gms | German Medical Science

The European network for health technology assessment (EUnetHTA) was established to create an effective and sustainable network for health technology assessment across Europe. One aim is to harmonize the assessment of new technologies at the European level. The development of common assessment tools is central to promote the production of reliable, transparent and transferable HTA information, which might be applicable also at the national level.

Going through the life cycle of health products (pharmaceuticals and medical devices), regulators and reimbursement agencies pose different questions, and thus, their recommendations and/or requirements in terms of study design and endpoints might be different. In analogy to scientific advice obtainable from regulators, the early dialogue (ED) project of EUnetHTA was established to allow exchange and meetings between companies and European HTA agencies in order to present their development plan for the product in question and to ask specific questions relative to their plan.

After the piloting phase, EDs were further financed by the European Commission as a EUnetHTA spin-off project called „Shaping European Early Dialogues (SEED)“. One major challenge in the process was to integrate both regulators’ and reimbursers’ perspectives. During the SEED project phase, concomitant parallel advice meetings of both EUnetHTA and EMA were held. Importantly, very often common requirements were defined. The potential and feasibility of EDs in terms of a permanent model will be evaluated, firstly by analysing questionnaires filled in by participating HTA agencies, and secondly by assessing the impact of EUnetHTA advice on the development plan and actual study design. First results are now being awaited in order to evaluate the success of EDs. A final report is being written and EC decision on the future of EDs is pending until end of 2015.