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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsAHCA Bronchitol Prior Auth Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Bronchitol (mannitol) Prior Authorization Criteria

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    This pharmacy policy governs prior authorization and continuation of Bronchitol (mannitol) inhalation powder for adults with cystic fibrosis. It establishes clinical eligibility, prerequisite therapy documentation, tolerance testing, dosing, and authorization duration.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBronchitol (mannitol) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation of age, cystic fibrosis diagnosis, pulmonologist involvement, prior therapy history, and a passed Bronchitol tolerance test.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsAuthorization duration
    ≥18 yearsMinimum patient age
    Cystic fibrosisRequired diagnosis
    400 mg twice dailyBronchitol dose
    BTT required

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    Tolerance test

    Coverage Criteria

    Initial Therapy Criteria

    Covered when all of the following initial review criteria are met:

    Initial therapy

    • Patient eligibility

      • Patient is at least 18 years of age.≥18 years
      • Patient has a diagnosis of cystic fibrosis.

    • Prescriber requirement

      • Bronchitol is prescribed by or in consultation with a pulmonologist.

    • Prior therapy and tolerance testing

      • Documentation demonstrates inadequate response, contraindication, or significant adverse reaction to hypertonic saline and Pulmozyme.
      • Documentation confirms that the patient has passed the Bronchitol tolerance test.

    Continuation Therapy Criteria

    Covered for continuation when all of the following are met:

    Continuation therapy

    • Patient met the initial review criteria.
    • Patient is responding positively to therapy.

    Initial Therapy Criteria

    Bronchitol Initial Authorization

    Initial therapy requires all of the following criteria:

    Initial therapy

    • Patient eligibility

      • Patient is at least 18 years of age.≥18 years
      • Patient has a diagnosis of cystic fibrosis.

    • Prescriber requirement

      • Bronchitol is prescribed by or in consultation with a pulmonologist.

    • Prior therapy and tolerance testing

    Continuation Criteria

    Bronchitol Continuation

    Continuation therapy requires both criteria below:

    Continuation therapy

    • Initial criteria

      • Patient met the initial review criteria.

    • Positive response

      • Patient is responding positively to therapy.

    Step Therapy

    StepTherapy requirementDocumentation standard
    1Hypertonic saline and Pulmozyme must be tried before Bronchitol authorization.Document inadequate response, contraindication, or significant adverse reaction to both therapies.

    Quantity Limits

    Quantity Limits
    MedicationBronchitol (mannitol)
    Dose frequency10 capsules twice daily
    Daily quantity limit20 capsules daily

    Prior Authorization and Documentation

    Prior Authorization

    Initial Prior Authorization Requirements

    Bronchitol requires prior authorization for patients who meet the age, diagnosis, and prescriber requirements.

    • Patient is 18 years of age or older.
    • Patient has a diagnosis of cystic fibrosis.
    • Bronchitol is prescribed by, or in consultation with, a pulmonologist.
    Step Therapy

    Document Required Prior Therapy

    Document that the patient had an inadequate response, a contraindication, or a significant adverse reaction to both prerequisite therapies before requesting Bronchitol.

    • Hypertonic saline
    • Pulmozyme

    Definitions

    Definitions
    AbbreviationBTT
    MeaningBronchitol tolerance test
    Authorization requirementThe patient must have passed the Bronchitol tolerance test
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyBronchitol (mannitol) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation of age, cystic fibrosis diagnosis, pulmonologist involvement, prior therapy history, and a passed Bronchitol tolerance test.
    SourceLink
    On This Page
    Coverage CriteriaInitial Therapy CriteriaContinuation CriteriaStep TherapyQuantity LimitsPrior Authorization and DocumentationDefinitions
    • Documentation demonstrates inadequate response, contraindication, or significant adverse reaction to hypertonic saline and Pulmozyme.
    • Documentation confirms that the patient has passed the Bronchitol tolerance test (BTT).
    Documentation Required

    Initial Authorization Documentation

    Submit the documentation package for initial review, including clinical documentation supporting the initial criteria and evidence that the patient passed the Bronchitol tolerance test (BTT).

    • Document the patient's age and cystic fibrosis diagnosis.
    • Identify the prescribing pulmonologist or consulting pulmonologist.
    • Document inadequate response, contraindication, or significant adverse reaction to hypertonic saline and Pulmozyme.
    • Include the result confirming that the patient passed the BTT.
    Documentation Required

    Continuation Documentation

    For continuation of therapy, document that the patient met the initial review criteria and is responding positively to Bronchitol.

    • Evidence that all initial authorization criteria were met
    • Clinical evidence of a positive response to therapy
    Denial Risk

    Failure to Meet Initial Authorization Criteria

    Initial coverage may be denied when the patient does not satisfy the required review criteria or when the required supporting documentation is not submitted.

    • Patient is younger than 18 years of age.
    • Patient does not have a diagnosis of cystic fibrosis.
    • Bronchitol is not prescribed by or in consultation with a pulmonologist.
    • There is no documented inadequate response, contraindication, or significant adverse reaction to both hypertonic saline and Pulmozyme.
    • The patient has not passed the Bronchitol tolerance test (BTT).
    Denial Risk

    Failure to Meet Continuation Criteria

    Continuation coverage may be denied when the patient did not meet the initial review criteria or is not responding positively to Bronchitol.

    • Initial review criteria were not met or cannot be documented.
    • The patient is not responding positively to therapy.