Obinutuzumab plus mycophenolate mofetil can be used, within its marketing authorisation, as an option to treat active class 3 or 4 (with or without class 5) lupus nephritis in adults. It can only be used if the company provides obinutuzumab according to the commercial arrangement.
Obinutuzumab plus mycophenolate mofetil must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. It must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that obinutuzumab plus mycophenolate mofetil provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for lupus nephritis includes mycophenolate mofetil alone or mycophenolate mofetil plus belimumab, rituximab or voclosporin (all given with corticosteroids).
Clinical trial evidence shows that obinutuzumab plus mycophenolate mofetil increases the chance of complete renal response and increases the time to renal flare compared with mycophenolate mofetil alone. Obinutuzumab plus mycophenolate mofetil has not been directly compared in a clinical trial with belimumab, rituximab or voclosporin. But indirect comparisons suggest it is likely to work as well as these.
The cost-effectiveness estimates that reflect the treatment comparisons most likely in clinical practice are within the range that NICE considers an acceptable use of NHS resources. So, obinutuzumab can be used.