CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Padcev (enfortumab vedotin-ejfv) coverage for urothelial carcinoma

Defines coverage criteria and authorization durations for Padcev (enfortumab vedotin-ejfv) for FDA-approved and compendial uses in urothelial carcinoma, including single-agent and combination with pembrolizumab, and rules for continuation/reauthorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) coverage for urothelial carcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for Padcev; authorizations are granted for up to 12 months for eligible indications as specified; reauthorization requires no evidence of unacceptable toxicity or disease progression.

POLICY UPDATE CHANGES

No material changes to policy — brief indicates has_material_change=false and no specific updates provided.

2FDA-approved regimen types (single-agent; combination with pembrolizumab)

12 monthsTypical authorization duration

4Listed urothelial carcinoma anatomic subtypes

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines coverage criteria and authorization durations for Padcev (enfortumab vedotin-ejfv) for FDA-approved and compendial uses in urothelial carcinoma, including single-agent and combination with pembrolizumab, and rules for continuation/reauthorization. Coverage aligns with the FDA label and NCCN compendia for the specified indications; all other uses are considered investigational/not medically necessary.

Initial Therapy Criteria (FDA-approved & Compendial Uses)

FDA-Approved Indications (Covered when ALL of the following are met)

Padcev is covered for the following FDA-approved indications when all listed conditions are met:

ALL of the following

Indication: Padcev in combination with pembrolizumab for treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).
Indication: Padcev as a single agent for treatment of 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 are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Compendial Uses (Covered when treating urothelial carcinoma subtypes listed below)

Compendial urothelial carcinoma uses are covered as listed; all other indications are investigational/not medically necessary.

ANY of the following

Bladder cancer (urothelial carcinoma of bladder).
Upper genitourinary (GU) tract tumors (urothelial carcinoma of upper tract).
Primary carcinoma of the urethra.
Urothelial carcinoma of the prostate.

Authorization Criteria for Urothelial Carcinoma (Covered when ALL of the following are met)

Authorization of up to 12 months may be granted when criteria below are met for single-agent or combination therapy as specified.

ALL of the following

Authorization duration: up to 12 months for treatment of urothelial carcinoma as a single agent when used as subsequent therapy following platinum-containing chemotherapy and prior treatment with a PD-1 or PD-L1 inhibitor, or when used as subsequent therapy for members ineligible for cisplatin-containing chemotherapy.
Applicable urothelial disease subtypes
- Stage II, locally advanced or metastatic disease.
- Urothelial carcinoma of the bladder: metastatic or local recurrence post-cystectomy.
- Primary carcinoma of the urethra with locally advanced, recurrent or metastatic disease.

Provider Actions

Prior Authorization

Authorization required

Providers must obtain authorization for Padcev; authorizations are granted for up to 12 months for eligible indications as specified; reauthorization requires no evidence of unacceptable toxicity or disease progression.

Authorizations are granted for up to 12 months for eligible indications.
Reauthorization requires no evidence of unacceptable toxicity or disease progression.

Documentation Required

Documentation of prior therapies and cisplatin eligibility

Providers must document prior receipt of a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or document ineligibility for cisplatin-containing chemotherapy and prior lines of therapy when seeking coverage for single-agent Padcev.

Documentation of prior receipt of a PD-1 or PD-L1 inhibitor.
Documentation of prior receipt of a platinum-containing chemotherapy.
If cisplatin-ineligible, documentation of cisplatin ineligibility and prior lines of therapy.

Background

Padcev (enfortumab vedotin-ejfv) is indicated per the FDA for treatment of adult patients with locally advanced or metastatic urothelial cancer as follows: in combination with pembrolizumab for first-line treatment of locally advanced or metastatic urothelial cancer, and as a single agent for patients who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy or who are ineligible for cisplatin and have previously received one or more prior lines of therapy. Coverage aligns with the FDA label and NCCN compendial uses for urothelial carcinoma (including bladder, upper GU tract, urethra, and prostate); all other indications are investigational and not medically necessary.

Key Policy Statistics

FDA-approved regimen types2

Typical authorization duration12 months

Listed urothelial carcinoma anatomic subtypes4

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPadcev (enfortumab vedotin-ejfv) coverage for urothelial carcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Padcev (enfortumab vedotin-ejfv) coverage for urothelial carcinoma

Coverage Summary

Initial Therapy Criteria (FDA-approved & Compendial Uses)

Continuation Therapy Criteria (Reauthorization)

Provider Actions

Applicable Codes & References

Background

Clinical Evidence / Sources

Revision History