Subject: Specialty Quantity Limit Emflaza 1637-H P2022

Drug

EMFLAZA  (deflazacort)

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
Emflaza tablets 6 mg	60 tablets per 30 days	0.9 mg/kg/day*  Dose modification is recommended for drug interactions with CYP3A4 inhibitors: ·   One third of the recommended dosage
Emflaza tablets 18 mg	30 tablets per 30 days
Emflaza tablets 30 mg	30 tablets per 30 days
Emflaza tablets 36 mg	30 tablets per 30 days
Emflaza suspension: 22.75 mg/mL	52 mL per 30 days (1.8 mL/day)

 * The maximum dose of deflazacort recommended by clinical practice guidelines is 36 to 39 mg per day.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Emflaza [package insert]. South Plainfield, NJ: PTC Therapeutics, Inc.; June 2021.
2. Bushby K, Finkel R, Birnkrant DJ, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis and pharmacological and psychosocial management. Lancet Neurol. 2010;9:77-93.
3. Birnkrant DJ, Bushby, K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018;17(3):251-267.
4. Biggar WD, Harris VA, Eliasoph L, Alman B. Long-term benefits of deflazacort treatment for boys with Duchenne muscular dystrophy in their second decade. Neuromuscul Disord. 2006;16(4):249-255.

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 21, 2022