From 6th–31st January 2025, NICE held a public consultation on a proposed modular update to its technology evaluations manual to incorporate guidance on health inequalities.1 In particular, NICE has proposed explicit guidance on when companies and stakeholders can submit evidence from health inequality analysis, specified its preferred or required methods and outlined how NICE Committees should (and, importantly, should not) incorporate evidence on health inequalities into their decision-making.
Traditional cost-effectiveness analysis conducted for NICE appraisals evaluates the efficiency of a new health intervention. The incremental cost-effectiveness ratio, when judged against a cost-effectiveness threshold, captures only whether a new technology will be health maximising after accounting for health foregone due to opportunity costs; it does not care where the benefits and health opportunity costs fall within society. NICE Committees can account for factors beyond the incremental cost-effectiveness ratio (such as inequalities) as part of a deliberative decision-making framework and NICE has a stated aim to reduce health inequalities. However, NICE processes and methods for technology appraisal have not to this point provided for the quantitative assessment of the impact of individual technology appraisal recommendations on health inequalities. This proposed modular update therefore represents an important shift, opening the door to the inclusion of formal, quantitative analysis of health inequalities to inform NICE Committee decision-making (albeit this is an invitation that is offered cautiously, with NICE suggesting such analysis will only have a place in exceptional circumstances). This proposed modular update comes after a 2024 NICE position statement on the topic and follows two recent NICE submissions for exagamglogene autotemcel that placed quantitative analysis of health inequality impact in the spotlight by including distributional cost-effectiveness analysis (DCEA):
Importantly, NICE’s focus on health inequalities at the start of 2025 is reflective an increased spotlight on this topic in the wider health economics and outcomes research (HEOR) and health technology assessment (HTA) field over recent years, as highlighted by the examples in the figure below. Of course, these initiatives come after the COVID-19 pandemic, which had a massive role in elevating the topic of health inequalities in the public consciousness by both exposing prevailing health inequalities and in heightening these by disproportionately affecting sections of society that already suffered worse health outcomes.4
For manufacturers who may be considering submitting health inequality analysis to NICE in the future, assuming there are no further changes to NICE’s proposal following the recent consultation these are the headline points to be aware of:
We were pleased to submit our response to the public consultation, which centred around the following comments:
As current Chair of the ISPOR Health Equity Research Special Interest Group, I am committed to advancing discussions on how health equity can be better integrated into HTA and HEOR. For those looking for an entry-level introduction to equity considerations in HEOR at a broad level, I highly recommend (though of course am biased!) the Special Interest Group’s recent report published in Value in Health (Primer on Health Equity Research in Health Economics and Outcomes Research: An ISPOR Special Interest Group Report), which provides a comprehensive introductory overview of key concepts, methods and challenges in this evolving field.11
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If you would like any further information on the themes presented above, please get in touch, or visit our HTA page to learn how our expertise can benefit you. Matt Griffiths (Global Head of HTA), with support from Somto Madueke (Senior Analyst), contributed to this article on behalf of Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients/affiliated partners.