NICE (UK) positive for Tremfya (guselkumab) for treating moderately to severely active ulcerative colitis – Johnson & Johnson

NICE (UK): Guselkumab can be used as an option for treating moderately to severely active ulcerative colitis in adults when: i) a conventional treatment, biological treatment or Janus kinase (JAK) inhibitor: 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.

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. 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.