Subject: Vemlidy 2901-A Supplemental Specialty PA P2022

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. 

FDA-Approved Indications
Treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

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

II.  CRITERIA FOR INITIAL APPROVAL 

Chronic hepatitis B virus infection
Authorization of 6 months may be granted for treatment of chronic hepatitis B virus (HBV) when all of the following criteria are met:
A.   Member is HIV-1 negative
B.   Member has compensated liver disease as evidenced by:
      1.   No evidence of ascites, hepatic encephalopathy, or variceal bleeding
      2.   INR < 1.5× ULN
      3.   Total bilirubin < 2.5× ULN
      4.   Albumin > 3.0 g/dL

III. CONTINUATION OF THERAPY 

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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Vemlidy [package insert]. Foster City, CA: Gilead Sciences, Inc.; September 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.

August 14, 2022