1 Recommendations

1.1

Guselkumab can be used as an option for previously treated moderately to severely active Crohn's disease in adults, when:

conventional or biological treatment:
- 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, risankizumab 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

Usual treatment for moderately to severely active Crohn's disease when conventional treatments stop working or are unsuitable is biological treatment, which can include TNF-alpha inhibitors or ustekinumab. If these do not work well enough, stop working or are not tolerated, or if TNF-alpha inhibitors are unsuitable, people can then have risankizumab or vedolizumab. Guselkumab would be offered to the same population as risankizumab and vedolizumab.

Clinical trial evidence shows that guselkumab increases the likelihood of disease remission and endoscopic response compared with placebo. It has not been directly compared in a clinical trial with risankizumab 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 risankizumab and vedolizumab. So, guselkumab can be used.

For all evidence see the committee papers. For more information on NICE's evaluation of risankizumab and vedolizumab, see NICE's technology appraisal guidance on risankizumab for previously treated moderately to severely active Crohn's disease and vedolizumab for treating moderately to severely active Crohn's disease after prior therapy.