OBJECTIVES:

NICE have recently introduced a severity-based decision modifier, assigning additional weight to quality-adjusted life year (QALY) gains for severe diseases, based on thresholds for estimated QALY shortfall. This analysis explores how outcomes of past health technology assessment (HTA) submissions made just prior to the change in NICE methods might have been affected by the modifier, and whether any could have benefitted from the disease severity modifier.

METHODS:

All NICE single technology appraisal (STA) and highly specialised technology (HST) submissions from June 2021 to June 2022 were identified. Appraisals with redacted standard care QALYs were excluded. The QALY shortfall (proportional and absolute) was calculated using data in the manufacturer’s submission, using an online calculator (Schneider et al 2021) to determine how many submissions would have met the threshold for QALY weighting for severity.

RESULTS:

Ninety-one published appraisals were reviewed. Standard care QALYs were redacted in 71 submissions. Twenty appraisals reported data required for the QALY shortfall calculations. Fifteen appraisals would not have qualified for a severity modifier. The 1.2x QALY weight would have applied to three appraisals (TA772, TA728, TA699). The 1.7x QALY weight would have applied to two appraisals (TA736, TA716). The five affected appraisals were for cancer therapies, and four satisfied NICE’s original end-of-life criteria. All five treatments were recommended by NICE.

CONCLUSIONS:

This review identified five cancer therapy appraisals that might have qualified for a severity-based decision modifier. Four benefited from the original end-of-life criteria; for these, it remains unclear whether inclusion of a disease severity modifier would have affected the recommendation. For the treatment recommended without consideration of end-of-life criteria, the inclusion of a disease severity modifier would not have changed the recommendation. The redaction of QALYs in manufacturer’s submissions limited the number of submissions that could be considered in this analysis, thereby restricting potential conclusions.