Towards a regulation of HTA in Europe: the proposal from the European Commission

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries

“…Last, but not least, Brexit and uncertainty in the HTA process in Europe should worry decision makers and industry. NICE will continue to offer advice through its early dialogues services as International Journal of Technology Assessment in Health Care Primarily, 2 Other perspectives are possible, 3 Whole duration of impact of the study/effects and costs, 4 Depends on research question, but ranges from weeks to years, 5 All generic instruments are acceptable, generally, 6 EQ-5D-3L, mainly. Notes: CBA is not recommended in Belgium, Hungary, and Norway while is acceptable in Finland, Portugal, and Sweden.…”

“…HTA, defined as the multidisciplinary process and method of analysis that assesses the economic, medical, social, and ethical effects of introducing and using a health technology (3), constitutes the mainstay of collective decision making in health, and its development is highlighted as a policy priority, especially in the European setting. Indicatively, and among other policy actions, the European Commission launched in 2018 an initiative for legislative proposal to the European Parliament and the European Council regarding the methodological convergence of HTA processes in EU member states, with the aim of shortening decision-making times, avoiding duplication of work, and enhancing the transferability of outcomes, through the introduction of the possibility of joint clinical assessments and joint scientific consultations on documentation (4).…”

HTA for pharmaceuticals in Europe: will the mountain deliver a mouse?

“…In 2017, the European Parliament called on the EC to propose legislation on HTA in Europe for assessing the therapeutic value of new technologies (especially of medicines) [15], recommending that future EU rules should be limited to clinical assessment. The EC subsequently released a legislative proposal for HTA regulation in 2018, supporting a European single assessment of relative effectiveness for pharmaceuticals (and certain types of medical devices) through a Member State Coordination Group [5], at the same time leaving pricing and reimbursement decisions to nations. In practice, this would imply devolving the assessment of the first group of more scientific technical and clinical domains to a European body, while Member States would remain responsible for the second group of more context-specific HTA domains [10].…”

“…2). After the very first American definitions of HTA in the late 1970s, many more followed [2][3][4][5]-one from the World Health Organization [6]-and an open consultation has been very recently launched to share a single, globally acknowledged definition [7]. According to this proposal, a technology can be a medicine, a test, a device or a procedure, and even a program or system, and the assessment has to be multidisciplinary including clinical, economic, organizational, social, ethical and legal aspects.…”

Health technology assessment for pharmaceutical regulation in the European Union: do we need another body?

“…Finally, the European Commission released a legislative proposal for health technology assessment regulation in 2018, supporting a European single assessment of relative effectiveness for pharmaceuticals through a Member State Coordination Group, 5 at the same time leaving pricing and reimbursement decisions to nations. In practice, Member States would remain responsible for the second group of more context-specific health technology assessment domains.…”