Subject: Zileuton PA Policy 4836-A UDR 10-2023

Drug

zileuton extended-release

ZYFLO  (zileuton)

Policy:

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
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
          AND
               °   The patient is 12 years of age or 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)

Duration of Approval (DOA):
     •     4836-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.; March 2023.
2. Zyflo [package insert]. Cary, NC: Chiesi USA, Inc.; January 2017.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed August 8, 2023.
4. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 07/13/2023).
5. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2023. Available at: http://www.ginasthma.org. Accessed July 2023.
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 July 2023.

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.

April 14, 2024