Health-economic evaluation in implant trials: design considerations

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.