Risankizumab is recommended as an option for treating moderately to severely active Crohn's disease in people 16 years and over, only if:
the disease has not responded well enough or lost response to a previous biological treatment, or
a previous biological treatment was not tolerated, or
tumour necrosis factor (TNF)-alpha inhibitors are not suitable.
Risankizumab is only recommended if the company provides it according to the commercial arrangement.
If people with the condition and their clinicians consider risankizumab to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.
These recommendations are not intended to affect treatment with risankizumab 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 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 TNF-alpha inhibitors [adalimumab and 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. Results from indirect comparisons of risankizumab with other biological treatments are uncertain. But there is enough evidence to suggest it is as effective as vedolizumab, a treatment recommended by NICE for use after a TNF-alpha inhibitor or when TNF-alpha inhibitors are not suitable.
A cost comparison of risankizumab with vedolizumab suggests that risankizumab has similar or lower costs than vedolizumab. NICE considers risankizumab an acceptable use of NHS resources. This is when it is used after a biological treatment has not worked well enough, has stopped working, or was not tolerated, or TNF-alpha inhibitors are unsuitable. So, risankizumab is recommended.