Mordin M, Warttig S, Gildea L, Long J, D'Souza V, Kinderås M, Ling C, Hartley L. Digging into the medical technology HTA process in Tunisia. Poster presented at the ISPOR Europe 2023; November 13, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 supplement):S429. doi: 10.1016/j.jval.2023.09.2242

OBJECTIVES: Publicly available information on the process and methods for health technology assessment (HTA) of medical technologies (MT) can be difficult to find.  Our objective was to understand the process and methods for MT HTA used by the National Authority for Evaluation and Accreditation in Health (INEAS) in Tunisia.

METHODS: A review of publicly available information from the INEAS website was performed and supplemented by an online survey that was sent to and completed by INEAS.  The survey requested information on the selection process, types of technologies evaluated, and types of evidence considered as part of the HTA process and timelines.  Quantitative and qualitative data were obtained and collated in Excel.

RESULTS: Although the INEAS website provides brief information about process and methods used, it is not clear if and how MTs are considered.  The online survey revealed that INEAS can evaluate invasive and noninvasive devices, diagnostics, and digital technology such as apps or software.  The selection process does not differ depending on technology type.  The same external referral process is used.  However, INEAS can use either a general HTA process (e.g., the same process used for assessing pharmaceuticals) or a dedicated HTA process specifically designed for assessing MTs.  For the dedicated process, INEAS considers clinical and economic data as well as opinions form healthcare professionals and patients.  Unpublished data are not considered.  It usually takes INEAS 3 to 6 months to complete and HTA for MT.

CONCLUSIONS: A major challenge for MT companies is establishing whether a technology requires or is eligible for HTA in different markets.  In Tunisia, information abut this was not explicitly clear on the INEAS website.  MT companies should be prepared to contact HTA agencies directly to obtain necessary information to inform market access strategies and HTA submission plans.

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