Ritlecitinib (Litfulo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Litfulo be reimbursed by public drug plans for “the treatment of adults and adolescents 12 years and older with severe alopecia areata” if certain conditions are met.
• Evidence from 1 clinical trial (ALLEGRO 2b/3) demonstrated that treatment with Litfulo improved hair regrowth of the scalp, eyebrows, and eyelashes compared with placebo in adults and adolescents aged 12 years and older with severe alopecia areata. In addition, an overall improvement was reported by a greater proportion of patients treated with Litfulo compared with placebo. However, there was little to no meaningful improvement in patient-reported symptoms of anxiety and depression for patients treated with Litfulo compared to placebo.
• The Canadian Drug Expert Committee (CDEC) determined that Litfulo demonstrates acceptable clinical value versus placebo in adults and adolescents aged 12 years and older with severe alopecia areata. This determination was enough for CDEC to recommend that Litfulo be reimbursed. Given that Litfulo is expected to be an alternative treatment option to baricitinib, acceptable clinical value refers to at least comparable value versus baricitinib. Evidence from indirect treatment comparisons suggested that scalp hair regrowth outcomes were similar between Litfulo and baricitinib in adults with severe alopecia areata.
• Litfulo may address an important unmet treatment need, particularly among adolescents with severe alopecia areata for whom targeted treatment options are limited.
• Litfulo should only be covered for adults and adolescents aged 12 years and older with severe alopecia areata.
• Litfulo should only be reimbursed based on the criteria used by each of the public drug plans for initiation (with the exception of age), renewal, discontinuation, and prescribing of baricitinib and the cost of Litfulo does not exceed the total cost of treatment with the least costly JAK inhibitor reimbursed for the same indication.