Risankizumab for treating moderately to severely active ulcerative colitis

Risankizumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if: • a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • the company provides it according to the commercial arrangement . a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • has not worked (that is the condition has not responded well enough or has lost response to treatment), or • cannot be tolerated or is not suitable, and has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and 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 (including ustekinumab), 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.

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 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. Why these recommendations were made TNF‑alpha inhibitors are the most used biological treatments for moderately to severely active ulcerative colitis. When TNF‑alpha inhibitors have not worked, or are not tolerated, one of the treatment options is ustekinumab. Risankizumab works in a similar way to ustekinumab and would be offered to the same population. Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. Risankizumab has not been directly compared with ustekinumab in a clinical trial in this population. But an indirect comparison suggests that it is similarly effective. A cost comparison suggests risankizumab has similar costs to ustekinumab. Using NICE's cost-comparison methods , risankizumab only needs to cost less or have similar costs to 1 relevant comparator to be recommended as a treatment option. So risankizumab is recommended. For all evidence see the committee papers . To see how NICE evaluated ustekinumab refer to the committee discussion section in NICE's technology appraisal guidance on ustekinumab for treating moderately to severely active ulcerative colitis .

Risankizumab (Skyrizi, AbbVie) is indicated 'for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy'.

The dosage schedule is available in the summary of product characteristics for risankizumab .

The list price of risankizumab is £3,326.09 per: • 600 mg vial of concentrate for solution for intravenous infusion (excluding VAT; BNF online accessed July 2024) • 360 mg doses of solution for injection for subcutaneous administration (excluding VAT; BNF online accessed July 2024) • 180 mg doses of solution for injection for subcutaneous administration (excluding VAT; company submission). 600 mg vial of concentrate for solution for intravenous infusion (excluding VAT; BNF online accessed July 2024) 360 mg doses of solution for injection for subcutaneous administration (excluding VAT; BNF online accessed July 2024) 180 mg doses of solution for injection for subcutaneous administration (excluding VAT; company submission).

The company has a commercial arrangement . This makes risankizumab available to the NHS with a discount. The size of the discount is commercial in confidence.

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. Because risankizumab has been recommended through the cost-comparison process , NHS England and integrated care boards have agreed to provide funding to implement this guidance 30 days after publication.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has moderately to severely active ulcerative colitis and the doctor responsible for their care thinks that risankizumab is the right treatment, it should be available for use, in line with NICE's recommendations.

Risankizumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if: • a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • the company provides it according to the commercial arrangement . a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • has not worked (that is the condition has not responded well enough or has lost response to treatment), or • cannot be tolerated or is not suitable, and has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and 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 (including ustekinumab), 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.

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 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. Why these recommendations were made TNF‑alpha inhibitors are the most used biological treatments for moderately to severely active ulcerative colitis. When TNF‑alpha inhibitors have not worked, or are not tolerated, one of the treatment options is ustekinumab. Risankizumab works in a similar way to ustekinumab and would be offered to the same population. Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. Risankizumab has not been directly compared with ustekinumab in a clinical trial in this population. But an indirect comparison suggests that it is similarly effective. A cost comparison suggests risankizumab has similar costs to ustekinumab. Using NICE's cost-comparison methods , risankizumab only needs to cost less or have similar costs to 1 relevant comparator to be recommended as a treatment option. So risankizumab is recommended. For all evidence see the committee papers . To see how NICE evaluated ustekinumab refer to the committee discussion section in NICE's technology appraisal guidance on ustekinumab for treating moderately to severely active ulcerative colitis .

Risankizumab is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or has lost response to treatment, only if: • a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • the company provides it according to the commercial arrangement . a tumour necrosis factor (TNF)-alpha inhibitor: has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and • has not worked (that is the condition has not responded well enough or has lost response to treatment), or • cannot be tolerated or is not suitable, and has not worked (that is the condition has not responded well enough or has lost response to treatment), or cannot be tolerated or is not suitable, and 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 (including ustekinumab), 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.

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 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. Why these recommendations were made TNF‑alpha inhibitors are the most used biological treatments for moderately to severely active ulcerative colitis. When TNF‑alpha inhibitors have not worked, or are not tolerated, one of the treatment options is ustekinumab. Risankizumab works in a similar way to ustekinumab and would be offered to the same population. Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. Risankizumab has not been directly compared with ustekinumab in a clinical trial in this population. But an indirect comparison suggests that it is similarly effective. A cost comparison suggests risankizumab has similar costs to ustekinumab. Using NICE's cost-comparison methods , risankizumab only needs to cost less or have similar costs to 1 relevant comparator to be recommended as a treatment option. So risankizumab is recommended. For all evidence see the committee papers . To see how NICE evaluated ustekinumab refer to the committee discussion section in NICE's technology appraisal guidance on ustekinumab for treating moderately to severely active ulcerative colitis .