A NICE Idea? Assessing the Impact of the Severity Modifier in Oncology and Nononcology Single Technology Appraisals
Author(s)
Will Foster, PhD, Fares Debs, MEng, Steven Kelly, BSc, MSc.
CRA, Charles River Associates, London, United Kingdom.
CRA, Charles River Associates, London, United Kingdom.
OBJECTIVES: In February 2022, NICE replaced its End of Life (EoL) modifier with a new Severity modifier to better reflect disease burden beyond mortality risk. The updated approach introduced QALY weightings of 1.2x or 1.7x based on disease severity. CRA sought to explore the application and impact of the Severity modifier since its implementation.
METHODS: CRA analysed all completed NICE Single Technology Appraisals (STAs) from February 2022 to March 2025 (n=290), excluding terminated appraisals. Data extracted included therapeutic area, discussion and application of the Severity modifier, QALY weighting (if applied), and instances of EoL modifier use. Committee discussion notes were also qualitatively reviewed. Assessment was undertaken by two researchers independently and disagreements reviewed by a third reviewer.
RESULTS: Among the 290 STAs, 52% (150) were for oncology products and 48% (140) non-oncology products. The Severity modifier was discussed in 12% (34) and applied in all but three appraisals. Oncology indications benefited from the severity modifier disproportionately: 17% (26/150) oncology appraisals received a QALY weighting versus 4% (5/140) for non-oncology. Of the 31 cases where the modifier was applied, 77% (24) received a 1.2x weighting and 23% (7) received 1.7x. Notably, 6 of the 7 STAs awarded a 1.7x weighting were for oncology indications. Furthermore, the original EoL modifier was applied to an additional 26 oncology appraisals, primarily due to initial submission prior to February 2022.
CONCLUSIONS: Like its predecessor, the Severity modifier disproportionately benefits oncology over non-oncology products. However, it also now appears to be more difficult for oncology products to achieve the ‘EoL-like’ weighting of 1.7x, with most weightings applied at 1.2x. While the new framework modestly expands QALY weighting opportunities for non-oncology indications, further refinement is needed to ensure broader equity of application to support access to innovative treatments for severe diseases.
METHODS: CRA analysed all completed NICE Single Technology Appraisals (STAs) from February 2022 to March 2025 (n=290), excluding terminated appraisals. Data extracted included therapeutic area, discussion and application of the Severity modifier, QALY weighting (if applied), and instances of EoL modifier use. Committee discussion notes were also qualitatively reviewed. Assessment was undertaken by two researchers independently and disagreements reviewed by a third reviewer.
RESULTS: Among the 290 STAs, 52% (150) were for oncology products and 48% (140) non-oncology products. The Severity modifier was discussed in 12% (34) and applied in all but three appraisals. Oncology indications benefited from the severity modifier disproportionately: 17% (26/150) oncology appraisals received a QALY weighting versus 4% (5/140) for non-oncology. Of the 31 cases where the modifier was applied, 77% (24) received a 1.2x weighting and 23% (7) received 1.7x. Notably, 6 of the 7 STAs awarded a 1.7x weighting were for oncology indications. Furthermore, the original EoL modifier was applied to an additional 26 oncology appraisals, primarily due to initial submission prior to February 2022.
CONCLUSIONS: Like its predecessor, the Severity modifier disproportionately benefits oncology over non-oncology products. However, it also now appears to be more difficult for oncology products to achieve the ‘EoL-like’ weighting of 1.7x, with most weightings applied at 1.2x. While the new framework modestly expands QALY weighting opportunities for non-oncology indications, further refinement is needed to ensure broader equity of application to support access to innovative treatments for severe diseases.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA11
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Infectious Disease (non-vaccine), Neurological Disorders, Oncology, Rare & Orphan Diseases