1 Recommendations

1.1 Mirikizumab 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 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

  • a TNF-alpha inhibitor 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 mirikizumab to be 1 of a range of suitable treatments (including vedolizumab and 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 mirikizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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, usually people are offered vedolizumab or ustekinumab. Mirikizumab is another biological treatment that would be offered to the same population as these 2 treatments.

Clinical trial evidence shows that mirikizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. But there are no clinical trials directly comparing mirikizumab with vedolizumab or ustekinumab. An indirect comparison suggests that all 3 treatments are similarly effective.

A cost comparison suggests the costs of mirikizumab are similar or lower to those of vedolizumab and ustekinumab. Using NICE's cost comparison methods, mirikizumab only needs to cost less than 1 relevant comparator to be recommended as a treatment option. So mirikizumab is recommended.

For all evidence see the committee papers. To see what NICE did for vedolizumab and ustekinumab, see the committee discussion section in NICE's technology appraisal guidance on vedolizumab and ustekinumab.

  • National Institute for Health and Care Excellence (NICE)