Abstract
Health Technology Assessment (HTA) has been defined as a ‘multidisciplinary approach studying the clinical, economic, social and ethical implications of development, diffusion and use of health technology’. While the general definition of HTA is widely accepted and its role in policy making is increasingly established in EU countries, the currently adopted methodological framework for HTA does not fully encounter the challenges rising from different types of health technologies, such as medical devices. This paper provides i) an introduction to the HTA methodology, highlight on ii) specific challenges medical devices pose in addition to other health technologies (i.e. short lifecycle and rapid changes, clinical outcomes often depend on training and experience of operator, dynamic pricing), iii) current HTA practices for medical devices and iv) the results of a FP7 funded project, “Methods for Health Technology Assessment of Medical Devices: a European Perspective” (MedTecHTA n. 305694) completed in December 2015. The general objective of MedtecHTA was to enhance HTA methods for medical devices that would acknowledge complexities rising from their integration into clinical practice and to develop recommendations for a wide range of stakeholders in the field. Overall, this paper provides a summary of the current and expected future trends in the assessment of medical devices technology to inform coverage and reimbursement decisions in healthcare within Europe and beyond.
The original version of this chapter was inadvertently published with an incorrect chapter pagination 1339–1342 and DOI 10.1007/978-3-319-32703-7_257. The page range and the DOI has been re-assigned. The correct page range is 1345–1348 and the DOI is 10.1007/978-3-319-32703-7_258. The erratum to this chapter is available at DOI: 10.1007/978-3-319-32703-7_260
An erratum to this chapter can be found at http://dx.doi.org/10.1007/978-3-319-32703-7_260
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Sorenson C, Drummond MF, and Kanavos P (2008) Ensuring value for money in health care, London.
Banta D. (2009) What is technology assessment? International Journal of Technology Assessment in Health Care, 25 (Supplement 1): 7-9.
Taylor RS, Drummond MF, Salkeld G, and Sullivan SD (2004) Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ 329(7472): 972-975.
Drummond MF, Schwartz JS, Jonsson B, Luce BR, Neumann PJ, Siebert U, and Sullivan SD (2008) Key principles for the improved conduct of health technology assessments for resource allocation decisions. International Journal of Technology Assessment in Health Care 24(3): 244-258.
Eucomed at http://www.eucomed.be/uploads/Modules/Publications/medtech_graphic_a2_130912_landscape.pdf
Drummond MF, Griffin A, and Tarricone R (2009) Economic evaluation for devices and drugs-same or different? Value in health 12 (4): 402-404.
Kirisits A, and Redekop WK (2013) The economic evaluation of medical devices: challenges ahead. Applied health economics and health policy 11(1): 15-26.
Taylor RS, and Iglesias CP (2009) Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value in health 12 (4): 404-406.
Tarricone R, Torbica A, Ferrè F, and Drummond MF (2014) Generating appropriate clinical data for value assessment of medical devices: what role does regulation play? Expert Review of Pharmacoeconomics and Outcomes Research 14 (5): 707-718.
Bernard A, Vaneau M, Fournel I, Galmiche H, Nony P, and Dubernard JM (2014) Methodological choices for the clinical development of medical devices. Medical Devices (Auckl) 7: 325-334.
Ciani O, Wilcher B, Blankart CR, Hatz M, Rupel VP, Erker RS, Varabyova Y, and Taylor RS (2015) Health technology assessment of medical devices: a survey of non-European union agencies. International Journal of Technology Assessment in Health Care 31 (3): 154-165.
Chapman AM, Taylor CA, and Girling AJ (2014) Are the UK systems of innovation and evaluation of medical devices compatible? The role of NICE’s Medical Technologies Evaluation Programme (MTEP). Applied health economics and health policy 12 (4): 347-357.
Peinemann F, McGauran N, Sauerland S, and Lange S (2008) Disagreement in primary study selection between systematic reviews on negative pressure wound therapy. BMC Medical Reserach Methodology 8: 41.
Pecchia L, Craven MP (2012) Early stage Health Technology Assessment (HTA) of biomedical devices. The MATCH experience, IFMBE Proc. Vol. 39 World Congress on Med. Phys. & Biomed. Eng., Bejing, China, 2012, pp 1525-1528.
Chapman AM, Taylor CA, Girling JA (2013) Early HTA to Inform Medical Device Development Decisions - The Headroom Method, IFMBE Proc. Vol. 41 XIII Mediterranean Conference on Medical and Biological Engineering and Computing pp 1151-1154.
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Ciani, O., Federici, C., Tarricone, R. (2016). Current and Future Trends in the HTA of Medical Devices. In: Kyriacou, E., Christofides, S., Pattichis, C. (eds) XIV Mediterranean Conference on Medical and Biological Engineering and Computing 2016. IFMBE Proceedings, vol 57. Springer, Cham. https://doi.org/10.1007/978-3-319-32703-7_258
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DOI: https://doi.org/10.1007/978-3-319-32703-7_258
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