Enfortumab vedotin-ejfv (Padcev) — CPB 0967 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 0967 governing enfortumab vedotin-ejfv (Padcev) coverage, effective October 18, 2025. Here's what changes for billing teams.

Aetna updated its Padcev coverage policy under CPB 0967 Aetna system to expand the approved indications — most notably adding combination use with pembrolizumab across several urothelial carcinoma subtypes. This change directly affects oncology billing teams managing precertification and reauthorization for Padcev claims. If your practice bills for urothelial carcinoma treatment, audit your active prior authorization workflows against the new criteria now.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Enfortumab vedotin-ejfv (Padcev) — CPB 0967
Policy Code	CPB 0967
Change Type	Modified
Effective Date	October 18, 2025
Impact Level	High
Specialties Affected	Medical oncology, urology, hematology/oncology, radiation oncology
Key Action	Update prior authorization workflows to reflect new Padcev + pembrolizumab combination criteria before submitting new claims

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Aetna Padcev Coverage Criteria and Medical Necessity Requirements 2025

The core of this coverage policy is a two-track structure. Aetna covers Padcev as a single agent in one set of scenarios and as a combination therapy with pembrolizumab in another. The criteria are not interchangeable — the wrong track gets you a denial.

Single-Agent Track

Aetna considers Padcev medically necessary as a single agent for urothelial carcinoma when used as subsequent therapy. That means the member must have already received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Alternatively, the member qualifies if they are ineligible for cisplatin-containing chemotherapy.

Eligible subtypes under the single-agent track include:

Combination Track (Padcev + Pembrolizumab)

This is where the policy update adds real complexity. Aetna now specifies medical necessity for Padcev in combination with pembrolizumab across multiple urothelial carcinoma subtypes. The criteria vary by subtype, and the line-item conditions matter.

For urothelial carcinoma of the bladder with combination therapy, Padcev is covered as subsequent therapy in Stage II, locally advanced, or metastatic disease, and in metastatic or local recurrence post-cystectomy. Muscle invasive local recurrence or persistent disease in a preserved bladder also qualifies — but notice this is listed separately from the bladder subtype, not nested under it.

For primary carcinoma of the urethra, the combination track covers both first-line use (locally advanced or metastatic disease) and subsequent therapy. Subsequent therapy covers locally advanced or metastatic disease, and also recurrent disease with T2 clinical staging. That T2 staging criterion is specific — document it clearly in the prior authorization request.

For urothelial carcinoma of the upper genitourinary tract and urothelial carcinoma of the prostate, locally advanced or metastatic disease qualifies under the combination track.

Prior Authorization Requirements

Prior authorization is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to precertify. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification page.

Whether you're asking whether Padcev is covered under this Aetna Padcev coverage policy as monotherapy or combination therapy, the answer depends entirely on which track you're billing. Submitting a combination claim against single-agent criteria — or vice versa — will produce a claim denial.

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Aetna Padcev Exclusions and Non-Covered Indications

Aetna's position here is straightforward: any indication not listed in Section I of CPB 0967 is experimental, investigational, or unproven. There are no partial approvals or case-by-case exceptions written into this policy.

The real exposure for billing teams is off-label use. If a treating oncologist uses Padcev for a tumor type not listed above — say, a non-urothelial solid tumor where some trial data exists — Aetna will not cover it under this policy. Document the indication precisely in the prior auth request. "Urothelial carcinoma" without specifying subtype and stage is not enough.

The same logic applies to combination regimens other than pembrolizumab. Padcev combined with any agent besides pembrolizumab falls outside covered indications unless Aetna updates this policy.

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Coverage Indications at a Glance

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Aetna Padcev Billing Guidelines and Action Items 2025

1. Separate your active prior auth queue by treatment track before October 18, 2025.

Pull every open Padcev authorization and tag it: single agent or combination with pembrolizumab. The approval criteria are different. A prior auth submitted under the wrong track — or without specifying the track — will likely trigger a request for additional documentation or a denial.

2. Confirm prior treatment history documentation for every single-agent request.

For the single-agent track, Aetna requires documented evidence of prior platinum-containing chemotherapy and prior PD-1 or PD-L1 inhibitor therapy — unless the member is cisplatin-ineligible. Pull that documentation before you submit. A missing chemo history is one of the fastest routes to a claim denial under this policy.

3. Capture T2 staging explicitly for urethral carcinoma combination cases.

For primary carcinoma of the urethra on the combination track, recurrent disease with T2 clinical staging is a covered criterion. That staging must be in the record and referenced in the prior auth. If your team is only documenting "recurrent urethral carcinoma," that's not sufficient. Add the clinical staging.

4. Update reauthorization checklists to include the "no unacceptable toxicity or disease progression" requirement.

Continuation of therapy is covered under CPB 0967 when there is no evidence of unacceptable toxicity or disease progression. Your reauthorization requests must address both conditions. Document the treating oncologist's assessment of toxicity and response status explicitly. Vague language here causes delays.

5. Verify plan design for prior authorization applicability.

Precertification is required for Aetna participating providers in applicable plan designs — not all plan designs. Check the member's specific plan before assuming prior auth is required. Skipping precertification on a plan that requires it creates reimbursement risk. Submitting unnecessary prior auth on a plan that doesn't require it wastes time.

6. Update your enfortumab vedotin-ejfv billing workflows to reflect the effective date of October 18, 2025.

Any claims with dates of service on or after October 18, 2025 fall under the updated CPB 0967 criteria. Claims billed against older criteria may not align with what Aetna's reviewers are checking. Flag this date in your billing guidelines documentation and charge capture systems.

If your patient mix includes a high volume of urothelial carcinoma cases or you manage combination immunotherapy regimens, loop in your compliance officer to review the updated criteria against your current workflows before the effective date.

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CPT, HCPCS, and ICD-10 Codes for Enfortumab Vedotin-ejfv Under CPB 0967

The policy data for CPB 0967 lists CPT codes as related to the policy — not as billing codes for Padcev itself. Padcev administration is billed through HCPCS drug codes, not the CPT codes listed here. The CPT codes below represent related procedures in the urothelial carcinoma treatment context.

The policy data notes 23 HCPCS codes and 47 ICD-10-CM codes are associated with CPB 0967, but the specific codes were not included in the published policy data at the time of this review. Check the full CPB 0967 policy at Aetna's clinical policy library for the complete HCPCS drug code for Padcev and the full ICD-10-CM code set.

CPT Codes Listed as Related to CPB 0967

The cystourethroscopy codes (52204, 52214, 52224, 52234, 52235, 52240) reflect the diagnostic and procedural context for bladder tumor evaluation. These are not Padcev administration codes — they appear as related procedural context within the CPB.

The radiation treatment delivery and management codes (77399 through 77481) are listed as related CPT codes. These reflect treatment pathway context for urothelial carcinoma, not Padcev billing directly.

For Padcev billing, your team should be using the appropriate HCPCS J-code. The 23 HCPCS codes listed in the policy data were not published in detail in the source document reviewed. Confirm the correct HCPCS code for enfortumab vedotin-ejfv with Aetna's fee schedule or your drug database before submitting claims.

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