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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsOklahoma Tobramycin Pulmozyme Coverage | OpenPayer
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    CurrentOklahoma Health Care AuthorityPolicy N/A

    Inhaled Tobramycin and Pulmozyme Coverage Criteria

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    This policy governs SoonerCare coverage and pharmacy claims processing for inhaled tobramycin products and Pulmozyme (dornase alfa) for members with cystic fibrosis.

    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyInhaled Tobramycin and Pulmozyme Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateApril 30, 2014
    Next Review DateN/A
    Key ActionSubmit a manual prior authorization when claims history does not show a cystic fibrosis diagnosis.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Cystic fibrosisRequired diagnosis for coverage
    12 monthsDiagnosis lookback period
    28 of 56 daysInhaled tobramycin therapy cycle
    Manual PARequired without qualifying diagnosis

    Coverage Criteria

    Cystic Fibrosis Diagnosis

    Covered when the member has cystic fibrosis and the applicable authorization pathway is satisfied.

    Cystic fibrosis coverage: The requested medication is an inhaled tobramycin product (Bethkis, Tobi, or Tobi Podhaler) or Pulmozyme (dornase alfa), and the member has a diagnosis of cystic fibrosis.

    Claims pay at the point of sale when a reported cystic fibrosis diagnosis is present within the past 12 months of claims history. If the diagnosis is not reported, manual prior authorization is required for coverage consideration.

    Inhaled Tobramycin Cycling

    Inhaled tobramycin is covered under the standard cycling regimen.

    Standard inhaled tobramycin regimen: Use inhaled tobramycin for 28 days followed by 28 days off therapy.28 days of therapy per 56 days

    Process prescriptions using appropriate units for 28 days of therapy as a 56-day supply.

    Policy Summary
    PayerOklahoma Health Care Authority
    PolicyInhaled Tobramycin and Pulmozyme Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateApril 30, 2014
    Next Review DateN/A
    Key ActionSubmit a manual prior authorization when claims history does not show a cystic fibrosis diagnosis.
    SourceLink
    On This Page
    Coverage CriteriaPrior Authorization and Exception HandlingPolicy BackgroundInitial Therapy QualificationProduct and Therapy Limits

    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.

    Prior Authorization and Exception Handling

    Prior Authorization

    Manual Prior Authorization Without Qualifying Diagnosis

    If claims history does not show a reported cystic fibrosis diagnosis within the past 12 months, submit a manual prior authorization for coverage consideration of inhaled tobramycin or Pulmozyme.

    • Claims pay at the point of sale without prior authorization when a qualifying cystic fibrosis diagnosis is reported within the 12-month claims-history lookback period.
    Prior Authorization

    Petition Required for Nonstandard Dosing

    Inhaled tobramycin is limited to 28 days of therapy per 56 days, following the standard cycle of 28 days on therapy and 28 days off therapy. Treatment outside this regimen requires a manual petition for coverage consideration.

    • Process prescriptions for the appropriate units for 28 days of therapy as a 56-day supply.
    Documentation Required

    Exception Documentation

    A manual petition for nonstandard inhaled tobramycin dosing must include a patient-specific, clinically significant explanation of why treatment outside the FDA-approved dosing regimen is medically necessary.

    • Provide supporting clinical documentation with the petition.
    • Explain why the member requires a regimen other than 28 days on therapy followed by 28 days off therapy.
    Denial Risk

    No Qualifying Cystic Fibrosis Diagnosis

    Coverage is at risk of denial when the member lacks a reported cystic fibrosis diagnosis in the applicable 12-month claims history and a manual prior authorization has not been obtained.

    • Inhaled tobramycin products and Pulmozyme are reserved for members diagnosed with cystic fibrosis.
    Prior Authorization

    Nonstandard Inhaled Tobramycin Regimen

    Use of inhaled tobramycin outside the standard 28-days-on and 28-days-off cycling regimen requires a manual petition and clinical justification before coverage can be considered.

    • Document the patient-specific, clinically significant reason for treatment outside the FDA-approved dosing regimen.
    • The standard restriction is 28 days of therapy per 56 days.

    Policy Background

    Inhaled tobramycin products—Bethkis, Tobi, and Tobi Podhaler—and Pulmozyme (dornase alfa) are managed as cystic fibrosis therapies under this policy. Coverage is reserved for members with a diagnosis of cystic fibrosis. Inhaled tobramycin is generally used in repeating cycles of 28 days on therapy followed by 28 days off therapy; treatment outside this regimen may require a manual petition.

    Initial Therapy Qualification

    Initial Cystic Fibrosis Qualification

    Initial coverage requires a qualifying cystic fibrosis diagnosis or manual authorization when the diagnosis is not reported.

    Initial coverage diagnosis: The member must have a reported diagnosis of cystic fibrosis within the past 12 months of claims history, or obtain manual prior authorization when the diagnosis is not reported.Diagnosis reported within 12 months of claims history

    Claims pay at the point of sale when the qualifying diagnosis is present in claims history.

    Product and Therapy Limits

    QUANTITY LIMITS
    ProductsBethkis, Tobi, and Tobi Podhaler
    Quantity limit28 days of therapy per 56 days
    Therapy cycle28 days on therapy followed by 28 days off therapy
    Claim processingProcess prescriptions using appropriate units for 28 days of therapy as a 56-day supply