Understanding the Impact of the NICE Severity Modifier: A Targeted Review of Oncology Submissions
Author(s)
Emily Matthews, MA, Mike Dolph, MSc, Angie Raad, PhD.
Cytel, Toronto, ON, Canada.
Cytel, Toronto, ON, Canada.
OBJECTIVES: The quality-adjusted life-year (QALY) provides a standardised metric for assessing the value of healthcare interventions and underpins the decision-making framework used by NICE and numerous other reimbursement bodies. To reflect the possibility that society places greater value on QALY gains in certain circumstances (children, life-threatening or debilitating diseases), NICE’s updated methods introduces a severity modifier applying QALY weighting based on disease burden. The present study sought to identify and assess the impact of NICE’s severity modifier in recent oncology health technology assessment submissions.
METHODS: A targeted review was conducted of NICE technology appraisals (TAs) published between January 2023 and June 2025. Descriptive analyses were used to examine patterns in the application of severity modifiers across appraisals in oncology.
RESULTS: Of the 213 TAs, 80 oncology appraisals were included after excluding duplicates from multiple technologies, updates, and terminations. Severity modifiers were discussed in 59 appraisals; three assessed two subgroups, yielding 62 data points. Modifiers greater than 1.0 were applied in 26 appraisals, with subgroup distinctions bringing the total to 29 assessed (sub)populations. Of these, 21 applied a 1.2 modifier (QALY shortfall: proportional 0.85-0.95 or absolute 12-18), and 8 applied a 1.7 modifier (proportional ≥0.95 or absolute ≥18). Most (25) were accepted; of these, 18 were for advanced-stage indications and 8 were for paediatric or young adult populations. Alternative justifications by the sponsor to increase the modifier above the calculated value were rejected.
CONCLUSIONS: Adjusting for disease severity through the NICE severity modifier may enhance alignment between healthcare resource allocation and societal values. However, the findings from this review show that most oncology indications do not qualify for severity modification, with paediatric and advanced-stage indications being the primary exception. The application of the modifier is strictly tied to the defined calculation framework, with limited flexibility based on perceived disease burden alone.
METHODS: A targeted review was conducted of NICE technology appraisals (TAs) published between January 2023 and June 2025. Descriptive analyses were used to examine patterns in the application of severity modifiers across appraisals in oncology.
RESULTS: Of the 213 TAs, 80 oncology appraisals were included after excluding duplicates from multiple technologies, updates, and terminations. Severity modifiers were discussed in 59 appraisals; three assessed two subgroups, yielding 62 data points. Modifiers greater than 1.0 were applied in 26 appraisals, with subgroup distinctions bringing the total to 29 assessed (sub)populations. Of these, 21 applied a 1.2 modifier (QALY shortfall: proportional 0.85-0.95 or absolute 12-18), and 8 applied a 1.7 modifier (proportional ≥0.95 or absolute ≥18). Most (25) were accepted; of these, 18 were for advanced-stage indications and 8 were for paediatric or young adult populations. Alternative justifications by the sponsor to increase the modifier above the calculated value were rejected.
CONCLUSIONS: Adjusting for disease severity through the NICE severity modifier may enhance alignment between healthcare resource allocation and societal values. However, the findings from this review show that most oncology indications do not qualify for severity modification, with paediatric and advanced-stage indications being the primary exception. The application of the modifier is strictly tied to the defined calculation framework, with limited flexibility based on perceived disease burden alone.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE741
Topic
Economic Evaluation, Health Technology Assessment, Organizational Practices
Topic Subcategory
Thresholds & Opportunity Cost
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology