Subject: Vemlidy 2901-A Supplemental Specialty PA P2023

Drug

VEMLIDY  (tenofovir alafenamide)

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
               Vemlidy is indicated for the treatment of chronic hepatitis B
               virus (HBV) infection in adults and pediatric patients 12 years
               of age and older with compensated liver disease.

          B.  Compendial Use
               1.  Coinfection with chronic hepatitis B virus and HIV
               2.  Hepatitis B virus reactivation/reinfection prophylaxis

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


   II.  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.  Member is HIV-1 negative
               2.  Member has compensated liver disease as evidenced by:
                    i.     No evidence of ascites, hepatic encephalopathy, or
                           variceal bleeding
                    ii.    International normalized ratio (INR) less than 1.5x
                           upper limit of normal (ULN)
                    iii.   Total bilirubin less than 2.5x ULN
                    iv.   Albumin greater than 3.0 g/dL

          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 all of
               the following criteria are met:
               1.  Vemlidy will not be used as monotherapy for treatment of
                    chronic hepatitis B virus and HIV coinfection
               2.  Member’s antiretroviral therapy regimen consists of either
                    emtricitabine or lamivudine
               3.  Member has compensated liver disease as evidenced by:
                    i.     No evidence of ascites, hepatic encephalopathy, or
                           variceal bleeding
                    ii.    International normalized ratio (INR) less than 1.5x
                           upper limit of normal (ULN)
                    iii.   Total bilirubin less than 2.5x ULN
                    iv.   Albumin greater than 3.0 g/dL

          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
               Authorization of 12 months may be granted for continued
               treatment in members requesting reauthorization for chronic
               HBV who achieve or maintain positive clinical response (e.g.,
               decreased HBV DNA level, ALT normalization, HBsAg and/or
               HBeAg loss and seroconversion) and are HIV-1 negative.

          B.  Coinfection with chronic hepatitis B virus and HIV
               Authorization of 12 months may be granted for continued
               treatment in members requesting reauthorization for
               coinfection with chronic HBV and HIV who achieve or
               maintain positive clinical response (e.g., decreased HBV DNA
               level, ALT normalization, HBsAg and/or HBeAg loss and
               seroconversion).

          C.  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. Vemlidy [package insert]. Foster City, CA: Gilead Sciences, Inc.; October 2022.
2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf. Accessed March 1, 2023.
3. 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.
4. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. http://micromedex.com/. Accessed March 1, 2023.
5. Clinical Pharmacology [Internet]. Tampa (FL): Elsevier; 2023 [cited 2023 Mar 1]. Available from: http://www.clinicalpharmacology.com.
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