Presentation (CTI)

OBJECTIVES: NICE introduced the severity modifier into its health technology assessment (HTA) framework in 2022, establishing a formal mechanism to incorporate disease severity into value-based decision-making by assigning differential weights to health gains based on anticipated QALY shortfall. In contrast, South Korea has not formally incorporated disease severity as a weighted component in its HTA framework. This study examined the distribution of severity modifier levels among recent anticancer appraisals and compared reimbursement status and assessment pathways in South Korea for therapies assigned the highest modifier.
METHODS: NICE technology appraisals (TAs) published between 2023 and 2025 were screened. Non-oncology and ineligible appraisals were excluded. Appraisals were categorized by severity modifier level: 1.0 (no modification), 1.2 (moderate severity), and 1.7 (highest severity). Therapies assigned 1.7 were cross-referenced with the South Korean HIRA reimbursement list (June 1, 2026). Reimbursement status was classified as reimbursed, non-reimbursed, or not approved. Among reimbursed therapies, the assessment pathway was classified as cost-utility analysis (CUA) or pharmacoeconomic evaluation waiver (PEW).
RESULTS: Of 260 TAs screened, 89 anticancer TAs were included. Because two TAs reported multiple modifier levels, 91 assignments were analyzed: 51 (56%) were 1.0, 30 (33%) were 1.2, and 10 (11%) were 1.7. Within the highest-severity group, 4 (40%) were reimbursed in South Korea, 5 (50%) were non-reimbursed, and 1 (10%) was not approved. Among reimbursed therapies, 1 (25%) was assessed through CUA, whereas 3 (75%) through PEW.
CONCLUSIONS: While the small sample size limits definitive conclusions, these findings suggest a potential alignment between NICE's severity weighting and South Korea's alternative reimbursement pathways for high-severity oncology indications. This highlights the need for further discussion on whether and how disease severity could be incorporated into South Korea's HTA framework in a manner consistent with value-based assessment principles.