The start of the new year saw the launch of a consultation by the National Institute for Health and Care Excellence (NICE) on its eagerly anticipated health inequalities modular update to the manual for health technology evaluation. NICE views reducing health inequalities as a “core part of its DNA” and lists it as one of its core principles. The organization already publishes an Equality Impact Assessment (EIA) for each appraisal conducted as part of its Technology Appraisal (TA) and Highly Specialised Technologies (HST) processes.
Debating impacts on health inequalities is not new to the technology appraisal (TA) process. Committees already consider the topic when determining whether to approve reimbursement of a new technology. However, these discussions have often lacked strong empirical or quantitative support, leading committees to conclude that issues raised could not be addressed in a TA. This modular update represents NICE’s first formal move into quantitative assessment of impacts on health inequalities. This was prompted, in part, by appraisals where manufacturers presented relevant evidence to the Evaluation Advisory Group/committee, such as the appraisal of exagamglogene autotemcel (exa-cel) for treating beta-thalassaemia (TA1003), where distributional cost-effectiveness analysis (DCEA) was presented by Vertex as the base case analysis.
Highlights of the Consultation
NICE is now formally inviting the submission of quantitative evidence on health inequalities for the UK population in technology appraisals. This includes descriptive statistics on disease burden, differences in prevalence or health outcomes between social groups, and the projected impact of a technology on the identified inequalities.
DCEA is referenced as the quantitative methodology of choice for assessing the impact of an intervention on health inequalities, with the Index of Multiple Deprivation (IMD) listed as the recommended equity subgroup. However, if included, DCEA should be supportive evidence rather than a part of the base-case analysis. The committee will consider impacts on health inequalities in its decision-making where robust evidence demonstrates that the technology substantially reduces or increases them; however, this consideration will only occur in ‘exceptional’ circumstances.
NICE reaffirms its previous position from 2024, stating that it will not consider health inequality aversion weights when weighting outputs of DCEA, citing a lack of strong evidence on population preferences. As a result, DCEAs will not trade-off equity and health maximization. Committees may also ‘apply flexibility’ to their standard willingness-to-pay threshold when the health inequality impacts of a technology are large, but NICE will not prescribe the degree of flexibility; the committee will make this judgement.
LCP’s Reaction
The modular update is a welcome step forward. It provides guidance to enable the inclusion of quantitative considerations of inequalities within TAs and HSTs, which in turn reflects reducing health inequalities as “a core part of NICE’s DNA.” Inviting submissions of quantitative evidence on health inequalities will help to build the body of evidence and help both NICE and manufacturers better understand the strengths and the challenges of utilizing DCEA, data requirements, and related nuances.
However, there are two areas that would benefit from greater clarity to improve the guidelines: discussion of other equity sub-groups (e.g., ethnicity) and considerations of form of DCEA.
The modular update excludes discussion of important nuances in DCEA implementation. Firstly, DCEA exists in two primary forms: aggregate and full form. Aggregate DCEA is advantageous due to its simplicity, time efficiency, and potential to facilitate comparisons across appraisals. However, it is limited, particularly for conditions with divergent epidemiological trends in incidence and mortality, or when more granular analyses are required to capture meaningful nuances in health inequalities.
Full-form DCEA offers richer insights, but its feasibility depends heavily on the availability of high-quality data. Including similar guidance for manufacturers would help ensure the appropriateness of submitted analyses using this relatively novel methodology. Secondly, while we agree that IMD is the most practical equity subgroup due to data availability and is often relevant, the modular update would benefit from explaining the reasons for this. The information needed to conduct DCEA for a given equity subgroup, namely quality-adjusted life expectancy (QALE) and health opportunity cost gradients by equity subgroup, is lacking for alternative domains of equity such as ethnicity.
The proposed modular update is a positive step toward structured consideration of health inequalities in NICE TA and HST processes. It brings NICE in line with Canada’s Drug Agency (CDA), which requests that companies present economic evaluations in a way that ‘supports equity concerns being reflected in decision-making,’ including the presentation of disaggregated results across relevant patient subgroups.
NICE’s position is a generally sensible and fair reflection of the current evidence base. For example, there is limited data available to support consideration of domains of equity other than IMD and health inequality aversion parameters in DCEA. Further, NICE carefully reflects on its remit as a decision maker and the extent of its influence, suggesting that factors such as access to care and health-seeking behaviors are outside its control, but they are significant contributors to health inequalities in society.
The consultation documents reveal the balance NICE has sought to strike between appropriately considering health inequalities and the risk of increasing complexity and uncertainty in decision making, potentially extending appraisal timelines and delaying patient access. This will also be at the forefront of manufacturers’ minds as they deliberate whether to invest in generating this evidence.
Progress in integrating inequalities considerations into TA and HSTs will rely on continued stakeholder engagement during the consultation, submission of inequalities evidence, and ongoing updates to the guidance to reflect the latest evidence and methodological advances.
