conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or
biological treatment cannot be tolerated or is not working well enough, and
the company provides it according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with ozanimod that was started in the NHS before this guidance was published. People having treatment outside this recommendation 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 the committee made these recommendations
Standard treatments for moderately to severely active ulcerative colitis after conventional treatments are biological treatments (adalimumab, golimumab, infliximab, ustekinumab or vedolizumab) or tofacitinib.
Clinical trial evidence shows that ozanimod is more effective than placebo for treating moderately to severely active ulcerative colitis. There is no direct evidence comparing ozanimod with standard treatments that are offered after conventional treatment, but indirect comparisons suggest that it is likely to be as effective as some of them.
When conventional treatment is not tolerated or not working well enough, infliximab is more cost effective than ozanimod. But the most likely cost-effectiveness estimates for ozanimod compared with most other treatments are within the range that NICE normally considers an acceptable use of NHS resources. So, ozanimod is recommended, but only if conventional treatment cannot be tolerated or is not working well enough, and only if infliximab is not suitable. Ozanimod is also recommended if a biological treatment cannot be tolerated or is not working well enough.