Therapeutic radiopharmaceuticals for prostate cancer using Lutetium (Lu) 177 vipivotide tetraxetan (Lu-177-PSMA-617), may be considered medically necessary for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) and with 1 or more PSMA-positive lesions and/or metastatic disease that is predominately PSMA-positive and with no dominant PSMA-negative metastatic lesions, who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy.
Therapeutic radiopharmaceuticals for prostate cancer using Lu-177-PSMA-617 is considered investigational for the treatment of prostate cancer when the above criteria are not met.