CurrentCignaPolicy N/A

Oncology - Fruzaqla Prior Authorization Policy

Prior authorization policy governing medical benefit prescription coverage of Fruzaqla (fruquintinib capsules) for adults with advanced or metastatic colon, rectal, or appendiceal cancer under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Fruzaqla Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision / selected prior revisions

Effective Date

Next Review Date

Key ActionPrior Authorization is required; document age, disease status, mismatch repair/MSI or POLE/POLD1 status, and prior therapies including fluoropyrimidine-, oxaliplatin-, irinotecan-based chemo, prior anti-VEGF, checkpoint inhibitor eligibility/progression, and prior anti-EGFR therapy or rationale if not appropriate.

SourceLink

POLICY UPDATE CHANGES

Annual revision added requirement about mismatch repair/MSI status or checkpoint inhibitor ineligibility/progression and specified dMMR/MSI-H or POLE/POLD1 positivity as options.

Appendiceal cancer added to the condition of approval in prior revisions.

1Year approval duration

3Required prior chemotherapies

1Required anti-VEGF therapy

conditionalRAS/EGFR conditional requirement

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Coverage Summary

Fruzaqla (fruquintinib) is indicated for the treatment of metastatic colorectal cancer (including colon, rectal, or appendiceal cancer) in adults who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. NCCN lists Fruzaqla as a single-agent subsequent therapy (category 2A) for advanced or metastatic colon, rectal, or appendiceal cancer.

This policy is a prior authorization policy governing medical benefit prescription coverage of Fruzaqla (fruquintinib capsules) for adults with advanced or metastatic colon, rectal, or appendiceal cancer under Cigna-administered health benefit plans. The overall coverage stance is covered_with_criteria, with approvals provided for 1 year when the specified criteria are met, including prior therapies and disease/molecular status requirements.

FDA-Approved Indication - Colon, Rectal, or Appendiceal Cancer (Approve for 1 year)

Approve for 1 year if the patient meets ALL the following (A, B, C, and D):

High-level scope and approval duration

Policy scopePrior authorization policy governing medical benefit prescription coverage of Fruzaqla (fruquintinib capsules) for adults with advanced or metastatic colon, rectal, or appendiceal cancer under Cigna-administered health benefit plans.

Coverage stanceCovered with criteria when FDA‑approved indication criteria are met (prior authorization required).

Approval duration1 year

Applicable Codes

DrugNDCCovered

No codes listed

Provider Actions / Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended/required for prescription benefit coverage of Fruzaqla; approvals are provided for 1 year when criteria are met.

Documentation Required

Clinical Documentation to Support Criteria

Provider must document patient age, advanced/metastatic disease status, mismatch repair/MSI or POLE/POLD1 status and prior therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, prior anti-VEGF, checkpoint inhibitor eligibility/progression and prior anti-EGFR therapy or rationale for not appropriate if RAS wild-type.

Patient age
Advanced or metastatic disease status
MMR/MSI status or POLE/POLD1 mutation status (dMMR/MSI‑H or POLE/POLD1 positive) or ineligibility/progression on checkpoint inhibitor
Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy

Clinical Evidence & References

Key evidence and guidance sources cited in this policy include the Fruzaqla capsules Prescribing Information (Takeda; November 2023) and the National Comprehensive Cancer Network (NCCN) Colon and Rectal Cancer Guidelines (v2024), which recommend Fruzaqla as subsequent single-agent treatment (category 2A) for advanced or metastatic colon, rectal, or appendiceal cancer.

Definitions & Background

Fruzaqla (fruquintinib) is a small-molecule kinase inhibitor targeting vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3. It is indicated for metastatic colorectal cancer in adults previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and when RAS wild-type, consideration of anti-EGFR therapy. NCCN lists Fruzaqla as a single-agent subsequent therapy (category 2A) for advanced or metastatic colon, rectal, or appendiceal cancer.

Glossary: RAS wild-type: tumor or metastases are KRAS and NRAS mutation negative.

pMMR/MSS: proficient mismatch repair / microsatellite-stable.

dMMR/MSI-H: deficient mismatch repair / microsatellite instability-high.

Revision History

01/15/2025annual_revisionLatest

Annual revision added requirement about mismatch repair/MSI status or checkpoint inhibitor ineligibility/progression and specified dMMR/MSI-H or POLE/POLD1 positivity as options.

12/13/2023selected_revision

Appendiceal cancer added to the condition of approval in prior revisions.