Subject: Fuzeon 3099-A SGM P2023

Drug

FUZEON  (enfuviride)

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 Indication¹
          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.

 

 
    II.  CRITERIA FOR INITIAL APPROVAL

          Human immunodeficiency virus (HIV)-1
          Authorization of 12 months may be granted for treatment of
          HIV-1 infection when either of the following criteria is met:
          A.  The member has viremia despite 3 or more prior months of
               therapy with at least one appropriate regimen used to treat
               HIV.
          B.  The member has viremia and documented resistance or
               intolerance to at least one appropriate regimen used to treat
               HIV.

 
  III.  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 11, 2023