CurrentUnitedHealthcarePolicy N/A

Iwilfin (eflornithine) prior authorization for high-risk neuroblastoma

Defines UnitedHealthcare Pharmacy prior authorization and reauthorization criteria for Iwilfin (eflornithine) for pediatric patients with high-risk neuroblastoma, including clinical prerequisites and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyIwilfin (eflornithine) prior authorization for high-risk neuroblastoma

Policy CodePolicy N/A

Change TypeMinor/no material change

Effective DateMay 1, 2025

Next Review DateFeb 20, 2025

Key ActionObtain prior authorization; initial approval issued for 12 months when all clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

<19age limit

requires anti-GD2prior therapy

NCCNrecognition

Coverage Criteria for Iwilfin (eflornithine)

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Initial Authorization: Diagnosis of high-risk neuroblastoma (HRNB).

Initial Authorization: Patient is less than 19 years of age.<19 years

Authorization will be issued for 12 months.

Initial Authorization: Patient has shown at least a partial response to multiagent, multimodality therapy.

Initial Authorization: Prior therapy included anti-GD2 immunotherapy (e.g., Danyelza [naxitamab-gqgk], Unituxin [dinutuximab]).

inv-02: Reauthorization

Reauthorization covered when the following are met:

Reauthorization: Patient does not show evidence of progressive disease while on Iwilfin therapy.

Authorization will be issued for 12 months.

Initial Therapy Requirements

inv-10: Initial Therapy

Initial coverage requirements for Iwilfin

Initial Therapy: Patient less than 19 years of age.<19 years

Authorization will be issued for 12 months.

Initial Therapy: Diagnosis of high-risk neuroblastoma (HRNB).

Initial Therapy: At least a partial response to multiagent, multimodality therapy has been demonstrated.

Initial Therapy: Prior therapy included anti-GD2 immunotherapy (e.g., Danyelza [naxitamab-gqgk], Unituxin [dinutuximab]).

Continuation / Reauthorization Criteria

inv-11: Reauthorization

Reauthorization condition

Continuation (Reauthorization): Patient must not show evidence of progressive disease while on Iwilfin therapy.

12-month reauthorization if criterion met.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — initial approval issued for 12 months when all specified clinical criteria are met.

Step Therapy

Prior Therapy Requirement

Prior therapy requirement — Requires prior therapy to have included anti-GD2 immunotherapy (examples: Danyelza, Unituxin).

Prior therapy must include anti-GD2 immunotherapy (e.g., Danyelza [naxitamab-gqgk], Unituxin [dinutuximab])

Documentation Required

Administrative and Documentation Considerations

Administrative and documentation considerations — state mandates, federal requirements, member-specific benefit plan coverage may impact coverage.

Authorization issued for 12 months
State mandates and federal regulatory requirements may apply
Member-specific benefit plan coverage and other policies/utilization management programs may impact coverage

Denial Risk

Reauthorization Risk

Reauthorization risk — Reauthorization may be denied for progressive disease while on Iwilfin.

Reauthorization requires no evidence of progressive disease while on Iwilfin therapy
Supply limits may be in place

Step	Requirement
1	Prior therapy must have included anti-GD2 immunotherapy (e.g., Danyelza [naxitamab‑gqgk], Unituxin [dinutuximab]).

Quantity Limits and Supply Information

Quantity limits — Iwilfin (eflornithine)

Quantity limit noteSupply limits may be in place for Iwilfin (eflornithine).

Limit frequencyLimits may apply to initial and reauthorization approvals as determined by UnitedHealthcare program rules.

Documentation impactPrevious claim/medication history and claim logic may be used to determine supply allocations.

Site-of-Care Considerations

Note

No explicit infusion center site‑of‑care rules

No specific site‑of‑care restriction is provided for infusion centers in this policy; however, administrative programs or other policies may impose site‑of‑care requirements.

Policy includes no explicit infusion center/site‑of‑care rule.
Other utilization management programs or policies may apply and could affect site‑of‑care.

Background and Drug Information

Eflornithine (Iwilfin) is described as an ornithine decarboxylase inhibitor indicated to reduce risk in patients with high-risk neuroblastoma (HRNB). The policy frames Iwilfin for pediatric use in HRNB following multiagent, multimodality therapy and in the context of prior anti-GD2 immunotherapy.

Definitions

HRNB — definition and relation to coverage

DefinitionHigh-risk neuroblastoma (HRNB): the cancer indication for which Iwilfin is recognized and covered when criteria are met.

Indication for IwilfinIwilfin is indicated to reduce risk in patients with HRNB who have at least a partial response to multiagent, multimodality therapy including anti-GD2 immunotherapy.

Age groupPolicy addresses use in pediatric patients (patients less than 19 years of age for approval).

Relation to coverage criteriaCoverage requires diagnosis of HRNB plus response to prior multiagent, multimodality therapy and prior anti-GD2 immunotherapy for initial authorization.

Policy Summary

PayerUnitedHealthcare

PolicyIwilfin (eflornithine) prior authorization for high-risk neuroblastoma

Policy CodePolicy N/A

Change TypeMinor/no material change

Effective DateMay 1, 2025

Next Review DateFeb 20, 2025

Key ActionObtain prior authorization; initial approval issued for 12 months when all clinical criteria are met.

SourceLink

On This Page

OpenPayer

Iwilfin (eflornithine) prior authorization for high-risk neuroblastoma

Coverage Criteria for Iwilfin (eflornithine)

Initial Therapy Requirements

Continuation / Reauthorization Criteria

Provider Actions, Prior Authorization, and Documentation

Step Therapy Requirements

Quantity Limits and Supply Information

Site-of-Care Considerations

Background and Drug Information

Definitions