Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - COMED (Pushing the boundaries of Cost and Outcome analysis of Medical Technologies)

Teaser

The overarching objective of the COMED project is to push the boundaries of existing methods for cost and outcome analysis of healthcare technologies, both within the Health Technology Assessment (HTA) and Health System Performance (HSP) frameworks and to develop tools to...

Summary

The overarching objective of the COMED project is to push the boundaries of existing methods for cost and outcome analysis of healthcare technologies, both within the Health Technology Assessment (HTA) and Health System Performance (HSP) frameworks and to develop tools to foster the use of economic evaluation in policymaking.
Within this general agenda, COMED focuses on medical devices (MDs) in order to:
(i) improve economic evaluation methods for MDs in the context of the HTA framework by increasing their methodological quality and integrating data from different data sources;
(ii) investigate health system performance through analysis of variation in costs and outcomes across different geographical areas;
(iii) strengthen the use of economic evaluation of MDs in policy making.
COMED is a highly ambitious project whose predominant purpose is to tangibly improve decision-making process in European healthcare systems, by providing a rigorous evidence base on some of the most pressing issues on the health policy agenda. On one side, we aim to advance the scientific knowledge by improving existing and developing new research streams for cost and outcome analysis of MDs. On the other, our aim is to provide immediately applicable policy advice and tools that will enhance the use of economic evidence in decision-making.

Work performed

The first reporting period covers the period up to 30/06/2019 and overall the project managed to achieve the following progress:
• Mapping of sources of Real World Data on MDs. We contribute to the ongoing debate on the importance of RWE in the field of MD, by giving an overview of the existing sources of RWD across Europe. This mapping provides information on which evidence is currently available and which are the features of existing RWD sources and the variables they include. The strength of our contribution is that we consider multiple types of RWD sources relevant to do economic evaluations of MD, as well as multiple case studies.
• A systematic review of existing methodological guidance for using surrogate outcomes across international HTA agencies, with a focus on Europe. We reviewed publicly available guidelines from European HTA bodies and a two reference countries (Australia and Canada) in terms of their recommendations on the use of surrogate outcomes. Our review shows that about two-thirds of European HTA agencies provide some form of methodological recommendations on how to handle surrogate outcomes. However, there exists a wide variety in the level of methodological detail across agencies indicating the opportunity for further harmonization and standardization.
• A systematic review to examine the methodological approaches adopted to the use of surrogate endpoints among HTA agencies and to assess how the use of surrogate endpoints influence the coverage or reimbursement decisions on health technologies by HTA agencies. We found evidence of variation across HTA agencies regarding: (i) level of acceptability of the surrogate endpoints, (ii) level of evidence acknowledged to support the reliability of the surrogate endpoints, (iii) metrics of correlation reported, (iv) approach to the quantification of the expected treatment effect on the final patient relevant endpoint. We found differences on the recommendations across the same technology evaluations and inter-agency variation in their likelihood to approve technologies based on surrogate endpoints.
• A systematic review of methodologies, measures and performance dimensions for the assessment of impacts related to mHealth applications; and policy documents and guidelines for the evaluation of mHealth technology applications. Results from our review show the need to follow a step-wise approach involving multi-stakeholders group, in particular patients and clinicians. With respect to the policy documents released by the WHO, European Commission and FDA, the reports and guidelines aim at addressing a fast moving and evolving range of technologies and, the policy responses to these developments are also evolving with a growing number of guidelines and working groups.
• Development of scientific model to investigate medical practice variations for MDs. Two models have been set up: international and country-specific analyses. The international analyses allow 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. The country-specific analyses allow to investigate effects at the patient and hospital level and are primarily focused on identifying and explaining variation within countries.
• Systematic review of challenges in Early Dialogues (EDs) between regulators and HTA Bodies. To evaluate the current knowledge, perceptions, and expectations of different stakeholders around EDs in MDs, a systematic review assessing the evidence requirements of HTABs and regulators was conducted. All health technologies were considered and we sought information on discrepancies between regulators’ and HTABs’ evidence requirements and differing requirements among HTABs in different countries and regions. The differences among HTABs were presented according to the structure of the EUnetHTA Core Model.
• Systematic review of challenges associ

Final results

It is too early to gauge the full impact of the work from COMED. The project aims to improve and develop new research streams for cost and outcome analysis of MDs, and provide immediately applicable policy advice and tools to enhance the use of economic evidence in decision-making. We believe that the work performed and the main results achieved so far have already contribute to achieve COMED’s ambitions to:
• Develop scientifically rigorous recommendations on what, when and how RWE sources can be used for the evaluation of MDs.
• Develop new methods for assessing patient-reported outcomes for mHealth technologies.
• Provide a comprehensive understanding of the main drivers of clinical practice variations across Europe.
• Promote research-driven policy advice and tools for the early assessment and conditional reimbursement of MDs.
• Expand the geographic scope of evidence generation from a single jurisdiction to collaborative evidence generation throughout Europe.

Website & more info

More info: http://www.comedh2020.eu.