Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
The use of enfortumab vedotin (Padcev) may be considered medically necessary in individuals 18 years of age and older for the following conditions:
Food and Drug Administration (FDA) Indications
Bladder Cancer
- As treatment for individuals with locally advanced or metastatic urothelial carcinoma who have 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
National Comprehensive Cancer Network (NCCN) Recommendations
Bladder Cancer
- As subsequent-line systemic therapy as a single agent for ANY of the following:
- Stage IIIB (cT1-T4a, N2, 3) disease following partial response or progression after primary treatment with downstaging systemic therapy or concurrent chemoradiotherapy; or
- Stage IVA (cT4b, any N, M0) disease if tumor is present following reassessment of tumor status after primary treatment with first-line systemic therapy or concurrent chemoradiotherapy; or
- Stage IVA (any T, any N, M1a) disease if stable disease or progression following reassessment of tumor status after primary treatment with first-line systemic therapy; or
- Stage IVB (any T, any N, M1b) disease; or
- For muscle invasive local recurrence or persistent disease in a preserved bladder; or
- For metastatic or local recurrence post cystectomy; or
Upper Genitourinary (GU) Tract Tumors
- As therapy for metastatic upper GU tract tumors as a single agent for subsequent line systemic therapy; or
Urothelial Carcinoma of the Prostate
- As therapy for metastatic urothelial carcinoma of the prostate as a single agent for subsequent-line systemic therapy; or
Primary Carcinoma of the Urethra
- As therapy for recurrent or metastatic primary carcinoma of the urethra as subsequent-line systemic therapy.
Enfortumab vedotin (Padcev) is considered experimental/investigational for all other indications. Scientific evidence does not support the use of enfortumab vedotin (Padcev) for any other indications not listed above.
Procedure Codes
