OBJECTIVES: Explore health technology assessment (HTA) processes for medical technologies and evaluate similarities/differences by region.
METHODS: The process for HTA evaluations in 5 regions were reviewed through December 2022. Information from Europe, North America, South America, Asia, and Oceania was obtained using primary and secondary data from direct communication with HTA authorities, HTA websites, and reports. Qualitative data were obtained and collated in Excel. HTA processes were compared by region.
RESULTS: All regions have HTA authorities that evaluate medical technologies. Europe is the only region with specific HTA medical technology assessment process; all other regions rely on a general HTA process. In Europe, North America and Oceania, economic evaluations are incorporated into HTA reviews using different methods. For example, in North America and Oceania the focus is QALYs whereas European HTAs consider other economic elements beyond QALYs. HTA review times vary across and within regions, for example in North America assessments can be as fast as 30 days, whilst in Asia assessments can be as long as 18 months. Within Europe reviews can be as short as 90 days or more than 200 days.
CONCLUSIONS: HTA processes vary by and within regions. While Europe has the most established HTAs with the reputation of being the most restrictive, other regions are beginning to follow the European model. The medical technologies space is a rapidly changing area and although some HTA organizations do not have specific processes currently, it doesn’t mean they won’t be introduced. Medical technology companies should plan their market access strategy and the associated evidence needs proactively and based on an understanding of regional HTA process – all hurdles are not the same.
