advantage of Gozellix is its extended shelf-life of up to six hours, which is longer than Telix's first-generation agent, Illuccix. This provides greater scheduling flexibility and expands the distribution radius, potentially reaching imaging centers farther from the production site that were previously unserved by gallium-based agents. - The choice between Gallium-68 (Ga-68) based agents like Gozellix and Fluorine-18 (F-18) agents like Pylarify involves a trade-off between logistics and image characteristics. F-18 has a longer half-life (about 110 minutes vs. 68 minutes for Ga-68), allowing for centralized manufacturing and wider distribution, while Ga-68 offers the potential for on-site, on-demand production via generators. Some studies suggest F-18 provides higher image resolution, though clinical trials have not shown meaningful differences in overall detection rates. - A significant reimbursement change impacting all PET agents is the CMS policy, effective January 1, 2025, to "unbundle" and provide separate payment for high-cost diagnostic radiopharmaceuticals (above $630 per day) in the hospital outpatient setting. This change mitigates financial losses for hospitals that were previously not reimbursed for the full cost of expensive agents and may influence site-of-care decisions and agent selection. - Gozellix has secured a permanent Healthcare Common Procedure Coding System (HCPCS) code (A9616) and was granted Transitional Pass-Through (TPT) payment status by CMS, effective October 1, 2025. This designation allows for separate reimbursement in the hospital outpatient setting and means patients are not subject to the standard 20% coinsurance, improving access. - Health systems are increasingly partnering with specialized operators to expand their outpatient imaging footprint. Outpatient Imaging Affiliates (OIA), for example, has formed joint ventures with systems like BJC HealthCare and Piedmont to develop and operate co-branded, freestanding imaging centers, a strategy designed to compete in markets where patients seek convenient, retail-style access. Similarly, RadNet and Providence Health System have formed a joint venture in Southern California, combining imaging centers and integrating technology platforms with the hospital's EMR. - Private equity continues to drive consolidation among radiology practices, with firms acquiring over 150 practices between 2013 and 2023, encompassing roughly 16% of all U.S. imaging locations. By 2023, nearly 12% of all radiologists were employed by PE-backed entities, with Florida being one of the states with the highest concentration of PE-employed radiologists (23.9%). - AI is being integrated into PSMA PET workflows to improve efficiency and standardization. For instance, Lantheus received FDA 510(k) clearance for aPROMISE, an AI software application that provides automated quantitative assessment of PYLARIFY PET/CT images to enhance consistency and reproducibility. Such tools can automate time-consuming tasks like lesion segmentation and measurement, helping to manage increasing scan volumes and reduce radiologist burnout.