ModifiedCignaPolicy IP0485

Antibiotics (Inhaled) - Cayston

Cigna coverage policy for inhaled aztreonam (Cayston) specifying prior authorization, FDA-approved indication criteria for cystic fibrosis patients with Pseudomonas aeruginosa, continuation coverage, exclusions, and prescribing/provider requirements.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Cayston

Policy CodePolicy IP0485

Change TypeTitle updateremoval of specialist consult for continuation

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Cayston; initial approvals require specialist prescribing/consultation and approvals are provided for specified durations (1 year initial, 1 month continuation).

SourceLink

POLICY UPDATE CHANGES

Updated coverage policy title from 'Aztreonam Inhalation Solution' to 'Antibiotics (Inhaled) - Cayston'.

Removed requirement for specialist consultation criterion from 'Continuation of Cayston'.

Annual Revision dated 6/15/2025 notes 'No criteria changes.'

1FDA-Approved Indication (CF with P. aeruginosa)

1Continuation approval duration (months)

1Not covered use example (nasal rinse)

Coverage Summary

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Scope: Cigna coverage policy for inhaled aztreonam (Cayston) specifying prior authorization, FDA‑approved indication criteria for cystic fibrosis patients with Pseudomonas aeruginosa, continuation coverage, exclusions, and prescribing/provider requirements. Coverage stance: covered_with_criteria. High‑level note: this policy aligns coverage determinations with applicable plan documents and laws and applies the stated criteria to determine coverage.

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication (Initial Approval)

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A: Patient has Pseudomonas aeruginosa in culture of the airway
Examples of culture of the airway include sputum culture, oropharyngeal culture, bronchoalveolar lavage culture.
B: Medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis

Continuation Therapy Criteria

Continuation of Therapy

Approve continuation when patient was started on Cayston and is continuing a course of therapy.

ALL of the following

Patient was previously started on Cayston (ongoing course of therapy)
Approval duration: 1 month

Material change: the policy has a documented material revision that removed the specialist consultation requirement from the continuation approval criteria, such that continuation approvals no longer require prior specialist consultation. See the revision history for the full change details and effective date.

Not Covered / Experimental or Unproven Uses

Any other use is considered experimental, investigational, or unproven, including but not limited to:

ANY of the following

Cayston is not approvable for compounding of aztreonam nasal rinse
Any indication not listed in the FDA-approved indication or continuation criteria

Safety/exclusions note: Safety and efficacy have not been established in pediatric patients < 7 years of age, in patients with FEV1 < 25% or > 75% predicted, or in patients colonized with Burkholderia cepacia; these limitations support applicable exclusions and use restrictions.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Cayston. Approvals are provided for the durations stated in the policy.

Initial approval duration: 1 year if initial criteria are met
Continuation approval duration: 1 month

Documentation Required

Specialist prescribing/consultation requirement

Initial approvals require Cayston to be prescribed by, or in consultation with, a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Billing Rule

Duration definitions

When approval is authorized in months, 1 month = 30 days.

Denial Risk

Coverage limited to specified diagnosis and codes

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered.

Denial risk applies when the required covered diagnosis or procedure codes are not present on the claim
Claims for conditions or diagnoses not covered under this policy will be denied

Clinical Evidence

91.5%Children <6 yrs culture-negative at end of ALPINE treatment (n=43/47)

76.6%Children <6 yrs remained culture-negative 4 weeks after ALPINE therapy (n=36/47)

Evidence highlights: An open‑label ALPINE study in children reported that among patients <6 years treated with inhaled aztreonam 75 mg TID for 28 days, 91.5% were culture‑negative at end of treatment and 76.6% remained culture‑negative 4 weeks after therapy (n=47 evaluated). The Cystic Fibrosis Foundation recommends chronic inhaled aztreonam for patients ≥6 years with persistent P. aeruginosa to improve lung function and quality of life, and supports inhaled antibiotics for initial/new growth eradication strategies.

Background & Definitions

Background and scope: Cayston (aztreonam inhalation solution) is indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. The policy aligns coverage determinations with plan documents and applicable laws. As noted in the prescribing information, safety and efficacy are not established in certain pediatric ages, in patients with extreme FEV1 values, or in those colonized with Burkholderia cepacia, which informs coverage limits.

Culture of the airway (definition / examples)Examples include sputum culture, oropharyngeal culture, bronchoalveolar lavage culture.

Revision History

7/1/2024title_change