CurrentUnitedHealthcarePolicy 2025 P 1433-2

Prior Authorization/Notification - Iwilfin (eflornithine)

Prior authorization and notification policy for Iwilfin (eflornithine) for reduction of relapse risk in high-risk neuroblastoma patients; affects providers submitting requests to UnitedHealthcare for this medication.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Notification - Iwilfin (eflornithine)

Policy CodePolicy 2025 P 1433-2

Change TypeNo material change

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit documentation showing diagnosis of high-risk neuroblastoma, evidence of at least partial response to prior multiagent multimodality therapy, and prior anti-GD2 immunotherapy to request initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization period

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

NCCN recognizedNCCN status

Coverage Criteria for Iwilfin (eflornithine)

Initial Therapy

Covered when ALL of the following are met

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Coverage decisions for Iwilfin (eflornithine) are subject to state mandates, applicable federal regulatory requirements, and the terms of the member-specific benefit plan, any of which may restrict or modify coverage. In addition, other UnitedHealthcare policies and utilization management programs (for example, prior authorization processes, quantity limits, or site-of-care programs) may apply and affect approval or the conditions of coverage.

Initial Therapy — Authorization Criteria

Initial Therapy

Initial authorization criteria for drug coverage

Initial therapy: Diagnosis of HRNB; partial response to prior multiagent, multimodality therapy; prior anti-GD2 immunotherapy administered.

12-month authorization.

Provider Action Requirements and Notes

Prior Authorization

Initial Authorization Required

Prior authorization is required. Initial requests must include documentation of diagnosis, prior therapies, and response to prior treatment. Authorization for initial approval will be issued for 12 months when criteria are met.

Diagnosis: high-risk neuroblastoma (HRNB)
Documented at least a partial response to prior multiagent, multimodality therapy
Prior therapy must have included anti-GD2 immunotherapy (e.g., Danyelza (naxitamab-gqgk), Unituxin (dinutuximab))
Initial authorization period: 12 months

Prior Authorization

Reauthorization Requirements

Reauthorization requires evidence that the patient is not experiencing disease progression while on therapy. When reauthorization criteria are met, approvals will be issued per the program (details below).

Reauthorization criterion: no evidence of progressive disease while on Iwilfin therapy
Reauthorization period: consistent with program (refer to authorization outcome; initial approvals issued for 12 months)

Documentation Required

Supporting Documentation and Program Notes

Approvals may be granted based on prior claims or medication history, submitted ICD-10 diagnosis codes, and automated claim-logic processes. Providers should include relevant supporting documentation (clinical notes, prior treatment records, and medication history) with authorization requests. Supply limits may apply.

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic
Automated approval and re-approval processes vary by program and therapeutic class
Supply limits may be in place; check program-specific limits
Include clinical documentation: diagnosis, prior therapies, response to therapy, and current status

Denial Risk

Clinical Criteria Not Met

Requests that do not meet the clinical criteria described for initial authorization or reauthorization will be handled per UnitedHealthcare policy and may be denied or referred for further review. Ensure submitted documentation addresses all required criteria to avoid delays or denials.

Clinical criteria not met: requests may be denied or require additional information
Ensure documentation demonstrates diagnosis, prior anti-GD2 therapy, and at least partial response for initial requests
For reauthorization, document lack of disease progression while on Iwilfin

Step	Requirement / Notes
1	No specific step therapy sequence is required. Approval (initial and reauthorization) may be automated based on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; use of automated approval and re‑approval processes varies by program or therapeutic class. Supply limits may apply.

Quantity Limits and Supply Constraints

Iwilfin (eflornithine) — Supply limits

Quantity limit statusSupply limits may be in place.

Unit/periodPer course (policy does not specify exact units or numeric limit).

Authorization impactSupply limits may be enforced in claims adjudication or prior authorization processes.

Documentation sourcePolicy note references Iwilfin package insert (Dec 2023) as supporting documentation for program rules.

Definitions

High-risk neuroblastoma (HRNB) — definition and applicability

DefinitionNeuroblastoma meeting criteria for high-risk disease; policy applies to patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

Applicable patient populationAdult and pediatric patients with HRNB who have shown at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

Pediatric notePolicy includes pediatric-specific approval: patients less than 19 years may be approved when criteria are met (authorization issued for 12 months).

Evidence recognitionRegimen is recognized by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B.

Authorization durationAuthorization will be issued for 12 months when criteria are met.

Background

Iwilfin (eflornithine) is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti‑GD2 immunotherapy. The policy references recognition of the regimen by the NCCN for this indication.