Table 1.
Summary of HTA systems across EU Member States, the United Kingdom, Canada and Australia
| Variable | Summary of evidence | Country examples |
|---|---|---|
| Governance of HTA | Arm’s length: 46 | Austria, Croatia, Finland, the Netherlands, Canada, England, France, Germany, Australia, Poland |
| Integrated: 16 | Cyprus, Greece, Malta, Slovakia, Slovenia, Italy, Spain (regional), Canada (regional) | |
| N/Aa: 1 | EU level | |
| Type of organisation performing HTA | Research institution: 6 | Austria, Belgium, Denmark, Estonia, Slovakia, England |
| HTA research institution: 6 | Austria, Finland, Ireland, Lithuania, Spain (national and regional) | |
| Drug regulator: 6 | Czech Republic, Finland, Hungary, Italy, Portugal, Romania | |
| Governmental institution: 8 | Cyprus, Greece, Lithuania, Luxembourg, Malta, Slovakia, Slovenia, Spain | |
| HTA body: 18 | France, Germany, Poland, Scotland, England, Wales, EU level, Canada, Australia | |
| National/regional healthcare organisation: 14 | Bulgaria, Croatia, Finland, Germany, Italy, Latvia, Lithuania, the Netherlands, Spain, Sweden | |
| National insurance organisation: 5 | Austria, Belgium, Croatia, Estonia, Slovenia | |
| Role of HTA | Advisory: 33 | Luxembourg, the Netherlands, Portugal, England, Canada, Australia |
| Coordination: 2 | Finland, UK | |
| Regulatory: 17 | Bulgaria, Croatia, Cyprus, Czech Republic, Italy, Estonia, Germany, Sweden | |
| Advisory and coordination: 10 | Austria, Belgium, Denmark, Ireland, Spain (national and regional), Canada | |
| N/Aa: 1 | EU level | |
| HTA scope | National: 48 | Australia, Germany, France, Sweden, Slovakia, Austria, Lithuania, Malta, Luxembourg, the Netherlands |
| Regional: 14 | Spain (AQuAS–Catalonia, OSTEBA–Basque County, AETSA–Andalusia, SECS–Canary Islands, UETS–Madrid, Avalia-t–Galicia, IACS–Aragon), Italy (AGENAS, CRU–Veneto, ER Salute–Emilia Romagna), Canada (INESSS–Quebec, HQO–Ontario, CED–Ontario, British Columbia) | |
| N/Aa: 1 | EU level | |
| Remit of HTAb | Pharmaceuticals: 48 | Austria, Belgium, Bulgaria, Croatia, Cyprus, Finland, France, Germany, Greece, Malta, Scotland, Australia, Canada |
| Medical devices: 43 | Denmark, Hungary, Ireland, Latvia, Lithuania, Portugal, Germany, Spain, Sweden | |
| Other technologies: 35 | Canada, EU level, England, Wales, Sweden, the Netherlands, Lithuania, Belgium, Croatia | |
| All: 20 | Belgium, Estonia, France, Finland, the Netherlands, Poland, England, EU level | |
| Model of HTA | Comparative clinical benefit assessment: 7 | Austria (GÖG and AIHTA), Germany (GBA and IQWiG), Greecec, Slovenia (Health Council), EU level |
| Clinical and cost-effectiveness: 46 | Belgium, Croatia (both agencies) Cyprus, Spain (national and regional), Malta, Lithuania, Ireland, Finland, Hungary, Denmark, Wales | |
| Clinical and cost-effectiveness/MCDA: 2 | Bulgaria, Canada | |
| Value-based assessment: 8 | France, Slovakia (both HTA bodies), Slovenia (ZZZS), Sweden, England, Scotland, Australia | |
| Assessment versus appraisal | Assessment only: 28 | Austria, Belgium, Croatia, Cyprus, Estonia, Denmark, Greece, Ireland, Italy (regional), Spain (regional), EU level, Canada (regional) |
| Assessment and appraisal: 35 | Austria, Belgium, France, Finland, Croatia, Canada, Australia, Romania, Luxembourg, Portugal, Poland, Slovenia, Sweden, Spain, England, Scotland, Wales | |
| Stakeholder involvement in HTA | Stakeholder participation as members of HTA committee: 59 | Croatia, Cyprus, Finland, Greece, the Netherlands, Portugal, Poland, Spain, Sweden, Canada, Australia |
| Stakeholders through public calls: 48 | Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Ireland, Latvia, Lithuania, Malta, Portugal, Slovakia, Slovenia, Spain, UK, EU level | |
| HTA recommendations and funding decisions | Binding: 12 | Bulgaria, Cyprus, Finland, Germany, Italy, Lithuania, Portugal, Sweden |
| Non-binding: 51 | Austria, Belgium, Croatia, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy (regional), Poland, the Netherlands, Spain, Wales, Canada, EU level | |
| Publicly available reports | Yes: 48 | Australia, Canada, England, Scotland, Wales, Sweden, Spain, the Netherlands, Germany, Belgium |
| No: 15 | Croatia, Estonia, Greece, Hungary, Luxembourg, Slovakia, Slovenia |
Source: The authors, based on primary and secondary data collection
EU European Union, EUnetHTA European network for Health Technology Assessment, HTA health technology assessment, MCDA multiple-criteria decision analysis, N/A not applicable
aEUnetHTA has been categorised as a supranational organisation that has been created and now coordinates the HTA Core Model, which is a methodological framework for collaborative production and sharing of HTA information. Therefore, EUnetHTA does not fall into the classification in which we have placed national HTA bodies
bUnder the remit of HTA, different organisations in each country may perform HTA for different technologies. Examples of agencies that perform HTA for pharmaceuticals only are SUKL in the Czech Republic and DPA in Malta. Examples of agencies that perform HTA for medical devices only are AGENAS in Italy and UETS in Spain. Examples of agencies that perform HTA for other technologies are SBU in Sweden and the Institute of Hygiene in Lithuania
cIn Greece, cost-effectiveness is envisaged in legislation, but is currently not mandatory and no cost-effectiveness threshold has been published