Pharmacy Prior Authorization Criteria

Leukotriene Modifiers

Indications for Prior Authorization

Zyflo (zileuton)

• For diagnosis of Asthma
  Indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zyflo is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with Zyflo can be continued during acute exacerbations of asthma.

Zileuton extended-release

• For diagnosis of Asthma
  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.

Criteria

Zyflo, Generic zileuton ER

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), intolerance or contraindication to at least one of the following generics:
• montelukast
• zafirlukast

P & T Revisions

2024-02-14, 2023-02-22, 2022-02-28, 2020-02-19

References

1. Zyflo [prescribing Information]. Cary, NC: Chiesi USA, Inc; January 2022.
2. Zileuton Extended-Release [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; August 2020

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Revision History

• 2024-02-14: 2024 UM Annual Review. Addition of language for minimum 30 day trial requirement. Background updates.
• 2023-02-22: 2023 Annual Review. No changes
• 2022-02-28: 2022 Annual Review - added criterion "Requested drug is being used for FDA-approved indication" , updated background information
• 2020-02-19: annual review - no changes to clinical criteria

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