1 Recommendations

1.1

Guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when:

a conventional treatment, biological treatment or Janus kinase (JAK) inhibitor:
- has not worked (that is, the condition has not responded well enough or lost response to treatment), or
- cannot be tolerated, and
a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable.

Guselkumab can only be used if the company provides it according to the commercial arrangement.

1.2

Use the least expensive option of the suitable treatments (including guselkumab, mirikizumab and vedolizumab), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.

1.3

These recommendations are not intended to affect treatment with guselkumab 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 healthcare professional consider it appropriate to stop.

What this means in practice

Guselkumab must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Guselkumab must be funded in England within 30 days of final publication of this guidance.

There is enough evidence to show that guselkumab provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Why these recommendations were made

TNF-alpha inhibitors are the most used biological treatments for moderately to severely active ulcerative colitis when a conventional treatment has not worked or cannot be tolerated. When a TNF-alpha inhibitor has not worked, or is not tolerated or suitable, potential treatment options include mirikizumab or vedolizumab. Guselkumab is another biological treatment that would be offered to the same population.

Clinical trial evidence shows that guselkumab is more effective than placebo. Guselkumab has not been directly compared in a clinical trial with mirikizumab or vedolizumab, but indirect comparisons suggest that it is likely to work as well as these.

A cost comparison suggests the costs for guselkumab are similar to or lower than mirikizumab and vedolizumab. So, guselkumab can be used.

For all evidence, see the committee papers. For more information on NICE's evaluations of mirikizumab and vedolizumab, see NICE's technology appraisal guidance on mirikizumab for treating moderately to severely active ulcerative colitis and vedolizumab for treating moderately to severely active ulcerative colitis.