1.1 Ustekinumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if:
a tumour necrosis factor‑alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment) or
a tumour necrosis factor‑alpha inhibitor cannot be tolerated or is not suitable, and
the company provides ustekinumab at the same price or lower than that agreed with the Commercials Medicines Unit.
1.2 This recommendation is not intended to affect treatment with ustekinumab 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
Tumour necrosis factor (TNF)‑alpha inhibitors are the most commonly used biological treatment option for moderately to severely active ulcerative colitis. People who cannot have TNF‑alpha inhibitors are usually offered vedolizumab, so this is the most relevant comparator for ustekinumab. Both drugs have similar safety profiles and work differently to TNF‑alpha inhibitors.
Clinical trial evidence shows that ustekinumab is more effective than placebo for treating moderately to severely active ulcerative colitis. During induction (the first 8 weeks of treatment), indirect comparisons suggest that ustekinumab may be more effective than one of the TNF‑alpha inhibitors. However, for maintenance treatment, indirect comparisons suggest there is no difference between the treatments.
The cost-effectiveness estimates for ustekinumab compared with vedolizumab are below what NICE considers a cost-effective use of NHS resources. Therefore, ustekinumab is recommended when a TNF‑alpha inhibitor is not appropriate or has not been effective.