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    Health inequalities modular update of NICE Health Technology Evaluations: the manual (PMG36)

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    Sections where no amendments are required

    Table 3. Sections where no amendments are required

    Existing wording

    Section

    Rationale for no change

    The characteristics of patients in the subgroup should be clearly defined and should preferably be identified based on an expectation of differential clinical or cost-effectiveness because of known, biologically plausible mechanisms, social characteristics or other clearly justified factors. When possible, potentially relevant subgroups will be identified at the scoping stage, considering the rationale for expecting a subgroup effect. However, this does not prevent the identification of subgroups later in the process; in particular, during the committee discussions.

    4.9.3

    We considered removing "social characteristics" from the list of ways to inform subgroup analyses because it may present an opportunity for companies to submit an alternative ICER on grounds of health inequalities issues (which is prohibited in our new guidance on DCEA).

    However, it was agreed that there are exceptional circumstances where subgroup analyses, based on factors such as age or gender, could inform optimised recommendations.

    For subgroups based on differences in baseline risk of specific health outcomes, systematic identification of data to quantify this is needed. It is important that the methods for identifying appropriate baseline data for the purpose of subgroup analysis are provided in enough detail to allow replication and critical appraisal.

    4.9.6

    As above.

    • However, it is possible that groups experiencing health inequalities may have different baseline risks for some health conditions. Further clarification on NICE's preferred approach to examining this is covered by new content.

    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:

    • the broad balance between the benefits and costs of providing health services or social care in England.

    • the degree of need of people in England for health services or social care.

    • the desirability of promoting innovation when providing health services or social care in England

    6.1.2

    • This paragraph is specifically about the legislation.