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Canadian Drug Review Reimbursement Decision

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Generic Aztreonam for inhalation solution
Company Gilead Sciences Canada Inc.
Indication cystic fibrosis
Condition Endocrine, nutritional and metabolic diseases
Submission Type
Patient Population Aztreonam is a monobactam antibiotic. Aztreonam for inhalation solution has a Health Canada indication for the management of CF patients with chronic pulmonary Pseudomonas aeruginosa infections. It is available as a sterile lyophilized powder in single-use vials of 75 mg per vial, for reconstitution and inhalation. The Health Canada-recommended dose for patients six years of age and older is one single-use vial (75 mg) administered three times a day for a 28-day course (followed by 28 days without aztreonam for inhalation solution).
Status Complete
Date of Recommendation 2011-07-18
Recommendation Summary List with criteria/condition
Recommendation Details TThe Canadian Expert Drug Advisory Committee (CEDAC) recommends that aztreonam for inhalation solution be listed for the treatment of chronic pulmonary Pseudomonas aeruginosa infections when used as cyclic treatment (28-day cycles) in patients with moderate to severe cystic fibrosis (CF) and deteriorating clinical condition despite treatment with inhaled tobramycin.
Reason for Recommendation 1. In one open-label randomized controlled trial (RCT) in tobramycin-experienced patients with moderate to severe lung disease, aztreonam for inhalation solution had a similar impact on hospitalizations and quality of life compared with inhaled tobramycin. In addition, aztreonam-treated patients had a statistically significant improvement in lung function and a statistically significant reduction in the incidence of intravenous antibiotic use compared with inhaled tobramycin. 2. Although the clinical trial data are limited and aztreonam is associated with additional cost compared with inhaled tobramycin, the Committee recognized patient input that stressed the need for additional antibiotic treatment options.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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