OBJECTIVES: The EU HTA framework adopted in 2021 will build on previous EUnetHTA cooperation with the aim to make health technologies more readily available to EU patients through a centralized HTA process. This will ensure faster and predictable processes and avoid duplication of efforts and discrepancies in assessments. The aim of this research is to identify the areas where evaluations between EUnetHTA and country HTA differed and understand whether these areas have driven an impact on the national HTA outcomes.

METHODS: Our research focused on previous EUnetHTA relative effectiveness assessments (REAs) (2016-2021), and corresponding national assessment reports in at least 3 of the selected countries: France, Germany, Italy and Spain. A framework was developed to assess the discrepancies and similarities between the EUnetHTA and national HTAs on 10 assessments items relevant to the population and subgroup analysis, assigned comparators, outcome selection and analysis, and study design issues. We further identified the impact of the discrepancy or similarity on the outcomes of the country assessments.

RESULTS: The assessment items which EUnetHTA approaches comprehensively (including selection of comparators and outcomes) or those which adopt standardized methodology (e.g., risk of bias analysis) were usually aligned between countries/EUnetHTA. In the analyzed REAs it was perceived that the misalignment in Italy and Spain assessments was generally smaller than in France and Germany. The least utilized analyses in country assessments were the ITC, potentially due to single-comparator acceptability or evidence from indirect comparisons being considered insufficient (e.g., France). The most common discrepancy areas that often resulted in an impact on the national outcome were the population slicing, subgroup analysis, study design and outcome analysis issues.

CONCLUSIONS: Discrepancies between the EUnetHTA and country assessments highlighted areas of highest impact on the national HTA. These areas are likely to drive focus of future EU HTA efforts for reconciliation with country HTA methodologies.