Presentation (CTI)

OBJECTIVES: The severity modifier is a quantitative weighting that NICE can, in selected circumstances, apply to quality adjusted life years (QALYs). This helps to reduce the incremental cost-effectiveness ratio (ICER), improving the chances of a positive recommendation and encouraging innovation in areas of unmet need. Non-qualification does not mean that NICE does not consider a disease to be severe, but instead the QALY shortfall associated with that disease has not met pre-specified thresholds for eligibility. The intent of the modifier is to attract medicines to underserved disease areas. Once achieved, the QALY shortfall reduces, and it becomes less likely that future treatments with the same indication will qualify. Upcoming changes to the EQ-5D value set may also impact eligibility. This study aimed to better understand which disease areas are more likely to qualify for the modifier, what proportion of topics qualify, and review changes over time.
METHODS: Publicly available NICE documentation published between 2022 and 2026 were systematically reviewed to identify the number of topics that both applied and qualified for severity. Results were further analysed to identify which disease areas were most likely to qualify, assess temporal trends and explore, where available, the rationale for severity modifier acceptance or non-qualification.
RESULTS: We present results that demonstrate approximately one third of topics qualified for the severity modifier. Most topics were cancer-related. The most common reasons for non-qualification included not meeting the severity eligibility cut-offs, and uncertainty about the underpinning utility values.
CONCLUSIONS: The severity modifier is applied in a minority of appraisals, and many topics for which stakeholders anticipate eligibility do not qualify. Reflective of intentionally stringent eligibility criteria, qualification for the higher severity weighting is uncommon. Understanding which types of topics are likely to qualify will help stakeholders better prepare for NICE submissions.