CurrentCignaPolicy IP0485

Antibiotics (Inhaled) - Cayston

Defines Cigna's prior authorization and coverage criteria for Cayston for treatment of cystic fibrosis patients with Pseudomonas aeruginosa, and continuation therapy rules. Applies to prescription benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Cayston

Policy CodePolicy IP0485

Change TypeTitle updateremoved specialist requirement for continuation

Effective DateJun 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document that patient has Pseudomonas aeruginosa in airway culture; approvals: 1 year for FDA indication, 1 month for continuation.

SourceLink

POLICY UPDATE CHANGES

Removed requirement for specialist consultation criterion for continuation of Cayston.

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

1 yearApproval duration for FDA-approved indication

1 monthApproval duration for continuation of therapy

≥6 yrsCFF recommended age

25%-75%Safety not established (FEV1)

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Initial (FDA-approved) therapy

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

FDA-approved CF indication

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) The medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Continuation Therapy

Approve for 1 month when continuing a course already started:

Continuation: Patient was started on Cayston and is continuing a course of therapy.1

Receipt of sample product does not satisfy any criteria requirements for coverage.

Experimental/Not Medically Necessary

Not covered uses: Any other use is considered experimental, investigational, or unproven, including use for aztreonam nasal rinse.any

List may not be all inclusive; criteria will be updated as new published data are available.

Cayston (aztreonam inhalation solution) is not approvable when used for compounding of an aztreonam nasal rinse. This specific use is listed under the policy’s Conditions Not Covered and should be treated as an exclusion from benefit coverage.

Any use of Cayston that is not explicitly listed as an approved indication in this policy is considered experimental, investigational, or unproven. This includes, but is not limited to, use as an aztreonam nasal rinse; the policy notes that the list of such uses may not be all-inclusive and will be updated as new published data become available.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended — Prior authorization is recommended for Cayston™ (aztreonam for inhalation). Approvals: 1 year for FDA‑approved cystic fibrosis indication when both criteria are met; 1 month (30 days) for continuation of a previously started course.

Approve for 1 year when both: patient has Pseudomonas aeruginosa in airway culture; and medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in cystic fibrosis.
Approve for 1 month (30 days) for continuation of therapy started previously.

Note

Guideline Context for Antibiotic Choice

Cystic Fibrosis Foundation guideline context: CFF recommends chronic inhaled aztreonam for patients ≥6 years with CF and persistent P. aeruginosa to improve lung function and quality of life; for initial/new P. aeruginosa growth, inhaled antibiotics are recommended (tobramycin preferred). Use this guidance to inform antibiotic selection.

Documentation Required

Prescriber Requirement and Approval Duration

Prescriber and Approval Duration — Cayston must be prescribed by a physician who has consulted with or specializes in cystic fibrosis care. Approvals are issued for the durations noted: 1 year for FDA‑approved CF indication when criteria are met; 1 month (30 days) for continuation of therapy.

Denial Risk

Coding-based Denial Risk

Coding-based Denial Risk — Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of submission and include covered diagnosis codes (e.g., cystic fibrosis with Pseudomonas aeruginosa) to support coverage.

Claims lacking covered diagnosis/procedure codes per this Coverage Policy will be denied as not covered.
Ensure billing includes appropriate covered diagnosis codes (e.g., CF with P. aeruginosa) and applicable procedure/drug codes.

Background

Cayston (aztreonam inhalation solution) is discussed in this policy in the context of treatment for cystic fibrosis patients infected with Pseudomonas aeruginosa. The document identifies specific covered and not-covered uses and clarifies that non‑listed indications are considered experimental or unproven. The policy also documents exclusions such as compounding for aztreonam nasal rinse and states that the list of non‑covered uses may be amended as new evidence is published.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Cayston

Policy CodePolicy IP0485

Change TypeTitle updateremoved specialist requirement for continuation

Effective DateJun 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document that patient has Pseudomonas aeruginosa in airway culture; approvals: 1 year for FDA indication, 1 month for continuation.

SourceLink

On This Page

OpenPayer

Antibiotics (Inhaled) - Cayston

Coverage Criteria for Cayston (aztreonam inhalation solution)

Coding and Safety Notes

Provider Actions and Prior Authorization

Definitions

Background

Revision History and Policy Changes