Subject: Actimmune 2375-A SGM P2021

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.  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.

 

     III.  CONTINUATION OF THERAPY

             Authorization of 12 months may be granted for continued treatment
             in members requesting reauthorization for an indication listed in
             Section II 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.; May 2021.

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 19, 2022