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

4.12 Impact on health inequalities

4.12.1 The benefits and costs of new health technologies may not be equally distributed across social groups, which can impact health inequalities. Distributional cost-effectiveness analysis (DCEA) is an economic evaluation framework for synthesising evidence on health inequalities. It determines how costs and benefits vary across population groups. It can be used to show the potential impact of a new technology on health inequalities and specifically the health inequality gap in the general population.

4.12.2 DCEA should only be included in a company submission if there is clear evidence of a significant burden of health inequalities in the eligible population. This should be supported by quantitative evidence (see the technology evaluation methods support document on health inequalities).

4.12.3 DCEA should only be used as supporting evidence of the potential for a technology to impact health inequalities. Cost-effectiveness results by subgroups based solely on social characteristics should not be part of the base-case analysis or presented as non-reference case scenarios.

4.12.4 DCEAs will not be done in economic evaluations produced by EAGs on behalf of NICE for all appraisals of HealthTech and multiple technology appraisals for medicines. For these types of evaluations, DCEA evidence can be provided by companies as part of the information requested on the evidence base and their technology.

4.12.5 NICE's technology appraisals and highly specialised technologies recommendations do not include guidance on service delivery or to support implementation for disadvantaged groups. The committee can only recommend technologies as options for use in the NHS. Differences in uptake may determine health inequality impacts and be relevant to the committee's deliberations, but they cannot be addressed by the committee's recommendations.

4.12.6 The committee should be aware of the remit of their guidance programme and consider how any variations in modelled uptake would be addressed by the new technology.

4.12.7 The results of the DCEA should not weigh the costs or benefits of a technology differently based on the social characteristics of the people affected by the recommendation.

4.12.8 Health inequalities may be relevant to a range of technologies and diseases. So, it is important that DCEAs that support decision making are consistent. The key components of DCEAs and NICE's preferred methods are summarised in the technology evaluation methods support document on health inequalities. Other approaches can be presented if appropriate, but deviations from the specified methods must be clearly justified and supported by evidence.

6.1 Evaluation of the evidence and structured decision making

6.1.2 When forming its recommendations to NICE, the committee considers those factors it believes are most appropriate for each evaluation. In doing so, the committee takes into account the provisions and regulations of the Health and Social Care Act 2012 relating to NICE, and NICE's legal obligations on equality and human rights. The Act expects NICE, when doing its general duties, to be aware of:

Structured decision making: health inequalities

6.2.35 If robust evidence shows that the technology substantially affects health inequalities, the committee will consider how this impacts its decision on whether the technology is an effective use of NHS resources (see sections 6.2.37 and 6.2.38).

6.2.36 Consideration of the health inequality impacts of a technology is separate from NICE's legal obligations on equality and human rights, including under the Equality Act 2010.

6.2.37 When assessing the relevance of health inequality impacts on the value of the technology, the committee will consider any uncertainty associated with the health inequality evidence and analysis. If robust condition- or disease-specific evidence shows that uncertainty or biases in the health inequality evidence are caused by structural or social barriers to accessing care or participating in research, the committee may accept a higher level of uncertainty in the health inequality evidence and analysis.

6.2.38 When considering the relevance of health inequality impacts on the value of the technology, the committee can apply flexibility to the range normally considered a cost-effective use of NHS resources. But, it must consider the effects of healthcare displacement and opportunity cost and provide a rationale for stakeholders. This flexibility should be applied to the most appropriate acceptable ICER decided by the committee for the reference case analysis, as described in sections 6.3.4 to 6.3.8. It should only be applied when the size of the health inequality impacts of a technology are substantial. It should not be used to justify restricting the population of interest to a subgroup based on cost effectiveness (see section 4.9). The committee will not use evidence on health inequality impacts to make optimised recommendations for subgroups based solely on social characteristics.

6.3 Decision making

Economic evaluations based on cost–utility analyses

6.3.5 Above a most plausible ICER of £20,000 per QALY gained, or £100,000 per QALY gained for highly specialised technologies, decisions about the acceptability of the technology as an effective use of NHS resources will specifically consider the following factors: