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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCareSource Georgia Bronchitol Prior Auth | OpenPay…
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    CurrentCareSource GeorgiaPolicy GA-MED-P-366579

    Bronchitol (mannitol) for cystic fibrosis

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    This policy governs pharmacy prior authorization coverage of Bronchitol (mannitol) as add-on maintenance therapy to improve pulmonary function in adults with cystic fibrosis for CareSource Georgia Medicaid members.

    Policy Summary
    PayerCareSource Georgia
    PolicyBronchitol (mannitol) for cystic fibrosis
    Policy CodePolicy GA-MED-P-366579
    Change TypeRevised
    Effective DateFeb 1, 2026
    Next Review DateN/A
    Key ActionSubmit chart notes documenting improvement or stabilization of disease signs and symptoms, including improved FEV1 or other lung function test results, for reauthorization.
    SourceLink
    POLICY UPDATE CHANGES

    Reauthorization criteria were simplified to require chart documentation of improvement or stabilization of disease signs and symptoms, such as improved FEV1 or other lung function tests.

    18+ yearsMinimum member age for initial authorization
    560 capsulesQuantity limit per 28 days
    400 mg twice dailyAllowed dose
    12 monthsInitial authorization duration

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    12 monthsAdditional authorization duration
    Prior authorization requiredBenefit status

    Coverage Criteria

    Initial Therapy Criteria

    Covered for initial authorization when ALL of the following are met:

    Initial therapy criteria

    • Member and prescriber requirements

      • The member is at least 18 years of age, and the medication is prescribed by or in consultation with a pulmonologist or infectious disease specialist.Age ≥ 18 years

    • Diagnosis and prior therapy

      • The member has a diagnosis of cystic fibrosis and has had an inadequate response, intolerance, or contraindication to documented prior therapy with nebulized hypertonic saline (7%).Nebulized hypertonic saline concentration: 7%

    • Tolerance testing

      • Documentation shows that the member passed the Bronchitol tolerance test (BTT).Passed BTT

    • Dose and quantity

      • The prescribed dose does not exceed 400 mg (10 capsules) twice daily by oral inhalation, and the quantity does not exceed 560 capsules per 28 days.400 mg twice daily; 560 capsules per 28 days

    Continuation Therapy Criteria

    Covered for reauthorization when the following requirement is met:

    Continuation response: Chart notes show improvement or stabilized signs and symptoms of disease, such as improved FEV1 and/or other lung function tests.Improved or stabilized disease response

    Authorization is approved for an additional 12 months when the requirement is met.

    Conditions or indications not listed in this policy are excluded from medical necessity consideration under this policy. Other indications should be evaluated under the applicable Off-Label policy.

    Bronchitol (mannitol) is not medically necessary for the treatment of conditions or indications that are not listed in this document.

    Dosage and Utilization Parameters

    Bronchitol dosage
    Dose400 mg twice daily
    Capsule equivalent10 capsules per dose
    RouteOral inhalation
    FrequencyTwice daily
    Bronchitol quantity limit
    MedicationBronchitol (mannitol)
    Quantity limit560 capsules
    Limit period

    Authorization and Documentation Actions

    Prior Authorization

    Initial Prior Authorization Required

    Pharmacy prior authorization is required for Bronchitol (mannitol). Initial authorization is available only when all policy criteria are satisfied, including the required clinical documentation and a passed Bronchitol tolerance test.

    • Approved initial authorization period: 12 months.
    • Allowed dose: 400 mg (10 capsules) twice daily by oral inhalation.
    • Quantity limit: 560 capsules per 28 days.
    Documentation Required

    Reauthorization Requires Clinical Response

    For reauthorization, the medical record must demonstrate that the member’s disease signs and symptoms have improved or stabilized. If the requirement is met, coverage may be approved for an additional 12 months.

    Clinical Background

    Bronchitol (mannitol) is a sugar alcohol used as add-on maintenance therapy to improve pulmonary function in adults with cystic fibrosis. Cystic fibrosis is an autosomal recessive disease associated with abnormal airway secretions, chronic endobronchial infection, and progressive airway obstruction.

    Key Definitions

    Cystic fibrosis
    DiseaseCystic fibrosis
    InheritanceAutosomal recessive disease
    Airway secretionsPatients can have abnormal airway secretions
    InfectionChronic endobronchial infection can occur
    Airway obstructionProgressive airway obstruction can occur
    Bronchitol tolerance test
    AbbreviationBTT

    Initial Authorization Criteria

    Bronchitol Initial Authorization

    Initial coverage requires ALL of the following:

    Initial Bronchitol criteria

    • Member and prescriber requirements

      • The member is at least 18 years of age, and Bronchitol is prescribed by or in consultation with a pulmonologist or an infectious disease specialist.Age ≥ 18 years

    • Diagnosis and prior therapy

      • The member has a diagnosis of cystic fibrosis and has had an inadequate response, intolerance, or contraindication to documented prior therapy with nebulized hypertonic saline (7%).Nebulized hypertonic saline concentration: 7%

    • Tolerance testing

    Reauthorization Criteria

    Bronchitol Reauthorization

    Reauthorization is available when the following response criterion is met:

    Continuation response: Chart notes must show improvement or stabilized signs and symptoms of disease, such as improved FEV1 and/or other lung function tests.Improved or stabilized disease response

    Authorization is approved for an additional 12 months when the requirement is met.

    Required Prior Therapy

    StepPrior therapy requirementRequired outcome
    1Documented prior therapy with nebulized hypertonic saline (7%)Inadequate response, intolerance, or contraindication

    Quantity and Dose Limits

    Quantity limits
    MedicationBronchitol (mannitol)
    Quantity limit560 capsules
    Limit periodPer 28 days
    Bronchitol dose
    Dose400 mg twice daily
    Capsule equivalent10 capsules per dose
    RouteOral inhalation
    Frequency
    Policy Summary
    PayerCareSource Georgia
    PolicyBronchitol (mannitol) for cystic fibrosis
    Policy CodePolicy GA-MED-P-366579
    Change TypeRevised
    Effective DateFeb 1, 2026
    Next Review DateN/A
    Key ActionSubmit chart notes documenting improvement or stabilization of disease signs and symptoms, including improved FEV1 or other lung function test results, for reauthorization.
    SourceLink
    On This Page
    Coverage CriteriaDosage and Utilization ParametersAuthorization and Documentation ActionsClinical BackgroundKey DefinitionsInitial Authorization CriteriaReauthorization CriteriaRequired Prior TherapyQuantity and Dose Limits
    Per 28 days
    Minimum age
    Minimum ageAt least 18 years
    Eligible populationAdults with cystic fibrosis
    Authorization applicationInitial authorization
    Step Therapy

    Document Prior 7% Hypertonic Saline Therapy

    Document that the member had an inadequate response, intolerance, or contraindication to prior nebulized hypertonic saline therapy at the 7% concentration.

    • Prior 7% hypertonic saline therapy must be documented before initial Bronchitol authorization.
    • The documentation must specify inadequate response, intolerance, or contraindication.

    Unsupported block type: documentation

    Documentation Required

    Submit Reauthorization Clinical Documentation

    For reauthorization, submit chart notes documenting improvement or stabilization of disease signs and symptoms, including improved FEV1 and/or other lung function test results when available.

    • Relevant chart documentation must support continued benefit.
    • Examples include improved FEV1 or improvement on other lung function tests.
    Denial Risk

    Initial Criteria Not Met

    Initial authorization may be denied when the member does not meet the required age, diagnosis, prescriber or specialist-consultation, prior-therapy, tolerance-test, or other initial clinical requirements.

    • Member is younger than 18 years.
    • Bronchitol is not prescribed by or in consultation with a pulmonologist or infectious disease specialist.
    • Required cystic fibrosis diagnosis, prior 7% hypertonic saline documentation, or passed Bronchitol tolerance test is absent.
    Denial Risk

    Insufficient Response for Reauthorization

    Reauthorization may be denied when chart documentation does not show improvement or stabilization of the member’s disease signs and symptoms, such as improved FEV1 or other lung function findings.

    • Insufficient or missing clinical response documentation creates denial risk.
    • Coverage is extended for 12 months only when the reauthorization requirement is met.
    Denial Risk

    Unlisted Indication Not Medically Necessary

    Bronchitol is not medically necessary for the treatment of conditions or indications not listed in this policy. For other indications, refer to the applicable Off-Label policy.

    Full term
    Bronchitol tolerance test
    Coverage requirementDocumentation must show that the member passed the BTT
    • Documentation shows that the member passed the Bronchitol tolerance test (BTT).Passed BTT

  1. Dose and quantity

    • The prescribed dose does not exceed 400 mg (10 capsules) twice daily by oral inhalation, and the quantity does not exceed 560 capsules per 28 days.400 mg twice daily; 560 capsules per 28 days
    2. Twice daily