Inebilizumab (Uplizna)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Uplizna be reimbursed by public drug plans for immunoglobulin G4-related disease (IgG4-RD) if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Uplizna demonstrates acceptable clinical value versus placebo in patients with IgG4-RD. However, CDEC concluded that it is uncertain whether inebilizumab demonstrates acceptable clinical value when compared with appropriate comparators (i.e., off-label rituximab, a B-cell depleting drug currently used in clinical practice in patients with IgG4-RD). Given that inebilizumab is expected to be an alternative treatment to rituximab, comparable clinical value to rituximab was considered to represent acceptable clinical value.
• Evidence from a clinical trial showed that patients who received Uplizna for 12 months experienced fewer flares requiring treatment and their condition required lower doses of glucocorticoids compared with placebo. In addition, more patients who received Uplizna experienced complete remission. Therefore, inebilizumab may address patient-identified unmet needs for treatments with meaningful impact on disease control, especially glucocorticoid-free maintenance of remission. Results from the trial about health-related quality of life (HRQoL) were inconclusive due to substantial uncertainty caused by a lack of tools validated in this population. Patients who received Uplizna were at higher risk of infections and of having too few blood cells circulating in their blood, which are common side effects of this class of drugs due to their immunosuppressive effect. Clinical expert input suggested that harms were considered manageable in clinical practice, and overall, Uplizna was considered to have an acceptable safety profile. The clinical trial enrolled a small number of patients, but CDEC acknowledged that it is difficult to generate evidence for drugs used in the treatment of rare diseases.
• There is a lack of information to compare the efficacy and safety of Uplizna with other drugs that are currently used in clinical practice to treat patients with IgG4-RD, even if they have been approved by Health Canada for use in other conditions. However, CDEC established that there was significant unmet clinical need due to the rarity and severity of IgG4-RD. The committee concluded that Uplizna may address a significant unmet clinical need to a degree that justifies a positive recommendation despite the uncertainty in the clinical value.