CMS grants pass-through payment status for new prostate imaging agent Gozellix
The Centers for Medicare & Medicaid Services has given a key reimbursement win for a new prostate imaging agent.
CMS recently granted pass-through status to PET (positron emission tomography) product Gozellix from Australian drugmaker Telix Pharmaceuticals. This enables separate reimbursement for the radionuclide diagnostic agent under the Hospital Outpatient Prospective Payment System (HOPPS).
Telix touted the decision Tuesday, noting it will take effect Oct. 1. Gozellix has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level 2 code (A9616), which will be recognized by CMS and commercial insurers on the same date.
“Granting [transitional pass-through] status for Gozellix is a strong endorsement of the clinical value of our next-generation imaging agent,” Kevin Richardson, MBA, CEO of precision medicine for Telix, said in a statement Sept. 23. “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.”
On the latter, Telix noted that healthcare consumers are not subject to a 20% co-insurance charge, thanks to pass-through status. Gozellix is indicated for PET imaging of PSMA (prostate-specific membrane antigen)-positive lesions in men with cancer suspected to have metastasized. It offers a longer shelf life of up to six hours and an extended distribution radius when compared to other existing gallium-based products. This helps to overcome logistical barriers that have hindered access to PSMA-PET imaging, noted Telix, which also makes a second prostate imaging agent, Illucix, with a shorter shelf life.
The company first announced the U.S. launch of Gozellix in June. CMS’ decision comes after Telix has faced multiple recent setbacks, including an announced investigation from the U.S. Securities and Exchange Commission and hurdles scoring approval for brain imaging agent Pixclara.
Transitional pass-through status typically grants additional payment for new medications and devices while CMS gathers data over the following 2 to 3 years.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.