Tisotumab Vedotin-tftv (Tivdak) — CPB 0998 | AETNA Coverage Update

Aetna modified CPB 0998 for tisotumab vedotin-tftv (Tivdak), effective January 15, 2026. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its Tivdak coverage policy under CPB 0998 to add vaginal cancer as a covered indication alongside the existing cervical cancer criteria. The primary billing code is HCPCS J9273 (tisotumab vedotin-tftv, 1 mg), billed alongside administration codes CPT 96413 and 96415. If your oncology or gynecologic oncology practice bills for Tivdak under Aetna commercial plans, this change expands your covered patient population—but the prior authorization requirements and documentation expectations are strict.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Tisotumab Vedotin-tftv (Tivdak)
Policy Code	CPB 0998
Change Type	Modified
Effective Date	January 15, 2026
Impact Level	High
Specialties Affected	Gynecologic Oncology, Medical Oncology, Oncology Infusion
Key Action	Add vaginal cancer (C52) to your precertification workflows and confirm PD-L1 testing documentation for cervical cancer combination regimens

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Aetna Tivdak Coverage Criteria and Medical Necessity Requirements 2026

Aetna's Tivdak coverage policy under CPB 0998 covers two indications as of January 15, 2026: recurrent or metastatic cervical cancer and recurrent or metastatic vaginal cancer. Both require precertification before you bill J9273. Call (866) 752-7021 or fax (888) 267-3277 to initiate the prior authorization process.

Cervical Cancer

For cervical cancer, Aetna considers tisotumab vedotin-tftv medically necessary when the patient has recurrent or metastatic disease with progression on or after chemotherapy. Tivdak is covered as a single agent in this setting. It's also covered in combination with pembrolizumab (J9271)—but only when two additional conditions are met: the patient has not received prior immune-oncology therapy, and the tumor is PD-L1 positive.

That PD-L1 requirement is the one most likely to cause claim denial. PD-L1 positivity is required per policy criteria, and CPT 88360 is listed as a related code in this policy and may be relevant to documenting that requirement. If PD-L1 status isn't clearly established in the record before submitting for precertification, Aetna has grounds to deny the combination regimen. Make PD-L1 documentation a checkpoint in your prior auth workflow.

Vaginal Cancer

The vaginal cancer indication is new to this policy as of the January 15, 2026 effective date. Aetna now considers Tivdak medically necessary as a single agent for subsequent treatment of recurrent or metastatic vaginal cancer, per the policy language. Document the treatment history clearly in your precertification request.

There is no PD-L1 requirement for vaginal cancer. There is no pembrolizumab combination approval for vaginal cancer either—single agent only. Keep those distinctions clear in your charge capture setup.

For reimbursement under both indications, Aetna requires the member's plan design to include the precertification requirement. Confirm the patient's specific commercial plan before assuming coverage applies.

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Aetna Tivdak Exclusions and Non-Covered Indications

Aetna's policy is direct: all indications other than recurrent or metastatic cervical cancer and recurrent or metastatic vaginal cancer are considered experimental, investigational, or unproven. That includes any off-label use of tisotumab vedotin-tftv for other gynecologic or solid tumor malignancies.

This matters because Tivdak has been studied in bladder cancer, endometrial cancer, and other solid tumors in clinical trials. Aetna will not cover those uses under CPB 0998. If a provider bills J9273 for a diagnosis code outside C52 or C53.0–C53.9, expect a denial.

Talk to your compliance officer about how to handle cases that fall outside the scope of this coverage policy before billing.

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Coverage Indications at a Glance

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Aetna Tisotumab Vedotin Billing Guidelines and Action Items 2026

These are the steps your billing team needs to take now. The effective date has already passed—January 15, 2026 is behind us. If you're treating vaginal cancer patients under Aetna commercial plans and haven't updated your workflows yet, do it today.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Tisotumab Vedotin-tftv Under CPB 0998

HCPCS Codes — Covered When Criteria Are Met

Code	Type	Description Copy
J9273	HCPCS	Injection, tisotumab vedotin-tftv, 1 mg
J9271	HCPCS	Injection, pembrolizumab, 1 mg (combination regimen, cervical cancer only)

CPT Codes Related to CPB 0998

Code	Type	Description Copy
96413	CPT	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415	CPT	Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure)
88360	CPT	Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, estrogen receptor/progesterone receptor); manual

Key ICD-10-CM Diagnosis Codes

One note on the ICD-10 codes: Aetna's policy lists C53.0 through C53.9 as the full range of cervical malignancy codes covered under CPB 0998. Use the most specific code available for the patient's tumor location. Unspecified codes will pass precertification, but specific codes reduce the risk of a medical necessity review request.

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A Note on the Combination Regimen

The Tivdak plus pembrolizumab combination is where most billing errors will happen. Three things must all be true at once: the patient has recurrent or metastatic cervical cancer with progression on or after chemotherapy, the patient has no prior immune-oncology therapy, and the tumor is PD-L1 positive.

Miss any one of those three, and you're billing an uncovered service. That's not a technicality—it's the difference between a clean claim and a denial that takes 90 days to work through appeals.

If your clinical team is ordering this combination and the documentation isn't clearly assembled before the claim goes out, loop in your compliance officer. The prior IO therapy exclusion in particular requires a careful treatment history review. Don't assume a clean record—verify it.

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