CurrentCentenePolicy N/A

Fruquintinib (Fruzaqla) — Coverage Criteria

Defines Centene-affiliated health plans' medical necessity criteria for coverage of fruquintinib (Fruzaqla) in adults with metastatic colorectal cancer previously treated with standard chemotherapy and targeted agents; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyFruquintinib (Fruzaqla) — Coverage Criteria

Policy CodePolicy N/A

Change TypeClarification

Effective Date03.01.24

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation showing progression through required CRC therapies and RAS wild-type status when applicable.

SourceLink

POLICY UPDATE CHANGES

Clarified RAS wild-type is mutation negative and references reviewed and updated.

Adults with metastatic CRCFDA-indicated population

6 moInitial authorization

12 moRenewal authorization

3–5 mg (days 1–21 q28d)Dose guidance

1 mg, 5 mgFormulations

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Coverage Criteria for Fruquintinib (Fruzaqla)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval - CRC: Member has colorectal cancer; age ≥ 18 years; prescribed by or in consultation with an oncologist; documentation of RAS (KRAS or NRAS) wild-type gene status (i.e., mutation negative); member has progressed through all available regimens for CRC including: (a) fluoropyrimidine (5-FU or capecitabine); (b) oxaliplatin; (c) irinotecan; (d) an anti-VEGF agent (e.g., bevacizumab, ramucirumab, aflibercept); and if tumor is RAS wild-type and medically appropriate, an anti-EGFR agent (e.g., cetuximab, panitumumab); prescribed as a single agent; member must use fruquintinib if available unless contraindicated or causes clinically significant adverse effects; dose is between 3 mg and 5 mg PO once daily on days 1-21 of each 28-day cycle; prescribed regimen must be FDA-approved or recommended by NCCN (off-label uses require supporting evidence).dose 3-5 mg days 1-21 q28d

Approval duration: 6 months

inv-02: Continuation Therapy

Covered when ALL of the following are met for continued therapy:

Continued Therapy: Member is currently receiving Fruzaqla via the Centene benefit or has documentation of receiving Fruzaqla for a covered indication and has received it for at least 30 days; member is responding positively to therapy; prescribed as a single agent; member must use fruquintinib if available unless contraindicated or causes clinically significant adverse effects; if request is for a dose increase, new dose must be between 3 mg and 5 mg PO once daily on days 1-21 of each 28-day cycle or be supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose 3-5 mg days 1-21 q28d

Approval duration: 12 months

Use of fruquintinib (Fruzaqla) for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the payer’s applicable off‑label use policies (e.g., CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP PMN.53 for Medicaid) or the member’s evidence of coverage.

For situations not covered by this policy, off‑label requests must include supporting clinical evidence and rationale per the referenced off‑label use policies. Documentation should demonstrate that the requested use is supported by peer‑reviewed literature, recognized compendia, or other clinical evidence showing efficacy and safety; absent that documentation, the request will be denied.

Dosing and Regimen Guidance

Regimen	Coverage status
5 mg PO once daily on days 1-21 of each 28-day cycle (maximum); permanently discontinue in patients unable to tolerate 3 mg PO once daily

Drug/Formulation and Dose Constraints

Neutral — drug/formulation detailsNDC

NDC not listed

No NDCs provided in the policy; capsule strengths listed (1 mg, 5 mg).

inv-06: Dose constraints

Dose range3 mg to 5 mg orally once daily on days 1–21 of each 28‑day cycle

Maximum dose5 mg PO once daily on days 1–21 of each 28‑day cycle

Tolerability threshold / discontinuationPermanently discontinue if the patient is unable to tolerate 3 mg PO once daily

Dose increase constraint (continuation)Any dose increase must remain within 3–5 mg PO on days 1–21 of each 28‑day cycle or be supported by practice guidelines/peer‑reviewed literature

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization and Approval Durations

Prior authorization may be required. Initial approvals are granted for 6 months. Continuation (renewal) approvals are granted for 12 months when continuation criteria are met.

Initial approval duration: 6 months
Continuation approval duration: 12 months

Step Therapy

Required Prior Therapies

Member must have progressed through available regimens for colorectal cancer unless contraindicated or clinically significant adverse effects occurred. Required prior therapies include: fluoropyrimidine (5‑fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti‑VEGF agent (e.g., bevacizumab), and if tumor is RAS wild‑type, an anti‑EGFR agent (e.g., cetuximab or panitumumab).

Required regimens: fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy
Required biologics: anti‑VEGF agent; if RAS wild‑type, anti‑EGFR agent

Intended Line of Therapy

inv-14: salvage

Line: Fruquintinib is indicated after progression on fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type and appropriate, an anti-EGFR therapy.

FDA-approved indication

Biomarker Requirements

inv-15: RAS (KRAS or NRAS)

Required biomarker statusRAS (KRAS or NRAS) — wild‑type (mutation negative)

DocumentationDocumentation of RAS (KRAS or NRAS) wild‑type gene status is required for initial approval

Clinical noteIf tumor is RAS wild‑type and medically appropriate, anti‑EGFR therapy should have been used prior to fruquintinib per criteria

Definitions

inv-12: Fruquintinib (Fruzaqla)

Generic name / brandFruquintinib (Fruzaqla)

Drug class / mechanismVascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor

Indication context (from policy)Indicated for adults with metastatic colorectal cancer previously treated with standard chemotherapy and targeted agents per policy background

inv-13: CRC

AbbreviationCRC = colorectal cancer

DefinitionColorectal cancer (CRC) — malignancy of the colon or rectum referenced throughout this policy

Context in criteria

Background

Fruquintinib is a vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor indicated in the metastatic colorectal cancer treatment setting described in this policy. When requested for non‑approved indications, coverage follows the off‑label documentation requirements noted above and per the payer’s off‑label use policies.

Revision History

2025-02-25annual_review_clarificationLatest

Clarified that RAS (KRAS or NRAS) wild-type denotes mutation-negative status and updated reviewed references during the 1Q 2025 annual review.

2023-12-11policy_creation

Policy created (initial document).

2024-02-24p_and_t_approval