Subject: entecavir-Baraclude 4779-A Supplemental Specialty PA P2022

Drug

BARACLUDE  (entecavir)

entecavir (generic)

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 Indications
      Baraclude is indicated for the treatment of chronic hepatitis B virus infection in adults and children at
      least 2 years of age 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 reactivation prophylaxis
      2.   Coinfection with Chronic Hepatitis B and HIV 

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

II.  CRITERIA FOR INITIAL APPROVAL 

A.   Chronic Hepatitis B Infection
      Authorization of 6 months may be granted for treatment of chronic hepatitis B 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.   Hepatitis B Prophylaxis
      Authorization of 6 months may be granted for prophylaxis of hepatitis B reactivation in immunosuppressed
      members.

C.   Coinfection With Chronic Hepatitis B and HIV
      Authorization of 6 months may be granted for treatment of coinfection with chronic hepatitis B and HIV
      when all of the following criteria are met:
      1.   Member meets the criteria for approval in Section A, and
      2.   Member is currently receiving highly active antiretroviral therapy (HAART). 

III. CONTINUATION OF THERAPY
       Authorization of 12 months may be granted for continued treatment in members requesting reauthorization
       for the indications listed in Section II who achieve or maintain a positive clinical response (e.g., decreased HBV
       DNA, histologic improvement, ALT normalization, HBeAg seroconversion).

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]. Waterford, Ireland: EirGen Pharma Ltd.; September 2017.
3. Micromedex Solutions. Greenwood Village, CO: Truven Health Analytics. http://micromedex.com/. Accessed March 7, 2022.
4. Clinical Pharmacology [Internet]. Tampla (FL) Elsevier. C2021- [cited 2022 March 7]. Available from http://www.clinicalpharmacology.com
5. Terrault, N.A., Lok, A.S., McMahon, et al. (2018), Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology, 67: 1560-1599. https://doi.org/10.1002/hep.29800

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 14, 2022