• Populations, interventions and comparators must be as specified in the clinical review protocol above.
• Studies must be of a relevant health economic study design (cost–utility analysis, cost-effectiveness analysis, cost–benefit analysis, cost–consequences analysis, comparative cost analysis).
• Studies must not be a letter, editorial or commentary, or a review of health economic evaluations. (Recent reviews will be ordered although not reviewed. The bibliographies will be checked for relevant studies, which will then be ordered.)
• Unpublished reports will not be considered unless submitted as part of a call for evidence.
• Studies must be in English.

Studies not meeting any of the search criteria above will be excluded. Studies published before 2002, abstract-only studies and studies from non-OECD countries or the US will also be excluded.

Studies published after 2002 that were included in the previous guideline(s) will be reassessed for inclusion and may be included or selectively excluded based on their relevance to the questions covered in this update and whether more applicable evidence is also identified.

Each remaining study will be assessed for applicability and methodological limitations using the NICE economic evaluation checklist which can be found in appendix H of Developing NICE guidelines: the manual (2014).¹³⁴

Inclusion and exclusion criteria

• If a study is rated as both ‘Directly applicable’ and with ‘Minor limitations’, then it will be included in the guideline. A health economic evidence table will be completed and it will be included in the health economic evidence profile.
• If a study is rated as either ‘Not applicable’ or with ‘Very serious limitations’, then it will usually be excluded from the guideline. If it is excluded then a health economic evidence table will not be completed and it will not be included in the health economic evidence profile.
• If a study is rated as ‘Partially applicable’, with ‘Potentially serious limitations’ or both, then there is discretion over whether it should be included.

The health economist will make a decision based on the relative applicability and quality of the available evidence for that question in discussion with the guideline committee if required. The ultimate aim is to include health economic studies that are helpful for decision-making in the context of the guideline and the current NHS setting. If several studies are considered of sufficiently high applicability and methodological quality that they could all be included, then the health economist, in discussion with the committee if required, may decide to include only the most applicable studies and to exclude selectively the remaining studies. All studies excluded based on applicability or methodological limitations will be listed with explanation in the excluded health economic studies appendix below.

The health economist will be guided by the following hierarchies.

Setting:

• UK NHS (most applicable).
• OECD countries with predominantly public health insurance systems (for example, France, Germany, Sweden).
• OECD countries with predominantly private health insurance systems (for example, Switzerland).
• Studies set in non-OECD countries or in the US will be excluded before being assessed for applicability and methodological limitations.

• Cost–utility analysis (most applicable).
• Other type of full economic evaluation (cost–benefit analysis, cost-effectiveness analysis, cost–consequences analysis).
• Comparative cost analysis.
• Non-comparative cost analyses including cost-of-illness studies will be excluded before being assessed for applicability and methodological limitations.

• The more recent the study, the more applicable it will be.
• Studies published in 2002 or later (including any such studies included in the previous guideline[s]) but that depend on unit costs and resource data entirely or predominantly before 2002 will be rated as ‘Not applicable’.
• Studies published before 2002 (including any such studies included in the previous guideline[s]) will be excluded before being assessed for applicability and methodological limitations.

• The more closely the clinical effectiveness data used in the health economic analysis match with the outcomes of the studies included in the clinical review, the more useful the analysis will be for decision-making in the guideline.
• Generally, economic evaluations based on excludes from the clinical review will be excluded.