CurrentUnitedHealthcarePolicy 2026 P 3184-3

Step therapy for Fruzaqla (fruquintinib)

Defines UnitedHealthcare's step therapy requirements for coverage of Fruzaqla (fruquintinib) for members, including pediatric automatic processing, colorectal cancer, appendiceal neoplasms, continuation rules, and state mandate notes.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Fruzaqla (fruquintinib)

Policy CodePolicy 2026 P 3184-3

Change TypeCriteria added and clarifications

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document trial of or contraindication/intolerance to Stivarga (regorafenib) unless member is under 19 or is an established user documented in claims history.

SourceLink

POLICY UPDATE CHANGES

New step therapy program created for Fruzaqla (fruquintinib).

Annual review with no changes to step criteria in 5/2025; background and references updated.

Criteria for appendiceal neoplasms and cancers were added.

Members currently on Fruzaqla documented in claims history may continue therapy; new members must meet step criteria.

12 monthsAuthorization duration for approved indications

Step therapyProgram type

RegorafenibRequired prior agent for most approvals

5/2024,5/2025,2/2025P&T approval dates

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Coverage Criteria for Fruzaqla (fruquintinib)

Patients less than 19 years of age

Automatic approval for pediatric prescriptions

Patients <19: Patient is less than 19 years of age

Authorization issued for 12 months

Colorectal Cancer

Covered when ALL of the following are met

Diagnosis of advanced or metastatic colorectal cancer

Prior therapy or continuation: Either (1) history of failure, contraindication, or intolerance to Stivarga (regorafenib) OR (2) continuation of therapy for established users who have not received manufacturer samples or Takeda-sponsored Here2Assist assistance to establish current use

Authorization issued for 12 months

Appendiceal Neoplasms and Cancers

Covered when ALL of the following are met

Diagnosis of appendiceal adenocarcinoma (AA), goblet cell adenocarcinoma (GCA), or undifferentiated carcinoma not otherwise specified (UC-NOS)

Authorization issued for 12 months

Other Indications

Other indications: Fruzaqla will be approved; state mandates, federal requirements, member benefit plan coverage, and other policies may impact coverage

Authorization issued for 12 months

Patients who were established on Fruzaqla solely through receipt of manufacturer‑supplied samples in the prescriber’s office or through Takeda‑sponsored Here2Assist assistance (for example, a redeemable sample card) are treated as new to therapy for authorization purposes. Such members must meet the initial authorization criteria rather than qualifying for continuation‑of‑therapy exceptions. Authorization for approved requests will be issued for 12 months.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fruzaqla (fruquintinib) for members aged 19 and older. Authorization, when granted, is issued for a duration of up to 12 months. Members under 19 years of age are exempt from prior authorization requirements per this policy.

Prior authorization required for members >= 19 years
Authorization duration: up to 12 months
Members < 19 years: no prior authorization required

Step Therapy

Step Therapy — Prior Regorafenib Requirement

For colorectal cancer and appendiceal cancer indications, a trial of Stivarga (regorafenib) is required prior to approval of Fruzaqla unless there is documented contraindication or intolerance to regorafenib. Requests without documentation of prior failure, contraindication, or intolerance to Stivarga may be denied or delayed pending evidence of trial or prescriber attestation.

Step therapy: trial of Stivarga (regorafenib) required for colorectal and appendiceal indications

Initial Authorization Requirements

Initial Therapy

Initial authorization requirements

Initial colorectal therapy: Diagnosis of advanced or metastatic colorectal cancer AND history of failure, contraindication, or intolerance to Stivarga (regorafenib)

Initial appendiceal therapy: Diagnosis of specified appendiceal neoplasm (AA, GCA, or UC-NOS) AND history of failure, contraindication, or intolerance to Stivarga (regorafenib)

Continuation of Therapy

Continuation allowance for members already on therapy

Continuation: Members currently on Fruzaqla therapy as documented in claims history will be allowed to continue on their current therapy; continuation approvals require that the patient has not been established solely via manufacturer samples or Takeda Here2Assist assistance

Authorization issued for 12 months

Step Therapy Requirements

Step	Requirement	Exceptions / Continuation
1	Prior trial of Stivarga (regorafenib) — or documented contraindication or intolerance to regorafenib — is required before coverage of Fruzaqla (fruquintinib) for advanced or metastatic colorectal cancer.	Continuation allowed for members currently on Fruzaqla documented in claims history (may continue without new trial of regorafenib). Authorization issued for 12 months.
1	Prior trial of Stivarga (regorafenib) — or documented contraindication or intolerance to regorafenib — is required before coverage of Fruzaqla (fruquintinib) for appendiceal neoplasms (appendiceal adenocarcinoma, goblet cell adenocarcinoma, or undifferentiated carcinoma NOS).	Continuation allowed for members currently on Fruzaqla documented in claims history (may continue without new trial of regorafenib). Members established solely via manufacturer‑supplied samples or Takeda Here2Assist assistance must meet initial step criteria as if new to therapy.
Notes	Members under 19 years of age: prescriptions are automatically processed/approved; prior regorafenib trial not required for this pediatric exception. Authorization is issued for 12 months when criteria are met.	Requests without documented history of failure, contraindication, or intolerance to regorafenib for the listed indications may be denied per the step therapy requirement. Documentation (claims history, ICD‑10, or prescriber attestation) may be required.

Definitions

Established user (definition and rules)

DefinitionEstablished user = member with Fruzaqla therapy documented in claims history who may be allowed to continue therapy without meeting initial step criteria.

Continuation conditionContinuation approvals require that the member’s Fruzaqla use is documented in claims history and was not established solely via manufacturer‑supplied samples or Takeda Here2Assist assistance.

Effect on step therapyEstablished users are exempt from the initial requirement for a prior trial of Stivarga (regorafenib).

Authorization durationWhen continuation is approved for an established user, authorization is issued for 12 months.

Documentation neededClaims history evidence of Fruzaqla dispensing is required to confirm established user status; prescriber attestation may also be used as applicable.

Background

Fruzaqla continuation approvals exclude patients whose only evidence of prior use is receipt of manufacturer samples or participation in the Takeda Oncology Here2Assist program. If a member’s documented ‘established’ status is based solely on samples or sponsor assistance, the member must satisfy the policy’s initial authorization requirements as if they were new to therapy. Authorization will be issued for 12 months when criteria are met.