The study’s overall aim was to support the Impact Assessment process of the EC and inform this process by generating data and evidence. In doing so, it provides inputs for analysing the impact of the current situation (baseline scenario) as well as potential future policy options (POs) for EU cooperation on Health Technology Assessment (HTA) beyond 2020 and utilises the data and information collected to undertake an Impact Assessment of the different cooperation options. The POs for further cooperation at EU level were proposed by the European Commission (EC) and combined with potential business models by the authors in close cooperation with the EC.
In order to establish the baseline scenario, a case study comprising a product sample of health technologies was analysed, which included 20 Pharmaceuticals, 15 medical devices and five ‘other technologies’ (including complex health interventions). The study team collected detailed information on the HTA process each technology underwent in the MS. Additionally, the costs of performing a HTA were identified for both the technolo-gy developer and the HTA body. Finally, the case study captured the influence of the regulatory framework on technology developers.
In order to analyse impacts of identified POs on future European cooperation in the field of HTA, a survey was performed on the economic and social impacts, complemented by focus groups, a number of interviews and findings from a literature review. A multi-criteria analysis served as an analytical approach for assessing impacts for each stake-holder group. Finally, a cost prognosis was performed to estimate potential costs and savings for implementing and maintaining the investigated POs and business models. An expert panel was involved throughout the study and validated the data obtained.
Study results provide an overview of current HTA practices and processes in Europe including advantages and drawbacks. An analysis of various POs for a future cooperation on HTA across Europe is provided.