Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Clinical trial evidence shows that risankizumab is more effective than placebo for treating moderately to severely active ulcerative colitis. However, it has not been directly compared with ustekinumab, which limits the strength of the evidence. The indirect comparison suggests similar effectiveness, but without direct Phase 3 evidence, the rating is moderate.
Cost effectiveness
Risankizumab is recommended based on a cost comparison that suggests it has similar costs to ustekinumab. The NICE cost-comparison methods indicate that it only needs to cost less or have similar costs to one relevant comparator to be recommended, which supports its cost-effectiveness.
Quality of life
The document does not provide specific data on HRQoL improvements associated with risankizumab. While it is indicated for patients who have not responded to other treatments, the absence of validated tools or significant evidence on quality of life impacts leads to a rating of minimal or mixed impact.
Supporting Domains
Safety and Adverse Effects
The document does not detail specific adverse effects but indicates that risankizumab is used when TNF-alpha inhibitors are not effective or tolerated. This suggests an acceptable safety profile, although more detailed safety data would strengthen this rating.
Comparator Selection
Risankizumab has not been directly compared with ustekinumab in clinical trials, which is a limitation. The indirect comparison suggests similar effectiveness, but the lack of direct evidence with key comparators raises concerns about the robustness of the findings.
Patient Population and Subgroups
The patient population for risankizumab is well-defined, targeting adults with moderately to severely active ulcerative colitis who have had inadequate responses to other treatments. This specificity supports a broad generalizability of the findings.
Care Pathway Integration
Risankizumab is positioned as an option when conventional or biological treatments are not suitable, indicating a seamless fit into existing treatment pathways for ulcerative colitis. Minor adjustments may be needed for its integration.
Resource Use and Cost Implications
The document indicates that the Healthcare has agreed to provide funding for risankizumab, suggesting manageable budget impacts. However, the overall resource implications are not extensively detailed, leading to a moderate rating.
Evidence Quality and Robustness
The evidence is based on clinical trial data showing effectiveness compared to placebo, but the lack of direct comparisons with ustekinumab introduces some methodological concerns. Overall, the evidence is acceptable but not without limitations.
Uncertainty, Sensitivity, and Broader Impacts
While there is some uncertainty regarding the direct comparison with ustekinumab, the context of unmet need for patients with ulcerative colitis supports a favorable evaluation. The societal context is also supportive of the treatment’s use.
