Understanding the Expected Severity Modifiers Across Diseases Following Changes to NICE Methodology

OBJECTIVES: In January 2022 NICE replaced their end-of-life (EoL) quality-adjusted life year (QALY) modifier with severity QALY modifiers, based on absolute and proportional QALY shortfall of a disease versus a healthy population. It is important for biopharmaceutical companies to understand the potential severity modifier associated with their drug’s target population, to ensure products are assessed against the most appropriate willingness-to-pay (WTP) threshold.

METHODS: MAP developed a baseline healthy population model to estimate the absolute and proportional QALY shortfall across various diseases. The model predicts the expected QALYs healthy individuals would experience versus those experienced by patients diagnosed with a disease. Healthy life has been modelled using age-related utilities (Ara and Brazier, 2011; Ara and Brazier, 2010) and age-related mortality of the general population (Office for National Statistics, 2021). The model adopted a 100-year time horizon and a discount rate of 3.5% was applied. To estimate the absolute and proportional QALY shortfall for each disease area, the mean age at disease onset and discounted lifetime QALYs associated with standard of care were inputted into the model.

RESULTS: A total of 22 diseases and six disease sub-populations were investigated for potential severity modifier weights, totalling 25 analyses. Two diseases (gastric/ gastro-oesophageal junction cancer, colorectal cancer) had highest severity weights (1.70). Seven diseases within oncology, plus multiple sclerosis and cystic fibrosis had medium severity weights (1.20), while the remaining twelve had no additional weight (1.00). Of the diseases with the highest severity weights, both had previous HTAs in which drugs met EoL criteria, however some areas of oncology considered to have medium severity weight also had previous HTAs in which drugs met EoL criteria.

CONCLUSIONS: These results suggest that innovative drugs in some areas of oncology may not benefit from a severity modifier of 1.70, where they may have previously met EoL criteria.