Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of enfortumab vedotin (Padcev) may be considered medically necessary in individuals 18 years of age and older for the following conditions:
Bladder Cancer
- As a single agent treatment for individuals with locally advanced or metastatic urothelial carcinoma who meet one (1) of the following:
- Individual has previously received a programmed cell death protein-1 (PD-1) or programmed death-ligand 1 (PDL-1), and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting; or
- Individual is ineligible for cisplatin-containing chemotherapy and have previously received one (1) or more prior lines of therapy; or
- In combination with pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer.
Compendia Sources
Enfortumab vedotin (Padcev) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of enfortumab vedotin (Padcev) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
Procedure Code