Subject: Iwilfin 6294-A SGM P2023

Drug

IWILFIN  (eflornithine)

Policy:

      I.  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 Indication
          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.


    II.  CRITERIA FOR INITIAL APPROVAL

          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]).


  III.  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 Section II 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.

February 23, 2024