OBJECTIVES: In May 2020 the Italian Medicine Agency (AIFA) has published the first Guidelines for economic evaluation of new health technologies in Italy. Given the pivotal role of the English Agency in setting the methodological standards for economic evaluation of new health technologies, it was deemed relevant to assess differences and similarities between the Italian and English guidelines.

METHODS: The Italian guidelines were analyzed and compared to the most updated guidelines published for the Single Technology Appraisal by the National Institute of Care Excellence (NICE) in England. Guidelines were compared qualitatively and topic-by-topic in order to assess the main points of difference and similarity in the recommended methods for economic evaluation.

RESULTS: Guidelines differ strongly in terms of level of technical detail provided, with the Italian guidelines being more specific on the reporting requirements than the methodology approach itself. In Italy, greater flexibility is still granted in the approaches for selecting the most appropriate methods for extrapolating long-term outcomes and selecting the modelling, while some parameters are now clearly established (e.g. discount rate and time horizon). Several similarities were also encountered such as the requirements of sensitivity analyses and the exploration of heterogeneity among patients’ subgroups.

CONCLUSIONS: The publication of Italian first official guidelines for the economic evaluation of health technology should be perceived as an important first step forward for the promotion decisions in healthcare financing based on the value for money. Legislation changes are expected to follow the new guidelines initiative.