NICE (UK) positive for Tremfya (guselkumab) for previously treated moderately to severely active Crohn’s disease – Johnson & Johnson

NICE(UK): Guselkumab can be used as an option for previously treated moderately to severely active Crohn’s disease in adults, when: i) conventional or biological treatment: a) has not worked (that is, the condition has not responded well enough or lost response to treatment), or b) cannot be tolerated, and ii) 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.

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.