Ruxolitinib (Opzelura)

Canada’s Drug Agency (CDA-AMC) recommends that Opzelura should not be reimbursed by public drug plans for the topical treatment of mild to moderate atopic dermatitis (AD) in adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids [TCS], topical calcineurin inhibitors [TCI]) or when those therapies are not advisable. Evidence from 2 clinical trials showed that Opzelura treatment improved the severity of AD compared with placebo in adult and adolescent patients with mild to moderate AD. However, it is unclear if these patients were representative of patients whose disease is not adequately controlled with TCS and/or TCI, or for whom such treatment(s) is not advisable, which is the patient population expected to receive Opzelura in clinical practice. No evidence that directly compared Opzelura to currently available treatments for mild to moderate AD was submitted. The submitted indirect evidence in patients with moderate AD was uncertain due to limitations of the analyses. The study was also not conducted in the patient population expected to receive Opzelura in clinical practice.