Subject: Vivitrol 1998-A SGM P2022

Drug

VIVITROL  (naltrexone for extended-release injectable)

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 Indications
          A.  Vivitrol is indicated for the treatment of alcohol dependence
               in patients who are able to abstain from alcohol in an
               outpatient setting prior to initiation of treatment with Vivitrol.
               Patients should not be actively drinking at the time of initial
               Vivitrol administration.
          B.  Vivitrol is indicated for the prevention of relapse to opioid
               dependence, following opioid detoxification.

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


     II. CRITERIA FOR INITIAL APPROVAL
         
          A.  Alcohol Dependence
               Authorization of 12 months may be granted for treatment of
               alcohol dependence.
          B.  Opioid Dependence
               Authorization of 12 months may be granted for prevention of
               relapse to opioid dependence.


   III. CONTINUATION OF THERAPY
          All members (including new members) requesting authorization
          for continuation of therapy must meet all initial authorization
          criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1.  Vivitrol [package insert]. Waltham, MA: Alkermes, Inc.; March 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.

March 20, 2022