Subject: Specialty Quantity Limit entecavir-Baraclude 4780-H P2023
|
BARACLUDE
(entecavir)
|
|
entecavir
|
Policy:
I. 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.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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FDA-recommended dosing
|
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Baraclude
(entecavir)
0.5 mg tablet
|
30 tablets per 30 days
|
Dosage in adult and adolescent patients
with compensated liver disease who are
nucleoside-inhibitor-treatment-naive: 0.5
mg once daily
Dosage in adult and adolescent patients
with compensated liver disease with a
history of hepatitis B viremia while
receiving lamivudine or know lamivudine
or telbivudine resistance substitutions
rtM2041/V with or without rtL180M,
rtL801/V, or rtV173L: 1 mg once daily
Dosage in adult patients with
decompensated liver disease:
1 mg once daily
|
|
Baraclude
(entecavir)
1 mg tablet
|
30 tablets per 30 days
|
|
Baraclude
(entecavir)
0.05 mg/mL
oral solution
|
630 mL per 30 days
|
Dosing is based on body weight
Dosage in pediatric patients with body
weight greater than 30 kg in treatment-
naive patients: 10 mL (0.5 mg) once daily
of oral solution or one 0.5 mg tablet once
daily
Dosage in pediatric patients with body
weight greater than 30 kg in lamivudine-
experienced patients: 20 mL (1 mg) once
daily of oral solution or one 1 mg tablet
once daily
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Baraclude [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; November 2019.
- Entecavir [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; April 2022.
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
