OBJECTIVES: National Institute for Health and Care Excellence (NICE) has replaced the end-of-life (EoL) premium with the disease severity modifier in its decision-making process since 2022. This study aims to explore how the outcomes of past health technology assessment (HTA) oncology submissions might have been affected by this change, and whether any have benefitted from the severity modifier.

METHODS: NICE technology appraisals (TAs) in oncology published between May 2023 and May 2024 were reviewed. A hypothetical EoL premium (£50,000 willingness-to-pay [WTP] threshold) was assumed if the reported median overall survival (OS) was ≤24 months in the standard of care (SoC) arm and the median OS gain was ≥3 months in the intervention arm.

RESULTS: Among 43 TAs reviewed, 28 TAs used the severity modifier in the submission. 16 (57.1%) TAs calculated a 1.0 x quality-adjusted life year (QALY) weighting and would not have qualified for the EoL premium. Eight (28.6%) TAs calculated a 1.2 x QALY weighting (equivalent to a £36,000 WTP threshold) and half of them would have qualified for the EoL premium. Only four (14.3%) TAs calculated a severity modifier of 1.7 x in the full- or sub-populations and all would have qualified for the EoL premium. Most (82.8%) TAs resulted in a positive recommendation with commercial arrangement.

CONCLUSIONS: This review shows that only a small proportion of oncology appraisals have qualified for the highest severity modifier. Half of the appraisals qualified for the 1.2 x QALY weighting would have also qualified for the previous EoL premium, indicating a risk that introducing the severity modifier could reduce the number of appraisals that would have previously benefited from a higher WTP threshold. This might require greater pricing flexibility from manufacturers. Nevertheless, the results should be cautiously interpreted due to the assumptions around criteria for the EoL premium.