Lebrikizumab (Ebglyss)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Ebglyss be reimbursed by public drug plans for the “treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable” if certain conditions are met.
• CDA-AMC previously reviewed Ebglyss for the treatment of moderate to severe AD in adults and adolescents whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and the recommendation issued was do not reimburse. This is a resubmission based on new information submitted by the sponsor to address evidence gaps identified in the previous recommendation.
• In this review, the Canadian Drug Expert Committee (CDEC) determined that Ebglyss demonstrates acceptable clinical value versus dupilumab, abrocitinib, and upadacitinib for the treatment of adults and adolescents with moderate to severe AD with a body weight of at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This determination was enough for CDEC to recommend that Ebglyss be reimbursed. Given that Ebglyss is expected to be an alternative to dupilumab, abrocitinib, and upadacitinib, acceptable clinical value refers to at least comparable value versus these comparators.
• Previously reviewed evidence from 3 clinical trials showed that, over 16 weeks, Ebglyss reduced AD severity and itching compared with placebo in adults and adolescents with moderate to severe AD that was not adequately controlled with topical therapies.
• New longer-term evidence suggests that the efficacy of Ebglyss may be sustained for up to 100 weeks and there are no new safety concerns, but no firm conclusions could be drawn due to limitations of the single-arm study design.
• Although new indirect treatment comparisons (ITC)s were associated with methodological limitations and imprecision, CDEC felt the results did not demonstrate significant differences in efficacy outcomes between the treatments and found it reasonable to consider them comparable in efficacy.
• Ebglyss meets some patient needs by offering an additional treatment option that could reduce severity of AD.
• Ebglyss should only be reimbursed to treat patients aged 12 years and older with moderate to severe AD, provided that Ebglyss is reimbursed in a similar way to other advanced systemic therapies (i.e., biologics or Janus kinase [JAK] inhibitors) currently reimbursed by public drug plans for the treatment of moderate to severe AD.