Canadian Drug Review Reimbursement Decision
|Condition||Skin and subcutaneous tissue|
|Patient Population||Azelaic acid has a Health Canada indication for the treatment of inflammatory papules and pustules and erythema of mild-to-moderate rosacea. Azelaic acid has antikeratinizing and antibacterial properties, but its mechanism of action in rosacea is unknown. It is available as a 15% topical gel, and the Health Canada-approved dose is 0.5 g applied twice daily.|
|Date of Recommendation||2011-02-16|
|Recommendation Details||The Canadian Expert Drug Advisory Committee (CEDAC) recommends that azelaic acid 15% gel be listed.|
|Reason for Recommendation||In two randomized controlled trials (RCT) azelaic acid 15% gel had similar efficacy compared with metronidazole, as either 0.75% or 1% gel, for patients with mild-to-moderate papulopustular rosacea in terms of reduced lesion count and investigator assessed global severity. Of Note: Azelaic acid 15% gel is similar in cost to metronidazole 0.75% gel, but more costly than metronidazole 1% gel, when all three products are applied at the frequencies recommended in the product monographs.|
|Final Recommendation 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.