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Draft guidance consultation

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1 Recommendations

1.1 Voclosporin plus mycophenolate mofetil is not recommended, within its anticipated marketing authorisation, for treating active class 3 to 5 (including mixed class 3 and 5, and 4 and 5) lupus nephritis in adults.

1.2 This recommendation is not intended to affect treatment with voclosporin that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatment options for lupus nephritis include immunosuppressants such as mycophenolate mofetil taken with hydroxychloroquine and corticosteroids. There are several immunosuppressant options depending on factors such as condition severity, previous treatments and other conditions such as organ damage.

Clinical trial evidence suggests voclosporin plus mycophenolate mofetil is more effective at stopping lupus nephritis from getting worse than mycophenolate mofetil alone. But these results are uncertain because it is not clear by how much a person's condition will improve in clinical practice. Indirect comparisons of voclosporin with other treatment options are also uncertain because the included trials look at different outcomes.

The company's cost-effectiveness estimates are uncertain because their accuracy is unclear. They also do not consider different treatments for lupus nephritis over time depending on whether the condition is responding to treatment.

Because of the uncertainty, the most plausible cost-effectiveness estimates are likely above the range NICE normally considers a cost-effective use of NHS resources. So, voclosporin is not recommended.