Understanding the NICE severity premium: Exploring its implementation and the implications for decision-making and patient access

Objective To evaluate the impact of NICE’s new severity modifier, which has replaced the end-of-life (EoL) premium, on future NICE recommendations, considering past decision-making patterns. Methods NICE technology appraisals (TAs) published between January 2020 and December 2022 were reviewed. Summary statistics were generated to assess how the new severity modifier might impact hypothetical decision-making in historical TAs. Results A total of 138 data points were identified from 132 TAs. While the EoL premium was applied in 46 (33%) appraisals, 57 (39%) qualify for a severity-based QALY multiplier. Only 19 (14.6%) appraisals not receiving an EoL premium met the severity criteria, the majority (17) qualifying for a 1.2x multiplier. In appraisals predicted to meet the severity criteria, 45 (79%) were in oncology, making them 4.04 (95% CI: 1.91 – 9.02) times more likely to qualify for a severity modifier than non-oncology indications. Among historically EoL indications, 42 (91%) were predicted to meet the severity criteria, making them 14.8 (95% CI: 6.37 – 37.6) times more likely to qualify for a severity modifier. Conclusions The new severity modifier will predominantly benefit oncology indications, continuing their previous explicit prioritisation under the EoL decision modifier. However, the new severity modifier is harder to achieve and less generous; only a fraction of appraisals qualify for the highest effective £51,000 per QALY threshold. The vast majority of indications previously approved at £50,000 per QALY would now need to meet a cost-effectiveness threshold of less than £36,000. This may necessitate greater pricing flexibility from manufacturers, and increase the likelihood of negative recommendations.