OBJECTIVES: The updated National Institute for Health and Care Excellence (NICE) Manual specifies that “all direct health effects, whether for patients, or when relevant, carers” should be included in health technology appraisals (HTA) (1). The objective of this project was to develop an asset agnostic process for justifying the inclusion of carers’ health-related quality of life (HRQoL) and appropriately integrating it in health economic models for HTA when the impact on carers is believed to be important.

METHODS: Leveraging results from systematic literature reviews (2, 3), more recent publications on carers’ HRQoL in HTA (4, 5) and recommendations from NICE (1, 6, 7), process recommendations across three areas were developed: how to determine the relevance of carer HRQoL; what data to collect and how; and how to include carer HRQoL in health economic evaluations.

RESULTS: The following tools were developed: five key questions to determine the relevance of carer HRQoL; two decision trees to determine appropriate HRQoL data sources when carer HRQoL is not available from the literature or previous appraisals, or available with limitations; five considerations for optimal inclusion of carer HRQoL in health-economic models.

CONCLUSIONS: We recommend that the relevance of carer HRQoL to a HTA is established during early clinical development to best understand data needs and optimize data collection. We recommend, in order of preference, either collecting de novo EQ-5D values, using de novo alternative generic utility values, mapping carer HRQoL values to EQ-5D, conducting a vignette study, or using qualitative description where none of the above is possible.

Finally, we identified four main parameters to link carer HRQoL with (patient health, interventions, adverse events or other factors e.g., institutionalization), recommending a de novo model if carer HRQoL has a large potential cost-effectiveness impact, or if the causal pathway is not well-represented or implementation unfeasible in an existing model.