Enfortumab vedotin-ejfv (Padcev)

Policy ID: I-215-005

Section: Injections

Effective Date: April 01, 2020

Revised Date: May 17, 2023

Revision Effective Date: July 01, 2023

Last Reviewed: May 23, 2023

Applies To: Commercial and Medicaid Expansion

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:

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 who are not eligible for cisplatin-containing chemotherapy

Compendia Sources

Enfortumab vedotin (Padcev) may be considered medically necessary for treatment of any of the current category 1 or 2A 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

J9177

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.

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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-16-2020 New policy for ND

Internal Medical Policy Committee 7-22-2020 - Effective July 01, 2020

Added new code, J9177

Internal Medical Policy Committee 3-17-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022 Annual review-no changes in criteria

Internal Medical Policy Committee 5-24-2022

Removed NCCN recommendations and
Added this statement 'Enfortumab vedotin (Padcev) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.',
Removed diagnosis codes (Z85.51 and Z85.59),
Updated the experimental/investigational statement

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Updated criteria

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-215-004

Section: Injections

Effective Date: April 01, 2020

Revised Date: May 19, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: May 24, 2022

Archived Date: June 30, 2023

Applies To: Commercial and Medicaid Expansion

Description

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 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.

Compendia Sources

Enfortumab vedotin (Padcev) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Codes

J9177

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

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date: April 1, 2020

Internal Medical Policy Committee 3-16-2020 New policy for ND

Internal Medical Policy Committee 7-22-2020 Add new code, J9177, effective 7-1-2020

Internal Medical Policy Committee 3-17-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022 Annual review-no changes in criteria

Internal Medical Policy Committee 5-24-2022 Removed NCCN recommendations and added this statement "Enfortumab vedotin (Padcev) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.", removed diagnosis codes (Z85.51 and Z85.59), updated the experimental/investigational statement

Links

References (PDF)

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