OBJECTIVES: In February 2022, NICE introduced a quality-adjusted life-year (QALY) severity modifier that aimed to give more weight to the health benefits of technologies for the most severe conditions. Like the previous end-of-life criteria, the QALY modifier aims to aid the evaluation of eligible technologies through making it easier to be within the range considered as cost-effective. However, by considering both the quality and quantity of life lost, as well as QALY lost over a prolonged period of time, the severity modifier should allow a greater range of conditions to be eligible, thereby facilitating patient access to treatments for the most severe diseases. Furthermore, manufacturers are able to qualify based on two measures of severity, either a proportional or absolute QALY loss.

METHODS: In order to understand which indications have benefited from the QALY modifier, as well as impact on health technology assessment (HTA) outcomes, we evaluated recent NICE technology assessment reports.

RESULTS: Between December 2022 (the date of the first published assessment including a severity modifier) and April 2024 we identified 75 eligible technology assessments. Of these, 12 unique assessments met the threshold for a QALY modifier. Only one of the 12 assessments was for a non-oncology indication. All 12 assessments met the criteria based on the proportion of QALY lost (with 5 of these meeting both the proportional and absolute criteria).

CONCLUSIONS: The vast majority of assessments are not eligible, suggesting a high threshold for what constitutes the most severe diseases. Acute and oncology conditions are more likely to qualify for a QALY modifier, suggesting that many health technologies that would have been eligible for the previous end-of-life criteria are those benefiting from the new modifier. It remains to be seen whether the new methodology broadens access as intended.