Pharmacy Prior Authorization Criteria

Cayston (aztreonam for inhalation solution) - PA, NF

Indications for Prior Authorization

Cayston (aztreonam for inhalation solution)

• For diagnosis of Cystic Fibrosis
  Indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

  Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 less than 25% or greater than 75% predicted, or patients colonized with Burkholderia cepacia.

  To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cayston and other antibacterial drugs, Cayston should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.

Criteria

Cayston

*NOTE: Step Therapy (ST) requirements may apply for brand Bethkis and brand TOBI

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of cystic fibrosis
AND
• Patient has evidence of Pseudomonas aeruginosa in the lungs
AND
• Patient is seven years of age or older
AND
• Trial and failure, contraindication, or intolerance to TWO of the following:
• Bethkis* (tobramycin [300 mg/4 ml] inhalation solution)
• TOBI* (tobramycin [300 mg/5 ml] inhalation solution)
• Tobi Podhaler (tobramycin capsule)

Cayston

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Diagnosis of cystic fibrosis
AND
• Patient has evidence of Pseudomonas aeruginosa in the lungs
AND
• Patient is benefiting from treatment (i.e., improvement in lung function [forced expiratory volume in one second {FEV1}], decreased number of pulmonary exacerbations)

Cayston

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of cystic fibrosis
AND
• Submission of medical records (e.g., chart notes) confirming patient has evidence of Pseudomonas aeruginosa in the lungs
AND
• Patient is seven years of age or older
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to TWO of the following:
• generic tobramycin [300 mg/4 ml] inhalation solution
• generic tobramycin [300 mg/5 ml] inhalation solution
• Tobi Podhaler (tobramycin capsule)

P & T Revisions

2024-08-01, 2023-06-07, 2022-06-01, 2021-11-30, 2021-09-27, 2021-06-02, 2021-05-20, 2021-01-06, 2020-05-21

References

1. Cayston Prescribing Information. Gilead Sciences, Inc. Foster City, CA. November 2019.
2. Retsch-Bogart GZ, Quittner AL, Gibson RL, et al. Efficacy and safety of inhaled aztreonam lysine for airway Pseudomonas in cystic fibrosis. Chest. 2009;135:1223-32.
3. Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic Fibrosis Foundation Pulmonary Guideline. Pharmacologic approaches to prevention and eradication of initial Pseudomonas aeruginosa infection. Ann Am Thorac Soc. 2014;11(10):1640-50.

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Revision History

• 2024-08-01: Annual review: Updated verbiage of Tobi Podhaler to “Tobi podhaler (tobramycin capsule).” For NF criteria, updated diagnostic criteria to include submission of medical records verbiage to align with standard language.
• 2023-06-07: Annual review: No criteria changes.
• 2022-06-01: Annual review: No changes to criteria.
• 2021-11-30: Updated criteria to indicate that the initial PA criteria should also be used for NF reviews. Updated GL name to add "- PA, NF"
• 2021-09-27: 2021 Annual Review, no changes to criteria.
• 2021-06-02: 2021 Annual Review, no changes to criteria.
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-06: Added step through tobramycin product
• 2020-05-21: 2020 Annual Review, no changes to criteria.

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