Digging into the Medical Technology HTA Process in Tunisia

Author(s)

Mordin M1, Warttig S2, Gildea L2, Long J3, D'Souza V3, Kinderas M2, Ling C3, Hartley L3
1RTI Health Solutions, Oak Hill, VA, USA, 2RTI Health Solutions, Manchester, LAN, UK, 3RTI Health Solutions, Manchester, UK

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 from healthcare professionals and patients. Unpublished data are not considered. It usually takes INEAS 3 to 6 months to complete an 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 about 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.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

MT13

Topic

Health Technology Assessment

Topic Subcategory

Systems & Structure

Disease

Medical Devices, No Additional Disease & Conditions/Specialized Treatment Areas

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