OBJECTIVES: On 31 January 2022, NICE published an updated manual regarding HTA submissions. Within this update, the EOL criteria was replaced by a new severity modifier where additional weightings can be applied to incremental QALYs, formally allowing for flexibility in the standard WTP threshold of £20,000-£30,000/QALY gained. This research aims to critically analyse the impact that the severity modifier has had on HTA submissions since June 2022.

METHODS: All NICE single and multiple technology appraisal submissions between June 2022 and June 2023 were reviewed. Key information was extracted, and an online calculator was utilised to calculate the severity modifier.

RESULTS: Of the 72 appraisals published between June 2022 and June 2023, 19 (26.4%) considered and/or calculated the severity modifier; however, only 2/19 (10.5%) had the modifier applied, benefiting from an increase in the WTP threshold. The remaining 17 appraisals did not apply the severity modifier. Furthermore, 20/72 appraisals (27.8%) supplied sufficient data for the modifier to be calculated, revealing that 6 appraisals would have had an altered WTP threshold based on the use of the severity modifier in comparison to the utilisation of the EOL criteria.

CONCLUSIONS: This review highlighted that 2 of the 72 published technology appraisals had the severity modifier applied, with 6 appraisals having an altered WTP threshold based on the application of the severity modifier instead of the EOL criteria. Five of these 6 appraisals were for oncological therapies, indicating that there is a greater scope to assess severity in other disease areas. Approximately 16% of the analysed appraisals did not have the modifier applied due to discrepancies in the shortfall values calculated by the company versus the EAG. This indicates that further considerations regarding alternative modelling scenarios are required for companies to prepare for appraisal outcomes following review by the EAG and the committee.