HTA Processes for Medical Technologies Across the World – Are All Hurdles the Same?

Liesl Gildea, MSc
Associate Director, Market Access and Outcomes Strategy
RTI Health Solutions

HTA processes for medical technologies across the world – are all hurdles the same?
Mordin M, Gildea LJ, Warttig S, Costello J, D'Souza V, Kinderas M, Ling C, Marcano Belisario J.


Using primary and secondary data from direct communication with Health Technology Assessment (HTA) authorities, websites, and reports, we explored health technology assessment processes for medical technologies and evaluated the similarities and differences in Europe, North America, South America, Asia, and Oceania.  The process for HTA evaluations in these 5 regions were reviewed through December 2022, and the qualitative data were collated in Excel.

The results showed all regions have HTA authorities that evaluate medical technologies. Europe is the only region with specific HTA medical assessment process; all other regions rely on a general 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 on 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. Reviews within Europe can be as short as 90 days or more than 200 days.

In conclusion, our results showed that 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.