CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cayston_Policy

Defines coverage criteria for Cayston for cystic fibrosis patients with Pseudomonas aeruginosa, including initial and continuation authorization durations and exclusion of non‑approved indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCayston_Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Cayston; document Pseudomonas aeruginosa in airway cultures or history of infection/colonization and for reauthorization document disease stability or improvement; initial and continuation authorizations may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material changes

1Covered Indications (CF with Pseudomonas)

>=2Minimum Age for Coverage

12 moAuthorization Duration

OtherNot Covered

Coverage Summary

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Cayston (aztreonam for inhalation solution) is covered with criteria for the FDA‑approved and compendial uses in cystic fibrosis patients with Pseudomonas aeruginosa. Coverage is limited to the FDA‑approved and compendial indications when all approval criteria are met; all other, non‑approved indications are considered not medically necessary.

Initial Therapy Criteria

Covered Indications / Initial Authorization

Cayston is covered for FDA‑approved indication when ALL of the following are met:

ALL of the following

Diagnosis of cystic fibrosis
Member must be 2 years of age or older for authorization
Pseudomonas aeruginosa evidence
- Present in airway cultures: Pseudomonas aeruginosa present in airway cultures
- History of infection/colonization: History of Pseudomonas aeruginosa infection or colonization in the airways

Regulatory context: Cayston is indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa (FDA‑approved).

Duration of Authorization

Authorization period if criteria met:

Initial authorization duration: Authorization of 12 months may be granted for initial therapy12 months

Continuation Therapy Criteria

Continuation of Therapy / Reauthorization

Reauthorization criteria:

Reauthorization requirements

Indication: Member requests reauthorization for an indication listed in the policy
Documentation of benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement
Reauthorization duration: Authorization of 12 months may be granted for continued treatment12 months

Provider Actions / Prior Authorization

Prior Authorization

Authorization requirement

Prior authorization is required for Cayston. When the coverage criteria are met, initial and continuation authorizations may be granted for up to 12 months.

Documentation Required

Documentation of infection status

Provider must document presence of Pseudomonas aeruginosa in airway cultures or a documented history of Pseudomonas aeruginosa infection or colonization in the airways to support coverage.

Documentation Required

Documentation of benefit for reauthorization

For reauthorization, provider must document that the member is experiencing benefit from therapy as evidenced by disease stability or disease improvement to demonstrate continued benefit.

Clinical Evidence & References

Supporting evidence includes the product labeling: Cayston [package insert], Gilead Sciences, Inc.; November 2019, and guideline support from cited sources (Cystic fibrosis pulmonary guidelines and Cystic Fibrosis Foundation clinical practice guidelines). No clinical trial metrics were provided in the policy.

Background

Cayston is FDA‑approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. The policy limits coverage to FDA‑approved and compendial uses and requires documentation of Pseudomonas aeruginosa infection or colonization in the airways. For members meeting criteria, authorization of 12 months may be granted; members must be 2 years of age or older for authorization.

Pseudomonas aeruginosa in airway cultures is defined as microbiologic evidence of P. aeruginosa in respiratory culture specimens or a documented history of prior infection/colonization in the airways.