The National Institute for Health and Care Excellence (NICE) has issued technology appraisal guidance on the use of risankizumab, marketed as Skyrizi by AbbVie, for the treatment of moderately to severely active ulcerative colitis in adults who have not responded adequately to conventional or biological therapies, particularly TNF-alpha inhibitors.
The guidance recommends risankizumab as an option provided it is supplied by the company in accordance with a commercial arrangement that includes a discount, the details of which are confidential.
NICE emphasises that when clinicians and patients consider risankizumab alongside other suitable treatments, such as ustekinumab, the least expensive option should be chosen, considering factors like administration costs, dosage, price per dose, and commercial arrangements. The guidance does not affect patients already receiving treatment with risankizumab before its publication.
The NHS in England and integrated care boards are required to comply with the recommendations within three months of publication, with funding for implementation to be provided 30 days after publication. In Wales, the NHS must usually provide funding and resources within two months of the final draft guidance.
The committee’s recommendation to use risankizumab is based on its effectiveness compared to placebo and its similar efficacy and costs to ustekinumab, as indicated by an indirect comparison and NICE’s cost-comparison methods.
The guidance acknowledges that the final decision on treatment should consider the individual needs, preferences, and values of patients, and that healthcare professionals have a responsibility to advance equality of opportunity, and reduce health inequalities, as well as to promote an environmentally sustainable health and care system.
In terms of cost, the list price of risankizumab is £3,326.09 per 600 mg vial for intravenous infusion and per 360 mg or 180 mg doses for subcutaneous administration, excluding VAT. However, the actual cost to the NHS is mitigated by the commercial arrangement with AbbVie. The guidance suggests that risankizumab is a comparator to ustekinumab, and the recommendation to use the least expensive option could potentially impact the market dynamics between the two drugs.
