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Work packages

Work packages

WP1. Cross-country analysis of HTA practices for medical devices

WP1 explore the state of the art in licensing and HTA of medical devices and thereby undertake the groundwork for subsequent WP activities by identifying existing gaps and critical issues. Specific objectives are:

  • To undertake a review of current licensing and HTA guidelines for medical devices
  • To assess how current guidelines for medical devices are being applied in HTA reports
  • To develop standardized template for comparing HTA guidelines and reports.    


WP2. Geographic variation in access to medical devices

There is some evidence that access to new medical technologies varies across countries and even within countries. This is due to a variety of reasons, including differences in guidelines recommendations, budget constraints and professional expertise. The objectives of WP2 are:

  • To produce evidence about differences in access to medical devices in electrophysiology (e.g. pacemakers, ICDs and devices for resynchronization) between and within European member states
  • To investigate the determinants of differences in access to electrophysiology technologies
  • To review differences among national guidelines across a selected number of EU member states
  • To assess potentials and limitations of registries and administrative databases for the analysis of rates of utilization of medical devices in electrophysiology.


WP3. Comparative effectiveness of medical devices

WP3 identify challenges and gaps in current methods of comparative effectiveness for medical devices using real world data (observational studies, administrative data and registries). In particular the objectives are:

  • To review state-of-the-art approaches currently used for comparative effectiveness and to identify challenges and gaps in methodology related to specific issues for medical devices
  • To develop a comprehensive framework with improved methods for evaluating comparative effectiveness of medical devices including recommendations for analytic methods and data collection
  • To test the framework and new methodological approaches on a selection of medical devices.


WP4. Economic evaluation and HTA

Budget constraints limit the space for new health interventions including medical devices which often require high cost upfront. Institutions deciding about what to make available to patients are increasingly facing difficult trade-offs and seek for appropriate criteria and tools to offer guidance to decision making. The field of economic evaluation offers both criteria and tools to face this challenging situation and have gained ground in the running of healthcare systems in Europe, North America and Australia. The aims of WP4 are:

  • To review the main methods proposed to create economic evidence about health interventions
  • To review possible approaches in the use economic evaluation to offer guidance to decision making
  • To make suggestions about future directions in the use of economic evaluation in Health Technology Assessment of medical devices.


WP5. Uncertainty and value of information analysis for medical devices

Policy makers have to make decision on whether to adopt (fund, cover or reimburse) the medical device based on the current state of evidence and/or wait until further research is conducted to support its use. The health economics modelling in WP5 forms an important component of this policy decision The development of the framework will promote rapid and consistent adoption of innovative clinically and cost-effective medical technologies and will identify when research might reasonably be expected to be provided by sponsors or when publically funded research might be needed. WP5 in particular will:

  • Establish the key principles of what assessments are needed to inform policy decisions about the value of medical devices, an assessment of uncertainty and the value of conducting further research
  • Examine the extent to which assessments of uncertainty differ between medical devices and other health technologies
  • Examine the relevance of the existing frameworks for health technologies and to develop a set of analytic principles specifically for medical devices.


WP6. Organizational impact of medical devices: development of survey and empirical analysis

The starting point for WP6 is that organizational issues, i.e. decision criteria for implementation of medical devices and their underlying organizational conditions, may be highly relevant to HTA. However, standardized methods to consider such issues are yet to be defined. The objectives of WP6 are:

  • To review state of the art approaches used to measure the organizational impact of health technologies
  • To propose a standardized methodology for incorporating organizational issues in a broader HTA framework
  • To evaluate the impact of organizational issues on the decisions to implement new medical devices


WP7. Recommendations on HTA methods for medical devices

The aims are:

  • to summarise the results of the project and to provide recommendations for methods in conducting HTA on medical devices
  • to discuss potential policy implications with a focus on the added value for the European Community


WP8. Dissemination


WP9. Consortium management


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