Inebilizumab (Uplizna)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Uplizna (inebilizumab) be reimbursed by public drug plans as an add-on therapy for adult patients with generalized myasthenia gravis (gMG) that is AChR or MuSK antibody positive and whose symptoms persist despite conventional therapy with AChE inhibitors, corticosteroids, and/or nonsteroidal immunosuppressive therapies (NSISTs), only if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Uplizna demonstrates acceptable clinical value versus conventional therapy (e.g., AChE inhibitors, corticosteroids, and/or NSISTs). This determination was enough for CDEC to recommend that Uplizna be reimbursed. Given that Uplizna is expected to be an additive treatment to conventional therapy, acceptable clinical value refers to added value versus conventional therapy.
• Evidence from 1 pivotal phase III randomized, double-blind, placebo-controlled trial demonstrated that treatment with Uplizna over 26 weeks likely results in improvements in daily function and disease severity compared to placebo in the overall population of patients with gMG. CDEC discussed that Uplizna offers a different mechanism of action as a Health Canada–approved B-cell–depleting therapy compared with other available funded advanced biologics, and it may address significant unmet clinical needs. There is added clinical value for patients with gMG, particularly for the subpopulation with MuSK antibody–positive gMG that has limited treatment options and for patients whose disease remains refractory despite available treatment.