1 Recommendations

1.1 Upadacitinib 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 condition has not responded well enough or has stopped responding to these treatments, and

  • if the company provides upadacitinib according to the commercial arrangement.

1.2 Choose the most appropriate treatment after discussing the advantages and disadvantages of the treatments available with the person having treatment. If patients and clinicians consider upadacitinib to be one of a range of suitable options, choose the least expensive treatment (taking into account drug administration costs, dose needed and frequency, and product price per dose).

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 upadacitinib is more effective than placebo for treating moderately to severely active ulcerative colitis. There is no direct evidence comparing upadacitinib with treatments that are offered after conventional treatment. Indirect comparison suggests that upadacitinib is likely to be at least as effective as the treatments it was compared with.

The most likely cost-effectiveness estimates for upadacitinib compared with other treatments are within the range NICE normally considers an acceptable use of NHS resources. So, upadacitinib is recommended.