Subject: Fuzeon SGM 3099-A P2025

Drug

FUZEON  (enfuviride)

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

Fuzeon in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

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

Coverage Criteria

Human Immunodeficiency Virus Type 1 (HIV-1) Infection¹

Authorization of 12 months may be granted for treatment of HIV-1 infection when either of the following criteria is met:

• The member has viremia despite 3 or more prior months of therapy with at least one appropriate regimen used to treat HIV.
• The member has viremia and documented resistance or intolerance to at least one appropriate regimen used to treat HIV.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for treatment of human immunodeficiency virus type 1 (HIV-1) infection when the member has had a positive or stable virologic response to Fuzeon.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Fuzeon [package insert]. South San Francisco, CA: Genentech USA, Inc.; December 2019.

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.

April 18, 2025