following a full submission:
obinutuzumab (Gazyvaro®) is accepted for use within NHSScotland.
Indication under review: in combination with mycophenolate mofetil (MMF), for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).
In a double-blind phase III study, obinutuzumab was associated with a statistically significant improvement in complete renal response rate at week 76 compared with placebo, with both treatments administered in addition to MMF and a tapered corticosteroid regimen. An indirect comparison suggests no evidence of a difference in clinical outcomes between obinutuzumab and belimumab, voclosporin or rituximab (all used in combination with MMF and corticosteroids).
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
Medicine details
- Medicine name:
- obinutuzumab (Gazyvaro)
- SMC ID:
- SMC2903
- Indication:
In combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).
- Pharmaceutical company
- Roche
- BNF chapter
- Nutrition and blood
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 12 October 2026