CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization and medical necessity criteria, dosing, and exclusions for medical-benefit coverage of Padcev (enfortumab vedotin-ejfv) for adults with locally advanced or metastatic urothelial carcinoma, including use as first-line in combination with pembrolizumab or as subsequent therapy.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeMaterial modifications to indication and dosing

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended and providers must document age, disease stage, line of therapy, and oncologist involvement to support a 1-year authorization.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that patient has tried at least one other systemic therapy.

Added requirement that Padcev is used as first-line therapy in combination with Keytruda OR Padcev is used as subsequent therapy.

Added dosing regimen of up to 125 mg administered intravenously no more frequently than twice in each 21-day cycle.

Annual Revision, Review Date updated to 01/29/2025.

1Approved Indication (urothelial carcinoma)

2Dosing options

1 yrApproval duration (typical)

Coverage Summary

Scope: Defines prior authorization and medical necessity criteria, dosing, and exclusions for medical-benefit coverage of Padcev (enfortumab vedotin-ejfv) for adults with locally advanced or metastatic urothelial carcinoma, including use as first-line in combination with pembrolizumab or as subsequent therapy. Coverage stance: covered_with_criteria. Typical approval duration: 1 year.

Evidence: FDA Prescribing Information and NCCN guidance support the recommended indications and use criteria for Padcev.

Key authorization facts

IndicationLocally advanced or metastatic urothelial carcinoma (urothelial cancer)

Coverage Stancecovered_with_criteria

Approval Duration1 year

Authorized Dosing OptionsTwo regimens: up to 125 mg IV no more frequently than three times per 28-day cycle OR up to 125 mg IV no more frequently than twice per 21-day cycle

PrescriberMust be prescribed by or in consultation with an oncologist

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical-benefit coverage of Padcev. Approvals are provided for the duration specified (1 year) for patients meeting the listed criteria and dosing. Approval requires that Padcev be prescribed by or in consultation with an oncologist.

Documentation Required

Required Clinical Documentation

Document the following to support authorization:

Patient age (≥ 18 years)
Disease stage: locally advanced or metastatic urothelial cancer
Line of therapy: first-line when used in combination with pembrolizumab (Keytruda) OR subsequent therapy
Padcev prescribed by or in consultation with an oncologist

Documentation Required

Specialist Prescriber Required

Padcev must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Billing Rule

Dosing Limits Enforcement

Up to 125 mg IV no more frequently than three times in each 28-day cycle
Up to 125 mg IV no more frequently than twice in each 21-day cycle
Requests for doses outside these authorized regimens will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist)

Background & Evidence

Padcev (enfortumab vedotin-ejfv) is an antibody-drug conjugate indicated for the treatment of locally advanced or metastatic urothelial cancer in adults, including when used in combination with Keytruda (pembrolizumab intravenous infusion) for first-line therapy. NCCN guidelines recommend Padcev for subsequent treatment of locally advanced or metastatic urothelial carcinoma and also recommend Padcev in combination with Keytruda for first-line treatment in the indicated settings.

Source	Reference / Date
FDA Prescribing Information	Padcev intravenous infusion prescribing information, December 2023
NCCN guideline	NCCN Bladder Cancer Clinical Practice Guidelines v6.2024 (Jan 17, 2025)

Revision History

01/10/2024annual_revision

Annual Revision, No criteria changes.

01/29/2025material_change

Removed requirement that patient has tried at least one other systemic therapy.

01/29/2025material_change

Added requirement that Padcev is used as first-line therapy in combination with Keytruda (pembrolizumab) OR Padcev is used as subsequent therapy.

01/29/2025material_change

Added dosing regimen of up to 125 mg administered intravenously no more frequently than twice in each 21-day cycle.

2025-01-29annual_revisionLatest

Annual Revision, Review Date updated to 01/29/2025.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeMaterial modifications to indication and dosing

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended and providers must document age, disease stage, line of therapy, and oncologist involvement to support a 1-year authorization.

SourceLink

On This Page

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Medical Necessity / Authorization Criteria

Provider Actions & Authorization Requirements

Coding

Background & Evidence

Definitions

Revision History