CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zileuton (extended-release) prior authorization

Defines prior authorization coverage criteria for zileuton extended-release (Zyflo) for prophylaxis and chronic treatment of asthma in patients ≥12 years; affects prescribers and pharmacy benefit adjudication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZileuton (extended-release) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review Date2023-04

Key ActionObtain prior authorization and document patient age ≥12 and inadequate response to an inhaled corticosteroid or an ICS/LABA (or intolerance/contraindication).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+minimum patient age for coverage

Yesprior authorization required

2required prior treatment trials

prophylaxis/chronicindicated use

Coverage criteria for zileuton (extended-release)

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Age: Patient is 12 years of age or older.>=12 years

From product indication and coverage criteria.

Indication: Requested drug is prescribed for the prophylaxis or chronic treatment of asthma.

Covered uses per product labeling and coverage section.

Prior treatment or contraindication/intolerance: Either: (1) patient has experienced an inadequate treatment response to an inhaled corticosteroid (ICS) OR an ICS/LABA combination; OR (2) patient has intolerance to an ICS or ICS/LABA; OR (3) patient has a contraindication to an ICS or ICS/LABA.

Step therapy requires trial and inadequate response to an ICS and/or an ICS/LABA prior to approval unless intolerance/contraindication documented.

Provider requirements and authorization process

Prior Authorization

Prior Authorization Required

Prior authorization required for zileuton extended-release (ZYFLO) when prescribed for prophylaxis or chronic treatment of asthma in patients aged 12 years and older.

Drug: zileuton extended-release (ZYFLO)
Indication: prophylaxis or chronic treatment of asthma
Age: ≥ 12 years

Step Therapy

Step Therapy Requirement

A trial and inadequate response to an inhaled corticosteroid (ICS) and/or an ICS/LABA combination is required prior to approval, unless there is documented intolerance or a contraindication to these therapies.

Step therapy: trial of ICS and/or ICS/LABA with documented inadequate response
Exception: documented intolerance or contraindication to ICS and/or ICS/LABA

Documentation Required

Required Documentation

Documentation must include patient age (≥12), the indication (prophylaxis or chronic treatment of asthma), and evidence of inadequate response to an ICS and/or ICS/LABA, or documentation of intolerance/contraindication to these agents.

Patient age documented (≥ 12 years)
Indication documented (prophylaxis or chronic treatment of asthma)
Documentation of inadequate response to ICS and/or ICS/LABA OR documentation of intolerance/contraindication to ICS and/or ICS/LABA

Denial Risk

Triggers for Denial

Denial is likely if the request is not for prophylaxis or chronic treatment of asthma; the patient is under 12 years of age; there is no documentation of prior inadequate response to ICS and/or ICS/LABA and no documented intolerance/contraindication; or if other exclusion criteria apply.

Not covered if prescribed for indications other than asthma prophylaxis/chronic treatment
Not covered if patient < 12 years of age
Not covered without documentation of inadequate response to ICS and/or ICS/LABA or documented intolerance/contraindication