This story has been updated to clarify that Blue Earth Therapeutics' investigational therapeutic radiopharmaceutical has a similar, but not identical, structure to Posluma.
NEW YORK – Bracco Imaging subsidiary Blue Earth Diagnostics said on Tuesday that the US Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through payment status to Posluma (flotufolastat F 18) for detecting prostate-specific membrane antigen (PSMA)-positive prostate cancer metastases.
The US Food and Drug Administration approved Posluma in May as an agent that can be used with PET imaging to identify PSMA-positive lesions in prostate cancer patients with suspected metastasis who are candidates for initial definitive therapy or whose cancers may have recurred based on elevated serum prostate-specific antigen (PSA) levels.
Posluma, which uses Blue Earth's radio-hybrid technology comprising a PSMA-targeting domain and a fluorine-18 label, will be available at 36 radiopharmacies across the US, according to the company.
With the transitional pass-through payment reimbursement code, providers can bill CMS separately from the associated PET imaging scan that patients receive with the injection in the outpatient setting. The code will go into effect on Oct. 1.
The transitional pass-through payment program allows CMS to temporarily pay for technologies it considers new and innovative for several years as it collects data on cost and efficacy to establish permanent rates. The program is meant to mitigate potential access barriers to new technologies that could otherwise be prohibitively expensive for a cancer center or a patient.
Separately, Blue Earth Diagnostics' sister company Blue Earth Therapeutics is developing a lutetium-labeled radiopharmaceutical with a similar structure to Posluma as a potential treatment for PSMA-positive prostate cancer.