Economic Evaluation of Medical Devices

Abstract

There are a number of challenges in the economic evaluation of medical devices (MDs). They are typically less regulated than pharmaceuticals, and the clinical evidence requirements for market authorization are generally lower. There are also specific characteristics of MDs, such as the device–user interaction (learning curve), the incremental nature of innovation, the dynamic nature of pricing, and the broader organizational impact. Therefore, a number of initiatives need to be taken in order to facilitate the economic evaluation of MDs. First, the regulatory processes for MDs need to be strengthened and more closely aligned to the needs of economic evaluation. Second, the methods of economic evaluation need to be enhanced by improving the analysis of the available clinical data, establishing high-quality clinical registries, and better recognizing MDs’ specific characteristics. Third, the market entry and diffusion of MDs need to be better managed by understanding the key influences on MD diffusion and linking diffusion with cost-effectiveness evidence through the use of performance-based risk-sharing arrangements.

Systematic literature review of cost-effectiveness analyses of robotic-assisted radical prostatectomy for localised prostate cancer

“…This may include the cost of training, increase in surgical volume and conversion of procedure from inpatient to outpatient setting. 47 Finally, the COVID-19 pandemic brings new challenges for constrained healthcare resources. The opportunity cost of using RAS to reduce downstream health resource use may be increasingly relevant in this environment.…”

Robot-Assisted Surgery vs Robotic Stereotactic Body Radiotherapy in Prostate Cancer: A Cost-Utility Analysis

“…As to costs, the cost of training of health care teams that, according to an interview conducted with experts (data not published), could amount to almost €800,000 in the case of rRP in public hospitals in Paris was not included. Costs of training staff for rSBRT should also be considered in the model but they are very difficult to document, as the Drummond et al study showed ( 30 ). Training costs for rSBRT were not available this is why we could not integrate this parameter into our model.…”

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“…The HTA-based MEs replacement strategic planning is a methodology based not only in key recommendations of HTA for MDs [5][6][7][8][9] and HTA 23 but also in economic evaluation of MDs [10,11], methods of economic evaluation 24 and methodology of Business Process Modeling, 25 as depicted in the flow chart in Figure 1.…”

“…4 There are particular characteristics of MDs, such as the device-user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for HTA. In this sense, there are publications that provide key recommendations for assessment of MDs, as well as, regulatory processes that highlight the need for integrated evaluations, [5][6][7][8][9] and economic evaluation. 10,11 In these publications have been identified that the regionalization may had an influence in the methods of assessing and appraising medical technologies, likewise, economic evaluation is only used as background information in some instances.…”