Fotivda (tivozanib) — Prior Authorization and Coverage Criteria
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Prior authorization and coverage criteria for Fotivda (tivozanib) for treatment of relapsed or refractory advanced renal cell carcinoma; affects prescribers and members covered by Colorado Rocky Mountain Health Plans and UnitedHealthcare Pharmacy prior authorization programs.
No material clinical or coverage changes in this revision.
Coverage Criteria for Fotivda (tivozanib)
Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization
Covered when ALL of the following are met
Authorization issued for 12 months
Patients <19 years
Automatic processing for pediatric prescriptions
Authorization will be issued for 12 months
NCCN Recommended Regimens
Supporting guideline recognition
May support coverage decisions
State law may affect coverage determinations. Some states mandate benefit coverage for off-label use of medications for certain diagnoses or circumstances, and may require use of specified compendia. Where such state mandates apply, they supersede the language in this policy or any notification criteria. Providers should confirm member-specific benefit plan terms and applicable state requirements when seeking coverage for off-label Fotivda use.
Initial Therapy Requirements
Initial Therapy
Covered when ALL of the following are met
Authorization for 12 months
Reauthorization / Continuation Criteria
Reauthorization / Continuation
Covered when ALL of the following are met
Authorization issued for 12 months
Provider Actions and Requirements
Prior authorization required; approvals issued for 12 months
Prior authorization is required for Fotivda. When the coverage criteria are met, initial approvals and reauthorizations are issued for a 12-month period.
Prior systemic therapy requirement: ≥2 therapies
Patient must have received two or more prior systemic therapies before Fotivda will be approved for advanced renal cell carcinoma.
Supporting documentation and automated approval allowed; supply limits apply
UnitedHealthcare may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval and re‑approval processes vary by program. A supply limit may apply and will be enforced during claim processing.
- Approvals can be based on previous claims or medication history, ICD-10 diagnosis coding, and/or claim-logic rules.
- Automated approval and re-approval processes vary by program and therapeutic class.
- Supply limits may be in place and enforced at claim processing.
Denial risk when initial criteria or prior therapies are not documented
Requests lacking documentation of (1) advanced renal cell carcinoma with relapsed or refractory disease or (2) at least two prior systemic therapies may be denied.
- Denial risk if diagnosis of advanced RCC is not documented.
- Denial risk if disease status (relapsed or refractory) is not documented.
- Denial risk if documentation does not show the patient received ≥2 prior systemic therapies.
Step Therapy / Prior Treatment Requirements
| Step | Requirement |
|---|---|
| 1 | Patient must have received two or more prior systemic therapies before initiating Fotivda (tivozanib) for advanced renal cell carcinoma. |
Background
Fotivda (tivozanib) is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. Coverage in this policy aligns with recognized guideline support and the Fotivda prescribing information for this indication.
For adults, prior authorization is required and approval is contingent on documentation of (1) a diagnosis of advanced renal cell carcinoma that is relapsed or refractory and (2) prior exposure to at least two systemic therapies. Authorization, when criteria are met, is issued for 12 months; continuation approvals similarly require absence of disease progression on therapy.
Definitions
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