Guselkumab for previously treated moderately to severely active Crohn's disease

Guselkumab can be used as an option for previously treated moderately to severely active Crohn's disease in adults, when: • conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement . conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • has not worked (that is, the condition has not responded well enough or lost response to treatment), or • cannot be tolerated, and has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement .

Use the least expensive option of the suitable treatments (including guselkumab, risankizumab and vedolizumab), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.

These recommendations are not intended to affect treatment with guselkumab 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 Guselkumab 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. Guselkumab must be funded in England within 30 days of final publication of this guidance. There is enough evidence to show that guselkumab 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 the implementation of this guidance . Usual treatment for moderately to severely active Crohn's disease when conventional treatments stop working or are unsuitable is biological treatment, which can include TNF-alpha inhibitors or ustekinumab. If these do not work well enough, stop working or are not tolerated, or if TNF-alpha inhibitors are unsuitable, people can then have risankizumab or vedolizumab. Guselkumab would be offered to the same population as risankizumab and vedolizumab. Clinical trial evidence shows that guselkumab increases the likelihood of disease remission and endoscopic response compared with placebo. It has not been directly compared in a clinical trial with risankizumab or vedolizumab, but indirect comparisons suggest that it is likely to work as well as these. A cost comparison suggests the costs for guselkumab are similar to or lower than risankizumab and vedolizumab. So, guselkumab can be used. For all evidence see the committee papers . For more information on NICE's evaluation of risankizumab and vedolizumab, see NICE's technology appraisal guidance on risankizumab for previously treated moderately to severely active Crohn's disease and vedolizumab for treating moderately to severely active Crohn's disease after prior therapy .

Guselkumab (Tremfya, Janssen-Cilag) is indicated for 'the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or biologic treatment'.

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

The list price of guselkumab is (excluding VAT; company submission). • £4,500 for a 200 mg solution for infusion vial • £2,250 for a 200 mg pre-filled pen • £2,250 for a 100 mg pre-filled pen £4,500 for a 200 mg solution for infusion vial £2,250 for a 200 mg pre-filled pen £2,250 for a 100 mg pre-filled pen

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

For information, Janssen-Cilag did not disclose its Carbon Reduction Plan for UK carbon emissions.

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 90 days of its date of publication. Because guselkumab 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 60 days 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 previously treated moderately to severely active Crohn's disease and the healthcare professional responsible for their care thinks that guselkumab is the right treatment, it should be available for use, in line with NICE's recommendations.

Guselkumab can be used as an option for previously treated moderately to severely active Crohn's disease in adults, when: • conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement . conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • has not worked (that is, the condition has not responded well enough or lost response to treatment), or • cannot be tolerated, and has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement .

Use the least expensive option of the suitable treatments (including guselkumab, risankizumab and vedolizumab), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.

These recommendations are not intended to affect treatment with guselkumab 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 Guselkumab 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. Guselkumab must be funded in England within 30 days of final publication of this guidance. There is enough evidence to show that guselkumab 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 the implementation of this guidance . Usual treatment for moderately to severely active Crohn's disease when conventional treatments stop working or are unsuitable is biological treatment, which can include TNF-alpha inhibitors or ustekinumab. If these do not work well enough, stop working or are not tolerated, or if TNF-alpha inhibitors are unsuitable, people can then have risankizumab or vedolizumab. Guselkumab would be offered to the same population as risankizumab and vedolizumab. Clinical trial evidence shows that guselkumab increases the likelihood of disease remission and endoscopic response compared with placebo. It has not been directly compared in a clinical trial with risankizumab or vedolizumab, but indirect comparisons suggest that it is likely to work as well as these. A cost comparison suggests the costs for guselkumab are similar to or lower than risankizumab and vedolizumab. So, guselkumab can be used. For all evidence see the committee papers . For more information on NICE's evaluation of risankizumab and vedolizumab, see NICE's technology appraisal guidance on risankizumab for previously treated moderately to severely active Crohn's disease and vedolizumab for treating moderately to severely active Crohn's disease after prior therapy .

Guselkumab can be used as an option for previously treated moderately to severely active Crohn's disease in adults, when: • conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement . conventional or biological treatment: has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and • has not worked (that is, the condition has not responded well enough or lost response to treatment), or • cannot be tolerated, and has not worked (that is, the condition has not responded well enough or lost response to treatment), or cannot be tolerated, and a tumour necrosis factor (TNF)-alpha inhibitor has not worked, cannot be tolerated or is not suitable. Guselkumab can only be used if the company provides it according to the commercial arrangement .

Use the least expensive option of the suitable treatments (including guselkumab, risankizumab and vedolizumab), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.

These recommendations are not intended to affect treatment with guselkumab 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 Guselkumab 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. Guselkumab must be funded in England within 30 days of final publication of this guidance. There is enough evidence to show that guselkumab 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 the implementation of this guidance . Usual treatment for moderately to severely active Crohn's disease when conventional treatments stop working or are unsuitable is biological treatment, which can include TNF-alpha inhibitors or ustekinumab. If these do not work well enough, stop working or are not tolerated, or if TNF-alpha inhibitors are unsuitable, people can then have risankizumab or vedolizumab. Guselkumab would be offered to the same population as risankizumab and vedolizumab. Clinical trial evidence shows that guselkumab increases the likelihood of disease remission and endoscopic response compared with placebo. It has not been directly compared in a clinical trial with risankizumab or vedolizumab, but indirect comparisons suggest that it is likely to work as well as these. A cost comparison suggests the costs for guselkumab are similar to or lower than risankizumab and vedolizumab. So, guselkumab can be used. For all evidence see the committee papers . For more information on NICE's evaluation of risankizumab and vedolizumab, see NICE's technology appraisal guidance on risankizumab for previously treated moderately to severely active Crohn's disease and vedolizumab for treating moderately to severely active Crohn's disease after prior therapy .