Subject: Iwilfin SGM 6294-A P2024_R

Drug

IWILFIN  (eflornithine)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-APPROVED INDICATIONS

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

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

High-risk neuroblastoma (HRNB)

Authorization of 12 months may be granted to reduce the risk of relapse in members with HRNB who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy (e.g., dinutuximab [Unituxin], naxitamab-gqgk [Danyelza]).

Continuation of Therapy

Authorization of 12 months may be granted (up to 24 months total therapy) for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Iwilfin [package insert]. Louisville, KY: US WorldMeds, LLC; December 2023.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2025