Padcev (enfortumab vedotin-ejfv) Intravenous — Coverage and Medical Necessity Criteria
Coverage and medical necessity criteria for Padcev (enfortumab vedotin-ejfv) IV for treatment of locally advanced or metastatic urothelial cancer; includes dosing, authorization length, coding, and renewal requirements for prescribers and reviewers.
Initial criteria were revised to specify that Padcev may be used as first-line therapy in combination with pembrolizumab or as subsequent therapy, and removed prior requirements regarding prior PD-1/PD-L1 inhibitor or platinum chemotherapy.
Updated examples of unacceptable toxicity in the renewal criteria.
Coverage and Medical Necessity Criteria
Initial Approval Criteria
Padcev may be considered medically necessary when ALL of the following are met for locally advanced or metastatic urothelial cancer:
Renewal Criteria
Renewal is allowed when ALL of the following are met:
| Dose level | Dose (mg/kg) | Maximum mg per dose | Notes |
|---|---|---|---|
| Third dose reduction | |||
| 0.5 mg/kg | |||
| 50 mg | |||
| Lowest recommended dose for toxicity management |
Indications that lack support in CMS‑recognized compendia or in acceptable peer‑reviewed medical literature may be deemed not approvable and not reimbursable. Requests for Padcev (enfortumab vedotin‑ejfv) for such unsupported indications will not meet the medical necessity criteria and are subject to denial.
Use of Padcev for indications without adequate support in CMS‑recognized compendia or acceptable peer‑reviewed literature is considered not medically necessary / not approvable. Providers must submit clinical evidence aligned with the policy’s covered indications to support medical necessity; absence of such evidence may result in non‑coverage.
Billing Codes and Identifiers
| J9177 | Injection,enfortumab vedotin-ejfv, 0.25 mg (Padcev) |
| 51144-020-01 | Padcev (Enfortumab Vedotin-Ejfv) Single Use Vial; 20 mg Powder For Injection |
| 51144-030-01 | Padcev (Enfortumab Vedotin-Ejfv) Single Use Vial; 30 mg Powder For Injection |
| C65.1 | Malignant neoplasm of right renal pelvis |
| C65.2 | Malignant neoplasm of left renal pelvis |
| C65.9 | Malignant neoplasm of unspecified renal pelvis |
| C66.1 | Malignant neoplasm of right ureter |
| C66.2 | Malignant neoplasm of left ureter |
| C66.9 | Malignant neoplasm of unspecified ureter |
| C67.0 | Malignant neoplasm of trigone of bladder |
| C67.1 | Malignant neoplasm of dome of bladder |
| C67.2 | Malignant neoplasm of lateral wall of bladder |
| C67.3 | Malignant neoplasm of anterior wall of bladder |
Prescriber and Reviewer Requirements
Prior Authorization Required
Prior authorization is required. Coverage will be provided for up to 12 months when the coverage criteria are met. Authorization length and any renewals must align with the dosing and regimen for the requested indication.
- Authorization length: up to 12 months
- Dosing/regimen must align with approved or supported clinical use
Permitted Lines of Therapy
Padcev (enfortumab vedotin-ejfv) may be approved as a first-line therapy only when used in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma, or as a subsequent-line therapy for the same indication. Use must be consistent with the medical necessity criteria.
- Permitted lines: first-line (only in combination with pembrolizumab) or subsequent therapy
- Indication: locally advanced or metastatic urothelial cancer in adults
Clinical Evidence Submission Required
The treating physician or primary care provider must submit clinical evidence demonstrating the member meets the clinical criteria for Padcev. Requests lacking required documentation cannot be properly reviewed and may be denied.
- Clinical evidence must show the member meets all applicable medical necessity criteria
- Requests must indicate whether Padcev is being used as first-line (with pembrolizumab) or subsequent therapy
- Prescriptions must be by or in consultation with an oncologist
Documentation and Evidence Requirements
Failure to submit required documentation (including supporting peer-reviewed literature or CMS-recognized compendia when applicable) prevents proper review; indications not supported by recognized compendia or acceptable peer-reviewed literature are not approvable and will not be reimbursed.
- Include relevant peer-reviewed literature or CMS-recognized compendia references when the indication is not FDA-labeled
- Unsupported indications may be deemed not approvable and not reimbursable
- If member benefits conflict with this guideline, the member's benefit program governs coverage
Permitted Lines of Therapy
first-line | second-line
Policy previously referenced prior PD-1/PD-L1 and platinum requirements which were removed per revision history.
Clinical Background
Enfortumab vedotin is an antibody–drug conjugate that targets Nectin‑4. After binding Nectin‑4 on tumor cells and internalization, it delivers the microtubule‑disrupting agent MMAE, which induces cell cycle arrest and apoptosis. This mechanism underlies its indication for locally advanced or metastatic urothelial cancer and informs the safety monitoring described in the policy.
Key Definitions
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.