Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The evidence from the SUNNY trials demonstrates that secukinumab significantly improves symptoms of moderate to severe hidradenitis suppurativa compared to placebo, with a higher proportion of patients achieving the primary endpoint of HiSCR50 at week 16. However, the response rates were not always statistically significant across all treatment arms, indicating some uncertainty in the robustness of the results.
Cost effectiveness
The cost-effectiveness estimates for secukinumab fall within NICE’s acceptable thresholds, with the company’s base-case ICER reported at £10,504 per QALY gained. This suggests a strong economic value proposition for the treatment.
Quality of life
The trials indicated that secukinumab improved quality of life measures, particularly in the no-response health state up to week 16. However, there is limited long-term data to support sustained improvements beyond this period, which introduces some uncertainty.
Supporting Domains
Safety and Adverse Effects
Secukinumab has a very good safety profile, with mostly mild to moderate adverse events reported in the trials. Serious adverse events were rare, indicating that the treatment is well-tolerated compared to existing therapies.
Comparator Selection
The comparator used in the trials was best supportive care, which is appropriate. However, the evidence suggests that the treatments allowed in the BSC arm may not fully reflect current clinical practice, leading to some limitations in the comparability of the results.
Patient Population and Subgroups
The patient population in the SUNNY trials included individuals with moderate to severe HS, which aligns with the intended use of secukinumab. However, there are concerns regarding the generalizability of the results to the narrower population that secukinumab is positioned for.
Care Pathway Integration
Secukinumab can be integrated into existing care pathways with minor adjustments, as it is positioned as a second-line treatment after adalimumab. The treatment does not require significant changes to current clinical practice.
Resource Use and Cost Implications
The resource implications of secukinumab are manageable, with the potential for cost savings compared to more invasive treatments like surgery. The economic model reflects a reasonable budget impact for the Healthcare.
Evidence Quality and Robustness
The evidence base is supported by two phase 3 trials, which provide a strong foundation for the efficacy claims. However, there are some methodological concerns and uncertainties regarding long-term outcomes.
Uncertainty, Sensitivity, and Broader Impacts
There are notable uncertainties regarding the long-term effectiveness of secukinumab and its generalizability to the broader patient population. The committee highlighted several areas of uncertainty that could impact the decision-making process.
