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    v1.0.28
    OpenPayerPolicy UpdatesInfectious DiseaseGeorgia DCH inhaled antibiotics Prior Auth | OpenP…
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    CurrentGeorgia Department of Community HealthPolicy N/A

    Inhaled Antibiotics (Cayston, Arikayce) — Prior Authorization and Coverage Criteria

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    This document governs prior authorization and coverage criteria for inhaled antibiotics, specifically Cayston (aztreonam for inhalation solution) and related inhaled antibiotic products for Georgia Medicaid members. It affects prescribers and pharmacy providers seeking coverage for these products.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyInhaled Antibiotics (Cayston, Arikayce) — Prior Authorization and Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionPrescriber must submit a written letter of medical necessity explaining why preferred tobramycin products are inappropriate to initiate prior authorization.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    7+min age for Cayston
    25%-75%Cayston FEV1 range
    RequiredPA requirement
    18+Arikayce age

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    Coverage Criteria for Inhaled Antibiotics

    Initial therapy — Cayston (aztreonam for inhalation)

    Cayston is approvable when ALL of the following are met

    Cayston for CF with Pseudomonas: Member is 7 years of age or older; has a diagnosis of cystic fibrosis with a lung infection due to Pseudomonas aeruginosa; forced expiratory volume in one second (FEV1) percent predicted is between 25% and 75%; and member has experienced an inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effect with tobramycin products (e.g., Bethkis, Kitabis Pak, Tobi).age >=7; FEV1 25%-75%

    Prescriber must submit a written letter of medical necessity documenting reasons preferred tobramycin products are inappropriate.

    Initial therapy — Arikayce (amikacin liposome inhalation)

    Arikayce is approvable when ALL of the following are met

    Arikayce for MAC lung disease: Member is 18 years of age or older; has a diagnosis of Mycobacterium avium complex (MAC) lung disease; has been on a multidrug background regimen for at least 6 consecutive months without achieving a negative sputum culture; member has limited or no alternative treatment options; and the medication will be used as part of a combination antibacterial regimen and prescribed by or in consultation with an infectious disease specialist.age >=18; >=6 months on background regimen

    Arikayce requires prior authorization.

    The policy lists Tobi Podhaler (tobramycin inhalation capsules, 28 mg) as Non-Preferred among inhaled antibiotic options for Georgia Medicaid fee‑for‑service.

    Prior Authorization & Documentation Requirements

    Prior Authorization

    Prior authorization required

    Cayston and Arikayce require prior authorization. Exceptions to the conditions of coverage are considered only through the prior authorization process; the prior authorization may be initiated by calling OptumRx at 1-866-525-5827.

    Step Therapy

    Step therapy / medication trial requirement

    Approval for Cayston requires documentation of prior inadequate response, allergy, contraindication, drug‑drug interaction, or intolerable side effect to preferred tobramycin products (Bethkis, Kitabis Pak, Tobi). The prescriber must document these reasons when requesting coverage.

    Documentation Required

    Coding for Inhaled Antibiotics

    Inhaled antibiotics listingmixed
    Arikayceamikacin liposome inhalation suspension
    Bethkistobramycin nebulization solution, 300 mg/4 mL
    Caystonaztreonam for inhalation solution
    Kitabis Paktobramycin nebulizer solution, 300 mg/5 mL, and PARI LC Plus nebulizer
    Tobramycin nebulization solution, 300 mg/5 mLgeneric
    Tobi Podhalertobramycin inhalation capsules, 28 mg (Non-Preferred)
    Non-Preferred inhaled antibioticmixedNot Covered
    Tobi Podhalertobramycin inhalation capsules, 28 mg (Non-Preferred)
    Preferred/Standard inhaled antibioticsmixedCovered
    Arikayceamikacin liposome inhalation suspension
    Bethkistobramycin nebulization solution, 300 mg/4 mL
    Caystonaztreonam for inhalation solution
    Kitabis Paktobramycin nebulizer solution, 300 mg/5 mL, and PARI LC Plus nebulizer
    Tobramycin nebulization solution, 300 mg/5 mLgeneric

    Definitions and Clinical Thresholds

    Inadequate response / intolerance to tobramycin — definition
    Documented inadequate clinical responseMember has experienced an inadequate clinical response to inhaled tobramycin products (Bethkis, Kitabis Pak, Tobi).
    Allergy to tobramycinDocumented allergy to tobramycin formulations (e.g., Bethkis, Kitabis Pak, generic tobramycin/Tobi) preventing safe use.
    Contraindication to tobramycinA documented medical contraindication to inhaled tobramycin that precludes its use for the member.
    Drug–drug interaction with tobramycinA documented drug–drug interaction that makes inhaled tobramycin inappropriate for the member.
    Intolerable side effect to tobramycinMember has experienced an intolerable side effect from inhaled tobramycin formulations that prevents continued use.

    Background

    Cayston (aztreonam for inhalation solution) is included in the Georgia Medicaid inhaled antibiotics prior authorization summary as a treatment option for respiratory infections caused by Pseudomonas aeruginosa in cystic fibrosis. The summary groups Cayston together with other inhaled antibacterial therapies (for example, Bethkis, Kitabis Pak, Arikayce) and notes that inhaled antibiotic products are managed under the PA process.

    Policy Summary
    PayerGeorgia Department of Community Health
    PolicyInhaled Antibiotics (Cayston, Arikayce) — Prior Authorization and Coverage Criteria
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionPrescriber must submit a written letter of medical necessity explaining why preferred tobramycin products are inappropriate to initiate prior authorization.
    SourceLink
    On This Page
    Coverage Criteria for Inhaled AntibioticsPrior Authorization & Documentation RequirementsCoding for Inhaled AntibioticsDefinitions and Clinical ThresholdsBackground

    Letter of medical necessity required

    Prescribers must submit a written letter of medical necessity explaining why preferred tobramycin products (Bethkis, Kitabis Pak, generic tobramycin/Tobi) are not appropriate for the member.

    Documentation Required

    Clinical eligibility documentation required

    Clinical documentation must show the member is ≥7 years old with cystic fibrosis and a lung infection due to Pseudomonas aeruginosa, and have an FEV1 percent predicted between 25% and 75%.

    Denial Risk

    Documentation and PA initiation required (denial risk)

    Failure to submit the required written letter of medical necessity and supporting clinical documentation may prevent approval; exceptions are considered only via the prior authorization process which must be initiated (call OptumRx at 1-866-525-5827).