CAYSTON (aztreonam for inhalation solution)

CAYSTON (aztreonam for inhalation solution)

Self-Administration – inhaled solution

Diagnosis considered for coverage: 

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.

Coverage Criteria: 

For diagnosis of cystic fibrosis:

• 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:
  • tobramycin [300 mg/4 ml] inhalation solution (Bethkis) 
  • tobramycin [300 mg/5 ml] inhalation solution (Tobi)
  • Tobi Podhaler

Reauthorization Criteria:

For diagnosis of cystic fibrosis:

• 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)
   

Dosing:

For CF (age 7 years and older):

• One single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy).
• Doses should be taken at least 4 hours apart.
• Administer by inhalation using an Altera Nebulizer System
• Patients should use a bronchodilator before administration of CAYSTON.

Coverage Duration: 

• Initial:1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Warnings & Precautions: 
  • Stop treatment if an allergic reaction occurs. Use caution when CAYSTON is administered to patients with a known allergic reaction to beta-lactams.
  • Bronchospasm has been reported with CAYSTON. Stop treatment if chest tightness develops during nebulizer use.
• According to guidelines from the Cystic Fibrosis Foundation for the eradication of initial P. aeruginosa infections, inhaled antibiotic therapy (tobramycin 300 mg twice a day for 28 days) is recommended for the treatment of initial or new growth of P. aeruginosa.

Policy Updates:

•    09/01/2023 - New program for CAYSTON approved by P&T (P&T meeting date).

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.