CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Padcev (enfortumab vedotin-ejfv) — Coverage Criteria for Urothelial Carcinoma

Defines coverage and authorization criteria for Padcev (enfortumab vedotin-ejfv) for treatment of adult patients with urothelial carcinoma, including single-agent and combination use with pembrolizumab, for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) — Coverage Criteria for Urothelial Carcinoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document FDA-approved or compendial indication plus required prior PD‑1/PD‑L1 and platinum chemotherapy exposure or cisplatin-ineligible status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

FDA-approved + comboindications included

Bladder/urethra/upper GU/prostateurothelial sites

Coverage Criteria for Enfortumab Vedotin (Padcev)

inv-01: Subsequent-line single-agent therapy

Covered when ALL of the following are met:

Single-agent Padcev subsequent therapy: Member has urothelial carcinoma of the bladder, urethra, upper genitourinary tract, or prostate with locally advanced, recurrent or metastatic disease; AND Padcev is being used as subsequent (single‑agent) therapy after prior platinum-containing chemotherapy and prior treatment with a PD-1 or PD-L1 inhibitor, OR the member is ineligible for cisplatin-containing chemotherapy and has previously received one or more prior lines of therapy.

Authorization of up to 12 months may be granted for treatment when criteria are met.

inv-02: First-line combination with pembrolizumab

Covered when ALL of the following are met:

First-line combination therapy with pembrolizumab: Padcev is prescribed in combination with pembrolizumab for first-line treatment of locally advanced or metastatic urothelial carcinoma.

Authorization of up to 12 months may be granted for first-line combination therapy when criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) — Coverage Criteria for Urothelial Carcinoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document FDA-approved or compendial indication plus required prior PD‑1/PD‑L1 and platinum chemotherapy exposure or cisplatin-ineligible status.

SourceLink

On This Page

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Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted for initial and continuation therapy when all approval criteria are met.

Authorization may be granted for up to 12 months for single-agent use as subsequent therapy after prior PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, or for members ineligible for cisplatin-containing chemotherapy when criteria are met.
Authorization of up to 12 months may be granted for first-line use in combination with pembrolizumab when criteria are met.
Reauthorization (continuation of therapy) may be granted for up to 12 months if there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Documentation Required

Prior Systemic Therapy Documentation

Patients treated with Padcev must have prior systemic therapy documentation as specified by the FDA-approved indication and compendia: specifically, prior receipt of a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy (unless the member is ineligible for cisplatin-containing chemotherapy and has received one or more prior lines of therapy). Documentation of prior therapies and reason for platinum ineligibility (when applicable) must be included in the request.

Documentation Required

Clinical Indication and Prior Therapy Documentation

Documentation must demonstrate the member meets FDA‑approved or compendial indications and the approval criteria. For urothelial carcinoma this includes documentation of the site/subtype (bladder, urethra, upper GU tract, or prostate), disease stage (locally advanced, recurrent or metastatic as applicable), prior lines of therapy, prior PD‑1/PD‑L1 inhibitor exposure, prior platinum chemotherapy or documented cisplatin ineligibility, and current disease status (no unacceptable toxicity or progression for continuation requests).

Denial Risk

Experimental/Investigational Exclusions

Use of Padcev for indications outside the FDA‑approved indications or the compendial uses listed (urothelial carcinoma: bladder, primary urethra, upper GU tract, urothelial carcinoma of the prostate) is considered experimental/investigational and is not covered.

Key Definitions

Cisplatin-ineligible: definition and criteria

DefinitionMember is considered cisplatin-ineligible when they are not a candidate for cisplatin-containing chemotherapy and therefore meet the alternative eligibility pathway described for Padcev therapy.

Context in FDA indicationPadcev as a single agent is indicated for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and a platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Implication for prior therapyIf cisplatin-ineligible, the member must have previously received one or more prior lines of therapy to qualify for single-agent Padcev per the FDA indication.

Relevant disease sitesApplies to urothelial carcinoma including bladder, primary urethral carcinoma, upper genitourinary tract tumors, and urothelial carcinoma of the prostate (compendial sites).

Coverage stanceUse consistent with the FDA indication for cisplatin-ineligible patients is considered a covered benefit when documentation supports the ineligibility and prior therapy requirements.

OpenPayer

Padcev (enfortumab vedotin-ejfv) — Coverage Criteria for Urothelial Carcinoma

Coverage Criteria for Enfortumab Vedotin (Padcev)

Provider Requirements and Authorization

Key Definitions

Background