CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cayston (aztreonam for inhalation) — Coverage Criteria for Cystic Fibrosis with Pseudomonas aeruginosa

Covers authorization criteria for Cayston in members with cystic fibrosis and Pseudomonas aeruginosa infection or history of infection; applies to Neighborhood Health Plan of Rhode Island members seeking coverage for this therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCayston (aztreonam for inhalation) — Coverage Criteria for Cystic Fibrosis with Pseudomonas aeruginosa

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization documentation showing airway culture positive for Pseudomonas aeruginosa or documented history of infection/colonization and evidence of clinical benefit for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration (initial/continuation)

>=2 yrsminimum age

P. aeruginosarequired pathogen

FDA-approvedindication basis

Coverage Criteria for Cayston (aztreonam for inhalation)

Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria: Member is 2 years of age or older AND has cystic fibrosis AND Pseudomonas aeruginosa is present in airway cultures OR the member has a documented history of Pseudomonas aeruginosa infection or colonization in the airways.age >= 2 years

Authorization may be granted for 12 months.

Continuation Therapy

Covered when ALL of the following are met

Continuation Criteria: Member has been receiving Cayston for an indication listed in the policy AND is experiencing benefit from therapy as evidenced by disease stability or disease improvement.clinical benefit documented

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCayston (aztreonam for inhalation) — Coverage Criteria for Cystic Fibrosis with Pseudomonas aeruginosa

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Authorization may be granted for 12 months.

Not Medically Necessary

Experimental/Investigational Exclusion: Any indication other than the FDA‑approved indication and compendial uses is considered experimental/investigational and not medically necessary.N/A

May be denied.

Any use of Cayston (aztreonam for inhalation) outside of the FDA‑approved indication is considered experimental/investigational and is not a covered benefit. The policy supports coverage only for the FDA‑approved use — improving respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa — and excludes other, non‑approved indications from authorization.

Specifically, use of Cayston for indications other than improvement of respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa is considered not medically necessary. Requests for non‑FDA‑approved indications may therefore be denied as experimental/investigational under this policy.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted for up to 12 months for members 2 years of age and older when used for cystic fibrosis with evidence of Pseudomonas aeruginosa infection or colonization.

Prior authorization period: up to 12 months
Age requirement: member must be ≥ 2 years old
Qualifying diagnosis: cystic fibrosis with Pseudomonas aeruginosa present in airway cultures OR documented history of Pseudomonas aeruginosa infection/colonization in the airways

Documentation Required

Required Documentation

Prescribers must document supporting clinical evidence when requesting authorization. Acceptable documentation includes airway culture showing Pseudomonas aeruginosa OR a documented history of prior Pseudomonas aeruginosa infection/colonization. For continuation requests, documentation of benefit (disease stability or improvement) should be provided.

Required documentation: positive airway culture for Pseudomonas aeruginosa OR documented history of Pseudomonas aeruginosa infection/colonization
Continuation requests: evidence of clinical benefit (disease stability or improvement) to support reauthorization up to 12 months

Denial Risk

Non‑approved Indications

Use of the medication for any indication other than the FDA‑approved cystic fibrosis indication with Pseudomonas aeruginosa (or compendial equivalent) is considered experimental/investigational and is not medically necessary and may be denied.

Non‑approved indications are experimental/investigational and may be denied

Background

Cystic fibrosis is associated with chronic airway infection that commonly includes Pseudomonas aeruginosa, which contributes to respiratory symptoms and decline. Inhaled aztreonam (Cayston) is FDA‑approved to improve respiratory symptoms in CF patients with Pseudomonas aeruginosa, and this policy limits coverage to that indication.

Definitions and Approved Use

Cayston approved use

FDA‑approved indicationImprovement of respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa.

Population ageApplies to cystic fibrosis patients (policy notes authorization may be granted for members 2 years of age and older).

Pathogen requirementPseudomonas aeruginosa must be present in airway cultures or there must be a documented history of airway infection/colonization.

Coverage basisCoverage is based on the FDA‑approved indication; other indications are considered experimental/investigational and not medically necessary.