Proposal for a regulation on health technology assessment in Europe – opinions of policy makers, payers and academics from the field of HTA

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

“…The first move for coordination of HTA in Europe was the EUR-ASSESS project, funded by the European Commission (EC) in the mid 1990s [10], followed by two other projects (again funded by the EC), which led to the establishment in 2006 of EUnetHTA; this large network of organizationsstill currently funded by the EC until 2020 [11]-aims at supporting HTA as a decision-making tool for the EU and its Member States [12]. To help limit misunderstandings, a glossary of HTA adaptation terms was issued in 2009 [13].…”

“…To help limit misunderstandings, a glossary of HTA adaptation terms was issued in 2009 [13]. Later, to strengthen cooperation among the EU Member States, a formal HTA Network including a representative from each of the EU countries was directly established by the EC and met for the first time in 2013 [10].…”

“…In 2016, the EC published an Impact Assessment on HTA in Europe, which recognized the validity of the EUnetHTA Core Model for HTA analyses [10]. The model includes nine 'core domains', which can be split into two groups according to the aspects analyzed [8,11]: (1) 'technical' (including technical aspects, safety and clinical effectiveness), (2) 'other' (economic, ethical, organizational, social and legal aspects).…”

“…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].…”

“…REAs of new therapies should compare their benefits and harms to one or more existing interventions [24,25], by analyzing the first group of the Core Model domains [10], in order to evaluate the clinical relevance of their potentially added therapeutic value compared with the best available treatments [12]. Since randomized clinical trials (RCTs) are unanimously considered the gold standard for assessing both efficacy under ideal conditions and effectiveness in healthcare practice [24,[26][27][28], they are still the preferred source for REAs together with solid meta-analyses based on homogeneous RCTs [4].…”