CurrentUnitedHealthcarePolicy 2026 P 1435-3

Fruzaqla (fruquintinib) prior authorization

Defines UnitedHealthcare prior authorization and notification requirements for Fruzaqla (fruquintinib) for treatment of metastatic colorectal cancer and specified appendiceal neoplasms; applies to members subject to pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyFruzaqla (fruquintinib) prior authorization

Policy CodePolicy 2026 P 1435-3

Change TypeAdded indication groupbackground revised

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization; approvals issued for 12 months when member meets diagnosis, prior-therapy, and RAS/anti‑EGFR logic.

SourceLink

POLICY UPDATE CHANGES

Added criteria for appendiceal neoplasms and cancers.

Updated background and references.

12 monthsAuthorization duration

3P&T approval years

1Program type

AppendicealNew indication group

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Initial Therapy - Metastatic Colorectal Cancer

Covered when ALL of the following are met:

Initial mCRC criteria: Diagnosis of colorectal cancer

Initial mCRC criteria: Disease is advanced OR metastatic

Initial mCRC criteria: Patient has been previously treated with all of the following: fluoropyrimidine-based chemotherapy (e.g., capecitabine, 5-FU); oxaliplatin-based chemotherapy (e.g., CAPEOX, FOLFOX); irinotecan-based chemotherapy (e.g., FOLFIRI, FOLFIRINOX); and anti-VEGF therapy (e.g., aflibercept, bevacizumab, ramucirumab)

Initial mCRC criteria

ONE of: Both of the following: disease is RAS wild-type AND patient has been previously treated with an anti-EGFR therapy (e.g., cetuximab, panitumumab)
OR: Disease is not RAS wild-type

Reauthorization - Metastatic Colorectal Cancer

Covered when the following is met:

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

Authorization issued for 12 months

Initial Therapy - Appendiceal Neoplasms and Cancers

Covered when ALL of the following are met:

Initial Appendiceal Neoplasms: One of the following diagnoses: appendiceal adenocarcinoma (AA) OR goblet cell adenocarcinoma (GCA) OR undifferentiated carcinoma not otherwise specified (UC-NOS)

Initial Appendiceal Neoplasms: Patient has been previously treated with all of the following: fluoropyrimidine-based chemotherapy (e.g., capecitabine, 5-FU); oxaliplatin-based chemotherapy (e.g., CAPEOX, FOLFOX); irinotecan-based chemotherapy (e.g., FOLFIRI, FOLFIRINOX); and anti-VEGF therapy (e.g., aflibercept, bevacizumab, ramucirumab)

Initial Appendiceal Neoplasms

ONE of: Both of the following: disease is RAS wild-type AND patient has been previously treated with an anti-EGFR therapy (e.g., cetuximab, panitumumab)

Reauthorization - Appendiceal Neoplasms and Cancers

Covered when the following is met:

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

Authorization issued for 12 months

This policy defines prior authorization and notification requirements for Fruzaqla (fruquintinib) when used for indications covered by the criteria. Members under age 19 will have prescriptions automatically processed without a coverage review. Where applicable, state mandates that require coverage for off-label use or the use of alternate compendium references take precedence and supersede the language in this document.

Initial Authorization Requirements

Initial Therapy Requirements

Initial authorization requirements by diagnosis (see specific diagnosis criteria below):

Initial Therapy Requirements: For metastatic colorectal cancer: meet all Initial mCRC criteria (diagnosis of colorectal cancer; disease advanced or metastatic; prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies; prior anti-VEGF therapy; and RAS/anti-EGFR treatment logic)

Authorization for 12 months

Initial Therapy Requirements: For appendiceal neoplasms and cancers: meet all Initial Appendiceal Neoplasms criteria (diagnosis of AA, GCA, or UC‑NOS; prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies; prior anti-VEGF therapy; and RAS/anti-EGFR treatment logic)

Authorization for 12 months

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Fruzaqla. Requests must document the diagnosis, disease stage, and that specified prior therapies were tried and failed or are contraindicated.

Prior Authorization Required — submit clinical documentation supporting diagnosis (ICD-10) and disease stage.
Include prior treatment history: fluoropyrimidine-based, oxaliplatin-based, irinotecan-based regimens, and anti-VEGF therapy; note anti-EGFR exposure when RAS wild-type status is claimed.
Authorization duration: up to 12 months for approved cases.

Step Therapy

Step Therapy / Supply Limits May Apply

Supply limits and step therapy may apply. Program-level automated approval or reauthorization may use claims, medication history, and diagnosis codes as supporting evidence.

Step therapy/limits may restrict initial or subsequent fills — verify program-level quantity limits before billing.
Automated reauthorization processes may rely on claims and medication history; manual review may still be required if criteria are not met.

Documentation Required

Permissible Documentation Sources

Acceptable sources to support an authorization include medical records, prior claims, fill history (pharmacy claims), and documented ICD-10 diagnosis codes. Where available, lab/pathology reports or molecular testing results (e.g., RAS status) should be included.

Permissible documentation: medical chart notes, procedure/infusion claims, pharmacy fill history, ICD-10 diagnosis codes, and molecular testing reports (e.g., RAS status).
For members under 19, prescriptions may process without coverage review — verify age-specific processing rules.

Denial Risk

Denial Triggers / Risk

Requests that do not meet the stated clinical criteria (diagnosis, disease stage, required prior therapies, or RAS/anti-EGFR requirements where applicable) are subject to denial.

Denial triggers include: missing documentation of required prior therapies, unsupported diagnosis or stage, absence of molecular testing when required (e.g., RAS status), or evidence of alternative unmet criteria.
Automated approval pathways based on claims/medication history will not override manual denial if supporting documentation is absent or contradictory.

Program feature	Details
Supply limits and/or step therapy	May be in place at the program level; specifics (step definitions, prior-step agents, and quantity limits) are not detailed in this document
Where specifics are defined	Program-level policy and benefit plan rules govern exact limits and step requirements; automated approval logic may vary by program

Background

Fruzaqla (fruquintinib) is a small-molecule kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer after prior therapy. Indication and clinical use in this policy reflect the product labeling and recognized compendia guidance.

The drug is intended for patients with advanced or metastatic colorectal cancer who have received prior systemic therapy including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti‑VEGF therapy. For tumors that are RAS wild-type and when clinically appropriate, prior treatment with an anti‑EGFR therapy is also required by the coverage criteria; alternatively, patients whose disease is not RAS wild-type meet the equivalent pathway in the criteria.

NCCN guidance and the manufacturer’s package insert are referenced in the background for clinical context and to align coverage with accepted treatment sequencing. The NCCN Drugs & Biologics Compendium recognizes fruquintinib for advanced colorectal cancer and for selected appendiceal neoplasms after progression through available regimens, consistent with the policy’s coverage groups.

Definitions

NCCN recognition

DefinitionNCCN-recognized: The drug is listed in the NCCN Drugs and Biologics Compendium with category designations of 1, 2A, or 2B.

Scope of recognitionRecognition indicates NCCN includes the drug for use in relevant tumor types (e.g., advanced colorectal cancer and appendiceal neoplasms) per the Compendium guidance.

Clinical implicationNCCN recommendation supports use of Fruzaqla for advanced colorectal cancer and appendiceal neoplasms after progression through available regimens (excluding regorafenib or trifluridine/tipiracil), which aligns with coverage criteria requiring prior therapies.

Use with RAS/anti‑EGFR logicNCCN guidance is consistent with requiring prior anti‑EGFR therapy when disease is RAS wild‑type, as reflected in the policy's prior therapy requirements.

Evidence tiers referencedCategories 1, 2A, and 2B reflect NCCN evidence/consensus tiers used to classify recognition in the Compendium.

OpenPayer

Fruzaqla (fruquintinib) prior authorization

Coverage Criteria

Initial Authorization Requirements

Continuation / Reauthorization Criteria

Provider Actions and Documentation

Step Therapy and Quantity Limits

Site of Care

Background

Definitions