ObinutuzumabGazyva

7.1 The PBAC recommended obinutuzumab for the treatment of patients with active class III or IV lupus nephritis with or without class V who are receiving standard therapy with mycophenolate mofetil (MMF) and corticosteroid, on the basis that it should be available only under special arrangements under Section 100 under the Highly Specialised Drugs (HSD) program. The PBAC considered that obinutuzumab was 49 OFFICIALPSD · Mar 2026

OFFICIAL Public Summary Document - March 2026 PBAC Meeting associated with improvements in complete renal response (CRR), CRR with prednisone taper and proteinuric response compared with standard therapy alone.PSD · Mar 2026

6.32 The submission presented a stepped cost-utility analysis of obinutuzumab plus standard therapy (glucocorticoids and MMF) compared to standard therapy alone (herein obinutuzumab arm and SOC arm, respectively), primarily based on the REGENCY trial, with long-term extrapolation based on observational data from the US-based Hopkins Lupus Cohort (Davidson et al., 201818) and Australia and New Zealand dialysis and transplant registry (ANZDATA 202419).PSD · Mar 2026

Table 6: Summary of model structure, key inputs and rationale Component Summary Treatments Obinutuzumab plus SOC (obinutuzumab arm) vs SOC alone (SOC arm) 20 years in the model base case versus 76 weeks in REGENCY.PSD · Mar 2026

6.27 The submission described obinutuzumab plus SOC (MMF plus glucocorticoids) as superior in terms of effectiveness and inferior in terms of safety compared with placebo plus SOC in patients with class III/IV ± V lupus nephritis.PSD · Mar 2026

6.28 The evaluation considered that overall, the clinical claim for superior efficacy versus placebo may be reasonable, however the following issues were noted: 23 OFFICIALPSD · Mar 2026

4.1 The PBAC noted and welcomed the input from individuals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described the fear of relapse as a significant mental and physiological challenge. Lymphoma Australia outlined the importance of having a range of therapeutic options given that patients often experience multiple relapses.PSD · Mar 2018

4.31 The resubmission did not propose a risk sharing arrangement stating that there was no additional impact on PBS budget. However, the PBAC considered that an additional budget impact would be associated with the listing of obinutuzumab in rituximab-refractory follicular lymphoma.PSD · Mar 2018