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Canadian Drug Review Reimbursement Decision


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  Daxas
Generic roflumilast
Company Nycomed Canada Inc.
Indication COPD
Condition Respiratory
Submission Type
Patient Population Roflumilast has a Health Canada indication for add-on therapy to bronchodilator treatment for the maintenance treatment of severe COPD associated with chronic bronchitis (i.e., patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations. Roflumilast is a selective inhibitor of the enzyme phosphodiesterase 4. It is available as a 500 mcg tablet and the Health Canada-approved dose is 500 mcg daily.
Status Complete
Date of Recommendation 2011-07-27
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that roflumilast not be listed
Reason for Recommendation 1. In the two double-blind randomized controlled trials (RCTs), in the patient population for which roflumilast is approved, there were no statistically significant differences between roflumilast and placebo in the clinical outcomes of: severe chronic obstructive pulmonary disease (COPD) exacerbations, quality of life, or mortality. 2. In the two double-blind RCTs, differences between roflumilast and placebo for the coprimary outcomes (pre-bronchodilator forced expiratory volume in one second [FEV1] and the rate of moderate or severe COPD exacerbations) were small. Of Note: Neither RCT included an active comparator, therefore the trials were considered to have limited clinical relevance for patients with severe COPD because they disallowed concomitant treatment with long-acting anticholinergics and/or inhaled corticosteroids
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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