CMS Grants Transitional Pass-Through Payment Status for PSMA PET Imaging Agent for Prostate Cancer

November 24, 2021

On November 22, the Centers for Medicare and Medicaid Services (CMS) granted transitional pass-through payment status for 18F-piflufolastat (Pylarify; 18F-DCFPyL), increasing patient access to an innovative imaging approach for detecting the spread of prostate cancer to other parts of the body. The decision takes effect on January 1, 2022.

18F-piflufolastat is the first fluorinated prostate-specific membrane antigen (PSMA) agent approved for reimbursement by CMS and also the first commercially available PSMA PET imaging agent. The nuclear medicine agent, manufactured by Lantheus Holdings, was approved in May by the Food and Drug Administration (FDA) for PET imaging of PSMA-positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy or
  • with suspected recurrence based on elevated serum prostate-specific antigen level.

The Medicare Transitional Pass-Through Payment program is designed to facilitate patient access to cutting-edge treatments by allowing for adequate payment for these new imaging agents  while permanent reimbursement rates are being established.

The first FDA-approved PSMA-targeted PET imaging drug, 68Ga-PSMA-11, received Transitional Pass-Through Payment Status on July 1, 2021.