Clascoterone (Winlevi)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Winlevi not be reimbursed by public drug plans for the topical treatment of acne vulgaris in patients aged 12 years and older.
• Evidence from 2 clinical trials demonstrated that Winlevi increased the rate of treatment success (assessed using a measure of overall acne severity) compared with its vehicle cream (without active ingredient).
• Patients identified a need for treatments that improve skin clearance (i.e., reduce the number of acne lesions and prevent scarring) and health-related quality of life (HRQoL). However, based on the evidence reviewed in the initial meeting and the reconsideration meeting, the Canadian Drug Expert Committee (CDEC) could not determine if Winlevi would address the unmet needs relative to other active treatments. This uncertainty stems from missing data, a lack of HRQoL data, and uncertainty about whether the results were clinically meaningful. There were limitations in the submitted indirect evidence that also made it uncertain how Winlevi compares to other acne treatments in terms of efficacy and tolerability.