FAQ

Health technology assessment of medical devices

Publication date: 28.12.2018

Public Health and Governance, 2018, Volume 16, Issue 3, pp. 187 - 194

https://doi.org/10.4467/20842627OZ.18.021.10434

Authors

,
Paweł Kawalec
Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Medical College, Kraków
https://orcid.org/0000-0002-0125-0947 Orcid
All publications →
,
Magdalena A. Mrożek-Gąsiorowska
Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland
https://orcid.org/0000-0003-1528-6876 Orcid
All publications →
Ewa Stawowczyk
The University of Bielsko-Biala, ul. Willowa 2, 43-309 Bielsko-Biała, Poland
All publications →

Titles

Health technology assessment of medical devices

Abstract

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.

References

Keltie K., Bousfield D.R., Cole H., Sims A.J., Medical Technologies Evaluation Programme: A review of NICE progression decisions, 2010–2013, “Health Policy and Technology” 2016; 5: 243–250.

Campbell B., NICE medical technologies guidance: Aims for clinical practice, “Perioperative Medicine” 2013; 2: 15.

Campbell B., Campbell M., NICE Medical Technologies Guidance a Novel and Rigorous Methodology to Address a New Health Technology Assessment Challenge, “Appl. Health Econ. Health Policy” 2012; 10 (5): 295–297.

Campbell B., Dobson L., Higgins J. et al., A new health technology assessment system for devices: the first five years, “International Journal of Technology Assessment in Health Care” 2017; 33 (1): 19–24.

Ustawa z dnia 27 sierpnia 2004 r. o świadczeniach opieki zdrowotnej finansowanych ze środków publicznych (Dz.U. 2004 Nr 210 poz. 2135 z późn. zm.).

Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2012–2015; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2012–2015 (accessed: 10.10.2018).

Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2016; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2016 (accessed: 10.10.2018).

Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2017; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2017 (accessed: 10.10.2018).

Agencja Oceny Technologii Medycznych i Taryfikacji, Zlecenia MZ 2018; http://bipold.aotm.gov.pl/index.php/zlecenia-mz-2018 (accessed: 10.10.2018).

Medical Technologies Evaluation Programme, Methods guide, NICE, April 2011.

Fournel I. et al., Methodological Choices for the Clinical Development of Medical Devices, “Medical Devices” (Auckland, N.Z.) 2014; 7: 325–334. 

AOTMiT, Wytyczne oceny technologii medycznych (HTA, ang. health technology assessment), wersja 3.0, Agencja Oceny Technologii Medycznych i Taryfikacji, Warszawa sierpień 2016.

Information

Information: Public Health and Governance, 2018, Volume 16, Issue 3, pp. 187 - 194

Article type: Original article

Titles:

Polish:

Health technology assessment of medical devices

English:

Health technology assessment of medical devices

Authors

https://orcid.org/0000-0002-0125-0947

Paweł Kawalec
Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Medical College, Kraków
https://orcid.org/0000-0002-0125-0947 Orcid
All publications →

Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Medical College, Kraków

https://orcid.org/0000-0003-1528-6876

Magdalena A. Mrożek-Gąsiorowska
Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland
https://orcid.org/0000-0003-1528-6876 Orcid
All publications →

Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland

The University of Bielsko-Biala, ul. Willowa 2, 43-309 Bielsko-Biała, Poland

Published at: 28.12.2018

Article status: Open

Licence: CC BY-NC-ND  licence icon

Percentage share of authors:

Paweł Kawalec (Author) - 33%
Magdalena A. Mrożek-Gąsiorowska (Author) - 33%
Ewa Stawowczyk (Author) - 34%

Article corrections:

-

Publication languages:

English

View count: 1646

Number of downloads: 1933

<p> Health technology assessment of medical devices</p>