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    2 Development of EHIA

    How was the EHIA developed?

    This equality and health inequality impact assessment (EHIA) was informed by the conclusions of 2 impact assessments: 1 from the NIHR Policy Research Unit for Economic methods of Evaluation in health and care interventions (EEPRU), and 1 from the Decision Support Unit (DSU). EEPRU examined how the cost effectiveness of new medicines might be impacted by using the EQ-5D-5L value set instead of the EQ-5D-3L value set (referred to from here as the '5L value set' and '3L value set') to calculate utility values (Biz et al. 2026). The DSU looked specifically at the impact of adopting the 5L value set on the frequency with which the severity modifier would be applied in technology appraisal decisions (Wailoo et al. 2026). These analyses (described below) identified several conditions for which new interventions might become less cost effective after adopting the 5L value set, compared with if NICE continued its current approach of using the 3L value set. Based on these findings, we did a pragmatic review to identify other populations that could be negatively affected by adopting the 5L value set (that is, where the treatments for their conditions might become less cost effective) and explored the equalities and health inequalities considerations relevant to these conditions.

    In assessing the impact of the proposed modular update, we have paid due regard to the need to eliminate discrimination, harassment, victimisation and any other conduct prohibited by the Equality Act 2010 (HM Government 2010), and the need to advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it.

    Impact on cost-effectiveness estimates

    NICE decides whether a new treatment offers value for money by calculating the incremental cost-effectiveness ratio (ICER). This compares the additional cost of a new treatment with the additional health benefits it provides compared with other available treatments. These health benefits are expressed as a combination of how long people live and the quality of those years of life, known as quality-adjusted life years (QALYs). To calculate QALYs we need a mathematical model called a 'value set' to convert data about people's health-related quality of life, collected using the EQ-5D measure, into values that we can use in economic models ('utility values'). EEPRU assessed how using the 5L value set instead of the 3L value set could affect estimates of QALYs and ICERs.

    EEPRU purposively selected 39 decisions from 37 technology appraisals, published between 2016 and August 2024, that reported using EQ-5D-3L utility values in the economic model. The selected case studies broadly reflect the range of disease areas considered by NICE, but the sample was not formally designed to precisely mirror our portfolio of guidance topics. EEPRU found that all cancer medicines in the sample became more cost effective (based on 17 decisions from 17 technology appraisals). The impact on cost effectiveness of medicines for non-cancer conditions differed depending on whether the intervention's health benefits were driven by extending how long people live or improving health-related quality of life. For medicines that helped extend how long people with non-cancer conditions live the results were mixed, but most of these treatments became more cost effective (7 out of the 11 decisions reviewed by EEPRU). All of the medicines in EEPRU's sample that did not affect how long people with non-cancer conditions live became less cost effective (based on 11 decisions from 10 technology appraisals). These included treatments for chronic diseases that can be classed as disabilities, and therefore are protected under the Equality Act 2010. Of the 37 technology appraisals included in EEPRU's analysis, 10 treatments did not affect how long people lived and became less cost effective using the 5L value set. These 10 treatments covered the following 9 conditions:

    • alopecia areata

    • atopic dermatitis

    • chronic sialorrhoea

    • hidradenitis suppurativa

    • migraine

    • obstructive sleep apnoea

    • plaque psoriasis

    • prurigo nodularis

    • ulcerative colitis.

    We did a pragmatic review of a larger sample of published technology appraisals to identify additional populations that could be negatively affected by adopting the 5L value set, based on the trends observed in EEPRU's analysis. We reviewed the 214 most recently published technology appraisals (at the time of the analysis; published between 22 March 2023 and 8 October 2025) and identified 29 treatments that did not affect how long people lived (in addition to the 10 included in EEPRU's analysis), for the following conditions:

    • allergic rhinitis

    • anaemia in chronic kidney disease dialysis

    • angioedema

    • asthma

    • CDKL5 deficiency disorder

    • conjunctivitis

    • COVID-19

    • Duchenne muscular dystrophy

    • endometriosis

    • familial hypercholesterolaemia

    • graft-versus-host disease

    • haemophilia A and B

    • hearing loss

    • hidradenitis suppurativa

    • insomnia

    • Lennox–Gastaut syndrome

    • multiple sclerosis

    • optic neuropathy

    • osteoporosis

    • Parkinson's disease

    • paroxysmal nocturnal haemoglobinuria

    • Pompe disease

    • uterine fibroids

    • vitiligo.

    We reviewed NICE's published equality impact assessments for each of the 39 technology appraisals of treatments that did not affect how long people lived (from the sample of 214 recently published technology appraisals combined with those in EEPRU's sample). This was to identify potential equalities and health inequalities considerations for populations that EEPRU's impact assessment indicated could be negatively affected by adopting the 5L value set.

    Impact on severity weighting

    NICE committees can give extra weight to the health benefits of a treatment when it is used for a particularly severe condition (hereafter referred to as 'severity weighting'). A treatment qualifies for the severity weighting if the condition it treats is expected to cause a large loss in a person's future QALYs, compared with the future QALYs someone in the general population without the condition would be expected to experience. This loss may be measured either as total QALYs lost (absolute shortfall, AS) or as a proportion of the QALYs the person would be expected to experience without the condition (proportional shortfall, PS). The treatment is eligible for severity weighting if either the AS or PS reaches one of the cutoffs set by NICE (see table 6.1 of NICE's technology appraisal and highly specialised technologies guidance manual, presented in appendix A). When this happens, the QALYs gained from that treatment are multiplied by either 1.2 or 1.7 depending on which cutoff has been reached. Increases in AS, PS or both can mean a treatment qualifies for a higher severity weighting, which would make the treatment more cost effective (that is, it has a lower ICER).

    The DSU assessed the impact of adopting the 5L value set on severity weightings using 2 samples:

    • the sample of 39 decisions from 37 appraisals used in EEPRU's analysis, outlined above

    • an additional 18 decisions from 12 appraisals deliberately selected because they either met one of the cutoffs to qualify for severity weighting or were just below one of the cutoffs.

    The results showed that using the 5L value set led to a change in severity weighting for only 2 of the 57 decisions across the 2 samples. One decision was from an appraisal of a treatment for spinal muscular atrophy in children and the other decision related to a treatment for metastatic colorectal cancer in adults. In both cases, the severity weighting fell from 1.7 to 1.2, meaning that a severity weighting would still be applied using the 5L value set, but not at the highest level.

    Exploratory analyses looking at how the impact varied by technology type and population indicated that adopting the 5L value set had a very small effect on AS and PS estimates for cancer treatments (slightly higher AS and slightly lower PS using the 5L than using the 3L). AS and PS decreased for most treatments for non-cancer conditions (particularly those that did not affect how long people with non-cancer conditions live). Larger reductions in both AS and PS were seen in appraisals of treatments for patients with younger average starting ages in the cost-effectiveness models. This seems to suggest that adopting the 5L value set might be less favourable for younger people, although the evidence supporting this conclusion is limited because these reductions in AS and PS did not lead to lower severity weightings in the vast majority of cases.

    Limitations of the EHIA

    The impact assessments focus on technology appraisals for medicines, but the adoption of the 5L value set will affect all NICE recommendations for which the reference case requires a cost–utility analysis (including some HealthTech and guideline recommendations).

    We have not been able to identify all the populations that might be negatively affected by adopting the 5L value set or all the ways in which equalities and health inequalities will be impacted. This is because EEPRU's impact assessment on cost effectiveness used a small sample of published technology appraisals. Regardless, it is not possible to predict in advance all the populations that might be negatively affected by the methods update. The impact of adopting the 5L value set depends on whether an intervention's health benefits are driven by extending how long people live or improving health-related quality of life. This would not be known until the cost-effectiveness analysis and committee evaluation has been completed.

    The fact that some populations might have been negatively affected by adopting the 5L value set in the past does not mean that future appraisals of treatments for their conditions will be affected in the same way, because new treatments may help extend how long people live where existing options had only improved health-related quality of life.

    Although the assessment specific to the effects on severity weighting did not identify particular conditions at risk of being systematically disadvantaged by adopting the 5L value set, it is possible that such impacts could have been missed. This is because of the small sample size and the way the sample case studies were selected.

    Summary of the information considered

    • Results of EEPRU's impact assessment on ICERs (Biz et al. 2026).

    • Results of the DSU's impact assessment on severity weighting (Wailoo et al. 2026).

    • A review of 214 recently published technology appraisals (published between 22 March 2023 and 8 October 2025).

    • NICE's published equality impact assessments for:

      • 39 technology appraisals of medicines that did not affect how long people with non-cancer conditions live (identified by EEPRU's impact assessment and the review of 214 recently published technology appraisals)

      • 2 technology appraisals of treatments that would have had a lower severity weighting using the 5L value set, based on DSU's impact assessment.