Mirikizumab can be used as an option to treat moderately to severely active Crohn's disease in adults, only if:
the disease has not responded well enough or stopped responding to a previous biological treatment, or
a previous biological treatment was not tolerated, or
tumour necrosis factor (TNF)-alpha inhibitors are not suitable.
Mirikizumab can only be used if the company provides it according to the commercial arrangement.
If people with the condition and their healthcare professional consider mirikizumab to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, the least expensive should be used. Take into account the administration costs, dosage, price per dose and commercial arrangements.
These recommendations are not intended to affect treatment with mirikizumab 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 healthcare professional consider it appropriate to stop.
What this means in practice
Mirikizumab must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Mirikizumab must be funded in England within 30 days of final publication of this guidance.
There is enough evidence to show that mirikizumab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support implementation of this guidance.
Usual treatment for moderately to severely active Crohn's disease includes biological treatments such as TNF-alpha inhibitors, risankizumab, ustekinumab and vedolizumab. Mirikizumab is another biological treatment.
Clinical trial evidence shows that mirikizumab works as well as ustekinumab in reducing symptoms and achieving disease remission. Indirect comparisons of mirikizumab with other biological treatments are uncertain. But, together with clinical expert opinion, there is enough evidence that mirikizumab is likely to work as well as risankizumab. Clinical expert opinion also suggests that mirikizumab would be used at the same point in the treatment pathway as risankizumab.
To be recommended as a treatment option, mirikizumab needs to cost less or have similar costs to 1 relevant comparator recommended in a published NICE technology appraisal guidance (see NICE's cost-comparison methods). A cost comparison suggests the costs for mirikizumab are similar to or lower than risankizumab, which is recommended after biological treatment has not worked well enough, stopped working or was not tolerated, or when TNF-alpha inhibitors are unsuitable. So, mirikizumab can be used for this population.
For all evidence see the committee papers. For more information on NICE's evaluation of risankizumab, see the committee discussion section in NICE's technology appraisal guidance on risankizumab.