Presentation (CTI)

OBJECTIVES: Detailed, publicly available information on the process and methods for health technology assessment (HTA) of medical technologies (MTs) can be difficult to find. Our objective was to understand the process and methods used for HTAs of MTs by the Federal Joint Committee (G-BA) in Germany.
METHODS: A review of publicly available information from the G-BA website was performed and supplemented with an online survey in 2023. The survey requested information on the MT selection process, types of MTs evaluated, and types of evidence considered within the HTA process. Quantitative and qualitative data were obtained and collated in Excel. In 2025, a review of the G-BA website was performed for potential updates to the available information on HTAs of MTs.
RESULTS: Initial searches provided minimal information about the process and methods used to review MTs. Survey results revealed that G-BA evaluates invasive and non-invasive devices, diagnostics, and digital technologies. G-BA uses a general HTA process that covers all products and medicines. It considers only clinical data and allows confidential information to be included. An economic evaluation is not required. An update in 2022 requires the G-BA to assess additional benefit, impacting reimbursement of the statutory health insurance funds in Germany. It usually takes G-BA > 12 months to complete an HTA for an MT. However, the 2025 G-BA review found that methods for high-risk MTs are evaluated within 6 months.
CONCLUSIONS: A major challenge for MT companies is establishing whether a technology requires or is eligible for an HTA in different markets. For MT evaluation in Germany, information was available on the G-BA websites, but contact from G-BA directly revealed additional details. MT companies should be prepared to contact HTA agencies directly to obtain necessary information to inform evidence generation, market access strategies, and HTA submission plans.