Mordin M, Gildea L, Long J, D'Souza V, Kinderås M, Ling C, Warttig S, Hartley L. What evidence should medical technology companies expect HTA bodies to review? Poster presented at the ISPOR Europe 2023; November 13, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 supplement):S431. doi: 10.1016/j.jval.2023.09.2254

OBJECTIVES: Publicly available information on the type of evidence considered for health technology assessment (HTA) of medical technologies (devices, diagnostics, digital health technologies) (MTs) is difficult to find.  Our objective was to determine what types of evidence HTA bodies consider in the assessment of different types of MT.

METHODS: An online survey was sent to 55 HTA organisations worldwide.  HTA organisations from Argentina, Australia, Austria, Belgium, Brazil, Canada, Columbia, Denmark, England, Finland, France, Germany,, Italy, Japan, Malaysia, Norway, Peru, Poland, Portugal, Republic of Ireland, Scotland, Singapore, South Korea, Spain, Sweden, Switzerland, the Netherlands, Tunisia, the United States, Uruguay, and Wales were contacted. The survey requested information on the types of evidence considered part of the HTA process for MT. Quantitative and qualitative data were obtained and collated in Excel.

RESULTS: Of the 55 invitations sent, 17 (30.9%) organisations responded to the survey: 12 confirmed that they assess MTs, 3 stated they do not assess MTs and 2 declined participation.  All 12 organisations (100%) consider clinical evidence, and most (n=10; 83%) consider economic evidence.  Two-thirds of organizations (n=8; 67%) also consider opinions from healthcare staff or the opinion of patients, and a few (n=3; 25%) include ethical considerations such as environmental factors.  One organisation also specifically mentioned consideration of data security, data protection, and usability for digital technologies.

CONCLUSIONS: ALL HTA organisations consider clinical evidence in the assessment of MT's.  However, the vast majority also consider economic evidence, highlighting the importance to companies of considering the cost/cost-effectiveness impact of introducing their new MT into the healthcare system.  HTA organisations are also starting to consider the environmental impact of introducing a new MT into the care pathway.

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