Leukotriene Modifiers
Indications for Prior Authorization
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
Generic zileuton ER
Step Therapy
Length of Approval: 12 Month(s)
For diagnosis of Asthma
- 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, 2021-09-27, 2021-05-20, 2021-02-22, 2020-02-19
References
- Zileuton Extended-Release [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; August 2020
Revision History
- 2024-02-14: 2024 UM Annual Review. Addition of language for minimum 30 day trial requirement. Background updates.
- 2023-02-22: 2023 UM Annual Review. No changes
- 2021-09-27: EHB specific guideline, added to EHB formulary, removed from ORx standard formulary. no changes to criteria
- 2021-05-20: EHB specific guideline, added to EHB formulary, removed from ORx standard formulary. no changes to criteria
- 2021-02-22: Annual review - no changes to clinical criteria
- 2020-02-19: annual review - no changes to clinical criteria
HEALTHY LIVING