Enfortumab vedotin-ejfv (Padcev)

Section: Injections
Effective Date: April 01, 2020
Last Reviewed: March 16, 2020

Description

Enfortumab vedotin-ejfv (Padcev™) is a nectin-4-directed antibody and microtubule inhibitor conjugate that disrupts monomethyl auristatin E (MMAE). When MMAE is released due to proteolytic cleavage, cell cycles arrest and the disruption of the microtubule network within the cell causes apoptosis.

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

J3590 J9999

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

C61

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

D09.0

Z85.51

Z85.59

Professional Statements and Societal Positions Guidelines

NA

Links