Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Secukinumab shows comparable efficacy to existing TNF-alpha inhibitors based on indirect comparisons, but lacks direct head-to-head trial data. The evidence indicates that secukinumab is effective compared to placebo, with an increased proportion of patients achieving an ASAS 40 response. However, the uncertainty regarding its effectiveness compared to TNF-alpha inhibitors limits the rating to B++.
Cost effectiveness
Secukinumab is not considered cost-effective compared to TNF-alpha inhibitors, with ICERs indicating it is more costly and less effective. However, it is deemed cost-effective compared to conventional care, which supports a B++ rating.
Quality of life
The clinical evidence suggests that secukinumab improves quality of life measures such as BASDAI and BASFI scores compared to placebo, indicating a moderate benefit in HRQoL. However, specific data on long-term HRQoL improvements are limited, justifying an A rating.
Supporting Domains
Safety and Adverse Effects
Secukinumab has a favorable safety profile with mostly mild to moderate adverse events reported. Serious adverse events are rare, indicating good tolerability compared to existing therapies, which supports an A+ rating.
Comparator Selection
The evidence primarily compares secukinumab to placebo, with no direct comparisons to TNF-alpha inhibitors. While indirect comparisons are made, the lack of direct evidence limits the robustness of the comparator selection, leading to a B+ rating.
Patient Population and Subgroups
The trial population is generally representative of the intended patient population, although there are some limitations in subgroup analyses. The inclusion of patients with objective signs of inflammation supports an A rating.
Care Pathway Integration
Secukinumab can be integrated into existing treatment pathways with minor adjustments, as it is used after NSAIDs and TNF-alpha inhibitors. This ease of integration supports an A+ rating.
Resource Use and Cost Implications
While secukinumab has a manageable budget impact when compared to conventional care, its overall cost compared to TNF-alpha inhibitors raises concerns about resource burden, justifying a B++ rating.
Evidence Quality and Robustness
The evidence base includes a well-conducted RCT (PREVENT), but the reliance on indirect comparisons and limited data for certain populations introduces uncertainty, leading to a B+ rating.
Uncertainty, Sensitivity, and Broader Impacts
There are significant uncertainties regarding the effectiveness of secukinumab compared to TNF-alpha inhibitors and the generalizability of trial results. This uncertainty, coupled with the potential for broader impacts on treatment pathways, supports a B+ rating.
