CurrentUnitedHealthcarePolicy 2025 P 1435-2

Fruzaqla (fruquintinib) prior authorization criteria for metastatic colorectal cancer

UnitedHealthcare prior authorization policy for Fruzaqla (fruquintinib) specifying initial and reauthorization clinical criteria for coverage in patients with colorectal cancer, including special rules for members under 19 and reference to state mandates and NCCN recognition. Authorization durations are specified as 12 months.

Policy Summary

PayerUnitedHealthcare

PolicyFruzaqla (fruquintinib) prior authorization criteria for metastatic colorectal cancer

Policy CodePolicy 2025 P 1435-2

Change TypeAnnual review (no coverage changes)

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization requests and document prior therapies and RAS status; authorizations issued for 12 months when criteria are met.

POLICY UPDATE CHANGES

Annual review performed with no changes to coverage criteria (2/2025).

Effective date for this program set to 5/1/2025.

12Authorization duration (months)

3Required prior therapy classes

No progressionReauthorization clinical requirement

Coverage Summary

Fruzaqla (fruquintinib) is indicated for adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. The policy applies UnitedHealthcare prior authorization criteria for metastatic colorectal cancer and references NCCN recognition of the drug for later-line advanced colorectal cancer settings.

Initial Authorization (Adults)

Fruzaqla will be approved based on the following criteria:

ref_exactly?__DO_NOT_USE__ref?__REPLACED_BY_ref?__6370b1a6a3a74?__ref?__b1_0?__KEEP?__true?__rm?__no??!#@$%^^&*()_++|}{":

ref_exactly__DO_NOT_REMOVE__ref?__b1_0?__KEEP?__true?__rm?__no?___unused_field_for_schema_hack__ignore_me__eyes_only__end__

ref

Special Rule — Patients Less Than 19 Years

Patients less than 19 years of age

Fruzaqla will be approved based on the following criterion:

Patient is less than 19 years of age

Authorization will be issued for 12 months

Documentation Required

Pediatric automatic processing — members <19

Members under age 19 will have prescriptions for Fruzaqla automatically processed without a coverage review. This exception means that prior authorization workflows do not require manual clinical review for these pediatric members; the prescription will process through claims/benefit systems and an authorization will be issued for 12 months when criteria are met for that age group.

Reauthorization / Continuation Therapy

Reauthorization

Fruzaqla will be approved for reauthorization when the following criterion is met:

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

Authorization will be issued for 12 months when criteria are met

Denial Risk

Denial for progressive disease at reauthorization

Reauthorization requests will be denied if there is evidence of progressive disease while the patient is receiving Fruzaqla. Providers should be aware that documentation demonstrating lack of progression is required to support continued coverage.

Provider Actions & Program Rules

Prior Authorization

Prior authorization required

Fruzaqla is subject to UnitedHealthcare’s prior authorization/notification program. When the clinical criteria are met, an authorization will be issued for 12 months. Note the exception that members under age 19 automatically process without a coverage review and are handled under the pediatric processing rules.

Documentation Required

Documentation of prior therapies and RAS status

Document in the medical record that the patient received prior treatments: fluoropyrimidine‑based chemotherapy, irinotecan‑based chemotherapy, and an anti‑VEGF therapy. Also document the patient’s RAS status; if RAS is wild‑type, document prior anti‑EGFR therapy (e.g., cetuximab, panitumumab). These documentation elements correspond to the initial‑authorization clinical criteria.

Billing Rule

Automated approvals may be used

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim or medication history, diagnosis codes (ICD‑10), and/or claim logic using automated processes. Providers should expect that some approvals or denials may be determined by claim-level data and submission patterns rather than manual review.

Clinical Evidence & References

Evidence and reference notes for this policy include P&T committee approval dates of 2/2024 and 2/2025 and the Fruzaqla package insert from Takeda Pharmaceuticals America, Inc.; November 2023.

The policy also notes NCCN recommendation and recognition of Fruzaqla in the NCCN Drugs and Biologics Compendium for advanced colorectal cancer, supporting use in later-line settings.

Background & Definitions

Fruzaqla (fruquintinib) is a kinase inhibitor indicated for treatment of adult patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

The National Comprehensive Cancer Network (NCCN) also recommends Fruzaqla for advanced colorectal cancer in patients who have progressed through available regimens (other than regorafenib or trifluridine/tipiracil with or without bevacizumab), and the drug is recognized in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

Initial authorization requires documented prior treatments including fluoropyrimidine-based chemotherapy (e.g., capecitabine, 5-FU), irinotecan-based chemotherapy (e.g., FOLFIRI, FOLFIRINOX), and an anti-VEGF therapy (e.g., aflibercept, bevacizumab, ramucirumab); reauthorization is allowed when the patient does not show evidence of progressive disease while on Fruzaqla.

Term	Definition / Examples
Anti-VEGF therapy	Examples include aflibercept, bevacizumab, ramucirumab.
Anti-EGFR therapy	Examples include cetuximab, panitumumab.

Revision History

2024-02-01P&T_approval

P&T approval recorded (2/2024).

2025-02-01P&T_approval

P&T approval recorded (2/2025).

2025-02-01annual_review