CurrentNeighborhood Health Plan of Rhode IslandPolicy 3469-A

Padcev

Defines coverage and authorization criteria for Padcev (enfortumab vedotin-ejfv) for FDA-approved and compendium-listed urothelial carcinoma indications, duration of authorization, continuation criteria, and exclusions (experimental/investigational).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev

Policy CodePolicy 3469-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior PD-1/PD-L1 and platinum chemotherapy or cisplatin ineligibility as applicable; initial and reauthorizations may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3FDA-Approved Indications Listed

4Urothelial Tumor Sites

12Authorization Duration (months)

Coverage Summary & Indications

Covered Indications - FDA-Approved and Compendial Uses

Padcev is covered when ALL of the following are met for the specified indications:

ALL of the following

Drug: Padcev (enfortumab vedotin-ejfv).
ALL of the following
- ANY of the following FDA indications
  - Padcev, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfapmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
  - Padcev, as a single agent, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy; OR for patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
  - Padcev, in combination with pembrolizumab, for adult patients with locally advanced or metastatic urothelial cancer (mUC).
Tumor types included under urothelial carcinoma: bladder cancer; primary carcinoma of the urethra; upper genitourinary (GU) tract tumors; urothelial carcinoma of the prostate.
ALL of the following
- 12-month authorization applies to
  - Padcev as single-agent subsequent therapy following platinum-containing chemotherapy and prior PD-1/PD-L1 inhibitor therapy.
  - Padcev as single-agent subsequent therapy for members ineligible for cisplatin-containing chemotherapy.
  - Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for stage II, recurrent, locally advanced, or metastatic urothelial carcinoma.

This policy defines coverage for Padcev (enfortumab vedotin-ejfv) for FDA-approved and compendial urothelial carcinoma indications. Covered FDA indications include Padcev in combination with pembrolizumab (or pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant treatment continued adjuvantly after cystectomy for cisplatin-ineligible muscle invasive bladder cancer (MIBC); Padcev as a single agent for locally advanced or metastatic urothelial cancer after prior PD‑1/PD‑L1 inhibitor and platinum chemotherapy or for patients ineligible for cisplatin who have received prior therapy; and Padcev in combination with pembrolizumab for locally advanced or metastatic urothelial cancer.

Initial authorizations and reauthorizations may be granted for up to 12 months for the indicated urothelial carcinoma uses when all approval criteria are met. Uses of Padcev outside the listed urothelial carcinoma indications are considered investigational / not medically necessary and are not covered.

Initial Authorization Criteria

Initial Authorization Requirements

Initial authorization requirements and duration for Padcev for covered urothelial carcinoma indications:

ALL of the following

Drug: Padcev (enfortumab vedotin-ejfv).
ALL of the following
- ANY of the following FDA indications
  - Padcev, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfapmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
  - Padcev, as a single agent, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy; OR for patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
  - Padcev, in combination with pembrolizumab, for adult patients with locally advanced or metastatic urothelial cancer (mUC).
ALL of the following
- 12-month authorization applies to
  - Padcev as single-agent subsequent therapy following platinum-containing chemotherapy and prior PD-1/PD-L1 inhibitor therapy.
  - Padcev as single-agent subsequent therapy for members ineligible for cisplatin-containing chemotherapy.
  - Padcev in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for stage II, recurrent, locally advanced, or metastatic urothelial carcinoma.

Reauthorization / Continuation Criteria

Continuation (Reauthorization) Criteria

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member is currently receiving Padcev for an indication listed in the coverage criteria.
There is no evidence of unacceptable toxicity while on the current regimen.
There is no evidence of disease progression while on the current regimen.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Padcev requires prior authorization; initial authorizations may be granted for up to 12 months for covered indications. Reauthorization for up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Documentation Required

Documentation of prior therapies and cisplatin eligibility

Providers must document prior receipt of a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy when applicable for Padcev use, or document ineligibility for cisplatin-containing chemotherapy as required by the specific indication.

Typical authorization length for both initial and continuation requests is up to 12 months.

Continuation (reauthorization) requires that the member is currently receiving Padcev for a listed indication and that there is no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.

When submitting prior authorization requests, include documentation of the specific indication and prior therapies as applicable (for example, prior PD‑1/PD‑L1 inhibitor and platinum-containing chemotherapy, or documentation of ineligibility for cisplatin-containing chemotherapy) on the PA form.

Evidence & References

Key evidence sources for the covered indications are the manufacturer package insert: Padcev [package insert], Astellas Pharma US, Inc.; November 2025, and guideline/compendium references: NCCN Drugs & Biologics Compendium® (2026) and NCCN Bladder Cancer Guidelines (Version 3.2025).

These references serve as the primary supporting documents for the FDA‑approved and compendial urothelial carcinoma indications described in this policy.

Background & Indications Context

Padcev (enfortumab vedotin-ejfv) is FDA‑approved for multiple urothelial carcinoma settings, including neoadjuvant/adjuvant use with pembrolizumab for cisplatin‑ineligible MIBC, and for locally advanced/metastatic urothelial cancer as monotherapy or in combination with pembrolizumab. Uses of Padcev outside these specified urothelial carcinoma indications are considered investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev

Policy CodePolicy 3469-A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Padcev

Coverage Summary & Indications

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Not Medically Necessary / Experimental

Prior Authorization & Documentation Requirements

Applicable Codes

Evidence & References

Background & Indications Context

Revision History