CurrentUnitedHealthcarePolicy 2026 P 1016-14

Cayston (aztreonam for inhalation) prior authorization

UnitedHealthcare prior authorization policy for Cayston (aztreonam for inhalation) describing initial and reauthorization coverage criteria for members with cystic fibrosis infected with Pseudomonas aeruginosa.

Policy Summary

PayerUnitedHealthcare

PolicyCayston (aztreonam for inhalation) prior authorization

Policy CodePolicy 2026 P 1016-14

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document diagnosis of cystic fibrosis plus a positive culture for Pseudomonas aeruginosa for initial approval; document positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

≥2011–2026P&T approval history range

age ≥7 yrspediatric age limitation noted

25–75%FEV1 range referenced

Coverage Criteria

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Safety and effectiveness of Cayston (aztreonam solution for inhalation) have specific limits that affect coverage. Use is not established in pediatric patients younger than 7 years. Coverage should also consider pulmonary function: Cayston’s safety and effectiveness have not been established for patients with FEV1 < 25% predicted or > 75% predicted. Additionally, Cayston is not established for use in patients colonized with Burkholderia cepacia. The policy requires treatment only for cystic fibrosis patients known to have Pseudomonas aeruginosa in the lungs to reduce the risk of developing drug-resistant bacteria.

Initial Therapy

Initial therapy is covered when ALL of the following are met:

Initial therapy: Diagnosis of cystic fibrosis (CF) AND positive culture demonstrating Pseudomonas aeruginosa infection

Prior authorization required

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Covered when ALL of the following are met for continuation of therapy:

Continuation: Documentation of positive clinical response to Cayston therapy

Authorization period: 12 months

Coding and Patient Characteristics

Age — pediatric safety

Age limitationSafety and effectiveness have not been established in pediatric patients below the age of 7 years.

Coverage implicationMembers under 7 years generally do not meet coverage criteria unless specific exception is documented.

Source guidanceCayston should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs to reduce resistance.

FEV1 — pulmonary function limits

FEV1 range limitationSafety and effectiveness have not been established in patients with FEV1 < 25% or > 75% predicted.

Clinical assessmentFEV1 outside 25–75% should be considered outside studied population and may not meet coverage criteria.

Documentation recommendedProvide recent pulmonary function test (FEV1 percent predicted) with authorization request if available.

Definition — CF with Pseudomonas aeruginosa

Required diagnosisCystic fibrosis (CF) with lung infection by Pseudomonas aeruginosa is required for coverage of Cayston.

RationaleCayston is indicated to improve respiratory symptoms in CF patients with Pseudomonas aeruginosa; use should be limited to patients known to have this organism.

Documentation to submitPositive culture demonstrating Pseudomonas aeruginosa should be included with initial authorization requests.

Provider Actions and Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cayston. Initial authorization will be issued for up to 12 months. State mandates, federal regulatory requirements, and the member's benefit plan may also affect coverage and authorization length.

Authorization period: 12 months
Note: State mandates and member-specific benefits may affect coverage

Denial Risk

Initial Authorization Requirements

Initial authorization requests must include documentation that supports both required clinical criteria. Requests lacking a documented diagnosis of cystic fibrosis and/or lacking evidence of a positive culture for Pseudomonas aeruginosa may be denied.

Required for initial approval: diagnosis of cystic fibrosis (CF)
Required for initial approval: positive culture demonstrating Pseudomonas aeruginosa lung infection
Operational guidance: Missing diagnosis and/or positive culture are grounds for denial

Documentation Required

Required Clinical Documentation (Initial Authorization)

Required clinical documentation for initial authorization: provider must document the CF diagnosis, laboratory results or culture report confirming Pseudomonas aeruginosa infection, and any other supporting clinical information relevant to the request (e.g., prior treatments, baseline pulmonary status).

Documented diagnosis of cystic fibrosis
Positive culture result demonstrating Pseudomonas aeruginosa
Supporting documentation: prior treatment history, baseline clinical status, relevant lab or microbiology reports

Denial Risk

Reauthorization Requirement

Reauthorization requests must include documentation demonstrating a positive clinical response to Cayston therapy. Reauthorization may be denied if clinical improvement or benefit is not documented.

Documentation of positive clinical response to Cayston required for reauthorization
Reauthorization may be denied if benefit is not demonstrated

Note

Automated Approval / Claim-History Note

UnitedHealthcare may use automated approval processes and previous claim/medication history, diagnosis codes (ICD-10), and program logic to approve initial or reauthorization requests. Supply limits and other utilization management rules may also apply.

Approvals may be granted based on claim history, ICD-10 diagnosis codes, and automated program logic
Supply limits may be enforced

Step Therapy

No step therapy requirements are specified for Cayston in this policy.

Background

Cayston (aztreonam solution for inhalation) is a monobactam antibacterial indicated to improve respiratory symptoms in patients with cystic fibrosis who have lung infection with Pseudomonas aeruginosa. To preserve antibacterial effectiveness, Cayston should be used only in CF patients known to have Pseudomonas aeruginosa, and members must meet the policy’s coverage criteria for authorization.

Quantity Limits / Supply

Cayston (aztreonam for inhalation) — supply and authorization notes

Quantity/supply limitsSupply limits may be in place for Cayston (aztreonam for inhalation).

Authorization periodAuthorization will be issued for 12 months (per policy authorization rules).

Automated approvalsUnitedHealthcare may approve based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits still may apply.