Subject: Specialty Quantity Limit phenylbutyrate-Buphenyl-Pheburane 3016-H P2022a

Drug

BUPHENYL  (sodium phenylbutyrate)

PHEBURANE  (sodium phenylbutyrate)

sodium phenylbutyrate

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  

Medication	Standard Limit	FDA-recommended dosing
Buphenyl (sodium    phenylbutyrate)    500mg tablets	1200 tablets per 30 days	450–600 mg/kg/day in patients   weighing less than 20 kg, or 9.9–   13.0 g/m2/day in larger patients.      The safety or efficacy of doses in    excess of 20 grams per day has    not been established.

Place of Service:

Outpatient

The above policy is based on the following references:

 

1. Buphenyl [package insert]. Lake Forest, IL: Horizon Pharma USA, Inc.; March 2021.
2. Pheburane [package insert]. Bryn Mawr, PA: Medunik USA, Inc.; June 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.

October 02, 2022