CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1491

Fruzaqla (fruquintinib) drug policy — Coverage criteria for metastatic colorectal cancer

Defines coverage, inclusion and exclusion criteria, and utilization management requirements for Fruzaqla (fruquintinib) in the treatment of cancer for plan members managed by Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFruzaqla (fruquintinib) drug policy — Coverage criteria for metastatic colorectal cancer

Policy CodePolicy UM ONC_1491

Change TypeNo material change

Effective DateDec 27, 2024

Next Review Date

Key ActionObtain prior authorization and document prior therapies and supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 mgsingle dose limit

84 mgmonthly max

mCRCcovered indication

C9399billing code

Coverage Criteria

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Initial and Continuation Therapy for mCRC

Covered when ALL of the following are met for metastatic colorectal cancer:

mCRC prior therapy and population: Member is an adult with metastatic colorectal cancer (mCRC) who has been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and if RAS wild-type, an anti-EGFR therapy; member may or may not have received prior Lonsurf or Stivarga.

Based on policy indication statement

Continuation authorization: For continuation requests: member has not experienced disease progression on fruquintinib and the medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Continuation criteria from policy

Dosing limits: Requested dosing does not exceed the single dose limit of 5 mg and does not exceed the maximum monthly total of 84 mg (equivalent to 21 capsules of 5 mg).single dose <=5 mg; monthly <=84 mg (21 x 5 mg)

Explicit exclusion/dosing limits

Supporting evidence: Use must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting policy standards.

Refer to policy Purpose and medication management guidance

Coverage for Fruzaqla (fruquintinib) is limited by disease status, concurrent therapy, and dosing. Requests are excluded if there is disease progression while taking fruquintinib, or if the medication is being used concurrently with other anticancer therapies. Dosing must not exceed a single dose of 5 mg and must not exceed the maximum monthly total of 84 mg (equivalent to 21 capsules of 5 mg). These limits apply to both initial and continuation authorizations and will be enforced during prior authorization review.

Use of fruquintinib for indications that are investigational or off‑label is not supported by this policy unless adequate evidence is provided. The policy requires supporting evidence from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature. The policy defines sufficient evidence by considerations including whether the patient and tumor characteristics are represented in published evidence, whether the regimen studied matches the requested therapy, whether reported outcomes are clinically meaningful, and whether study design and size provide reliable support. Case reports and abstracts without full peer‑reviewed publication are generally inadequate to establish an accepted off‑label use.

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Coverage

Prior Authorization Required: Prior authorization is required for Fruzaqla (fruquintinib). Coverage is limited to the accepted indications described below.

Prior authorization required for initial and continuation requests
Coverage limited to accepted indications (see criteria)

Step Therapy

Prior Therapy Requirements

Prior therapy requirements: For metastatic colorectal cancer (mCRC), the member must have received prior lines of therapy including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. Member may or may not have received prior trifluridine/tipiracil (Lonsurf) and/or regorafenib (Stivarga).

Documentation Required

Required Supporting Documentation

Documentation required: Requests must include supporting documentation consistent with accepted evidence sources — FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards. Include clinical history, prior therapies and dates, evidence of RAS status when relevant, prior authorization history if requesting continuation, and dosing details consistent with product labeling.

Clinical history and indication
Complete prior therapy list with dates
RAS mutation status when applicable
Evidence citations (labeling, compendia, guidelines, or peer-reviewed studies)
For continuation: proof of prior authorization within last year without >30-day lapse and no disease progression on fruquintinib

Denial Risk

Exclusion Triggers / Denial Risks

Exclusion triggers / denial risks: Do not approve if the member experienced disease progression while on fruquintinib; if fruquintinib is used concurrently with other anticancer agents; if dosing exceeds the single-dose limit of 5 mg or the monthly maximum (greater than 21 capsules/ month or total >84 mg); or if the requested use is investigational or lacks sufficient evidence (not supported by CMS compendia or acceptable peer-reviewed literature).

Disease progression while taking fruquintinib — exclusion
Concurrent use with other anticancer therapies — exclusion
Single dose >5 mg or monthly supply >21 capsules (>84 mg) — exclusion
Off-label/Investigational uses without adequate supporting evidence per CMS standards — may be denied

Background

Fruquintinib (Fruzaqla) is an oral targeted oncology agent with clinical trial evidence supporting use in refractory metastatic colorectal cancer. The policy frames fruquintinib as a therapy for adult members with metastatic colorectal cancer who have received prior standard lines of therapy and requires that use align with recognized evidence sources (FDA label, CMS compendia, or peer‑reviewed literature). For medication management details and additional prescribing information, reviewers are directed to the FDA package insert and referenced clinical literature.

Initial Therapy Criteria

Initial therapy — prior lines of therapy and supporting evidence

Initial therapy coverage requires prior lines of therapy and supporting evidence sources.

Initial therapy requirements: Member is an adult with metastatic colorectal cancer (mCRC) and has received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and an anti-VEGF therapy; if the tumor is RAS wild-type, the member has also received an anti-EGFR therapy.

Per colorectal cancer inclusion criteria

Evidence requirement: Indication and requested use must be supported by one of: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets the policy's evidentiary standards.

Per policy Purpose

Continuation Therapy Criteria

Continuation therapy

Continuation requests are acceptable when prior authorization remains active and member meets continuity criteria.

Continuation rules: Member has not experienced disease progression on fruquintinib and the medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Continuation request definition from policy

Exclusion triggers for continuation: Continuation will not be authorized if disease progression occurred while taking fruquintinib, if there is concurrent use with other anticancer therapies, or if requested dosing exceeds the single dose limit (5 mg) or the monthly maximum (84 mg/21 capsules of 5 mg).single dose <=5 mg; monthly <=84 mg (21 x 5 mg)

Per exclusion criteria

Step Therapy / Prior Treatments

Prior therapy	Notes
Fluoropyrimidine-based chemotherapy
Member previously treated with fluoropyrimidine-based chemotherapy as part of prior lines of therapy for mCRC.
Oxaliplatin-based chemotherapy
Member previously treated with oxaliplatin-based chemotherapy as part of prior lines of therapy for mCRC.
Irinotecan-based chemotherapy
Member previously treated with irinotecan-based chemotherapy as part of prior lines of therapy for mCRC.
Anti-VEGF therapy
Prior receipt of an anti-VEGF therapy is required before fruquintinib for mCRC.
Anti-EGFR therapy (if RAS wild-type)
If the tumor is RAS wild-type, prior anti-EGFR therapy is required before fruquintinib.
Lonsurf (trifluridine/tipiracil) or Stivarga (regorafenib)
Member may or may not have received prior therapy with Lonsurf and/or Stivarga; these are not required prerequisites.