CurrentUnitedHealthcarePolicy 2026 P 1016-14

Pa Notification Cayston

UnitedHealthcare prior authorization/notification policy governing coverage criteria and reauthorization for Cayston (aztreonam for inhalation solution) for members; includes initial diagnosis and microbiology requirements, reauthorization clinical response requirement, authorization duration, and notes on automated approvals and supply limits.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Cayston

Policy CodePolicy 2026 P 1016-14

Change TypeAnnual review (no changes)

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization/notification with documentation of CF diagnosis and a positive culture for Pseudomonas aeruginosa for initial approval; provide documentation of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Annual review 2/2026: Annual review. No changes to coverage criteria.

2/2016 changed authorization period to 12 months and added re-authorization period for 12 months.

2Required initial criteria

1Reauthorization criterion

12mAuthorization duration

>=7Minimum age for established safety

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Coverage Summary

UnitedHealthcare covers Cayston (aztreonam for inhalation solution) with criteria as a prior authorization/notification medication for members. Coverage is effective 5/1/2026. Authorization duration is 12 months per approval.

Key Thresholds and Criteria

Authorization duration12 months

Pediatric age limitation< 7 years (safety/effectiveness not established)

FEV1 limitation< 25% or > 75% predicted (safety/effectiveness not established)

Required initial criteriaDiagnosis of cystic fibrosis and positive lung culture for Pseudomonas aeruginosa

Reauthorization criterionDocumentation of positive clinical response to Cayston therapy

Initial Therapy Criteria

Initial Authorization

Cayston will be approved based on both of the following criteria:

ALL of the following

Diagnosis of cystic fibrosis (CF)
Lung infection with positive culture demonstrating Pseudomonas aeruginosa infection

Prior Authorization

Prior authorization required

Prior authorization/notification is required. Initial approval requires documentation of a diagnosis of cystic fibrosis and a positive culture demonstrating Pseudomonas aeruginosa lung infection.

Reauthorization / Continuation Criteria

Reauthorization

Cayston will be approved based on the following criterion:

Documentation of positive clinical response to Cayston therapy

Not explicitly defined in policy; generally requires documentation from clinical records showing benefit from Cayston therapy.

Prior Authorization

Reauthorization requirement

Reauthorization requires documentation of a positive clinical response to Cayston therapy. Authorizations are issued for 12 months.

Unproven / Exclusions

Safety and effectiveness of Cayston have not been established in pediatric patients <7 years, in patients with baseline FEV1 <25% or >75% predicted, or in patients colonized with Burkholderia cepacia. Per provider guidance, these populations may be considered contraindicated or unsupported and may be denied.

Denial Risk

Contraindicated/unsupported populations

Safety and effectiveness have not been established for pediatric patients under 7 years, patients with FEV1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia; use in these populations may be denied.

Applicable Codes

DrugNDC|HCPCSCovered

No codes listed

Provider Actions & Operational Notes

Documentation Required

Microbiology documentation

Provide culture results demonstrating Pseudomonas aeruginosa lung infection for initial approval. Note operationally that supply limits may be in place and member-specific benefit plans and state mandates can affect coverage.

Billing Rule

Supply limits

Supply limits may be in place. Member-specific benefit plan details and applicable state mandates can also impact coverage and limits.

Billing Rule

Automated approvals may apply

Program-dependent automated approval and re-approval processes may be used; UnitedHealthcare may rely on prior claims/medication history and diagnosis codes as the basis for automated approvals.

Clinical Evidence

Primary reference: Cayston [package insert], Gilead Sciences; November 2019. Cayston is indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa; safety and effectiveness are not established in children <7 years, in patients with FEV1 <25% or >75% predicted, or in those colonized with Burkholderia cepacia, and use should be limited to patients known to have Pseudomonas aeruginosa to reduce resistance.

Positive clinical response: Not explicitly defined in the policy; generally requires documentation in the clinical record demonstrating benefit from Cayston therapy (for example, symptom improvement or other clinician-documented therapeutic effect).

Background & Scope

Cayston (aztreonam solution for inhalation) is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below age 7, in patients with FEV1 <25% or >75% predicted, or in patients colonized with Burkholderia cepacia. To reduce development of drug-resistant bacteria, use is limited to patients with documented Pseudomonas aeruginosa in the lungs. Members must meet initial criteria requiring diagnosis of CF and positive culture for Pseudomonas aeruginosa; reauthorization requires documentation of positive clinical response. Authorizations are issued for 12 months; automated approvals and supply limits may apply.

Policy Metadata

Policy Number2026 P 1016-14

Effective Date2026-05-01

Last Review2026-02

Next Review

StatusCURRENT

Revision History

2/2016material_change

Changed authorization period to 12 months and added re-authorization period for 12 months.

2/2026annual_reviewLatest

Annual review. No changes to coverage criteria. (P&T approval history includes 2/2026; effective date set to 5/1/2026.)

2/2017annual_review