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    v1.0.28
    OpenPayerPolicy UpdatesPulmonologyallcareadvantage Leukotriene Inhibitor Coverage | …
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    CurrentallcareadvantagePolicy 015.2

    Approval Criteria for Leukotriene inhibitors

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    Prior authorization and coverage criteria for leukotriene inhibitor medications for members, primarily for asthma indications; defines required trials, age limits, coverage status, and approval length.

    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Leukotriene inhibitors
    Policy CodePolicy 015.2
    Change TypeNo material changes
    Effective DateJun 14, 2022
    Last ReviewJun 13, 2024
    Next Review DateJun 13, 2024
    Key ActionObtain prior authorization and document asthma diagnosis, current use of a formulary inhaled corticosteroid, and trial or contraindication to preferred agents.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Up to 1 yearApproval length
    1/dayQuantity limit
    1–15+Age formulations
    LeukotrieneDrug class

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Initial Authorization (Asthma)

    Covered when ALL of the following are met

    Initial authorization criteria: Member has a diagnosis of asthma or reactive airways disease.
    Member is on a formulary inhaled corticosteroid.
    There is documented trial of, or documented contraindication to, preferred formulary agents (e.g., trial of 1st-line SABA and 2nd-line inhaled corticosteroid per step therapy).

    If all conditions are met → Approve up to 1 year; if any condition is not met → Deny.

    Use of leukotriene inhibitors for atopic dermatitis is not supported by the evidence and is not covered under this policy (off‑label use). The policy states that, because available studies are limited and of low quality, the role of leukotriene receptor antagonists in managing atopic dermatitis remains uncertain and the policy does not support their use for this indication.

    Specifically, montelukast for atopic dermatitis is considered not supported due to limited and low‑quality evidence. A systematic review of randomized trials found inconsistent results and overall low quality, with montelukast not demonstrating consistent reductions in disease severity, pruritus, or topical corticosteroid use versus placebo; therefore the policy does not support montelukast for this condition.

    Medication Codes and Formulations

    Medication codes / identifiersNDC
    NDCs not listedNo specific NDCs provided in document
    Age limits by formulation — montelukast formulations and age-specific dosing
    Montelukast 10 mg tabletFormulary, preferred for age ≥ 15 years
    Montelukast 5 mg chewable tabletFormulary, preferred for ages 6–14 years
    Montelukast 4 mg chewable tabletFormulary, preferred for ages 2–5 years
    Montelukast 4 mg granulesFormulary, non-preferred for ages 1–5 years

    Provider Actions and Authorization Rules

    Prior Authorization

    Prior authorization required for non‑preferred/nonformulary leukotriene inhibitors

    Prior authorization is required for non-preferred and nonformulary leukotriene inhibitors. Approval is granted only when the member has a diagnosis of asthma or reactive airways disease, is on a formulary inhaled corticosteroid, and there is documentation of a trial of or contraindication to preferred formulary agents; if all criteria are met, approve up to 1 year.

    • Non-preferred and nonformulary agents require a PA for approval.
    • Approval length: Up to 1 year when criteria are met.
    Step Therapy

    Step therapy: trial of SABA then ICS required

    Step therapy requires prior use of a short-acting beta-agonist (SABA) as first-line and an inhaled corticosteroid (ICS) as second-line; leukotriene inhibitors are covered for members with asthma who have failed step therapy and/or preferred agents.

    • 1st Line Agent(s): SABA (eg Albuterol)
    • 2nd Line Agent(s): ICS
    • Covered when member has failed step therapy and/or preferred agents.
    Documentation Required

    Required documentation for prior authorization

    For approval, submit documentation that the member has a diagnosis of asthma or reactive airways disease, is currently on a formulary inhaled corticosteroid, and has a documented trial of—or a contraindication to—preferred formulary agents.

    • Documentation of diagnosis (asthma or reactive airways disease).
    • Documentation of current use of a formulary inhaled corticosteroid.
    • Documentation of trial of or contraindication to preferred formulary agents.
    Denial Risk

    Denial risk: no asthma or reactive airways diagnosis

    If the member does not have a diagnosis of asthma or reactive airways disease, the request must be denied per the policy criteria.

    • Criteria #1: Does the member have a diagnosis of asthma, or reactive airways — Not Met = Deny.
    Denial Risk

    Denial risk: not currently on a formulary inhaled corticosteroid

    If the member is not on a formulary inhaled corticosteroid, the request is denied per the coverage criteria.

    • Criteria #2: Is the member on a formulary inhaled corticosteroid — Not Met = Deny.
    Denial Risk

    Denial risk: no trial or contraindication to preferred formulary agents

    If there is no documented trial of, or documented contraindication to, preferred formulary agents, the request must be denied.

    • Criteria #3: Is there documented trial of or contraindication to preferred formulary — Not Met = Deny.

    Definitions and Indications

    FDA approved indication — chronic treatment and prevention of asthma symptoms; monotherapy or add-on for persistent mild-moderate asthma
    FDA approved indicationChronic treatment and prevention of asthma symptoms either as monotherapy or as add-on therapy in patients whose persistent mild–moderate asthma is inadequately controlled with inhaled corticosteroids; montelukast also indicated for exercise-induced bronchospasm prophylaxis.
    Scope of useUsed for chronic prevention of asthma symptoms and as add-on when inhaled corticosteroids are inadequate
    Off-label noteUse for atopic dermatitis is not supported by current evidence and is not covered under this policy
    Preferred vs Non-preferred — formulary designations and preferred montelukast formulations
    Formulary preferred formulationsMontelukast 10 mg tablet; 5 mg chewable tablet; 4 mg chewable tablet are listed as formulary, preferred for specified ages
    Non-preferred formulationMontelukast 4 mg granules are listed as formulary, non-preferred for ages 1–5 years
    Non-formulary agentsZafirlukast and other non-formulary leukotriene inhibitors require prior authorization
    Prior authorization requirementNon-preferred and nonformulary agents require PA; covered when member has asthma, failed step therapy and/or preferred agents

    Background

    Leukotriene receptor antagonists (for example, montelukast and zafirlukast) are oral medications typically used chronically to prevent asthma symptoms and as add‑on therapy when inhaled corticosteroids do not adequately control persistent mild‑to‑moderate asthma. Montelukast is also indicated for prophylaxis of exercise‑induced bronchospasm. These agents are formulary for specific age groups and are considered after step therapy (first‑line SABA, second‑line ICS); non‑preferred or non‑formulary agents require prior authorization.

    Policy Summary
    Payerallcareadvantage
    PolicyApproval Criteria for Leukotriene inhibitors
    Policy CodePolicy 015.2
    Change TypeNo material changes
    Effective DateJun 14, 2022
    Last ReviewJun 13, 2024
    Next Review DateJun 13, 2024
    Key ActionObtain prior authorization and document asthma diagnosis, current use of a formulary inhaled corticosteroid, and trial or contraindication to preferred agents.
    SourceLink
    On This Page
    Coverage CriteriaMedication Codes and FormulationsProvider Actions and Authorization RulesDefinitions and IndicationsBackground