Health Inequalities: NICE Takes a Step Forward

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.

The Context

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):

  • Exagamglogene autotemcel for treating transfusion-dependent beta-thalassaemia in people 12 years and over [TA1003]2
  • Exagamglogene autotemcel for treating severe sickle cell disease in people 12 years and over [TA1044]3

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

diagram showing examples of health equity in the spotlight in HTA & HEOR

 

NICE’s Proposals – Key Points

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:

  • Manufacturers can submit health inequality analyses in their submissions in cases where they can justify that the health inequality impact is expected to be substantial (“proportionately meaningful”). NICE expects that the consideration of health inequality impacts within an evaluation will continue to be in exceptional circumstances only – in other words, it’s only worth submitting these analyses if you have a clear case, and we suggest it would be worth discussing this intention with NICE in advance (for example at the decision problem meeting)
  • The health inequality analyses provided should be in the form of DCEA and should be presented as supplementary to the main (conventional) cost-effectiveness analysis
  • NICE Committees can account for evidence that the technology under evaluation has a positive impact on reducing health inequalities by applying flexibility to the cost-effectiveness range that they are willing to consider. The degree of flexibility applied is at Committee discretion: it is not prescribed by NICE and is not formulaic. The way in which NICE Committees can use submitted health inequality analyses to inform decision-making was a key focus of our consultation response (see below)
  • NICE Committees should explicitly not use the output of DCEA as part of any quantitative formulaic adjustment to the incremental cost-effectiveness ratio (i.e. QALY weighting) or to input into a social welfare function that quantitatively trades-off efficiency and equity concerns based on an assumed level of inequality aversion of society
  • NICE will provide support to manufacturers looking to include DCEA in their submission through a technical ‘Methods Support Document’. Key points to note from the draft of this document are:
    • The recommended equity variable for stratifying social groups in a submitted DCEA is the Index of Multiple Deprivation (IMD) – a measure of socioeconomic status. Committees can consider analyses based on other equity variables but these must be justified with reference to the lack of suitability of IMD
    • Probabilistic sensitivity analysis of the DCEA is not required
    • Opportunity costs should be assumed to be equally distributed across social groups in the DCEA, though scenario analyses can explore this

Costello Medical’s Response to the Consultation

We were pleased to submit our response to the public consultation, which centred around the following comments:

  • We welcomed this modular update, as it represents a significant step towards more formally and transparently embedding health equality considerations within NICE’s technology appraisal process. We supported NICE’s efforts to provide clear and structured guidance and commented that the proposed approach strikes a reasonable balance in seeking to incorporate health equity considerations whilst acknowledging key outstanding limitations to methods and data
  • The decision over how the outputs of health inequality analyses should be used to inform decision-making in a NICE evaluation is a crucial one. We agreed with NICE’s stance that the results of health inequality analysis should not at this stage be used as part of a formula to quantitatively adjust cost-effectiveness results (i.e. via triggering QALY weighting or being used to input into a social welfare function). As noted by NICE, currently there is too much uncertainty over what level of weighting (inequality aversion) should be applied to the trade-off of efficiency and equality. However, we stressed in our consultation response that this decision creates a risk that NICE Committees are not required to be sufficiently transparent about how they have considered submitted evidence on health inequalities in their decision-making. We recommended that NICE require Committees to explicitly state in their final guidance whether or not evidence from a submitted DCEA influenced their decision-making; in the case that it did, we proposed that Committees should have to make clear the form that this influence took, for example whether this led them to apply greater flexibility to cost-effectiveness thresholds, accept greater uncertainty in incremental cost-effectiveness ratios, both or neither. Ideally NICE Committees would also categorise the impact on their decision-making on a qualitative scale (e.g. minor, moderate, significant) to provide a clearer signal of impact, though we appreciate this scale will be inherently subjective. We believe this transparency is important to reinforce that NICE’s commitment to health equality feeds through to the practical conduct of their evaluations and decision-making (and does not just represent words on a page). Furthermore, having clear signals as to the impact on decisions is important to help incentivise further investment on behalf of industry and the wider HTA community in improving methods and data quality for health equality analyses
  • Inequality in uptake of/access to a health intervention is an important potential source of ultimate health inequalities. We understand NICE’s rationale for stating they prefer a default assumption that uptake of new health technologies across social groups will be equal, on the basis that the NHS is legally obliged to fund NICE-recommended medicines (i.e. the UK health system should reduce financial barriers to access/uptake). However, we noted that, despite the UK’s healthcare system, significant inequality of access nevertheless exists, and differential uptake can be very important in driving health inequalities. We hence commented that NICE Committees should be very open to moving from this default position if presented with sufficient evidence
  • We supported a proportionate approach to uncertainty analysis in DCEA, agreeing that sensitivity and scenario analyses are more appropriate than full probabilistic sensitivity analysis given that DCEA results will not directly quantitatively influence decision-making
  • Finally, we requested that NICE’s modular update provide greater procedural clarity for manufacturers who are intending to submit evidence from DCEA, such as specifying whether or not companies need to confirm their intention to submit a DCEA early in the appraisal process and ahead of filing their full submission (e.g., at the decision problem meeting)

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

References

  1. NICE. Health inequalities modular updates to NICE health technology evaluations: the manual (PMG36). Available here. Last accessed: 10 March 2025.
  2. NICE. Exagamglogene autotemcel for treating transfusion-dependent beta-thalassaemia in people 12 years and over (TA1003). Available here. Last accessed: 10 March 2025.
  3. NICE. Exagamglogene autotemcel for treating severe sickle cell disease in people 12 years and over (TA1044). Available here. Last accessed: 10 March 2025.
  4. The King’s Fund. Health Inequalities in a Nutshell. Available here. Last accessed: 10 March 2025.
  5. ISPOR Health Equity Research Special Interest Group. Available here. Last accessed: 10 March 2025.
  6. ICER. Advancing Health Technology Assessment Methods that Support Health Equity. 2023. Available here. Last accessed: 10 March 2025.
  7. CADTH (now CDA-AMC). CADTH Special Report: Equity-Focused Health Technology Assessment at CADTH. Canadian Journal of Health Technologies. 2023.
  8. University of York. Distributional Cost-Effectiveness Analysis: Online Course. Available here. Last accessed: 10 March 2025.
  9. ISPOR. 2022-2023 Top 10 HEOR Trends. Available here. Last accessed: 10 March 2025.
  10. ISPOR. 2024-2025 Top 10 HEOR Trends. Available here. Last accessed: 10 March 2025.
  11. Griffiths et al. Primer on Health Equity Research in Health Economics and Outcomes Research: An ISPOR Special Interest Group Report. Value in Health. 2025; 28(1):16–24

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.

Discover more insights

Cookies Overview
Costello Medical

Our website uses cookies to distinguish you from other users. This helps us to provide you with a good experience when you browse our website and also allows us to improve our site. Cookies are files saved on your phone, tablet or computer generated when you visit a website and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

You can select to accept or reject non-essential cookies using the toggle below. For full details of the cookies we use, please see our Cookies Policy and Privacy Notice.

Non-essential Cookies

We use these to collect information on how our users engage with our website so that we can improve the experience of the website for our users. For example, we collect information about which of our pages are most frequently visited, and by which types of users.