Subject: Actimmune 2375-A SGM P2023

Drug

ACTIMMUNE  (interferon gamma-1b)

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.

          A.  FDA-Approved Indications
               1.  Actimmune is indicated for reducing the frequency and
                    severity of serious infections associated with chronic
                    granulomatous disease (CGD).
               2.  Actimmune is indicated for delaying time to disease
                    progression in patients with severe, malignant
                    osteopetrosis (SMO).

          B.  Compendial Uses
               Mycosis fungoides/Sezary syndrome

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


    II.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with
          one of the following:
          A.  Chronic Granulomatous Disease (CGD): immunologist or 
               prescriber who specializes in the management of CGD.
          B.  Severe, Malignant Osteopetrosis (SMO): endocrinologist.
          C.  Mycosis Fungoides/Sezary Syndrome: hematologist or
               oncologist.


  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Chronic Granulomatous Disease
               Authorization of 12 months may be granted to reduce the
               frequency and severity of infections associated with chronic
               granulomatous disease.

          B.  Severe, Malignant Osteopetrosis
               Authorization of 12 months may be granted to delay time to
               disease progression in patients with severe, malignant
               osteopetrosis.

          C.  Mycosis Fungoides/Sezary Syndrome
               Authorization of 12 months may be granted for treatment of                 mycosis fungoides or Sezary syndrome.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued
          treatment in members requesting reauthorization for an
          indication listed in Section III who are experiencing benefit from
          therapy as evidenced by disease stability or disease
          improvement.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Actimmune [package insert]. Deerfield, IL: Horizon Therapeutics USA, Inc.; March 2021.
2. The NCCN Drugs & Biologics Compendium^® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 8, 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 18, 2024