CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1381

Padcev (enfortumab vedotin‑ejfv) — coverage criteria for urothelial carcinoma

Defines coverage and prior authorization requirements for Padcev (enfortumab vedotin-ejfv) for treatment of locally advanced or metastatic urothelial carcinoma, including first-line combination with pembrolizumab and later-line single-agent use; applies to requests processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business listed.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) — coverage criteria for urothelial carcinoma

Policy CodePolicy UM ONC_1381

Change TypeRevised — added first‑line comboupdated exclusions and dosing cap

Effective Date

Next Review Date

Key ActionObtain prior authorization referencing HCPCS J9177 and document indication per FDA labeling, CMS compendia, or NCCN/ASCO guidance.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1381 guideline with updated indication and exclusion criteria.

Updated indication section to include Padcev in combination with pembrolizumab as first-line therapy for locally advanced/metastatic urothelial carcinoma.

Updated exclusion criteria, including prohibition on concurrent use with other chemotherapy/targeted agents (except pembrolizumab) and single-dose maximum limit.

J9177HCPCS

1.25 mg/kgDose cap

Padcev + pembrolizumabFirst‑line combo

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Padcev (enfortumab vedotin-ejfv)

Covered Indications

Covered when ANY of the following clinically qualified scenarios are met:

Urothelial cancer indications

First-line combination: Padcev in combination with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma as first-line therapy.
Supported by cited trials.
Single-agent Padcev after prior therapy: Single-agent Padcev for members with locally advanced or metastatic urothelial carcinoma who either: (a) have previously received an immune checkpoint inhibitor (e.g., pembrolizumab, avelumab, atezolizumab, nivolumab) AND a platinum-containing chemotherapy regimen (cisplatin or carboplatin) in the neoadjuvant/adjuvant, locally advanced, or metastatic setting; OR (b) have previously received an immune checkpoint inhibitor (e.g., pembrolizumab, atezolizumab, nivolumab) and are ineligible for platinum-based therapy.
Examples of ICIs listed in policy.

Requests for Padcev (enfortumab vedotin-ejfv) will be excluded when the medication is being used after documented disease progression on a prior enfortumab-containing regimen. Concurrent administration with other chemotherapy or targeted therapies is not permitted, with the sole exception of pembrolizumab (Keytruda). Dosing must not exceed a single dose of 1.25 mg/kg (maximum 125 mg). Providers should ensure supporting documentation demonstrates the member does not meet any of these exclusion conditions prior to authorization submission.

Use of Padcev for off-label indications or investigational purposes that lack sufficient supporting evidence is considered not medically necessary. Sufficient evidence is defined by support from CMS-recognized compendia or acceptable peer‑reviewed literature and by demonstration that the patient population, regimen, and clinically meaningful outcomes are adequately represented in the published evidence. Case reports and meeting abstracts without full peer‑reviewed publications generally do not provide adequate support.

Regimens and Line of Therapy

first-line | second-line

Line of therapy options: First-line: Padcev in combination with pembrolizumab for untreated locally advanced or metastatic urothelial carcinoma; Subsequent/eligible patients: single-agent Padcev for members previously treated with an immune checkpoint inhibitor and a platinum-containing chemotherapy regimen, or for those previously treated with an immune checkpoint inhibitor who are platinum-ineligible.

Regimen	Indication / Line of Therapy	Coverage Status
Enfortumab vedotin-ejfv (Padcev) + pembrolizumab (Keytruda)	First-line therapy for locally advanced or metastatic urothelial carcinoma	Covered

Regimen	Indication / Line of Therapy	Coverage Status
Single-agent enfortumab vedotin-ejfv (Padcev)	Subsequent therapy for locally advanced or metastatic urothelial carcinoma in patients who have previously received an immune checkpoint inhibitor AND a platinum-containing chemotherapy regimen; OR patients who have previously received an immune checkpoint inhibitor and are ineligible for platinum-based therapy	Covered

Billing and Coding

Covered HCPCS CodeHCPCSCovered

J9177

Injection, enfortumab vedotin-ejfv, 0.25 mg

inv-05: Single dose maximum — 1.25 mg/kg (maximum 125 mg).

Single dose maximum1.25 mg/kg (maximum 125 mg)

Dose cap applicabilityApplies to individual Padcev (enfortumab vedotin-ejfv) doses — dosing that exceeds this single-dose limit is an exclusion criterion.

EnforcementRequests citing doses above the limit will be excluded/denied per policy exclusion criteria.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior Authorization Required. Padcev (enfortumab vedotin-ejfv) prior authorization is required for coverage. Reference HCPCS J9177 for dosing unit.

Prior authorization required
HCPCS: J9177 per 0.25 mg unit
Single dose limit: 1.25 mg/kg (maximum 125 mg)

Step Therapy

Continuation / Renewal Criteria

Continuation (renewal) requests may be approved without restarting initial review when all of the following are met: the member has not experienced disease progression on Padcev, the medication was used within the last year with no lapse greater than 30 days of an active authorization, and no additional medications are being added to the request.

No disease progression on requested medication
Used within last year with ≤30-day lapse from active authorization

Definitions

inv-11: Examples of Immune Checkpoint Inhibitors — pembrolizumab, avelumab, atezolizumab, nivolumab as listed in the policy.

Examples of Immune Checkpoint Inhibitors (ICIs)pembrolizumab

Additional ICI examplesavelumab

Additional ICI examplesatezolizumab

Additional ICI examplesnivolumab

Background

Enfortumab vedotin (Padcev) is an antibody–drug conjugate indicated for treatment of locally advanced or metastatic urothelial carcinoma. Clinical trial data support its use both as a first‑line combination with pembrolizumab for previously untreated advanced disease and as single‑agent therapy in patients previously treated with immune checkpoint inhibitors and platinum chemotherapy or in those who are platinum‑ineligible. Serious cutaneous adverse reactions, including Stevens‑Johnson syndrome and toxic epidermal necrolysis, have been reported and can occur early in treatment; such reactions require immediate withholding of Padcev and may necessitate permanent discontinuation.

Documentation Required

Required Supporting Documentation

Required supporting documentation: The use of Padcev must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets CMS standards (see policy for evidentiary thresholds). Provide clinical documentation demonstrating the indication (e.g., diagnosis of locally advanced or metastatic urothelial carcinoma), prior therapies received (including immune checkpoint inhibitor and platinum-containing chemotherapy when applicable), rationale for platinum ineligibility if claimed, prior response and progression history, and dosing calculations (weight and mg/kg) to verify compliance with dosing limits.

Evidence of indication must be supplied from FDA labeling, CMS compendia, NCCN, ASCO, or acceptable peer-reviewed literature
Document prior therapies: immune checkpoint inhibitors and platinum-containing chemotherapy regimens when applicable
If claiming platinum ineligibility, provide supporting clinical rationale
Provide weight and dosing calculation to confirm dose ≤1.25 mg/kg and ≤125 mg per single dose
For investigational/off-label requests, include supportive literature meeting CMS criteria (study population relevance, regimen representation, clinically meaningful outcomes, and adequate study design)