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Draft guidance consultation

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1 Recommendations

1.1 Risankizumab is not recommended, within its marketing authorisation, for treating moderately to severely active Crohn's disease in people 16 years and over that has not responded well enough or lost response to conventional treatment or a biological treatment, or when these treatments are not tolerated or suitable.

1.2 This recommendation is not intended to affect treatment with risankizumab 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. For young people, this decision should be made jointly by the clinician, the young person, and their parents or carers.

Why the committee made these recommendations

Standard treatments for moderately to severely active Crohn's disease when conventional treatments stop working are biological treatments (such as adalimumab, infliximab, ustekinumab and vedolizumab). Risankizumab is another biological treatment.

Clinical trial evidence suggests that risankizumab reduces symptoms and increases the likelihood of disease remission compared with placebo whether used as a first or second biological treatment. It is not clear how risankizumab compares with other biological treatments. This is because risankizumab has only been compared indirectly with them and the results are uncertain because of differences between the populations included in the trials and how the trials were carried out.

The company's economic model estimates that risankizumab is less effective and more expensive than other biological treatments for people having a first biological treatment. The cost-effectiveness estimates for risankizumab for people who have already had a biological treatment are above the range NICE considers a cost-effective use of NHS resources. These estimates are uncertain because the company's economic model does not reflect NHS clinical practice and new analyses are needed. So, risankizumab is not recommended.