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Journal of Long-Term Effects of Medical Implants
SJR: 0.332 SNIP: 0.491 CiteScore™: 0.89

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v19.i4.50
pages 279-285

Health-Economic Evaluation in Implant Trials: Design Considerations

Volker Alt
Department of Trauma Surgery, University Hospital Giessen-Marburg GmbH, Giessen, Germany
Theodoros Pavlidis
Department of Trauma Surgery, University Hospital Giessen-Marburg GmbH, Giessen, Germany
Gabor Szalay
Department of Trauma Surgery, University Hospital Giessen-Marburg GmbH, Giessen, Germany
Christian Heiss
Department of Trauma Surgery, University Hospital Giessen-Marburg GmbH, Giessen, Germany
Reinhard Schnettler
Department of Trauma Surgery, University Hospital Giessen-Marburg GmbH, Giessen, Germany

ABSTRACT

In today’s world, demonstration of the safety, efficacy, and quality of a new treatment strategy is no longer sufficient in many countries for market entry and reimbursement in the public healthcare system. This implies that new implants in orthopedic and orthopedic trauma surgery not only must be shown to lead to better medical outcome compared with the standard of care implant, but also must be shown to exhibit "good value" for the money for the public health-care system based on sound economic data from health-economic studies. The purpose of this article is to elucidate a framework for health-economic aspects alongside implant trials, with the assumption that the new implant is more costly but potentially better than the control implant. Cost-effectiveness, cost-utility, and cost-benefit studies are suitable for the assessment of the health-economic value of a new implant. The following criteria should be considered for a health-economic study design in the context with an implant: i) it should state medical benefits of the new implant compared with the control implant; ii) it should precise the type of health economic study; iii) it should define the methodological approach, perspective of the study, and types of costs; iv) if necessary, it should state discount costs and/benefits; and v) a sound sensitivity analysis should be included. Furthermore, close cooperation between researchers, clinicians, and health economists is essential.