CurrentUnitedHealthcarePolicy N/A

Fotivda (tivozanib) prior authorization

This policy defines prior authorization and reauthorization criteria for Fotivda (tivozanib) for members, including special handling for patients under 19 and references to state mandates and NCCN recognition. It applies to UnitedHealthcare pharmacy benefit management programs.

Policy Summary

PayerUnitedHealthcare

PolicyFotivda (tivozanib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionDocument diagnosis of advanced relapsed or refractory renal cell carcinoma and confirm patient received two or more prior systemic therapies when submitting for initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

>=2prior systemic therapies required

age <19automatic processing without coverage review

NCCNNCCN recognition

Coverage Criteria — Fotivda (tivozanib)

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Authorization for adults: Diagnosis of advanced renal cell carcinoma (RCC); AND disease has relapsed OR disease is refractory; AND patient has received two or more prior systemic therapies

Authorization length 12 months. State mandates and member-specific benefit plans may supersede.

Continuation Therapy / Reauthorization — Reauthorization requires:

Reauthorization requires:

Reauthorization: Patient does not show evidence of progressive disease while on Fotivda therapy

Authorization issued for 12 months. State mandates and member-specific benefit plans may impact coverage.

Pediatric (<19 years) — Special handling for patients under 19 years of age

Special handling for patients under 19 years of age

Pediatrics (<19 years): Patient is less than 19 years of age — prescription will automatically process without a coverage review

Authorization will be issued for 12 months.

NCCN Recommended Regimens — Guidance note

Guidance note

NCCN Recommended Regimens: Drug recognized by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

NCCN recognition may support coverage decisions.

Provider Actions, Documentation & Authorization

Prior Authorization

Prior Authorization Required — Initial Authorization

Initial authorization requires all of the following: diagnosis of advanced renal cell carcinoma (RCC); disease that is relapsed or refractory; and documentation that the patient has received two or more prior systemic therapies. Authorizations are issued for 12 months.

Diagnosis: advanced renal cell carcinoma (RCC)
Disease status: relapsed or refractory
Prior therapy: received two or more prior systemic therapies
Authorization length: 12 months

Prior Authorization

Reauthorization Criteria

Reauthorization is approved when the patient does not show evidence of progressive disease while on Fotivda therapy. Authorizations are issued for 12 months.

Reauthorization criterion: no evidence of disease progression on therapy
Authorization length: 12 months

Note

Pediatrics (<19 years) — Automatic Approval

For patients under 19 years of age, Fotivda will be approved when the patient is less than 19 years old. Authorizations are issued for 12 months.

Age criterion: < 19 years
Authorization length: 12 months

Denial Risk

Prior Therapy Requirement

Prior therapy requirement: approval requires documentation that the patient has received two or more prior systemic therapies. Lack of documentation that the patient has received two or more prior systemic therapies may result in denial.

Required prior therapy: ≥ 2 systemic therapies
Denial risk if prior therapy not documented

Documentation Required

Supporting Documentation & Operational Notes

Supporting documentation may include prior claim or medication history, diagnosis codes (ICD-10), and other claim logic. Automated approval or reauthorization processes may be used based on available claim data. A supply limit may apply. State mandates, federal requirements, and member-specific benefit plans may impact coverage.

Acceptable documentation: prior claims, medication history, ICD-10 diagnosis codes
Operational note: automated approval/reauthorization may be used
Limit: supply limits may apply
Compliance: state mandates and member benefit plans may affect coverage

Background

Fotivda (tivozanib) is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma. The policy covers Fotivda for patients with a diagnosis of advanced RCC when the disease has relapsed or is refractory and the patient has received two or more prior systemic therapies. For pediatrics, prescriptions for members under 19 years will automatically process without coverage review (see pediatric criteria). Authorization for approved use is issued for 12 months.

Initial Therapy Criteria (Structured)

Initial Authorization — Initial authorization requirements

Initial authorization requirements

Initial Authorization: Diagnosis of advanced RCC; disease relapsed or refractory; patient has received two or more prior systemic therapies

Authorization length 12 months.

Continuation / Reauthorization Criteria (Structured)

Reauthorization — Reauthorization criteria

Reauthorization criteria

Reauthorization: Patient does not show evidence of progressive disease while on Fotivda therapy

Authorizations are issued for 12 months. State mandates and member-specific benefit plans may impact coverage.

Step	Requirement
1	Patient must have received two or more prior systemic therapies prior to initiation of Fotivda (tivozanib).

Policy Summary

PayerUnitedHealthcare

PolicyFotivda (tivozanib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionDocument diagnosis of advanced relapsed or refractory renal cell carcinoma and confirm patient received two or more prior systemic therapies when submitting for initial authorization.

SourceLink

On This Page

OpenPayer

Fotivda (tivozanib) prior authorization

Coverage Criteria — Fotivda (tivozanib)

Coding & Prior Therapy Summary

Provider Actions, Documentation & Authorization

Background

Definitions

Initial Therapy Criteria (Structured)

Continuation / Reauthorization Criteria (Structured)

Step Therapy Requirements

Quantity Limits

Site of Care