Subject: Specialty Quantity Limit entecavir-Baraclude 4780-H P2026

Drug

BARACLUDE  (entecavir)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Baraclude (entecavir) 0.5 mg tablet	30 per 30 days
Baraclude (entecavir) 1 mg tablet	30 per 30 days
Baraclude (entecavir) 0.05 mg/mL oral solution	630 mL per 30 days

FDA-recommended Dosing

Tablets

Adult and adolescents (16 years of age and older) with compensated liver disease who are nucleoside-inhibitor-treatment-naive: 0.5 mg once daily

Adult and adolescents (16 years of age and older) with compensated liver disease with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg once daily

Adult patients with decompensated liver disease: 1 mg once daily

Oral Solution

Pediatric patients with body weight 10 kg to 30 kg: Up to 18 mL (0.9 mL), based on body weight and treatment status

Pediatric patients with body weight greater than 30 kg in treatment-naive patients:

·        10 mL (0.5 mg) of oral solution once daily, or

·        One 0.5 mg tablet once daily

Pediatric patients with body weight greater than 30 kg in lamivudine-experienced patients:

·        20 mL (1 mg) oral solution once daily, or

·        One 1 mg tablet once daily

Oral solution is also recommended in adult patients for doses less than 0.5 mg due to renal impairment.

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.; June 2020.

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 16, 2026