OBJECTIVES: The Horizon Europe SUSTAIN-HTA project aims to create a sustainable framework to understand the needs of European HTA bodies for new innovative HTA methods and tools and align those with the development of methods and tools by academic groups. This review aims to identify the methodological needs of HTA bodies and support a wider gap analysis as part of the foundational work of SUSTAIN-HTA.

METHODS: A pragmatic targeted review of published methods guides from national HTA organizations and EUnetHTA21, and relevant reviews from previous EU funded HORIZON 2020 and IMI projects was carried out. Methods were categorized by their primary purpose; methods for assessing relative effectiveness evidence (REA), cost-effectiveness evidence (CEA), and methods to incorporate other evidence into the assessment (e.g., budget impact, patient preferences).

RESULTS: This review included guidance documents from 58 HTA agencies across Europe, alongside a review of EUnetHTA documents. This review identified methods gaps in areas of real-world evidence, surrogate endpoints and wider considerations. There is variability in the level of reference to published HTA methods amongst agencies, however common methods are often referenced.

CONCLUSIONS: Using the results from this review, an implementation review will be carried out to focus on a sample of published HTA reports to examine how current methods are being implemented in HTA practice. This will target specific, high-priority technologies (e.g., ATMPs, high-risk medical devices) or therapeutic areas (e.g., cancer) year on year. This foundational work will be used alongside other ongoing activities SUSTAIN-HTA horizon scanning tool for HTA methodological needs and SUSTAIN-HTA methods observatory to identify current developments in HTA methods, and the prioritization of methods and tools for implementation and further development.