Subject: entecavir-Baraclude 4779-A Supplemental Specialty PA P2023

Drug

BARACLUDE  (entecavir)

entecavir

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 Indication
               Baraclude is indicated for the treatment of chronic hepatitis B
               virus (HBV) infection in adults and pediatric patients 2 years
               of age and older with evidence of active viral replication and
               either evidence of persistent elevations in serum
               aminotransferases (ALT or AST) or histologically active
               disease.

          B.  Compendial Uses
               1.  Hepatitis B virus reactivation/reinfection prophylaxis
               2.  Coinfection with chronic hepatitis B virus and human
                    immunodeficiency virus (HIV)

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


  III.  CRITERIA FOR INITIAL APPROVAL

          A.  Chronic hepatitis B virus infection
               Authorization of 6 months may be granted for treatment of
               chronic hepatitis B virus when all of the following criteria are
               met:
               1.  There is evidence of active viral replication (e.g.,
                    detectable serum HBV DNA, as measured by the bDNA
                    hybridization or PCR assay).
               2.  Member meets any of the following criteria:
                    i.     Member has evidence of persistent elevations in
                           serum aminotransferases (ALT or AST), or
                    ii.    Member has histologically active disease or hepatic
                           fibrosis is detected on transient elastography.

          B.  Coinfection with chronic hepatitis B virus and HIV
               Authorization of 6 months may be granted for treatment of
               coinfection with chronic hepatitis B virus and HIV when both
               of the following criteria are met:
               1.  Member meets the criteria for approval in Section A, and
               2.  Member is currently receiving antiretroviral therapy.

          C.  Hepatitis B virus reactivation/reinfection prophylaxis
               Authorization of 12 months may be granted for prophylaxis
               of hepatitis B virus reactivation/reinfection in
               immunosuppressed members.


  III.  CONTINUATION OF THERAPY

          A.  Chronic hepatitis B virus infection and coinfection with
               chronic hepatitis B virus and HIV
               Authorization of 12 months may be granted for continued
               treatment in members requesting reauthorization for chronic
               hepatitis B virus infection or coinfection with chronic hepatitis
               B virus and HIV who achieve or maintain a positive clinical
               response (e.g., decreased HBV DNA, histologic improvement,
               ALT normalization, HBeAg seroconversion).

          B.  Hepatitis B virus reactivation/reinfection prophylaxis
               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. Baraclude [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; November 2019.
2. Entecavir [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; April 2022.
3. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. http://micromedex.com/. Accessed March 1, 2023.
4. Clinical Pharmacology [Internet]. Tampa (FL): Elsevier; 2023 [cited 2023 Mar 1]. Available from: http://www.clinicalpharmacology.com.
5. Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599. doi: 10.1002/hep.29800.
6. Lexicomp Online, Pediatric and Neonatal Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed March 1, 2023.

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.

August 13, 2023