Health technology assessment of medical devices

Paweł Kawalec,

Magdalena A. Mrożek-Gąsiorowska,

Ewa Stawowczyk

Abstrakt

The current challenge for healthcare systems is to assess the clinical and economic value of non-drug technologies. Attempts have been made to use Health Technology Assessment, a standard method used in many countries to assess and make decisions regarding the reimbursement of medicines. The use of health technology assessment for non-drug technology can be a challenge because of the lower availability of high-quality scientific evidence in comparison with drugs. In several European countries attempts were made to develop guidelines for the clinical and economic evaluation of non-drug technologies; we presented specific guidelines prepared by British and French HTA agencies: NICE and HAS, respectively. In the case of Poland, the role of the Agency for Health Technology Assessment and Tariff System (AOTMiT) is to assess and appraise all medical technologies and services claiming public money funding; most of these assessments concern drug technologies. Only 103 of 1,550 orders (6.6%) issued by the Ministry of Health, from 1st January 2012 to 1st July 2018, were related to non-drug technologies. The health services assessed by the AOTMiT include different non-drug medical technologies, both specialized medical devices as well as surgical interventions or diagnostic procedures or screenings. Orders for non-drug technologies issued by the Ministry of Health vary in scope and type of assessment.

Słowa kluczowe: : medical devices, health technology assessment, The Agency for Health Technology Assessment and Tariff System, wyroby medyczne, ocena technologii medycznych, Agencja Oceny Technologii Medycznych i Taryfikacji
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AOTMiT, Wytyczne oceny technologii medycznych (HTA, ang. health technology assessment), wersja 3.0, Agencja Oceny Technologii Medycznych i Taryfikacji, Warszawa sierpień 2016.

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