Costello J, D'Souza V, Gildea L, Kinderas M, Ling C, Belisario JM, Warttig S. Process and requirements for submitting nonpharmaceutical medical technologies to health technology assessment authorities. Poster presented at the ISPOR Europe 2022; November 6, 2022. Vienna, Austria.


OBJECTIVES: Explore differences between health technology assessment (HTA) authorities in terms of HTA evaluation processes and requirements for medical technologies and suggest the most efficient and cost-effective market access strategy for submission in these countries.

METHODS: The guidelines and process documents for HTA evaluations in 20 countries were reviewed up to June 2022. Information from 13 countries from Europe, 1 from North America, 2 from Latin America, and 4 from Asia Pacific 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. The processes and requirements of each organization were compared.

RESULTS: The published processes and requirements of HTA authorities for medical technologies vary around the world. Some HTA authorities have dedicated medical technology assessment programs. Not all HTA authorities allow company submissions, and few attach funding mandates to positive recommendations. Of the 20 countries, 3 had a dedicated nonpharmaceutical medical technologies program, 13 followed a general HTA process, 1 had a mixture of general and dedicated HTA processes across regions, and details were unclear for 3. The time taken from start of assessment to final decision also varied widely across countries.

CONCLUSIONS: There are important differences in HTA processes across the world. Variations in the evaluation process and the differing requirements for clinical and economic evidence mean that medical technology companies should plan their market access strategy and the associated evidence needs proactively and based on an understanding of global requirements.

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