CurrentEmblemHealthPolicy N/A

Tivdak (tisotumab vedotin-tftv) Usage Policy

Defines accepted indications, clinical criteria, exclusions, monitoring, and billing code for Tivdak (tisotumab vedotin-tftv) for cancer treatment requests processed by Evolent on behalf of EmblemHealth across commercial and government lines of business.

Policy Summary

PayerEmblemHealth

PolicyTivdak (tisotumab vedotin-tftv) Usage Policy

Policy CodePolicy N/A

Change TypeTemplate conversion and reference updates

Effective Date

Next Review Date

Key ActionDocument that use is supported by FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

SourceLink

POLICY UPDATE CHANGES

Policy converted to new Evolent guideline template in July 2025 and replaced UM ONC_1449 Tivdak policy; updated references.

July 2024 update changed NCH verbiage to Evolent.

1Primary covered indication (cervical cancer)

1HCPCS drug code listed

3Key exclusion categories

Coverage Summary & Indications

Defines accepted indications, clinical criteria, exclusions, monitoring, and billing code for Tivdak (tisotumab vedotin‑tftv) for cancer treatment requests processed by Evolent on behalf of EmblemHealth across commercial and government lines of business. This policy applies to medication requests processed by Evolent and outlines that use must be supported by FDA labeling, CMS‑approved compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15. Coverage stance: covered_with_criteria.

General Coverage Requirements

Tivdak is covered when ALL of the following are met:

ALL of the following

Supportive evidence requirement: Use is supported by one of: FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements
Continuation exemption
- Member has not experienced disease progression on the requested medication
- Requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationno lapse > 30 days within last year
- Additional medication(s) are not being added to the continuation request

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Coverage for Cervical Cancer

Tivdak monotherapy for recurrent or metastatic cervical cancer is covered when ALL of the following are met:

ALL of the following

Diagnosis: recurrent or metastatic cervical cancer
Prior platinum therapy: Disease progression on or after platinum‑containing therapy
PD-L1 status specific requirement
- PD-L1 positive: If tumor PD‑L1 positive (CPS >= 1): prior therapy with pembrolizumab (Keytruda) is requiredCPS >= 1
- PD-L1 negative: If tumor PD‑L1 negative (CPS < 1): prior therapy with pembrolizumab (Keytruda) is not requiredCPS < 1

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Exclusion / Not Medically Necessary Criteria

Tivdak is NOT covered when ANY of the following exclusion criteria are present:

ANY of the following

Progression on therapy: Disease progression while taking Tivdak (tisotumab vedotin‑tftv)
Concurrent therapy: Concurrent use of other anticancer therapies
Dose limit: Dosing exceeds single dose limit of 2 mg/kg (maximum 200 mg for weight >= 100 kg)2 mg/kg; max 200 mg for weight >= 100 kg
Investigational/off-label: Investigational use for off‑label indication lacking sufficient evidence or not generally accepted by the medical community per CMS compendia or acceptable peer‑reviewed literature
Sufficient evidence considerations per policy (study representation, outcomes, design); case reports/abstracts insufficient

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Prior Authorization, Documentation, and Billing Rules

Documentation Required

Supportive evidence requirement

Document that use is supported by FDA labeling, CMS‑approved compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Prior therapy documentation for cervical cancer

Provide documentation of prior platinum‑containing therapy. If the tumor PD‑L1 Combined Positive Score (CPS) is >= 1, also document prior pembrolizumab (Keytruda) therapy.

Documentation Required

Ophthalmic exam and monitoring

Conduct and document an ophthalmic exam including assessment of ocular symptoms, visual acuity, and slit lamp anterior segment exam prior to initiation, before every cycle for the first nine cycles, and as clinically indicated. Document adherence to required premedication and eye care and any actions taken (withhold, resume, reduce dose, or discontinue) based on severity.

Billing Rule

Dose limit enforcement

Ensure single doses do not exceed 2 mg/kg and the single dose maximum is 200 mg for patients weighing >=100 kg. Claims may be denied if dosing exceeds these limits.

J9273

Denial Risk

Investigational/off‑label exclusion

Requests for investigational or off‑label indications that lack support from CMS‑recognized compendia or acceptable peer‑reviewed literature may be denied as not approvable and not reimbursable.

Documentation Required

Continuation exemption documentation

For continuation exemption of a not‑approvable medication, document that the member has not experienced disease progression on the requested medication, that the medication was used within the last year without a lapse of more than 30 days of active authorization, and that no additional medications are being added to the continuation request.

Evidence Summary

Key clinical evidence and information sources cited: the pivotal trials innovaTV‑301 (NEJM 2024) and innovaTV‑204 (Lancet Oncology), and reference drug information sources including Clinical Pharmacology (Elsevier) 2025 and Micromedex Drugdex 2025, as well as the NCCN 2025 compendium.

Surface thresholds

PD-L1 CPS threshold>= 1 defines PD-L1 positive (CPS >= 1)

Single dose maximum2 mg/kg per dose, up to a maximum of 200 mg for patients >= 100 kg

Continuation lapse windowContinuation exemption requires use within the last year without a lapse of more than 30 days of having an active authorization

Background & Definitions

This guideline specifies Evolent's requirements for processing Tivdak requests, noting that Evolent is responsible for processing medication requests and that uses must be supported by FDA labeling, CMS‑approved compendia, NCCN, ASCO, or acceptable peer‑reviewed literature. The policy emphasizes ophthalmic monitoring because of a US Boxed Warning for severe ocular toxicities; an ophthalmic exam (ocular symptoms assessment, visual acuity, and slit lamp anterior segment exam) is required prior to initiation, before every cycle for the first nine cycles, and as clinically indicated, with adherence to required premedication and eye care.

PD‑L1 CPS: Combined Positive Score (CPS); CPS >= 1 is considered PD‑L1 positive per policy.

Policy Summary

PayerEmblemHealth

PolicyTivdak (tisotumab vedotin-tftv) Usage Policy

Policy CodePolicy N/A

Change TypeTemplate conversion and reference updates

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Tivdak (tisotumab vedotin-tftv) Usage Policy

Coverage Summary & Indications

Applicable Codes

Prior Authorization, Documentation, and Billing Rules

Evidence Summary

Background & Definitions

Policy Revision History