CurrentCignaPolicy N/A

Fotivda (tivozanib) — Coverage Criteria for Relapsed or Refractory Renal Cell Carcinoma

Coverage policy governing prior authorization and medical necessity criteria for Fotivda (tivozanib) for treatment of relapsed or refractory advanced renal cell carcinoma in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFotivda (tivozanib) — Coverage Criteria for Relapsed or Refractory Renal Cell Carcinoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateApr 16, 2025

Key ActionObtain prior authorization and document that the patient is ≥18 years and has received at least two prior systemic regimens for renal cell carcinoma.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2required prior systemic regimens for coverage

≥18minimum age for approval

1 yeartypical approval period

NCCN 2Aguideline recommendation

Coverage Criteria for Fotivda (tivozanib)

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Fotivda; approvals are provided for the duration noted (see FDA‑Approved Indication criteria).

Fotivda (tivozanib tablets - AVEO)

Step Therapy

Prior Systemic Therapy Requirement

Patient must have tried at least two other systemic regimens for renal cell carcinoma prior to approval. Examples include: Inlyta + Keytruda; Cabometyx + Opdivo; Lenvima + Keytruda; Yervoy + Opdivo; sunitinib; pazopanib; Lenvima + everolimus.

Documentation Required

Submission, Documentation, and Coding-Related Denial Risk

Providers must submit prior authorization requests in accordance with the applicable benefit plan document and use the most appropriate diagnosis and procedure codes as of the date of service. Claims submitted without covered diagnosis/procedure codes or not accompanied by covered code(s) under the applicable coverage policy may be denied as not covered.

Regimen	Indication / Line of therapy	Coverage
Fotivda (tivozanib tablets)	Subsequent therapy for relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have received ≥ two prior systemic regimens; patient age ≥ 18 and relapsed or Stage IV disease required	Covered

Line of Therapy Criteria

inv-10: subsequent — Line of therapy requirement

Line of therapy requirement: Used as subsequent therapy after two or more prior systemic therapies (i.e., patient has received ≥ two prior systemic regimens).>= two prior systemic therapies

NCCN gives Fotivda a category 2A recommendation as a subsequent therapy option for clear cell histology in patients who have received ≥ two systemic therapies.

Definitions

Definition: Relapsed or Stage IV renal cell carcinoma

Age requirementPatient is ≥ 18 years of age.

Disease statusRelapsed or Stage IV (metastatic) renal cell carcinoma.

Prior therapy requirementPatient has tried at least two other systemic regimens for renal cell carcinoma.

Approval durationIf criteria met, approve for 1 year.

Examples of prior systemic regimensIncludes regimens such as axitinib + pembrolizumab; cabozantinib + nivolumab; lenvatinib + pembrolizumab; ipilimumab + nivolumab; sunitinib; pazopanib; lenvatinib + everolimus.