Roflumilast (Zoryve)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Zoryve be reimbursed by public drug plans for the topical treatment of plaque psoriasis of the scalp and body in patients aged 12 years or older.
• The Canadian Drug Expert Committee (CDEC) determined that Zoryve provides clinical value compared to vehicle only, but it is uncertain whether roflumilast demonstrates acceptable clinical value versus other topical therapies used in practice in Canada — including vitamin D analogues, topical corticosteroids, fixed-dose combination products, and topical calcineurin inhibitors — in patients with plaque psoriasis of the scalp and body. Given that roflumilast is expected to be an alternative to these therapies, acceptable clinical value refers to having at least comparable value versus available treatment options.
• Evidence from 1 randomized, double-blind, phase III trial demonstrated that treatment with roflumilast for 8 weeks improved disease clearance, itch severity, and scalp-specific disease severity compared with vehicle in patients with plaque psoriasis of the scalp and body. These outcomes were considered clinically meaningful because itch and visible disease are important contributors to disease burden and worsening quality of life. Evidence from 1 sponsor-submitted indirect treatment comparison suggested that roflumilast may improve certain scalp-specific outcomes compared with calcipotriol; however, the results were highly uncertain. For other relevant topical comparators, there was no evidence of a difference, although estimates were imprecise and uncertain.
• The committee acknowledged that plaque psoriasis is a chronic condition associated with substantial morbidity, including persistent itch, visible lesions, and psychosocial burden. Patients and clinicians identified limitations with existing therapies, including inadequate effectiveness for some patients, tolerability concerns with long-term corticosteroid use, and challenges with applying conventional topical formulations to hair-bearing and sensitive areas. CDEC considered that roflumilast may address some of these unmet needs as a nonsteroidal topical treatment with a foam formulation suitable for scalp and body involvement.
• Based on all the preceding considerations, CDEC recommended that roflumilast be reimbursed.
• Zoryve should only be reimbursed for the topical treatment of plaque psoriasis of the scalp and body in patients aged 12 years or older in line with the Health Canada indication and only be covered for patients with plaque psoriasis of the scalp and body for whom topical therapy is appropriate.
• Zoryve should only be reimbursed if the total cost of Zoryve does not exceed the cost of treatment with the least costly topical therapy currently used to treat plaque psoriasis of the scalp and body.
• Important budget impact considerations must be addressed for health systems to be able to adopt Zoryve.