CurrentEmblemHealthPolicy N/A

Tivdak (tisotumab vedotin‑tftv) — Coverage Criteria

Defines accepted indications, clinical criteria, and authorization requirements for use of Tivdak for members covered by the plan; applies to providers submitting medication requests processed by Evolent. Covers FDA-approved and accepted off-label indications supported by recognized compendia or peer-reviewed literature.

Policy Summary

PayerEmblemHealth

PolicyTivdak (tisotumab vedotin‑tftv) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for Tivdak and requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9273HCPCS code

2 mg/kg (max 200 mg)Dose limit

Recurrent/metastatic cervicalPrimary cancer

Exam each cycle (first 9)Ocular monitoring

2nd/3rd-lineLines of therapy

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Coverage Criteria for Tivdak (tisotumab vedotin‑tftv)

Initial Therapy - Recurrent or Metastatic Cervical Cancer

Covered when ALL of the following are met

Primary indication and prior therapy: Member has recurrent or metastatic cervical cancer with disease progression on or after platinum-containing therapy; if tumor PD-L1 CPS ≥ 1, member must have received pembrolizumab (Keytruda); if PD-L1 CPS < 1, prior pembrolizumab is not required.

Based on policy statement for cervical cancer and biomarker-driven prior therapy requirement (chunks 2).

Supportive evidence: Use is supported by FDA product labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Per policy purpose and evidentiary standards (chunk 0).

Safety monitoring: Baseline ophthalmic exam (assessment of ocular symptoms, visual acuity, slit-lamp/ slit exam of the anterior segment) prior to initiation and ophthalmic exam every cycle for the first nine cycles; adhere to required premedication and eye care, and withhold, resume, reduce dose, or permanently discontinue based on severity of ocular toxicity.

Ocular toxicity boxed warning and monitoring requirements (chunk 3).

Dosing limits: Single dose must not exceed 2 mg/kg, with a maximum single dose of 200 mg.<=2 mg/kg; <=200 mg

Dosing exclusion specified in policy thresholds (see coding/thresholds summary and exclusions).

Coverage does not allow concurrent administration of Tivdak with other anticancer therapies; requests that propose simultaneous use with other systemic anticancer agents will be denied. Coverage is also limited when dosing exceeds the single-dose limit of 2 mg/kg (maximum single dose 200 mg). Requests for members who experienced disease progression while taking Tivdak are excluded from coverage.

Use of Tivdak for investigational or off‑label indications that lack sufficient evidence or broad professional acceptance is not approvable. Sufficient evidence requires support from CMS‑recognized compendia or acceptable peer‑reviewed literature and must adequately represent the patient and cancer characteristics, the administered regimen, and clinically meaningful outcomes (for example, a hazard ratio < 0.80 or at least a 3‑month benefit in OS or PFS where applicable). Case reports and abstracts without full peer‑reviewed publication generally do not meet the evidentiary standard; nonrandomized trials with substantial subject numbers may provide supportive evidence when appropriate.

Regimen	Indication / Prior therapy requirements	Coverage status
Tisotumab vedotin-tftv monotherapy	Recurrent or metastatic cervical cancer with disease progression on or after platinum-containing therapy; if tumor PD-L1 CPS ≥1, prior pembrolizumab (Keytruda) is required. If PD-L1 CPS <1, prior pembrolizumab is not required.	Covered

Coding and Dosing Limits

Covered HCPCS CodesHCPCSCovered

J9273

Injection, tisotumab vedotin-tftv , mg

Single dose maximum — dosing limit

Single dose maximum2 mg/kg (up to a maximum of 200 mg for weight ≥ 100 kg)

Exceeds limit — denial triggerRequests exceeding this single dose limit may be denied per exclusion criteria.

Applies to dosing calculationsWeight-based dosing; cap applies when member weight is greater than or equal to 100 kg.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tivdak (tisotumab vedotin-tftv). Evolent (on behalf of the payer) processes all medication requests from network ordering providers. Requests must be submitted and approved prior to dispensing/administration. Coverage determinations must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards.

All medication requests processed by Evolent on behalf of EmblemHealth
Coverage support required: FDA label, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature

Prior Authorization

Line and Prior Therapy Requirements

Tivdak is indicated for recurrent or metastatic cervical cancer in members with disease progression on or after platinum-containing therapy. If the member's tumor is PD-L1 positive (CPS ≥ 1), prior therapy with pembrolizumab (Keytruda) is required; if PD-L1 negative (CPS < 1), prior pembrolizumab is not required. Treatment must be as monotherapy.

Indication: recurrent or metastatic cervical cancer after progression on/after platinum-containing therapy

Line of Therapy Definitions

second-line | third-line

Line of therapy: Tivdak is used as second- or third-line therapy for recurrent cervical cancer after progression on platinum-containing therapy; supporting clinical trial evidence includes innovaTV 301 (NEJM 2024) and innovaTV 204 (Lancet Oncology).

Line-of-therapy statement and references (chunks 2, 9).

Biomarker Requirements

PD-L1 (CPS) requirement

PD-L1 (CPS) thresholdCombined Positive Score (CPS) ≥ 1

Implication for prior therapyIf tumor CPS ≥ 1, prior pembrolizumab (Keytruda) is required before Tivdak

If CPS <1Prior pembrolizumab is not required when CPS is less than 1

Definitions and Monitoring Requirements

Ophthalmic exam requirements

Baseline ophthalmic assessmentAssess ocular symptoms, visual acuity, and perform slit‑lamp exam of the anterior segment prior to initiation of therapy

Ongoing monitoring frequencyPerform ophthalmic exam every cycle for the first nine cycles

Additional monitoringContinue exams as clinically indicated beyond the first nine cycles

Management of ocular toxicityWithhold therapy until improvement; then resume, reduce dose, or permanently discontinue based on severity

Supportive measuresAdhere to required premedication and eye care before, during, and after infusion

PD-L1 (CPS) — definition of positivity

Background

Tisotumab vedotin‑tftv (Tivdak) is an antibody‑drug conjugate indicated in the recurrent or metastatic cervical cancer setting; coverage decisions require alignment with FDA labeling and recognized compendia. A key safety concern is ocular toxicity, and use must follow recommended ophthalmic monitoring and management. Therapeutic use that does not meet dosing limits, involves concurrent anticancer therapy, or is investigational/off‑label without adequate evidence is excluded.