1 Recommendations

1.1

Risankizumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if:

a tumour necrosis factor (TNF)-alpha inhibitor:
- has not worked (that is the condition has not responded well enough or has lost response to treatment), or
- cannot be tolerated or is not suitable, and
the company provides it according to the commercial arrangement.

1.2

If people with the condition and their clinicians consider risankizumab to be 1 of a range of suitable treatments (including ustekinumab), after discussing the advantages and disadvantages of all the options, use the least expensive. Take into account the administration costs, dosage, price per dose and commercial arrangements.

1.3

These recommendations are not intended to affect treatment with risankizumab 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 these recommendations were made

TNF‑alpha inhibitors are the most used biological treatments for moderately to severely active ulcerative colitis. When TNF‑alpha inhibitors have not worked, or are not tolerated, one of the treatment options is ustekinumab. Risankizumab works in a similar way to ustekinumab and would be offered to the same population.

Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. Risankizumab has not been directly compared with ustekinumab in a clinical trial in this population. But an indirect comparison suggests that it is similarly effective.

A cost comparison suggests risankizumab has similar costs to ustekinumab. Using NICE's cost-comparison methods, risankizumab only needs to cost less or have similar costs to 1 relevant comparator to be recommended as a treatment option. So risankizumab is recommended.

For all evidence see the committee papers. To see how NICE evaluated ustekinumab refer to the committee discussion section in NICE's technology appraisal guidance on ustekinumab for treating moderately to severely active ulcerative colitis.