CurrentMass General Brigham Health PlanPolicy N/A

Padcev (enfortumab vedotin-ejfv) — Coverage Criteria for Locally Advanced or Metastatic Urothelial Cancer

Policy governs prior authorization, quantity limits, and coverage criteria for Padcev (enfortumab vedotin-ejfv) for adults with locally advanced or metastatic urothelial cancer under Mass General Brigham Health Plan Pharmacy and Medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPadcev (enfortumab vedotin-ejfv) — Coverage Criteria for la/mUC

Policy CodePolicy N/A

Change TypeMaterial revision + clarification

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with oncologist documentation, prior therapy history (platinum and PD‑1/PD‑L1 therapies) or contraindications, and specify if requesting Padcev with pembrolizumab.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that Padcev be used only as monotherapy and allowed combination use with pembrolizumab as subsequent therapy after chemo- or immunotherapy.

Initial approvals and reauthorizations are granted for 12 months.

12 monthsapproval duration

Adults la/mUCindication population

Prior authaccess control

Combo allowed

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Coverage Criteria for Padcev (enfortumab vedotin-ejfv)

Initial and combination therapy criteria

Covered when ALL of the following are met:

Entry criteria: Member has a diagnosis of locally advanced or metastatic urothelial cancer; prescriber is an oncologist or consult notes from an oncologist are provided; appropriate dosing is requested; for reauthorization, physician attestation of positive response to therapy is required.

Continuation requests require documentation consistent with ongoing clinical benefit.

Prior therapy or setting

Option 1: Inadequate response or adverse reaction to ONE platinum-based chemotherapy.
Option 2: Both of the following: inadequate response or adverse reaction to a PD-1 or PD-L1 inhibitor therapy; and contraindication to ALL cisplatin-containing chemotherapy.
Option 3: Both of the following: member has received at least ONE prior line of therapy for the requested indication; and the requested agent will be used in combination with pembrolizumab (Keytruda).
Reflects expanded indication to allow Padcev plus pembrolizumab as subsequent therapy following prior systemic therapy.

Authorization review may be performed case-by-case for members who are new to the plan and are currently receiving Padcev. This individualized review applies when a member transfers coverage and is already on therapy; it does not apply to product samples or medications obtained through manufacturer patient assistance programs. Providers should submit documentation of ongoing treatment (including dosing and recent clinical status) to support continuation requests during the transition of coverage.

Regimen	Coverage status	Coverage criteria summary
Padcev (enfortumab vedotin) monotherapy	Covered when all of the following are met: diagnosis of locally advanced or metastatic urothelial cancer; prescriber is an oncologist or consult notes provided; appropriate dosing requested; and one of the following prior-therapy conditions is met (inadequate response or adverse reaction to one platinum-based chemotherapy; inadequate response or adverse reaction to a PD‑1 or PD‑L1 inhibitor; contraindication to all cisplatin-containing chemotherapy)	Initial approvals and reauthorizations are granted for 12 months (policy clarification).

Line of Therapy and Sequencing

Second-line

Line of therapy: Policy applies to patients after one or more prior lines of therapy; allows use after platinum-based chemotherapy and/or PD-1/PD-L1 therapy failures, and allows Padcev plus pembrolizumab as subsequent therapy following chemo- or immunotherapy.

Reflects expanded indication and NCCN support.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Padcev under the plan. Authorization may be reviewed case-by-case for members new to the plan who are currently receiving the medication.

Payer: Mass General Brigham Health Plan
Effective Date: 2025-07-01

Step Therapy

Therapy Sequencing Requirements

Prior exposure and inadequate response or intolerance to specified prior lines of therapy are required before approval. Specifically, authorization requires one of the following therapy-sequencing pathways: (1) inadequate response or adverse reaction to at least ONE platinum-based chemotherapy; OR (2) both: prior inadequate response or adverse reaction to a PD-1 or PD-L1 inhibitor and contraindication to ALL cisplatin-containing chemotherapy; OR (3) member has received at least ONE prior line of therapy for the requested indication and the requested agent will be used in combination with pembrolizumab (Keytruda).

Covered Regimens and Dosing

Regimen	Coverage status	Coverage criteria summary
Padcev (enfortumab vedotin) in combination with pembrolizumab (Keytruda)	Covered when all of the following are met: diagnosis of locally advanced or metastatic urothelial cancer; prescriber is an oncologist or consult notes provided; appropriate dosing requested; and one of the following prior-therapy conditions is met OR the member has received at least one prior line of therapy and the requested agent will be used in combination with pembrolizumab.	NCCN-supported update effective 7/01/2025 removes monotherapy-only language and allows combination use as subsequent therapy following chemo- or immunotherapy.

Definitions

Padcev (enfortumab vedotin-ejfv) — definition and mechanism

Generic nameEnfortumab vedotin-ejfv

Brand namePadcev

Drug class / mechanismNectin-4 directed antibody–drug conjugate (antibody linked to a microtubule inhibitor)

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

Molecular targetNectin-4 (nectin cell adhesion molecule 4)

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. The policy covers Padcev when specific clinical criteria are met, including documented diagnosis, appropriate dosing, and required prior therapy history; it also permits use of Padcev in combination with pembrolizumab per the updated indication. Reauthorizations presuppose a positive clinical response and, per policy administrative practice, approvals (initial and reauthorization) are issued for 12 months when criteria are satisfied.