CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Padcev (enfortumab vedotin-ejfv) — Coverage Criteria

Defines accepted indications, coverage criteria, exclusions, coding, and authorization expectations for Padcev (enfortumab vedotin-ejfv) for treating cancer (primarily urothelial carcinoma) for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) — Coverage Criteria

Policy CodePolicy N/A

Change TypeUpdated indications and exclusionstemplate conversion

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests (including HCPCS J9177) with supporting FDA labeling or CMS/NCCN/ASCO compendia evidence.

SourceLink

POLICY UPDATE CHANGES

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

First-line combination use with pembrolizumab for locally advanced/metastatic urothelial carcinoma included.

Clarified single-agent use criteria after prior immune checkpoint inhibitor and platinum chemotherapy or for platinum-ineligible patients after prior ICI.

J9177HCPCS code listed for Padcev

1.25 mg/kgSingle-dose max

PembrolizumabFirst-line combo allowed

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 ALL of the following are met for the specified indication:

First-line combination with pembrolizumab: Member has locally advanced or metastatic urothelial carcinoma AND Padcev (enfortumab vedotin-ejfv) is being used in combination with pembrolizumab as first-line therapy

Supports first-line combination use per guideline

Single-agent after prior ICI and platinum: Member has locally advanced or metastatic urothelial carcinoma AND Padcev is being used as a single agent AND member has previously received immune checkpoint inhibitor therapy and a platinum-containing chemotherapy regimen in the neoadjuvant/adjuvant, locally advanced, or metastatic setting

Covers post-ICI plus platinum setting

Single-agent after prior ICI and platinum-ineligible: Member has locally advanced or metastatic urothelial carcinoma AND Padcev is being used as a single agent AND member has previously received immune checkpoint inhibitor therapy and is ineligible for platinum-based therapy

Covers platinum-ineligible after prior ICI

Coverage for Padcev (enfortumab vedotin-ejfv) is permitted only when the request meets the policy's clinical criteria for the specified indication and dosing limits. Concurrent administration of Padcev with other chemotherapy or targeted therapies is not allowed except when used in combination with pembrolizumab as specified for first-line therapy. Requests where Padcev is administered after documented disease progression on an enfortumab-containing regimen will be excluded. Dosing that exceeds the single-dose limit of 1.25 mg/kg (maximum 125 mg) will also be excluded. Continuation (renewal) prior authorizations may be considered without full re-review when the member has not progressed, the prior authorization was active within the previous year without a gap greater than 30 days, and no new antineoplastic agents have been added to the regimen.

Use of Padcev for indications that are off-label and unsupported by sufficient evidence is considered not approvable. Sufficient evidence requires support from CMS-recognized compendia, or acceptable peer-reviewed literature that adequately represents the patient's clinical characteristics, the regimen used, and reports clinically meaningful outcomes. Case reports and abstracts without a full peer-reviewed article generally do not provide adequate evidence. Investigational or off-label uses failing to meet these standards are excluded from coverage.

Regimens and Lines of Therapy

First-line

First-line: Padcev in combination with pembrolizumab for untreated locally advanced or metastatic urothelial carcinoma

first-line combination as specified

Second-line / Subsequent-line

Subsequent-line single-agent: Padcev single-agent for locally advanced or metastatic urothelial carcinoma after prior immune checkpoint inhibitor and platinum-containing chemotherapy OR after prior immune checkpoint inhibitor if platinum-ineligible

post-ICI or platinum-ineligible scenario

Regimen	Indication	Coverage
Enfortumab vedotin-ejfv (Padcev) combined with pembrolizumab (Keytruda)	First-line therapy for locally advanced or metastatic urothelial carcinoma	Covered when used as first-line combination with pembrolizumab

Regimen	Indication / Eligibility	Coverage
Enfortumab vedotin-ejfv (Padcev) as single agent	Locally advanced or metastatic urothelial carcinoma in members who 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 have previously received an immune checkpoint inhibitor and are ineligible for platinum-based therapy.	Covered with criteria (see eligibility and exclusions)

Billing and Coding

Drug HCPCS CodesHCPCS

J9177

Injection, enfortumab vedotin-ejfv, 0.25 mg

Single dose limit — maximum per dose

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

Rationale for limitExclusion criteria specify dosing above this single-dose limit is not allowed

ApplicabilityApplies to all Padcev (enfortumab vedotin-ejfv) administrations in this policy

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Evolent is responsible for processing all medication requests from network ordering providers. Prior authorization is required for Padcev (enfortumab vedotin-ejfv) — medications not authorized by Evolent may be deemed not approvable and not reimbursable. Providers must submit requests to Evolent prior to drug administration.

Affects: All lines of business listed as applicable (Commercial, Exchange/Marketplace, Medicaid).
Prior authorization required before initiation of therapy or for new starts; continuation requests may qualify for exemption when criteria are met (see continuation criteria).

Documentation Required

Required Supporting Documentation

Clinical documentation must support the requested use with one of the following sources: FDA approved product labeling, CMS‑recognized compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) guidelines, or peer‑reviewed literature that meets CMS standards. Documentation should clearly demonstrate the patient’s diagnosis, prior therapies, dates of prior therapies, rationale for Padcev, and dosing that does not exceed the single dose limit of 1.25 mg/kg (maximum 125 mg).

Accepted Evidence Sources and Definitions

Accepted evidence sources

Required evidence sourcesFDA approved product labeling (Padcev prescribing information)

CompendiaCMS-recognized compendia and NCCN Cancer Guidelines and Drugs and Biologics Compendium

Society guidelinesAmerican Society of Clinical Oncology (ASCO) clinical guidelines

Peer-reviewed literatureAcceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards

Background

Enfortumab vedotin-ejfv (Padcev) is an antibody–drug conjugate indicated for the treatment of locally advanced or metastatic urothelial carcinoma. Clinical evidence supporting Padcev includes trials of Padcev combined with pembrolizumab in previously untreated advanced urothelial cancer and studies of Padcev as a single agent after prior immune checkpoint inhibitor and platinum-containing chemotherapy or for patients who are platinum-ineligible after prior ICI. These trials and guideline sources inform the policy’s covered regimens and line-of-therapy recommendations.

Policy Revision History

2025-06operational_reformatting_and_substantive_editsLatest

Converted to the new Evolent guideline template, replaced prior UM ONC_1381 Padcev guideline, and updated the indication and exclusion sections.

2024-06clinical_criteria_update

Removed platinum ineligibility with pembrolizumab under the first-line setting for locally advanced/metastatic urothelial carcinoma and added a new reference; updated NCH verbiage to Evolent.