CurrentMass General Brigham Health PlanPolicy N/A

Tivdak (tisotumab vedotin‑tftv) — Coverage Criteria (Medical Benefit)

Policy governs coverage and prior authorization requirements for Tivdak administered under the medical benefit (and available via pharmacy) for adult members with recurrent or metastatic cervical cancer in the MassHealth program.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTivdak (tisotumab vedotin‑tftv) — Coverage Criteria (Medical Benefit)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and provide physician documentation confirming diagnosis, oncologist prescriber, weight-based dosing, age ≥18, and prior inadequate response/adverse reaction/contraindication to one line of platinum-based chemotherapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for coverage

1 lineRequired prior chemotherapy

6 moInitial approval duration

12 moReauthorization duration

Coverage Criteria for Tivdak (tisotumab vedotin-tftv)

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Main coverage criteria: 1. Diagnosis of recurrent or metastatic cervical cancer; 2. Prescriber is an oncologist; 3. Appropriate dosing documented (weight required); 4. Member is ≥18 years of age; 5. Physician documentation of an inadequate response, adverse reaction, or contraindication to one line of platinum-based chemotherapy; 6. If PD-L1 positive, TMB-H, or MSI-H/dMMR positive, physician documentation of an inadequate response, adverse reaction, or contraindication to pembrolizumab (Keytruda).

TMB-H = tumor mutational burden-high; PD-L1 = programmed cell death ligand; MSI-H = microsatellite instability-high; dMMR = deficient mismatch repair

Operational notes: Prior authorization is required when Tivdak is billed under the medical benefit. Initial approvals will be granted for 6 months and reauthorizations for 12 months.

Documentation must be provided to support each numbered criterion above.

Continuation of Therapy / Reauthorization — Reauthorization requirements

Reauthorization requirements

Reauthorization criteria: Physician attestation of continuation of therapy and documentation of a positive clinical response to therapy.

Reauthorizations will be granted for 12 months; prior authorization review required.

Authorizations for members who are new to the plan and are currently receiving Tivdak may be reviewed on a case-by-case basis. Such reviews do not apply when the product was obtained as samples or through the manufacturer's patient assistance programs.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for tivdak (tisotumab vedotin‑tftv) when billed under the medical benefit. Authorizations for members new to the plan who are already receiving treatment may be reviewed case-by-case (excluding samples or manufacturer patient assistance program supply). Contact Medical Benefit prior authorization: 833-895-2611.

Medical Benefit prior authorization phone: 833-895-2611

Step Therapy

Step therapy and biomarker considerations

Policy requires prior platinum‑based chemotherapy (one line) before tivdak for coverage. If the tumor is PD‑L1 positive, TMB‑H, or MSI‑H/dMMR, documentation must show prior inadequate response, intolerance, or contraindication to pembrolizumab (Keytruda) as well.

Step therapy: Prior 1 line of platinum‑based chemotherapy required
Biomarker considerations: If PD‑L1+, TMB‑H, or MSI‑H/dMMR — document prior inadequate response/intolerance/contraindication to pembrolizumab

Documentation Required

Required documentation

Provide physician documentation confirming diagnosis, prescriber specialty, dosing, age, and prior therapy details. For initial authorization include: weight for dosing, confirmation prescriber is an oncologist, member age ≥18, diagnosis of recurrent or metastatic cervical cancer, and documentation of inadequate response, adverse reaction, or contraindication to one line of platinum‑based chemotherapy. If applicable, include biomarker test results and documentation of prior pembrolizumab therapy failure/intolerance/contraindication. For continuation/reauthorization include physician attestation of continued positive response to therapy.

Required documentation: diagnosis of recurrent/metastatic cervical cancer; prescriber specialty = oncologist; member weight for dosing; member ≥18 years; documentation of inadequate response/adverse reaction/contraindication to one line platinum‑based chemotherapy
If PD‑L1+, TMB‑H, or MSI‑H/dMMR: biomarker results and documentation of inadequate response/adverse reaction/contraindication to pembrolizumab
Continuation: physician attestation of continued positive response to therapy

Denial Risk

Triggers for denial

Denial is likely if required criteria or documentation are missing. Common triggers for denial include absence of a diagnosis of recurrent or metastatic cervical cancer, prescriber is not an oncologist, missing weight for dosing, member age <18, lack of documentation of prior platinum‑based chemotherapy failure/intolerance/contraindication, or — when biomarker positive — lack of documentation of prior pembrolizumab failure/intolerance/contraindication.

Denial triggers: no diagnosis of recurrent/metastatic cervical cancer; prescriber not an oncologist; missing weight for dosing; member <18 years; no documentation of prior 1 line platinum‑based chemotherapy (inadequate response/intolerance/contraindication)
If PD‑L1+, TMB‑H, or MSI‑H/dMMR and no documentation of prior pembrolizumab failure/intolerance/contraindication — denial risk

Biomarker Requirements and Definitions

inv-13: PD-L1 — biomarker item

DefinitionProgrammed cell death ligand (PD-L1)

Policy implicationIf PD-L1 positive, physician documentation of inadequate response, adverse reaction, or contraindication to pembrolizumab (Keytruda) is required

ContextListed as a biomarker considered when determining prior treatment with immune checkpoint inhibitor

inv-14: TMB-H — biomarker item

DefinitionTumor mutational burden-high (TMB-H)

Policy implicationIf TMB-H positive, physician documentation of inadequate response, adverse reaction, or contraindication to pembrolizumab (Keytruda) is required

ContextTMB-H is a biomarker that may trigger requirement for prior pembrolizumab documentation before coverage

inv-15: MSI-H/dMMR — biomarker item

DefinitionMicrosatellite instability-high / deficient mismatch repair (MSI-H/dMMR)

Policy implicationIf MSI-H/dMMR positive, physician documentation of inadequate response, adverse reaction, or contraindication to pembrolizumab (Keytruda) is required

ContextMSI-H/dMMR is treated as a biomarker that may affect prior immunotherapy requirements for coverage

Background — Drug Indication and Clinical Context

Tivdak (tisotumab vedotin‑tftv) is indicated for adults with recurrent or metastatic cervical cancer after progression on or after chemotherapy. Prior authorization is required when billed under the medical benefit, and coverage is available with specified clinical criteria including a diagnosis of recurrent or metastatic cervical cancer, a prescriber who is an oncologist, documentation of appropriate weight‑based dosing, age ≥18 years, and physician documentation of inadequate response, adverse reaction, or contraindication to one line of platinum‑based chemotherapy. Initial approvals are granted for 6 months with reauthorizations for 12 months.

Key Definitions

inv-09: TMB-H — Tumor mutational burden-high

TermTumor mutational burden-high (TMB-H)

Role in coverageWhen positive, documentation of inadequate response/adverse reaction/contraindication to pembrolizumab is required prior to Tivdak coverage

Abbreviation noteTMB-H defined in policy as 'tumor mutational burden-high'

inv-10: PD-L1 — Programmed cell death ligand

TermProgrammed cell death ligand (PD-L1)

Role in coverageIf PD-L1 positive, physician documentation of inadequate response/adverse reaction/contraindication to pembrolizumab is required prior to Tivdak coverage

Abbreviation notePD-L1 stands for programmed cell death ligand as used in the policy

inv-11: MSI-H/dMMR — Microsatellite instability-high / deficient mismatch repair

TermMicrosatellite instability-high / deficient mismatch repair (MSI-H/dMMR)

Role in coverageIf MSI-H/dMMR positive, physician documentation of inadequate response/adverse reaction/contraindication to pembrolizumab is required prior to Tivdak coverage

Abbreviation noteMSI-H and dMMR are defined in the policy as microsatellite instability-high and deficient mismatch repair, respectively