Requirements for Economic Evaluations for Health Technology Assessment Submissions across Different Countries

OBJECTIVES: Health technology assessment (HTA) is a key tool in healthcare policy decision-making. HTA requirements regarding the approach to economic evaluations vary globally as a result of differences in specific markets. The objective was to overview the requirements of HTA agencies in the UK, France, Germany, the US, Canada, Australia and Japan, and the new requirements published by EUnetHTA.

METHODS: Based on a comprehensive search of agencies’ websites conducted in June 2023, up-to-date guidelines were extracted and compared.

RESULTS: Overall, agencies from the UK and France presented the most demanding requirements for economic evaluations. EUnetHTA did not present its own recommendations, but summarised available guidelines from analysed European countries and made conclusions based on them. Five analysed agencies (French, German, US, Australian, and Japanese) allow for both cost-effectiveness, as well as cost-utility analyses (CUA) to be presented, depending on the clinical context, whereas the UK recommends using CUA only. France is the only agency requiring a systematic review of previous economic evaluations to be conducted; in contrast, the UK allows for non-systematic reviews. The Australian agency requires such evidence, but does not specify if it should come from a systematic review or not; the German agency states that the search should be conducted at least in Medline. Agencies from the UK and France state that an appropriate and validated instrument should be used for the critical appraisal of identified economic evaluations. Both UK and France require that utilities should be collected systematically; for costs, the recommendations are usually less strict among analysed agencies.

CONCLUSIONS: Constructing economic evaluation is dependent on the clinical context and the specifics of the healthcare system in a given country. HTA agencies provide manufacturers with more or less detailed recommendations on analytical techniques, methodology for study selection, critical appraisal, and model structure.