CurrentViva HealthPolicy IC-0624

Tivdak (tisotumab vedotin-tftv) IV

Policy governing prior authorization, coverage criteria, dosing, renewal, allowable units, billing codes, and covered diagnoses for intravenous tisotumab vedotin (Tivdak) for treatment of recurrent or metastatic cervical and vaginal cancers in adults.

Policy Summary

PayerViva Health

PolicyTivdak (tisotumab vedotin-tftv) IV

Policy CodePolicy IC-0624

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization for an initial 6 months and provide documentation that the patient meets initial criteria.

SourceLink

POLICY UPDATE CHANGES

No material changes

2Covered Indications

200 mgMax Dose per Cycle

6 moInitial PA Duration

J9273Primary Billing Code

Coverage Summary

Coverage stance: covered_with_criteria. Subject: Tivdak (tisotumab vedotin-tftv) IV. Status: CURRENT.

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Brief policy scope: Prior authorization is required and is provided initially for 6 months and may be renewed every 6 months; dosing is 2 mg/kg up to a maximum of 200 mg IV every 3 weeks (billing via HCPCS J9273, 1 billable unit = 1 mg, maximum 200 billable units (200 mg) every 21 days). Covered diagnoses include malignant neoplasm of vagina and cervix (ICD-10 codes C52, C53.0, C53.1, C53.8, C53.9). Universal and indication-specific criteria apply, including age (≥ 18 years) and required baseline and ongoing ophthalmic exams.

Continuation / Renewal Criteria

Renewal Criteria

Prior authorization validity may be renewed based upon the following criteria:

ALL of the following

Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug (examples include: peripheral neuropathy, hemorrhage, persistent or recurrent grade 2 or greater pneumonitis, ocular adverse reactions such as conjunctival adverse reactions, dry eye, corneal adverse reactions, blepharitis, ulcerative keratitis, severe cutaneous adverse reactions including Stevens-Johnson Syndrome)

Applicable Codes

HCPCS CodeHCPCSCovered

J9273

Injection, tisotumab vedotin-tftv, 1 mg; 1 billable unit = 1 mg

NDCNDC

511440003-xx

Tivdak 40 mg as a lyophilized cake or powder in a single-dose vial for reconstitution

Covered Diagnosis Codes (ICD-10)ICD-10Covered

C52	Malignant neoplasm of vagina
C53.0	Malignant neoplasm of endocervix
C53.1	Malignant neoplasm of exocervix
C53.8	Malignant neoplasm of overlapping sites of cervix uteri
C53.9	Malignant neoplasm of cervix uteri, unspecified

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization validity will be provided initially for 6 months and may be renewed every 6 months thereafter. Providers must submit documentation that the patient meets the initial criteria specified in the policy.

Documentation Required

Baseline and ongoing ophthalmic exams

Provider must document an ophthalmic exam that includes visual acuity, a slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement. This exam must be performed at baseline, prior to every cycle for the first nine cycles, and thereafter as clinically indicated.

Visual acuity
Slit lamp anterior segment exam
Assessment of eye movement

Documentation Required

PD-L1 testing for combination therapy

When tisotumab vedotin is used in combination with pembrolizumab, document tumor PD-L1 expression with a combined positive score (CPS) ≥1 as determined by an FDA-approved assay or a CLIA-compliant test.

Denial Risk

Renewal requires disease control and tolerability

Renewal of prior authorization may be denied if the patient has disease progression or unacceptable toxicity, or otherwise fails to meet ongoing criteria (including performance status and concomitant therapy requirements). Examples of unacceptable toxicity that may lead to denial include peripheral neuropathy, hemorrhage, persistent or recurrent grade ≥2 pneumonitis, ocular adverse reactions (such as conjunctival reactions, dry eye, corneal reactions, blepharitis, ulcerative keratitis), and severe cutaneous adverse reactions including Stevens-Johnson Syndrome.

Billing Rule

HCPCS unit reporting

Report HCPCS code J9273 with 1 billable unit = 1 mg of tisotumab vedotin. Do not bill more than 200 billable units (200 mg) per 21-day cycle.

J9273 = Injection, tisotumab vedotin-tftv, 1 mg (1 unit = 1 mg)
Maximum 200 billable units (200 mg) every 21 days

Clinical Evidence & References

Evidence sources cited in the brief:

• Package insert: Tivdak [package insert], Seagen, April 2024.

• Key trial: innovaTV 204/GOG-3023/ENGOT-cx6 phase 2 study (Lancet Oncol. 2021).

• Additional evidence: innovaTV 205/GOG-3024/ENGOT-cx8 and NEJM 2024 correspondence.

Background

Background: Tisotumab vedotin (Tivdak) is an intravenous antibody-drug conjugate.

FDA-approved and compendium-recommended uses: The drug has FDA-approved indications and compendium-recommended uses for recurrent or metastatic cervical cancer and for vaginal cancer per referenced clinical trials and product labeling.

Route and formulation: Administered by intravenous infusion; dosing for all indications is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks. Billing code: J9273 (1 mg = 1 billable unit). Covered ICD-10 diagnoses include C52 (vagina) and C53.0, C53.1, C53.8, C53.9 (cervix).

Definitions

Billable unit1 billable unit = 1 mg of tisotumab vedotin (per J9273 descriptor)

Subsequent therapyTherapy used after prior systemic treatment(s) for recurrent or metastatic disease (policy context)