Periodic Reporting for period 2 - COMED (Pushing the boundaries of Cost and Outcome analysis of Medical Technologies)
Periodo di rendicontazione: 2019-07-01 al 2021-06-30
The overarching aim of the COMED project is to push the boundaries of existing methods for cost and outcome analysis of health technologies, and to develop tools to foster the use of economic evaluation in policymaking. Within this general agenda, the COMED project focuses on one broad category of healthcare technologies (medical devices) to reach three main objectives:
1. improve methods for economic evaluation of medical devices in the context of the HTA
2. investigate health system performance through analysis of variation in access to medical devices across different geographical areas
3. strengthen the use of economic evaluation of medical devices in policy making
1. improve methods for economic evaluation of medical devices in the context of the HTA
2. investigate health system performance through analysis of variation in access to medical devices across different geographical areas
3. strengthen the use of economic evaluation of medical devices in policy making
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.
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.
COMED project is an ambitious research initiative that aims to tangibly improve decision-making process in EU, by providing a rigorous evidence base on the most pressing issues around evaluation, diffusion and use of heath technologies in Europe. COMED strives to advance the scientific knowledge by improving existing and developing new research streams and it provides directly applicable policy advice and tools to inform decision-making which ultimately impact on public health in the EU.
Impact on the policy making
The COMED project will substantially improve the policy-making process through the following tools:
-Policy recommendation for collection and analysis of real-world data for medical devices
-Policy tool for the evaluation of medical devices and other health technologies that depend on surrogate outcomes evidence
-Comprehensive framework for the evaluation of mHealth technologies
-Policy recommendations for the early assessment of medical devices
-Policy guide for the design and conduct of CED schemes for medical devices
-Policy guidelines on transferability of coverage with evidence development schemes based on foreign data
Impact on healthcare industry
COMED project helps medical device manufacturers to improve their business and research decision making processes, and to develop their current knowledge on what evidence to collect, and how to rigorously conduct HTA studies on their products.
Impact on health care practitioners
COMED project will substantially improve managers’ and decision-makers’ understanding on how the existing data sets can be exploited to estimate the costs and outcomes of medical technologies. This knowledge will provide them with evidence-based tools for making decisions concerning the delivery process of healthcare services and procedures. The results of COMED will also provide clinicians with useful information for comparing their practices in the use of medical devices to those of peers in other EU countries and thus learn from evidence beyond their country of practice.
Impact on patients and the general public
Some results of COMED will serve as useful information for the broader public and particularly for patients to improve transparency, enabling them to act as informed self-determined partners (patient empowerment) in health care systems. This is particularly important in areas such as mHealth, where patients’ informed participation is critical to the success of therapy.
Impact on the policy making
The COMED project will substantially improve the policy-making process through the following tools:
-Policy recommendation for collection and analysis of real-world data for medical devices
-Policy tool for the evaluation of medical devices and other health technologies that depend on surrogate outcomes evidence
-Comprehensive framework for the evaluation of mHealth technologies
-Policy recommendations for the early assessment of medical devices
-Policy guide for the design and conduct of CED schemes for medical devices
-Policy guidelines on transferability of coverage with evidence development schemes based on foreign data
Impact on healthcare industry
COMED project helps medical device manufacturers to improve their business and research decision making processes, and to develop their current knowledge on what evidence to collect, and how to rigorously conduct HTA studies on their products.
Impact on health care practitioners
COMED project will substantially improve managers’ and decision-makers’ understanding on how the existing data sets can be exploited to estimate the costs and outcomes of medical technologies. This knowledge will provide them with evidence-based tools for making decisions concerning the delivery process of healthcare services and procedures. The results of COMED will also provide clinicians with useful information for comparing their practices in the use of medical devices to those of peers in other EU countries and thus learn from evidence beyond their country of practice.
Impact on patients and the general public
Some results of COMED will serve as useful information for the broader public and particularly for patients to improve transparency, enabling them to act as informed self-determined partners (patient empowerment) in health care systems. This is particularly important in areas such as mHealth, where patients’ informed participation is critical to the success of therapy.