CurrentAetnaPolicy N/A

TIVDAK (tisotumab vedotin-tftv) Medication Precertification Request - Coverage Criteria

Precertification request form and instructions for Aetna providers seeking authorization for TIVDAK (tisotumab vedotin-tftv) medication; used for start or continuation of therapy and applicable to Aetna members (Medicare Advantage Part B has a separate form).

Policy Summary

PayerAetna

PolicyTIVDAK (tisotumab vedotin-tftv) precertification request form / coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Aetna precertification request form with required clinical documentation to obtain authorization for TIVDAK.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page

1-866-752-7021precert phone

1-888-267-3277precert fax

TIVDAKdrug

Coverage and Precertification Criteria

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Form completion and clinical documentation: All required sections of the precertification form (patient, insurance, prescriber, dispensing/administration, product, diagnosis, and clinical information) must be completed and legible.

Supporting documentation may be requested by the plan.

Diagnosis context: Provider should indicate if the diagnosis is cervical cancer and whether use is for recurrent or metastatic disease or other setting.

Form specifically queries cervical cancer and disease setting.

Prior therapy for initiation: For initiation requests, indicate whether the patient experienced disease progression on or after chemotherapy.

This implies documentation of prior chemotherapy and progression if applicable.

Continuation criteria: For continuation requests, provide evidence of lack of unacceptable toxicity and absence of disease progression while on current regimen; if toxicity or progression present, indicate details.

Continuation section explicitly asks about toxicity or progression.

The precertification form focuses clinical queries specifically on a diagnosis of cervical cancer. The form does not list any explicit exclusions; instead it limits required clinical information to items related to the cervical cancer diagnosis and the treatment setting (for example, whether the drug is requested for recurrent or metastatic disease, or other specified setting). All required clinical fields in section G must be completed for the request to be considered.

The plan may request additional information or clarification as needed to evaluate a precertification request. The acknowledgement warns that knowingly providing materially false or fraudulent information is a crime and may result in criminal and civil penalties; the plan may deny requests when fraudulent or materially false information is provided.

Relevant Billing and Diagnosis Codes

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be listed by provider on form

Diagnosis codes (ICD-10)ICD-10

Primary ICD Code	Primary diagnosis ICD code to be provided by prescriber
Secondary ICD Code	Secondary diagnosis ICD code to be provided by prescriber
Other ICD Code	Additional diagnosis ICD codes to be provided

What Providers Must Do

Prior Authorization

Prior Authorization Required

Precertification is required for TIVDAK (tisotumab vedotin-tftv). Providers must submit the Aetna precertification request form (or the Medicare Request Form for Medicare Advantage Part B) to obtain authorization before starting or continuing therapy.

Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277
Use Medicare Request Form for Medicare Advantage Part B

Documentation Required

Required Documentation for Precertification

Complete and legible documentation must be provided with the precertification request. The form requires patient, insurance, prescriber, place of administration, product and clinical details for review.

Patient information: name, DOB, contact, weight, height, allergies
Insurance information: Aetna member ID, group #, other coverage details, Medicare/Medicaid IDs if applicable
Prescriber information: name, credentials, address, phone, NPI, state license
Dispensing/provider and administration details: place of administration, facility/agency names, administration CPT codes, pharmacy or dispensing provider, TIN/PIN
Product information: requested drug (TIVDAK), dose and frequency
Diagnosis information: primary and secondary ICD-10 codes

Documentation Required

Prior Chemotherapy / Progression Information

The precertification form specifically asks whether the patient experienced disease progression on or after chemotherapy and requests the clinical setting (recurrent, metastatic, other). Documentation of prior chemotherapy and progression (or lack thereof) must be provided for initiation requests.

For initiation: indicate clinical setting (recurrent, metastatic, other) and whether disease progressed on or after chemotherapy
For continuation: provide evidence of unacceptable toxicity or disease progression while on the current regimen

Denial Risk

Incomplete Information May Trigger Denial or Delay

Failure to complete required clinical information or to provide requested additional information may result in a delay or denial of the precertification request. The plan may request clarification or additional records as needed.

All required clinical fields in Section G must be completed for review
Signature and date required on acknowledgement section

Policy Background

TIVDAK (tisotumab vedotin-tftv) is an oncologic specialty medication and this precertification request form centers on its use for cervical cancer. Section G collects required clinical information relevant to initiation (including the disease setting and whether the patient experienced disease progression on or after chemotherapy) and continuation (including whether there is evidence of unacceptable toxicity or disease progression while on the current regimen). Providers must complete these clinical items to support authorization consideration.

Request Type Definitions

Initiation Requests

TermInitiation Requests

DefinitionA precertification request submitted when starting TIVDAK; form requires indication of clinical setting (recurrent, metastatic, or other) and whether the patient experienced disease progression on or after chemotherapy.

Required clinical infoClinical setting for use (recurrent, metastatic, other) and documentation of prior chemotherapy progression must be completed.

Continuation Requests

TermContinuation Requests

DefinitionA precertification request submitted for ongoing TIVDAK therapy; form requires documentation regarding unacceptable toxicity or disease progression on the current regimen.

Required clinical infoIndicate presence or absence of unacceptable toxicity or disease progression while on the current regimen; provide details if present.

Criteria for Initiation Requests

Initial therapy requirements

Initiation requests must indicate disease setting and prior chemotherapy progression.

Initiation evidence: Indicate the clinical setting for use (recurrent disease, metastatic disease, or other) and whether the patient experienced disease progression on or after chemotherapy.

Form lists checkboxes for disease setting and for progression on or after chemotherapy.

Criteria for Continuation Requests

Continuation therapy requirements

For continuation requests the form requires documentation regarding toxicity and disease progression while on the current regimen.

Continuation evidence: Provide documentation that there is no unacceptable toxicity and no disease progression while on the current regimen; if unacceptable toxicity or progression is present, provide details.

Form asks whether there is evidence of unacceptable toxicity or disease progression for continuation requests.

Step Therapy / Prior Treatment Documentation

Step	Requirement
1	For initiation requests: document diagnosis setting (recurrent, metastatic, or other) and indicate whether the patient experienced disease progression on or after chemotherapy (Yes/No).
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Place of Administration

Note

Specify place of administration

Indicate the place of administration on the form by selecting the appropriate option (self‑administered, physician's office, outpatient infusion center, or home infusion) and provide the corresponding site/contact details.

Select place of administration: Self‑administered, Physician's Office, Outpatient Infusion Center, or Home Infusion Center
Provide site phone, center/agency name and address as requested