Modular update: Equality and health inequality impact assessment (EHIA)

6.2 Decision modifiers: severity

6.2.12 The committee will consider the severity of the condition, defined as the future health lost by people living with the condition with standard care in the NHS (including use of other available treatments, diagnostics, or best supportive care). The extent of unmet health need is reflected within the severity definition. Initially, the severity modifier will not be applied to technology appraisals of HealthTech. Here the severity of the condition should be captured within the QALY benefits and then deliberatively within decision making. NICE is exploring approaches for how the severity modifier could be applied for technology appraisals of HealthTech.

6.2.13 When assessing the severity of the condition in technology appraisals, the committee will consider the associated absolute and proportional QALY shortfall.

6.2.14 Absolute QALY shortfall is the future health, including quality and length of life, that is lost by people living with a condition, compared with the expected future health without the condition over the remaining lifetime of the patients. Absolute QALY shortfall is calculated as the expected total QALYs that people living with a condition would be expected to have with current treatment over their remaining lifetime subtracted from the total QALYs that the general population with the same age and sex distribution would be expected to have. The expected QALYs for the condition with current treatment is equivalent to the total QALYs gained with established practice in the NHS.

6.2.15 Proportional QALY shortfall represents the proportion of future health, including quality and length of life, that is lost by people living with the condition. Proportional QALY shortfall is calculated by taking the absolute QALY shortfall and dividing it by the remaining QALYs that the general population with the same age and sex distribution would be expected to have over their remaining lifetime.

6.2.16 The committee may apply a greater weight to QALYs if technologies are indicated for conditions with a high degree of severity. The data used to estimate both absolute and proportional QALY shortfall should focus on the specific population for which the new technology will be used and be based on established clinical practice in the NHS.

6.2.17 Absolute and proportional shortfall calculations include an estimate of the total QALYs for the general population with the same age and sex distribution as those with the condition. The population EQ‑5D data and survival data used for the estimates should be based on a recent and robust source. Absolute and proportional shortfall calculations should include discounting at the reference-case rate.

6.2.18 The QALY weightings for severity are applied based on absolute and proportional shortfall, whichever implies the greater severity level. If either the proportional or absolute QALY shortfall calculated falls on the cut-off between severity levels, the higher severity level will apply.

6.2.19 For diagnostics, a QALY weight for severity based on absolute and proportional QALY shortfall is unlikely to reflect the societal value and severity of disease in a way that is relevant to the diagnostics context.

6.2.20 For highly specialised technologies, the severity of the condition is already implicitly captured in the selection of technologies for evaluations. No additional QALY weighting for the severity of disease is applied.

6.2.21Technologies recommended after applying the severity modifier will be considered as relevant comparators for future evaluations of new technologies introduced for the same condition. They must have been recommended for routine use and represent established practice in the NHS at the time of evaluating the new technology. Second and subsequent extensions to the regulatory approval for the same technology will be considered on their individual merits.