Kinderås M, Gildea L, Mordin M, Long J, D'Souza V, Ling C, Warttig S, Hartley L. Submission process and requirements of Nordic health technology assessment organisations for medical technologies: results of an online survey. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S435. doi: 10.1016/j.jval.2023.09.2272

OBJECTIVES: Up-to-date, publicly available information on the types of medical technologies (devices, diagnostics, digital health technologies) (MTs) that are eligible to undergo health technology assessment (HTA) is difficult to find. Our objective was to assess the different requirements and processes in Nordic countries that may affect strategic decisions for MT companies.

METHODS: An online survey was sent to 11 HTA organisations across the Nordics, Denmark (n = 3), Finland (n = 2), Norway (n = 3) and Sweden (n = 3). The survey requested information on the selection process, types of technologies evaluated, types of evidence considered as part of the HTA process, and timelines. Quantitative and qualitative data were obtained and collated in Excel.

RESULTS: Of the 11 invitations sent, 5 (45.5% response rate) organisations responded to the survey, with at least one response from each country. There were a lot of similarities between organisations. All organisations evaluate all types of MT (e.g., devices, diagnostic and digital). They require clinical and economic evidence, and MT companies can submit evidence. However, there were some differences. The Finnish organisation is the only one without a dedicated HTA process for MT. The Danish organisation is the only one where confidential data cannot be submitted. The Swedish organisation is the only one that does not perform clinical and economic systematic literature reviews. The Norwegian organisation is the only one that does not use a societal perspective for health economic evaluations.

CONCLUSIONS: The different processes and requirements among organisations in the Nordics will likely affect strategic decision-making by MT companies regarding submissions of MT. The similar requirements allow efficiencies in submission planning. At the same time, it is important for the MT companies to be aware of specific differences in process and requirements that need to considered in evidence generation and submission planning.

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