Using the agreed starting and stopping criteria, ustekinumab (Stelara^®▼) can be made available within NHS Wales for the treatment of inflammatory bowel disease in children and young people aged 6 to 17 years: for ulcerative colitis following loss of response, non-response or intolerance to anti-TNF therapies and vedolizumab; for Crohn’s disease following loss of response, non-response or intolerance to anti-TNF therapies.

The risks and benefits of the off-label use of ustekinumab (Stelara^®▼) for this indication should be clearly stated and discussed with the patient to allow informed consent.

Providers should consult the relevant guidelines on prescribing unlicensed medicines before any off-label medicines are prescribed.

In February 2023 OWMAG recommended this treatment in NHS Wales, in April 2024 there was a review of the recommendation. OWMAG found nothing new that affects the original decision.

Next review: this advice will be reviewed after 2 years or earlier if new evidence becomes available.