Subject: Actimmune SGM 2375-A P2025

Drug

ACTIMMUNE  (interferon gamma-1b)

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 Indications¹

• Reducing the frequency and severity of serious infections associated with chronic granulomatous disease (CGD).
• Delaying time to disease progression in patients with severe, malignant osteopetrosis (SMO).

Compendial Uses²

Mycosis fungoides/Sezary syndrome

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

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

• Chronic Granulomatous Disease (CGD): immunologist or prescriber who specializes in the management of CGD
• Severe, malignant osteopetrosis (SMO): endocrinologist
• Mycosis fungoides/Sezary syndrome: hematologist or oncologist

Coverage Criteria

Chronic Granulomatous Disease¹

Authorization of 12 months may be granted to reduce the frequency and severity of infections associated with chronic granulomatous disease (CGD).

Severe, Malignant Osteopetrosis^1,3

Authorization of 12 months may be granted to delay time to disease progression in patients with severe, malignant osteopetrosis (SMO).

Mycosis Fungoides/Sezary Syndrome²

Authorization of 12 months may be granted for treatment of mycosis fungoides or Sezary syndrome.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria 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® © 2025 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 9, 2025.
3. Autosomal recessive malignant osteopetrosis. Rare disease and orphan drug database. Last updated July 2023. Accessed August 18, 2025. https://www.orpha.net/

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 15, 2026