1.1 Filgotinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults:
when conventional or biological treatment cannot be tolerated, or
if the disease has not responded well enough or has stopped responding to these treatments, and
if the company provides filgotinib according to the commercial arrangement.
Why the committee made these recommendations
Standard treatments for moderately to severely active ulcerative colitis after conventional treatment are tumour necrosis factor (TNF)‑alpha inhibitors (adalimumab, golimumab or infliximab), tofacitinib, ustekinumab or vedolizumab.
Clinical trial evidence shows that filgotinib is more effective than placebo for treating moderately to severely active ulcerative colitis. There is no direct evidence comparing filgotinib with treatments that are offered after conventional treatment. Indirect comparison suggests that filgotinib is likely to be as effective as most of them.
The most likely cost-effectiveness estimates for filgotinib compared with other treatments are within the range NICE normally considers an acceptable use of NHS resources. So filgotinib is recommended.