CurrentCentenePolicy CP.PHAR.561

Tisotumab Vedotin-tftv (Tivdak) (PDF)

Defines medical necessity criteria, initial and continuation approval criteria, dosing limits, covered diagnoses (FDA-approved and NCCN-off-label), exclusions, approval durations by line of business, coding implications and administrative requirements for Tivdak across Commercial, HIM and Medicaid lines.

Policy Summary

PayerCentene

PolicyTisotumab Vedotin-tftv (Tivdak) (PDF)

Policy CodePolicy CP.PHAR.561

Change TypeAdded NCCN-supported off-label use, clarified single-agent requirement, updated approval durations and coding

Effective DateDec 1, 2021

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria, including current weight in kg and evidence of disease progression on or after prior chemotherapy.

SourceLink

POLICY UPDATE CHANGES

Added allowance for combination use with Keytruda for PD-L1 positive cervical cancer per NCCN.

Added off-label vaginal cancer indication per NCCN.

Added Section III listing Diagnoses/Indications for which coverage is NOT authorized per current template.

Clarified single-agent requirement and removed prior restriction on number of prior systemic regimens.

Extended initial approval duration for HIM/Medicaid from 6 to 12 months.

Converted FDA approval for cervical cancer from accelerated to full approval per prescribing information.

1FDA-approved indications (cervical cancer)

1Off-label supported indication (vaginal cancer per NCCN)

12Medicaid/HIM approval duration (initial)

6Commercial approval duration (initial)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: defines medical necessity criteria, initial and continuation approval criteria, dosing limits, covered diagnoses (FDA-approved and NCCN-off-label), exclusions, approval durations by line of business, coding implications and administrative requirements for Tivdak. Diagnoses covered: FDA-approved cervical cancer (recurrent or metastatic cervical cancer with disease progression on or after chemotherapy) and NCCN-supported off-label vaginal cancer. Combination use: allowed in combination with pembrolizumab (Keytruda) for PD-L1 positive cervical cancer with CPS ≥ 1. Policy number: CP.PHAR.561. Approval durations: Commercial: 6 months (or to member renewal date); HIM/Medicaid: 12 months.

Thresholds / Policy Dates

Age≥ 18 years

Dose maximum≤ 2 mg/kg every 3 weeks, up to 200 mg for members ≥ 100 kg

Minimum continuation dose≥ 0.9 mg/kg every 3 weeks

PD-L1 CPS for pembrolizumab comboCPS ≥ 1

Minimum treatment duration before continuation request≥ 30 days

Policy effective date12.01.21

Policy last review date11.25

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

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Continuation Therapy Criteria

Continuation-specific Numeric Thresholds

Minimum treatment duration before continuation requestMember must have received Tivdak for at least 30 days

Minimum continuation doseDose must be at least 0.9 mg/kg every 3 weeks

Dose maximum for continuationNew or increased dose must not exceed 2 mg/kg every 3 weeks (up to 200 mg for patients ≥ 100 kg)

Unproven / Exclusions

Other and Not Authorized Diagnoses/Indications

If the requested use is not covered under sections above, must meet ONE of the following:

Other Diagnoses/Indications

Recent label change: Drug underwent a label change within last 6 months not reflected in this policy; refer to relevant formulary/non-formulary policy per line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary)
Off-label referral: Requested use not listed under Section III and criterion 1 does not apply; refer to off-label use policy per line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid)

Diagnoses/Indications Not Authorized: Non-FDA approved indications which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS for TivdakHCPCSCovered

J9273

Injection, tisotumab vedotin-tftv, 1 mg

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Requests must meet the policy's initial or continuation criteria to be approved. Include supporting evidence when prescribing off-label dosing or combination therapy (e.g., combination with pembrolizumab for PD-L1 positive cervical cancer).

J9273

Documentation Required

Support clinical criteria with documentation

Provider must submit clinical documentation demonstrating the member meets all approval criteria, including office chart notes, lab results or other clinical information, current weight in kg, and evidence of disease progression on or after prior chemotherapy.

Office chart notes
Lab results

Clinical Evidence & Guidelines

Evidence items: Prescribing Information: Tivdak Prescribing Information, Seagen Inc.; April 2024. NCCN guidance: NCCN Cervical Cancer and Vaginal Cancer compendia (Version 4.2025 and 5.2025). Note: This policy incorporates FDA labeling and NCCN recommendations, including an NCCN-supported off-label use for vaginal cancer and allowance for combination use with pembrolizumab for PD-L1 positive cervical tumors.

Background

Background: Tisotumab vedotin-tftv (Tivdak) is a tissue factor-directed antibody-drug conjugate indicated for adult patients with recurrent or metastatic cervical cancer after progression on or after chemotherapy. The policy aligns with FDA labeling and NCCN recommendations, and also incorporates NCCN-supported off-label use for vaginal cancer and combination use with pembrolizumab for PD-L1 positive cervical tumors.

Definitions: CPS — Combined positive score for PD-L1 expression.

Revision History

05.08.24regulatory

Converted FDA approval for cervical cancer from accelerated approval to full approval per prescribing information. (RT4 note describing conversion)

undatedguideline_addition

Added NCCN-supported off-label indication for vaginal cancer (policy lists Cervical Cancer, Vaginal Cancer (off-label) in initial approval criteria and references NCCN compendia).

07.14.25guideline_additionLatest

Policy Summary

PayerCentene

PolicyTisotumab Vedotin-tftv (Tivdak) (PDF)

Policy CodePolicy CP.PHAR.561

Change TypeAdded NCCN-supported off-label use, clarified single-agent requirement, updated approval durations and coding

Effective DateDec 1, 2021

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria, including current weight in kg and evidence of disease progression on or after prior chemotherapy.

SourceLink

On This Page

Current weight in kg

Documentation of progression on or after prior chemotherapy

Billing Rule

Dose billing

Bill J9273 per mg (J9273 = injection, 1 mg). Ensure the total billed dose does not exceed policy maximums (dose limits described in the policy).

Maximum: 2 mg/kg every 3 weeks, up to 200 mg for members ≥ 100 kg
J9273 = 1 mg per HCPCS unit (bill mg as units)

Denial Risk

Denial for non-covered indications

Requests for non–FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off-label use policies.

Refer to off-label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Added allowance for combination use with Keytruda (pembrolizumab) for PD-L1 positive (CPS ≥ 1) cervical cancer per NCCN; policy specifies combination option in Initial Approval Criteria (prescribed as single agent OR in combination with Keytruda for PD-L1 positive cervical cancer) and documents PD-L1 CPS ≥ 1 threshold.

08.04.22criteria_clarification

Clarified single-agent requirement: policy criteria require prescribing 'as a single agent' for standard use; removed prior restriction limiting number of prior systemic regimens (policy history notes removal of 'no more than two prior systemic regimens').

08.08.24template_update

Template/administrative update: added Section III listing Diagnoses/Indications for which coverage is NOT authorized per current template (administrative/template change; no clinical policy statement changes).

undatedcoding_update

Updated HCPCS code listing J9273 (Injection, tisotumab vedotin-tftv, 1 mg) as the code for Tivdak.

07.14.25approval_duration_changeLatest

Extended initial approval duration for HIM/Medicaid from 6 to 12 months (4Q 2025 annual review note).