Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Secukinumab demonstrated a clear clinical advantage over etanercept, showing a higher PASI response rate (PASI 75) at both 12 and 52 weeks in a randomized control trial. The evidence indicates that secukinumab is likely more effective than etanercept and placebo, while its effectiveness compared to ustekinumab is similar, which supports a strong therapeutic impact.
Cost effectiveness
The cost-comparison analysis indicates that secukinumab’s total costs are similar to or lower than those of ustekinumab and etanercept, with the potential for cost savings through commercial arrangements. This suggests a clear cost-effective profile under common thresholds.
Quality of life
The evidence includes Children’s Dermatology Life Quality Index scores, indicating positive impacts on HRQoL. While the improvements are moderate, they are supported by validated tools, suggesting a beneficial effect on patients’ overall well-being.
Supporting Domains
Safety and Adverse Effects
Secukinumab has a very good safety profile, with adverse events primarily being mild to moderate. The safety outcomes are comparable to other biological treatments, indicating a favorable tolerability.
Comparator Selection
The clinical trials compared secukinumab against relevant biological treatments (etanercept and ustekinumab), which are appropriate standards of care. However, the absence of adalimumab in the network meta-analysis is a minor limitation.
Patient Population and Subgroups
The trial population is representative of the intended use in children and young people aged 6 to 17 years. The committee’s considerations regarding the population align with previous NICE recommendations, enhancing generalizability.
Care Pathway Integration
Secukinumab can be integrated into existing treatment pathways with minor adjustments. The recommendations for treatment align with current clinical practices, indicating a good fit within the healthcare delivery system.
Resource Use and Cost Implications
The analysis indicates that the resource implications of secukinumab are manageable, with the potential for budget impact being justifiable given the clinical benefits. The commercial arrangement further supports its economic viability.
Evidence Quality and Robustness
The evidence base includes a randomized control trial and network meta-analyses, which provide a strong foundation for the conclusions drawn. While there are some limitations, the overall quality of evidence is acceptable.
Uncertainty, Sensitivity, and Broader Impacts
The committee acknowledged some uncertainties, particularly regarding the effectiveness of adalimumab. However, the context of unmet need and the robustness of the evidence mitigate these concerns, supporting a favorable assessment.
