OBJECTIVES: Treatments may not only influence patients but also their significant others. Lately, it has become more common that applications submitted to HTA agencies, such as the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden, contain information about the effects on the quality of life (QoL) of significant others. Currently, TLV do not consider these spillover effects in decisions regarding reimbursement of pharmaceuticals. The aim of this research is to discuss the arguments for and against considering these effects and the associated methodological and ethical challenges.

METHODS: A literature search in PubMed was conducted and reference lists were checked to identify relevant papers. To analyse challenges in the Swedish context, consequences were discussed in the context of current praxis and guidelines for decision making regarding reimbursement of pharmaceuticals. The results have previously been presented in a report in Swedish delivered to TLV.

RESULTS: The main arguments for and against considering effects on significant others are related to the effects on the allocation of resources and the distribution of health. Identified methodological challenges associated with including spillover effects among significant others in economic evaluations were related to how to handle these effects when a treatment prolongs the life of patients, what effects to include, a risk of double counting, and the impact on opportunity cost. The identified ethical challenges were related to the number of significant others that are included in the assessments, and how to consider the severity of the health states of patients and significant others when these may differ.

CONCLUSIONS: This paper discusses the complexity associated with considering effects in significant others when making decisions regarding reimbursement of pharmaceuticals. There are arguments for and against, as well as ethical and methodological challenges associated with considering spillover effects in significant others.