Presentation (CTI)

OBJECTIVES: The National Institute for Health and Care Excellence (NICE) severity modifier, introduced in 2022 to replace end‑of‑life criteria, can affect Committee decisions. We assessed how often technology appraisals (TAs) claimed the modifier, the extent of disagreement between companies, evidence assessment groups (EAGs) and Committees, and whether companies tried to claim it outside the formal criteria.
METHODS: On 8/6/28, using TAcrawlR, we searched NICE guidance documents for severity‑modifier keywords and extracted company, EAG and Committee positions and outcomes.
RESULTS: We identified 41 TAs where the company claimed that the severity modifier should apply (38/280 [13.6%] of TAs published in 2023-2026). In 15/41 (36.6%), the EAG disagreed at least partially, including eight TAs where it concluded that no modifier should apply. Key drivers of disagreement were failure to meet thresholds under EAG modelling assumptions, differing views on disease natural history, utility inputs, and discount rates. Where the EAG disagreed, Committees accepted the EAG position in 7/15 (46.7%), accepted the company position in 3/15 (20.0%), took an intermediate approach in 4/15 (26.7%) and took even stricter view in 1/15 (6.7%). In two additional TAs, the EAG agreed with company calculations, but the Committee applied the modifier in narrower circumstances only (for selected comparators/subpopulations/scenarios). In TA1097, the Committee accepted a 1.2 modifier despite the formal criteria not being met. In four TAs, companies argued for 1.7 despite meeting only 1.2 criteria in some comparisons; none were successful. Overall, Committees accepted a modifier for at least one comparison in 39/41 TAs (95.1%). Among 18 TAs where companies claimed a 1.7 modifier, Committees fully accepted 1.7 in 10, accepted 1.2 instead in six, and accepted 1.7 in narrower circumstances in only two.
CONCLUSIONS: Company-EAG-Committee disagreement was common, but Committees usually accepted a severity modifier when claimed, albeit often at a lower level or in narrower circumstances.