HEALTH TECHNOLOGY ASSESSMENT OF MEDICAL DEVICES IN EUROPE: PROCESSES, PRACTICES, AND METHODS

Variation in Health Technology Assessment and Reimbursement Processes in Europe.

BACKGROUND It has been suggested that differences in health technology assessment (HTA) processes among countries, particularly within Europe, have led to inequity in patient access to new medicines. OBJECTIVES To provide an up-to-date snapshot analysis of the present status of HTA and reimbursement systems in select European countries, and to investigate the implications of these processes, ...

Specificities of Medical Devices Affecting Health Technology Assessment Methodology

Health Technology Assessment developed out of pharmacoeconomy; although it is routinely used for all health technologies incl. therapeutic interventions, preventive measures etc., its methodology fits best for drugs. Medical devices have their specificities that affect significantly all processess, where they are involved. The differences between medical devices and drugs from the perspective o...

Analysis of Duplication and Timing of Health Technology Assessments on Medical Devices in Europe.

OBJECTIVES Strengthening efforts toward better collaboration plays a pivotal role in the assessment of medical devices to reduce overlap and save resources. This study explored the level of duplication in health technology assessments (HTA) of medical devices in Europe and their respective timing in order to identify areas for better collaboration. METHODS An analysis of European HTA reports ...

Health Technology Assessment and Health Policy-making in Europe

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.

BACKGROUND Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations. OBJECTIVES The International Society for Pharmacoec...