CurrentMass General Brigham Health PlanPolicy N/A

Padcev (enfortumab vedotin-ejfv) — Medical Benefit prior authorization for locally advanced or metastatic urothelial cancer

Medical benefit prior authorization policy for Padcev (enfortumab vedotin-ejfv) for treatment of adults with locally advanced or metastatic urothelial cancer; applies to MassHealth members under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyPadcev (enfortumab vedotin-ejfv) prior authorization — Medical Benefit

Policy CodePolicy N/A

Change TypeMaterial clinical expansion — allows combination use with pembrolizumab

Effective Date07/01/2025

Next Review DateN/A

Key ActionObtain prior authorization under the Medical Benefit with documentation of diagnosis, oncologist involvement, prior therapies or contraindications, and intent to use with pembrolizumab when applicable.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that Padcev be used only as monotherapy; allows combination use with pembrolizumab as subsequent therapy following chemo- or immunotherapy.

Expanded indication criteria to include Padcev in combination with pembrolizumab for patients not eligible for cisplatin-containing chemotherapy.

Designation changed to medical benefit billing.

07/01/2025policy effective date

12 moapproval duration

MassHealthapplicable plan

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Coverage Criteria for Padcev (enfortumab vedotin-ejfv)

Initial Authorization Criteria

Authorization will be granted when ALL of the following are met:

Main inclusion: 1. Diagnosis of locally advanced or metastatic urothelial cancer; 2. Prescriber is an oncologist or consult notes from an oncologist are provided; 3. Appropriate dosing; 4. ONE of the following entitlement pathways (a OR b OR c)

Entitlement pathways: One of (a), (b), or (c) must be met

Pathway a: a. BOTH: i. Inadequate response or adverse reaction to ONE platinum-based chemotherapy; ii. Inadequate response or adverse reaction to a PD-1 inhibitor or PD-L1 inhibitor therapy

Pathway b: b. BOTH: i. Contraindication to ALL cisplatin-containing chemotherapy; ii. Member has received at least ONE prior line of therapy for requested indication

Pathway c: c. Requested agent will be used in combination with Keytruda (pembrolizumab)

Continuation of therapy / Reauthorization

Reauthorization

Reauthorization requirement: Reauthorization by physician will infer a positive response to therapy.

Requests for members who are new to the plan and are currently receiving Padcev may be reviewed on a case-by-case basis. Such reviews will consider the member’s prior clinical history and treatment course to determine ongoing medical necessity.

Do not submit requests for review if the product was supplied as samples or obtained through a manufacturer’s patient assistance program; these supplies are excluded from authorization review.

Regimen	Indication / Line of therapy	Coverage status
Enfortumab vedotin (Padcev) — monotherapy
Enfortumab vedotin (Padcev) in combination with pembrolizumab (Keytruda)
Use constraints: Monotherapy after inadequate response or adverse reaction to one platinum-based chemotherapy AND inadequate response or adverse reaction to a PD-1 or PD-L1 inhibitor; or for members ineligible for cisplatin who have received ≥1 prior line of therapy; combination use with pembrolizumab permitted per updated NCCN guidance (no specific prior-line requirement stated beyond criteria).

Line of Therapy Specification

second-line | subsequent

Line of therapy options: Pathway a: after one platinum and PD-(L)1 therapy failure; Pathway b: ineligible for cisplatin with at least one prior line of therapy; Pathway c: use in combination with pembrolizumab (no specific prior-line requirement stated)

Updated to permit Padcev plus pembrolizumab combination as subsequent therapy per NCCN and recent criteria updates.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required under the Medical Benefit for Padcev (enfortumab vedotin-ejfv) for MassHealth members. Initial and reauthorization approvals are granted only when the member meets the diagnosis and prior therapy criteria specified by the plan.

Benefit: Medical Benefit
Plan: MassHealth
Contact (Medical Benefit): Phone 833-895-2611, Fax 888-656-6671

Denial Risk

Authorization Requires Meeting Diagnosis and Prior Therapy Criteria

Authorization will be granted when ALL of the following are met: diagnosis of locally advanced or metastatic urothelial cancer; documentation that required prior therapy criteria or documented contraindications are met; and appropriate dosing is specified.

Diagnosis requirement: locally advanced or metastatic urothelial cancer

Covered Regimens and Administration

Regimen	Key coverage requirements / Notes	Coverage status
Enfortumab vedotin (Padcev) — monotherapy
Enfortumab vedotin (Padcev) + pembrolizumab (Keytruda)

Definitions

inv-09: Padcev (enfortumab vedotin-ejfv) — drug definition and mechanism (nectin-4 directed antibody-drug conjugate)

Generic nameEnfortumab vedotin-ejfv (Padcev)

Drug classNectin-4 directed antibody–drug conjugate (antibody linked to a microtubule inhibitor)

Mechanism of actionAntibody targets nectin-4 on urothelial cancer cells and delivers a microtubule inhibitor payload to induce tumor cell death

Indication (per policy)Treatment of locally advanced or metastatic urothelial cancer in adults

Formulation noteAntibody–microtubule inhibitor conjugate (enfortumab vedotin-ejfv)

Background

Padcev (enfortumab vedotin-ejfv) is a nectin-4–directed antibody–drug conjugate indicated for the treatment of adults with locally advanced or metastatic urothelial cancer. It is used either as monotherapy after prior platinum and PD-(L)1 therapy failure or, per recent updates and NCCN guidance, in combination with pembrolizumab for appropriate patients. The policy is written to support these FDA- and guideline-aligned roles and to define coverage pathways and documentation expectations for authorization.