COMED project reached all its objectives and milestones. Initial dissemination activities already demonstrated potential of COMED results to inform healthcare policies and advance scientific knowledge.
COMED project performed the following:
-Comprehensive mapping of sources of real-world data and real-world evidence on medical devices across Europe. These findings are crucial in enabling the incorporation of real-world data into decision-making and represent a readily available tool for getting acquainted with existing information sources, their potential and challenges to be addressed.
-Systematic evaluation of the quality of real-world evidence used in HTA of high-risk MDs in Europe. We found significant limitations in quality of data and evaluation methods, which suggest that guidance from HTA agencies on medical devices is (partially) based on evidence of which is riddled with uncertainty that could be largely improved.
-Empirical analysis and simulation study to test the appropriateness and feasibility of methods for analysis of real-world data. We make recommendations on most appropriate methodologies for analysis of real-world data to inform HTA of medical devices.
-In-depth analysis of methodological guidance and actual impact for using surrogate outcomes by international HTA agencies, with a focus on Europe. Our results show that there is a wide variety in the level of methodological detail across agencies indicating the opportunity for further harmonization and standardization.
-Systematic review of methodologies, measures and performance dimensions for the assessment of impacts related to mHealth applications. The systematic review, the subsequent panel discussion with key experts and focus groups with stakeholders in three EU countries, informed a list of recommendations that should be considered in the development of an assessment framework for mHealth applications adopting a lifecycle approach to evidence generation and assessment.
-Scientific model to investigate variations in access to medical devices across EU. Model allows for identifying and explaining variations in the utilization of MDs between countries at NUTS3 level and examination of regional clusters and spatial spillover effects in MD utilization.
-Comprehensive analysis of challenges and recommendations for enhancing the use of Early Dialogues (EDs) for medical devices in Europe. We explored whether EDs between manufacturers and regulators, between manufacturers and HTA bodies or EDs between all three parties improve the information basis for decisions on the side of manufacturers and authorities.
-Methodological recommendations for early health economic modelling. We focused on methods to deal with uncertainty at early stages of a technology life-cycle, when evidence is still sparse. We use a specific case study (i.e. artificial heart) and illustrate how value of information analysis can be used to support manufacturers by providing insights on whether investments in further research would be good value for money, and what type of research should be pursued.
-Policy recommendations for the design and implementation of coverage with evidence development (CED) scheme for medical devices. We explore potential solutions to challenges in CED for medical devices and provide recommendations. The results should be of interest to those who (consider to) apply or design CED schemes for MDs and want to improve a scheme’s chance of success.
-Taxonomy of CED schemes for medical devices. We develop a taxonomy to classify the existing CED schemes for medical devices in the EU. The taxonomy has been used in the design of a survey instrument, used in surveys of policy makers to obtain their views on the challenges in designing and implementing CED schemes.
-Developing tools for enhancing transferability of evidence generation across EU. Based on systematic review of evidence as well as insights obtained through a series of focus groups with key stakeholders in Central and Eastern European (CEE) countries, COMED provides guidance on how to address key challenges of HTA and CED for medical devices in these contexts, with special focus on the transferability of scientific evidence between early and late adopter countries of health innovation.
