Subject: Zileuton PA Policy 4836-A 04-2022

Drug

ZYFLO  (zileuton)

zileuton extended-release

Policy:

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

Zileuton extended-release
Zileuton extended-release tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Zileuton extended-release tablet is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. 

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
•   The requested drug is being prescribed for the prophylaxis or chronic treatment of asthma in a patient 12 years
     of age and older
AND
•   The patient has experienced an inadequate treatment response to any of the following: A) An orally
     inhaled corticosteroid (ICS), B) A combination product containing an orally inhaled corticosteroid and
     long-acting beta agonist (ICS/LABA)
     [Note: The patient may continue to use an ICS containing product.]
      OR
•   The patient has experienced an intolerance to any of the following: A) An orally inhaled corticosteroid (ICS),
     B) A combination product containing an orally inhaled corticosteroid and long-acting beta agonist (ICS/LABA)
     OR
•   The patient has a contraindication that would prohibit a trial of any of the following: A) An orally inhaled
     corticosteroid (ICS), B) A combination product containing an orally inhaled corticosteroid and long-acting
     beta agonist (ICS/LABA)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Zyflo [package insert]. Cary, NC: Chiesi USA, Inc.; January 2017.
2. Zileuton Extended-Release [package insert]. Upper Saddle River, NJ: DASH Pharmaceuticals LLC; November 2020.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: UpToDate, Inc.; 2021; Accessed February 18, 2022.
4. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed February 18, 2022.
5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2021. Available at: http://www.ginasthma.org. Accessed February 2022.
6. 2020 Focused Updates to the Asthma Management Guidelines. A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. Available at: https://www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates. Accessed February 2022.
7. National Heart, Lung, and Blood Institute National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma Full Report 2007. Available at http://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines. Accessed February 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 14, 2022