Obinutuzumab (Gazyva)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Gazyva be reimbursed by public drug plans for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) concluded that Gazyva demonstrates acceptable clinical value in patients with active lupus nephritis who are receiving standard therapy and addresses the need identified by patients to preserve kidney function and reduce corticosteroid use. Given that Gazyva is expected to be an alternative treatment to belimumab, comparable clinical value to belimumab was considered to represent acceptable clinical value. This determination was sufficient for CDEC to recommend that Gazyva be reimbursed for this indication.
• Evidence from 1 randomized controlled trial (the REGENCY trial) demonstrated that treatment for 76 weeks with Gazyva plus standard therapy with glucocorticoids and mycophenolate mofetil likely resulted in added clinical benefit for patients with active lupus nephritis compared with placebo plus standard therapy with glucocorticoids and mycophenolate mofetil, in terms of complete renal response (CRR) and CRR with successful prednisone taper to less than or equal to 7.5 mg/day or equivalent. Evidence from 1 indirect treatment comparison of Gazyva versus belimumab did not demonstrate significant differences in outcomes between the treatments, although it was associated with methodological limitations and imprecision. CDEC found it reasonable to consider that the drugs offer comparable value.
• Gazyva, in combination with standard therapy, should only be covered for adult patients with a confirmed diagnosis of active lupus nephritis. Patients should have an estimated glomerular filtration rate of at least 30 mL/min/1.73 m² and a urine protein to creatinine ratio of at least 1 g/g based on 24-hour urine collection.
• Gazyva should be reimbursed if prescribed in combination with standard therapy by clinicians with expertise and experience in treating lupus nephritis, and if the cost of Gazyva plus standard therapy does not exceed the total cost of treatment with belimumab plus standard therapy. For renewal after the initial authorization and for discontinuation, Gazyva should follow the same renewal and discontinuation criteria as belimumab, in accordance with the reimbursement criteria of each public drug plan for treating lupus nephritis.