1 Recommendations

1.1 Upadacitinib is recommended as an option for treating moderately to severely active Crohn's disease in adults, 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 contraindicated.

    Upadacitinib is only recommended if the company provides it according to the commercial arrangement.

1.2 If people with the condition and their clinicians consider upadacitinib to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take into account the administration costs, dosage, price per dose and commercial arrangements.

1.3 These recommendations are not intended to affect treatment with upadacitinib 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.

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, ustekinumab or vedolizumab).

Clinical trial evidence shows that upadacitinib increases the likelihood of disease remission compared with placebo. Indirect comparisons of upadacitinib with ustekinumab and vedolizumab suggest that it is as effective.

A cost comparison suggests that upadacitinib has a similar or lower cost than vedolizumab and ustekinumab. So upadacitinib is recommended.