Roflumilast (Zoryve)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Zoryve not be reimbursed by public drug plans for the topical treatment of mild to moderate atopic dermatitis (AD) in patients aged 6 years and older with inadequate response, intolerance, or contraindications to topical corticosteroids (TCSs).
• Evidence from 2 clinical trials showed that after 4 weeks of treatment, Zoryve reduced AD severity and itching compared with the vehicle cream in patients aged 6 years or older with mild to moderate AD and inadequate response, intolerance, or contraindications to TCSs. However, there was little to no difference between Zoryve and the vehicle cream in improving health-related quality of life (HRQoL).
• The clinical trials compared Zoryve with only the vehicle cream and did not include any active comparators. The sponsor submitted a network meta-analysis (NMA) to provide an indirect comparison of Zoryve with crisaborole, ruxolitinib, tacrolimus, and low- to medium-potency TCSs; however, the evidence was insufficient to draw definitive conclusions. This was due to several sources of uncertainty, including the heterogeneity across included trials, the lack of a closed loop involving Zoryve, uncertainty about whether the included studies could be compared fairly, and inconclusive data for several outcomes due to sparse networks.
• The Canadian Drug Expert Committee (CDEC) acknowledged that mild to moderate AD in patients with inadequate response, intolerance, or contraindications to TCSs is a condition with substantial disease burden and that patients identified a need for treatments that can improve disease severity or symptom control (e.g., itching, dryness, flaking, inflammation, blistering, and cracked skin), reduce flares, and improve quality of life (e.g., better sleep, less discomfort or pain, improved productivity, and activities of daily living). However, CDEC noted that the available evidence did not clearly demonstrate that Zoryve addresses these unmet needs as effectively as, or more effectively than, other available treatment options. In addition, evidence on the long-term effects of Zoryve is limited.