CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Padcev (enfortumab vedotin-ejfv) coverage for urothelial carcinoma

Defines covered FDA-approved and compendial indications for Padcev (enfortumab vedotin-ejfv), criteria for initial authorization (including combination with pembrolizumab), duration of authorization, continuation/re-authorization conditions, and exclusions (experimental/investigational for non-listed indications).

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 ActionPrior authorization is required for Padcev; authorization may be granted for 12 months when member meets indication-specific criteria (FDA-approved or compendial) and has no exclusions.

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

2FDA-approved regimen options listed

4Compendial anatomic sites listed

12Typical authorization duration (months)

Coverage Summary

Scope: This policy defines coverage for Padcev (enfortumab vedotin-ejfv) for FDA-approved and select compendial uses in urothelial carcinoma. It covers Padcev as a single agent and in combination with pembrolizumab for the FDA-approved indications in adult patients with locally advanced or metastatic urothelial cancer, and for select compendial urothelial carcinoma anatomic sites and subtypes. Typical authorization duration is 12 months. Uses not listed in the policy (non‑FDA/non‑compendial) are considered experimental/investigational and are not covered.

Initial Therapy Criteria

FDA-Approved Indications (Covered when ALL criteria are met)

Padcev is covered for the following FDA-approved indications provided approval criteria are met and member has no exclusions to the prescribed therapy:

Covered FDA-approved regimens

Padcev in combination with pembrolizumab for treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin-containing chemotherapy
Padcev (enfortumab vedotin-ejfv) 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 ALL criteria are met)

Padcev is covered for compendial uses listed below provided approval criteria are met and no member exclusions:

Compendial Uses

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

Urothelial Carcinoma — Authorization and Subtypes

Authorization of 12 months may be granted when used as single agent subsequent therapy after platinum and PD-1/PD-L1 inhibitor or for cisplatin-ineligible members when used in combination with pembrolizumab for listed subtypes:

ALL of the following

Eligible clinical subtypes
- Stage II disease if tumor is present following reassessment of tumor status 2-3 months after primary treatment with concurrent bladder-preserving chemoradiotherapy and maximal transurethral resection of bladder tumor (TURBT)Reassess 2-3 months
  Reassessment interval after bladder-preserving chemoradiotherapy: 2-3 months.
- Urothelial carcinoma of the bladder: locally advanced or metastatic disease
- Urothelial carcinoma of the bladder: muscle-invasive local recurrence or persistent disease in a preserved bladder

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

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

ALL of the following

Member requests reauthorization for an indication listed in the policy (Section II)
There is no evidence of unacceptable toxicity while on the current regimen
There is no evidence of disease progression while on the current regimen

Provider Actions

Prior Authorization

Authorization required

Prior authorization is required for Padcev; authorization may be granted for 12 months when the member meets the indication-specific (FDA-approved or compendial) criteria and has no exclusions.

Authorization duration: 12 months
Covered when FDA-approved or compendial criteria are met

Documentation Required

Clinical documentation for subtype and prior therapies

Document the urothelial carcinoma subtype and prior therapies: prior PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, or evidence of cisplatin ineligibility and prior lines of therapy, as applicable.

Documentation Required

Toxicity and progression for reauthorization

For reauthorization, document there is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression to support continued treatment.

Denial Risk

Not covered if indication not listed

Therapy for indications not listed (non‑FDA and non‑compendial) is considered experimental/investigational and not medically necessary and may be denied.

Background

Background: The policy covers Padcev for FDA-approved and select compendial uses in urothelial carcinoma, reflecting label indications for Padcev as a single agent for patients previously treated with a PD‑1/PD‑L1 inhibitor and platinum chemotherapy (or cisplatin‑ineligible with prior lines of therapy) and in combination with pembrolizumab for cisplatin‑ineligible patients with locally advanced or metastatic urothelial cancer. Covered compendial anatomic sites/subtypes include bladder (urothelial carcinoma), primary carcinoma of the urethra, urothelial carcinoma of the prostate, and upper genitourinary tract urothelial carcinoma.

Key Thresholds and Stats

Authorization duration12 months

Reassessment interval after bladder-preserving chemoradiotherapy2-3 months

FDA-approved regimen options2 (single-agent; combination with pembrolizumab)

Compendial anatomic sites listed4 (bladder, urethra, prostate, upper GU tract)