ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Fotivda (tivozanib) coverage for cancer treatment

Defines accepted indications, continuation conditions, exclusions, and coding for Fotivda (tivozanib) for members across lines of business. Specifies required evidence sources for off-label use and operational continuation rules.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFotivda (tivozanib) coverage for cancer treatment

Policy CodePolicy N/A

Change TypeUpdated exclusion criteria; template conversion

Effective Date

Next Review Date

Key ActionAll medication requests for Fotivda must be processed/authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and updated exclusion criteria (March 2025).

Updated NCH verbiage to Evolent (March 2024).

1Primary covered indication

5Referenced evidence sources

1J-code listed

Coverage Summary

Coverage stance: covered_with_criteria. This policy defines accepted indications for Fotivda (tivozanib) including the FDA-approved and compendia- or literature-supported off-label uses. The primary covered indication is for metastatic or unresectable renal cell carcinoma in patients who have experienced disease progression on a VEGFR tyrosine kinase inhibitor (e.g., lenvatinib, axitinib, cabozantinib, pazopanib) and on one or more immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, avelumab, ipilimumab). Continuation is permitted when recency and progression criteria are met. The policy applies across multiple lines of business including Medicaid and Medicare Advantage and other listed lines of business.

Initial Therapy Criteria

Initial Approval - Renal Cell Carcinoma

Fotivda (tivozanib) may be authorized when ALL of the following are met:

Member has metastatic or unresectable renal cell carcinoma
Disease progression on a VEGFR Tyrosine Kinase Inhibitor (e.g., lenvatinib, axitinib, cabozantinib, or pazopanib)
Disease progression on one or more Immune Checkpoint Inhibitor (e.g., pembrolizumab, nivolumab, avelumab, ipilimumab)

Continuation Therapy Criteria

Continuation Therapy

Continuation requests are allowed when ALL of the following are met:

Member has not experienced disease progression while taking the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationused within the last year with no lapse > 30 days of active authorization
No additional medication(s) are being added to the continuation request

Exclusion / Not Approvable Criteria

Fotivda is NOT approvable when ANY of the following apply:

Disease progression while taking Fotivda (tivozanib)
Concurrent use with other chemotherapy
Dosing exceeds single dose limit of Fotivda (tivozanib) 1.34 mg1.34 mg
Treatment exceeds the maximum limit of 21 (1.34 mg) or 21 (0.89 mg) capsules per month21 capsules (1.34 mg) or 21 capsules (0.89 mg) per month
Investigational use of Fotivda for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community
Off-label use without support from FDA labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS manual Chapter 15 requirements

Evidence Sufficiency Considerations (for off-label use)

Evidence must satisfy ALL of the following considerations to be deemed sufficient:

Whether the clinical characteristics of the patient and the cancer are adequately represented in the published evidence
Whether the administered chemotherapy/biologic/immune/targeted/other oncologic therapy regimen is adequately represented in the published evidence
Whether reported study outcomes represent clinically meaningful outcomes (ASCO-recommended: e.g., hazard ratio < 0.80 and recommended survival benefit for OS and PFS ≥ 3 months)HR < 0.80; OS/PFS ≥ 3 months
Whether the experimental design is appropriate for the investigative question
Non-randomized clinical trials with a significant number of subjects may provide supportive evidence
Case reports and abstracts without full articles generally do not provide adequate evidence

Off-label use must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15 (policy mirrors provider documentation requirements).

Provider Actions & Operational Rules

Prior Authorization

Evolent prior authorization required

All medication requests for Fotivda (tivozanib) must be processed/authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Affected code: J8999

Documentation Required

Support for off-label use

Off-label indications for Fotivda must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial if exclusion criteria met

Claims may be denied when any exclusion criteria apply. Examples that may trigger denial include: disease progression while taking Fotivda; concurrent use with other chemotherapy; dosing that exceeds the single dose limit of 1.34 mg or monthly capsule limits (21 capsules of 1.34 mg or 21 capsules of 0.89 mg); and investigational or off-label use lacking sufficient evidence or not generally accepted by the medical community.

Disease progression on Fotivda (tivozanib)
Concurrent chemotherapy use
Single dose > 1.34 mg or monthly capsules > 21 (1.34 mg or 0.89 mg)
Investigational or off-label use without sufficient evidence

Background & Definitions

Background: This policy defines accepted indications for tivozanib (Fotivda), covering the FDA-approved use and off-label uses supported by CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. Continuation requests are permitted only when the member has not experienced disease progression on the medication, the medication was used within the last year with no lapse of more than 30 days in active authorization, and no additional medications are being added. The policy and associated criteria apply across lines of business, including Medicaid and Medicare Advantage.

Revision History

2025-03material_changeLatest

Converted to new Evolent guideline template; replaced UM ONC 1425 Fotivda (tivozanib) and updated exclusion criteria (including limits on dosing, monthly capsule limits, concurrent chemotherapy, investigational/off-label evidence requirements).

2024-03administrative_update

Terminology/administrative update: updated NCH verbiage to Evolent.

2025-03last_reviewLatest

Policy last reviewed in 2025-03.