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Ustekinumab for treating moderately to severely active ulcerative colitis

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1 Recommendations

1.1 Ustekinumab is not recommended, within its marketing authorisation, 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.

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

Clinical trial evidence shows that ustekinumab is more effective than placebo for treating moderately to severely active ulcerative colitis. For induction (the first 8 weeks of treatment), indirect comparisons suggest that ustekinumab may be more effective than adalimumab for some people. For maintenance treatment, the results of the indirect comparisons are very uncertain.

The cost-effectiveness estimates vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources. And there is considerable uncertainty about these estimates. Therefore, ustekinumab cannot be recommended.