Understanding the National Institute for Health and Care Excellence Severity Premium: Exploring Its Implementation and the Implications for Decision Making and Patient Access.

This study aimed to evaluate the impact of the National Institute for Health and Care Excellence's (NICE) new severity modifier, which has replaced the end-of-life (EoL) premium, on future NICE recommendations, considering past decision-making patterns. 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 affect hypothetical decision making in historical TAs. A total of 138 data points were identified from 132 TAs. Although the EoL premium was applied in 46 appraisals (33%), 57 (39%) qualify for a severity-based quality-adjusted life-year (QALY) multiplier. Only 19 appraisals (14.6%) not receiving an EoL premium met the severity criteria, the majority (17) qualifying for a 1.2× multiplier. In appraisals predicted to meet the severity criteria, 45 (79%) were in oncology, making them 4.04 times (95% CI 1.91-9.02) more likely to qualify for a severity modifier than nononcology indications. Among historically EoL indications, 42 (91%) were predicted to meet the severity criteria, making them 14.8 times (95% CI 6.37-37.6) more likely to qualify for a severity modifier. The new severity modifier will predominantly benefit oncology indications, continuing their previous explicit prioritization 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 <£36 000. This may necessitate greater pricing flexibility from manufacturers and increase the likelihood of negative recommendations. • The National Institute for Health and Care Excellence has made major changes to the adjustment of their cost-effectiveness thresholds, replacing the "end-of-life" premium for life-extending treatments with a severity-based, tiered approach to valuing new technologies. • Based on historical decision making, very few technologies appraised by the National Institute for Health and Care Excellence are likely to be eligible for the highest cost-effectiveness threshold, with the new severity modifier continuing to predominantly benefit oncology technologies. • The vast majority of indications previously qualifying for the £50 000 per quality-adjusted life-year gained end-of-life premium would now need to meet a cost-effectiveness threshold of either £30 000 or £36 000. This more restrictive policy environment may present challenges to the introduction of new technologies into the United Kingdom, but may improve the allocation of resources to where they provide the greatest benefits. [ABSTRACT FROM AUTHOR]