Subject: Zileuton PA 5090-A P09-2024_R

Drug

zileuton extended-release (brand unavailable)  (zileuton extended-release )

ZYFLO  (zileuton)

Policy:

Indications

FDA-approved Indications

Zileuton extended-release

Zileuton Extended-Release Tablets is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Zileuton Extended-Release Tablets are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with Zileuton Extended-Release Tablets can be continued during acute exacerbations of asthma.

Zyflo

Zyflo is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.

Coverage Criteria

Asthma

Authorization may be granted when the requested drug is being prescribed for the prophylaxis or chronic treatment of asthma when the following criteria is met:

• The patient is 12 years of age or older.

Duration of Approval (DOA)

• 5090-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zileuton Extended-Release [package insert]. East Brunswick, NJ: Rising Pharmaceuticals, Inc.; May 2024.
2. Zyflo [package insert]. Cary, NC: Chiesi USA, Inc.; January 2017.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed July 31, 2024.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 07/31/2024).

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.

January 01, 2026