Currentblue cross blue shield - tennesseePolicy ID_CHS_2025a

Padcev (enfortumab vedotin) for urothelial carcinoma — Coverage Criteria

Defines medical policy coverage and authorization criteria for Padcev (enfortumab vedotin-ejfv) for adult patients with urothelial carcinoma, including FDA-approved and compendial uses, for BlueCross BlueShield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyPadcev (enfortumab vedotin) for urothelial carcinoma — Coverage Criteria

Policy CodePolicy ID_CHS_2025a

Change TypeNo material clinical or coverage changes

Effective DateJun 2, 2026

Next Review Date

Key ActionObtain prior authorization confirming FDA or compendial indication and required prior therapies (e.g., prior PD-1/PD-L1 inhibitor and platinum chemotherapy) before initiating treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

FDA & compendialindications described

Tennesseestate off-label coverage compliance

Listedoff-label/compendia-recognized sites

Coverage and Medical Necessity Criteria

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Initial therapy and allowed indications

Covered when ALL of the following are met for FDA-approved or compendial urothelial carcinoma indications

FDA single-agent metastatic/locally advanced: Patient is an adult with locally advanced or metastatic urothelial cancer AND has previously received a PD-1 or PD-L1 inhibitor AND has previously received a platinum-containing chemotherapy OR is cisplatin-ineligible and has previously received one or more prior lines of therapy.

Based on FDA single-agent indication.

Neoadjuvant/adjuvant combination in MIBC: Padcev in combination with pembrolizumab, or pembrolizumab and berahyaluronidase alfa, as neoadjuvant treatment then continued after cystectomy as adjuvant therapy for adult patients with muscle invasive bladder cancer who are cisplatin-ineligible.

FDA combination indication for neoadjuvant/adjuvant MIBC.

Combination for advanced disease: Padcev in combination with pembrolizumab is indicated for treatment of adult patients with locally advanced or metastatic urothelial cancer.

FDA combination indication for metastatic/locally advanced disease.

Compendial uses: Padcev may be authorized for compendial uses in urothelial carcinoma including urothelial carcinoma of the bladder, upper genitourinary tract, urothelial carcinoma of the prostate, and primary carcinoma of the urethra, provided compendial criteria are met.

Compendial uses permitted per policy when criteria satisfied.

Continuation Therapy

Continuation criteria

Continuation of therapy: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Reauthorization contingent on absence of progression or unacceptable toxicity.

All indications for Padcev (enfortumab vedotin) that are not FDA-approved or recognized in standard compendia for urothelial carcinoma are considered experimental/investigational and are not medically necessary.

Uses of Padcev outside the FDA-approved indications and those listed in recognized compendial sources for urothelial carcinoma are not medically necessary and will not be authorized.

Provider Action and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required to confirm the member meets indication and sequencing criteria prior to initiation of Padcev (enfortumab vedotin-ejfv). Authorization may be requested for up to 12 months when criteria are met.

Applies to Padcev (enfortumab vedotin-ejfv) as single-agent or in indicated combinations.
Authorization duration: up to 12 months for urothelial carcinoma meeting criteria.

Step Therapy

Sequencing Requirement

Padcev as a single agent is sequenced after prior receipt of both a PD-1/PD-L1 inhibitor and a platinum-containing chemotherapy for treatment of locally advanced or metastatic urothelial cancer. For members ineligible for cisplatin-containing chemotherapy, Padcev may be authorized when there has been prior receipt of one or more prior lines of therapy as specified in the FDA-approved indication. When used as neoadjuvant plus continued adjuvant therapy, follow the FDA-approved combination indications.

Single-agent Padcev: requires prior PD-1/PD-L1 inhibitor and platinum-containing chemotherapy unless member is cisplatin-ineligible with prior lines of therapy.
Combination regimens (e.g., with pembrolizumab) follow respective FDA-approved sequencing and indications.

Documentation Required

Supporting Clinical Documentation

Document clinical rationale, prior treatments, and supporting evidence in the medical record when requesting authorization. Refer to standard reference compendia or the Padcev package insert for dosing, contraindications, precautions, and monitoring.

Include prior treatment history with dates (PD-1/PD-L1 inhibitor, platinum chemotherapy, other lines of therapy).
Provide pathology, staging, and documentation of cisplatin ineligibility when applicable.
Attach relevant imaging, operative reports, and prior therapy response assessments.

Denial Risk

Non-Compendial Indications Not Covered

Uses of Padcev that are not FDA-approved indications or listed compendial uses (e.g., indications outside urothelial carcinoma and specified GU tumors) are considered experimental/investigational and are not medically necessary.

Non-compendial or off-label indications will be denied as not medically necessary.
Covered compendial uses include urothelial carcinoma of the bladder, upper GU tract, urethra, and urothelial carcinoma of the prostate; all other uses are not covered.

Definitions and Compendial Uses

Compendial uses

DefinitionUses recognized in standard reference compendia (e.g., NCCN Drugs & Biologics Compendium) for urothelial carcinoma sites including primary carcinoma of the urethra, bladder cancer, upper genitourinary tract tumors, and urothelial carcinoma of the prostate.

Permitted compendial sitesPrimary carcinoma of the urethra; bladder cancer; upper genitourinary (GU) tract tumors; urothelial carcinoma of the prostate.

Relation to FDA indicationsCompendial uses are allowed in addition to FDA‑approved Padcev indications when compendial criteria are met.

Coverage impactUses not listed as FDA‑approved indications or compendial uses are considered experimental/investigational and not medically necessary.

Source examplesStandard reference compendia such as the NCCN Drugs & Biologics Compendium are the references for compendial uses.