1. European network for Health Technology Assessment
EUnetHTA
European network for Health Technology Assessment
Name of author / presenter / organisation / title
European network for Health Technology Assessment | JA |

2. Outline The Making of EUnetHTA EUnetHTA and the HTA Network
EUnetHTA Achievements and Tools
General Information about HTA
European network for Health Technology Assessment | JA |

3. 10 November, 2018
The Making of EUnetHTA
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4. Historical Timeline of EUnetHTA
10 November, 2018
Historical Timeline of EUnetHTA
2004 The European Commission and the Council of Ministers target Health Technology Assessment (HTA) as “a political priority”, recognising “(…) an urgent need for establishing a sustainable European network on HTA”
2005 Call for project proposal answered by a group of 35 organisations throughout Europe
2006 EUnetHTA Project ( )
2009 EUnetHTA Collaboration (2009)
2010 EUnetHTA Joint Action 1 ( )
2012 EUnetHTA Joint Action 2 ( )
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European network for Health Technology Assessment | JA |

5. 10 November 2018
The timeline of reaching a sustainable and permanent HTA network in Europe
Health Programme
Call for project proposals
2009 Call for joint action
2011 Call for joint action
Financial support
HTA
Synergy
EUnetHTA Project
2009 EUnetHTA Collaboration
EUnetHTA JA1
EUnetHTA JA2
EUnetHTA Scientific and technical cooperation
Draft Cross Border Healthcare Directive. Article 15 on HTA network
CBHC Directive now decided
2013 EU Cooperation on HTA Implementing Decision
HTA Network
Legislation
DG R&I
2011 FP7-Health
2012-Innovation-1
New methodologies for HTA
Horizon 2020
Calls
Health Care
European network for Health Technology Assessment | JA |

6. EUnetHTA Project (2006-2008) Objectives
10 November, 2018
EUnetHTA Project ( ) Objectives
To establish an effective and sustainable European network for Health Technology Asessment – EUnetHTA – that informs policy decisions
To reduce overlap and duplication of effort and hence promote more effective use of resources
To increase HTA input to decision-making in Member States and the EU and hence to increase the impact of HTA
To strengthen the link between HTA and health care policy making in the EU and its Member States
To support countries with limited experience with HTA
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Total budget: € 3,233,858.10
European network for Health Technology Assessment | JA |

7. EUnetHTA Project (2006-2008) Work Packages
WP4 Common Core HTA
WP5 Adapting HTA
WP6 HTA and Health Policy
WP7 New Technologies
WP8 System to support HTA
WP1 Coordination
WP2 Communication
WP3 Evaluation
European network for Health Technology Assessment | JA |

8. EUnetHTA Project (2006-2008) Deliverables
10 November, 2018
EUnetHTA Project ( ) Deliverables
A generic methodological HTA framework based on current best practices (HTA Core Model®)
Handbook on Core HTA development
HTA Adaptation toolkit – from existing HTAs into other contexts
An open EUnetHTA Stakeholder Forum to exchange views, expectations/feedback on HTA with stakeholders
Web-based toolkit to facilitate European collaboration on evidence generation on promising health technologies
A handbook on HTA capacity building and institutionalising HTA
EUnetHTA Conference “HTA’s Future in Europe”
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European network for Health Technology Assessment | JA |

9. EUnetHTA Collaboration (2009)
10 November, 2018
EUnetHTA Collaboration (2009)
Since 2009, the EUnetHTA Collaboration has been operating to implement the permanent collaboration on HTA in Europe building on the work initiated during the EUnetHTA Project
The EUnetHTA Collaboration was organised into several teams of partners around specific functions
Members of each function were assigned according to the individual Founding Partner organisation's preferences of participation
The EUnetHTA Collaboration took an initiative in developing a proposal for the Joint Action on HTA
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10. EUnetHTA Joint Action 1 (2010-2012) Objectives
10 November, 2018
EUnetHTA Joint Action 1 ( ) Objectives
To put into practice an effective and sustainable HTA collaboration in Europe that brings added value at the European, national and regional level
Development of a general strategy and business model for sustainable European collaboration on HTA
Development of HTA tools and methods
Application and field testing of developed tools and methods
To facilitate efficient use of resources available for HTA
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Total budget: €
European network for Health Technology Assessment | JA |

11. EUnetHTA Joint Action 1 (2010-2012) Work Packages
10 November, 2018
EUnetHTA Joint Action 1 ( ) Work Packages
WP4 Core HTA
WP5 REA of Pharmaceuticals
WP6 IMS
WP7 New Technologies
WP8 Strategy and Business Model Development
WP1 Coordination
WP2 Dissemination
WP3 Evaluation
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European network for Health Technology Assessment | JA |

12. EUnetHTA Joint Action 1 (2010-2012) Deliverables
10 November, 2018
EUnetHTA Joint Action 1 ( ) Deliverables
An online Tool for producing, publishing, storing and retrieving HTA information and a new application of the HTA Core Model
A common methodology for the relative effectiveness assessment (REA) of pharmaceuticals
An operational web-based toolkit including database containing information on evidence generation for new technologies
An Information Management System (IMS) and the related documentation, processes and policies
Further development of a stakeholder involvement policy
Development of a collaborative business model for sustainability
A relative effectiveness assessment of a pharmaceutical
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European network for Health Technology Assessment | JA |

13. EUnetHTA Joint Action 2 (2012-2015) Objectives
10 November, 2018
EUnetHTA Joint Action 2 ( ) Objectives
To strengthen the practical application of tools and approaches to cross-border HTA collaboration
To achieve a better understanding for the European Commission and Member States of ways to establish a sustainable structure for the HTA work in the EU
To produce recommendations regarding the design and management of the future EU HTA cooperation
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Total budget: € 9,428,550
European network for Health Technology Assessment | JA |

14. EUnetHTA Joint Action 2 (2012-2015) Work Packages
10 November, 2018
EUnetHTA Joint Action 2 ( ) Work Packages
WP4 Testing collaborative production of HTA information
WP5 Applying the HTA Core Model for Rapid Assessment
WP6 Information Management Infrastructure and Services (IMIS)
WP7 Methodology development and evidence generation
WP8 Maintenance of HTA Core Model infrastructure
WP1 Coordination & Sustainable network Implementation
WP2 Dissemination & Capacity Building
WP3 Evaluation & Data Collection on cost- effectiveness
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15. EUnetHTA Joint Action 2 (2012-2015) Planned deliverables
10 November, 2018
EUnetHTA Joint Action 2 ( ) Planned deliverables
Recommendations on the implementation of sustainable European network for HTA
Full Core HTAs
Pilot rapid assessments
Methodological guidelines and templates to support production of core HTA information and rapid assessments
Guidelines and pilots to improve quality and adequacy of initial and additional evidence generation
Upgraded and updated application package of HTA Core Model
Report on yearly training courses on EUnetHTA tools and methodology
Report on evaluation of project completion including assessment of the impact on secondary users of HTA information
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European network for Health Technology Assessment | JA |

16. Strengthening practical application
Project JA JA2
Establishment
Putting into practice
Strengthening practical application
European network for Health Technology Assessment | JA |

17. Organisational and Governance Structure
10 November 2018
Organisational and Governance Structure
EU Institutions
Plenary Assembly
Executive Committee
Stakeholder Forum
The Secretariat
SAGs
WP1
WP2
WP3
WP4
WP5
WP6
WP7
WP8
EUnetHTA Organigram
European network for Health Technology Assessment | JA |

18. Composition of the Stakeholder Forum
Payers
Patients/ Consumers
Industry
Providers
European network for Health Technology Assessment | JA |

19. Purpose of the Stakeholder Forum
To provide stakeholders with the opportunity
to participate as stakeholder representatives in the EUnetHTA Joint Actions
to observe and comment on the EUnetHTA Joint Action work
to provide advice to overarching governance questions in the Joint Actions, and
to bring forward specific themes and concerns considered relevant by the stakeholders' constituencies in line with the aims of the EUnetHTA Joint Actions
European network for Health Technology Assessment | JA |

20. Purpose of the Stakeholder Advisory Groups (SAGs)
Representatives from Stakeholder organisations participate in WP activities via SAGs to
represent Stakeholder views
provide perspectives and knowledge on the EUnetHTA work in progress
Help WPs to improve the basis of their deliberations
Examples of participation:
Commenting on the scope of the project / selected methodologies
Commenting on draft reports in preparation of final draft documents before public consultation
European network for Health Technology Assessment | JA |

21. Participants JA2 EUnetHTA Partners and Associates in JA2.
10 November, 2018
Participants JA2
EUnetHTA Partners and Associates in JA2.
Large number of regional agencies and non-for-profit organisations that produce or contribute to HTA
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22. EUnetHTA and the HTA Network
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23. Article 15 of the Directive 2011/24/EU on cross-border health care
“The Union shall support and facilitate cooperation and the exchange of scientific information among Member States within a voluntary network connecting national authorities or bodies responsible for health technology assessment designated by the Member States… That network shall be based on the principle of good governance including transparency, objectivity, independence of expertise, fairness of procedure and appropriate stakeholder consultations”
European network for Health Technology Assessment | JA |

24. EUnetHTA’s Role in the Implementation of Article 15
To develop a general strategy, principles and recommendations for a sustainable European network for scientific and technical cooperation
To ensure the scientific and technical cooperation for the HTA Network according to the requirements of the Directive for cross-border healthcare
European network for Health Technology Assessment | JA |

25. EUnetHTA’s Role in the Implementation of Article 15
EUnetHTA JA2 General Objective (Grant Agreement p. 35)
“to strengthen the practical application of tools and approaches to cross-border HTA collaboration bringing it to a higher level and resulting in a better understanding for the Commission and the EU Member States of ways to establish a sustainable structure for HTA work in the EU that avoids unnecessary duplication of assessment efforts”
European network for Health Technology Assessment | JA |

26. EUnetHTA Output
European network for Health Technology Assessment | JA |

27. EUnetHTA has facilitated…
increased collaboration between European HTA organisations
practical efforts in improving efficient use of resources available for HTA
the creation of a sustainable system of HTA knowledge sharing
the promotion of good practice in HTA methods and processes
the basis for delivery of reliable, timely, transparent and transferable information contributing to HTAs in European countries
European network for Health Technology Assessment | JA |

28. EUnetHTA Tools EUnetHTA HTA Core Model Online
EUnetHTA Planned and Ongoing Projects Database (POP)
EUnetHTA Evidence database on new technologies (EVIDENT)
EUnetHTA Adaptation Glossary & Toolkit
EUnetHTA Contact Database
EUnetHTA Intranet Groups
EUnetHTA E-meeting facility
EUnetHTA News Aggregator
European network for Health Technology Assessment | JA |

29. The HTA Core Model® Description
The HTA Core Model® is a methodological framework for shared production and sharing of HTA information.
Purpose
To enable production of high quality HTA information in a structured format to support the production of local (national or regional) HTAs and reuse of existing information.
European network for Health Technology Assessment | JA |

30. The Structure of the HTA Core Model®
ONTOLOGY
Questions that an HTA should answer
METHODOLOGICAL
GUIDANCE
How to answer
the questions
Common reporting structure that enables standardised reporting of HTAs. Results are presented as collections of result cards. The theme of each result card is outlined by the assessment element cards.
REPORTING
STRUCTURE
How to present
the answers

31. The Domains of the HTA Core Model®
10 November, 2018
The Domains of the HTA Core Model®
Change colour on table Click on table to activate Table Tools Click on menu ‘Design’ Choose colour from Tables Styles / Medium Style 2
SCOPE
DOMAINS
1. Health problem and current use of technology
2. Description and technical characteristics
3. Safety
4. Clinical effectiveness
5. Costs and economic evaluation
6. Ethical analysis
7. Organisational aspects
8. Social aspects
9. Legal aspects
Rapid
Full
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32. Core HTA Structure Pool of structured HTA Information
10 November, 2018
Core HTA Structure
Primarily EUnetHTA
Primarily national
INFORMATION
Pool of structured HTA Information
Collections Serve also as project platforms
Local products
L HTA
L RHTA
Official EUnetHTA RC
Core HTA
L HTA RC RC RC RC RC
Rapid HTA RC RC RC RC RC
AUTOMATIC
VOLUNTARY
L RHTA RC RC RC RC RC
L RHTA
Other
Full domain RC RC RC RC RC
Free set (≥ 1)
L HTA RC RC RC RC RC
Graphics slides
L HTA
TAILORED
My collection
TOOLS
HTA Core Model
Online Tool & Service
Local Tools
Primarily EUnetHTA
Primarily local
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33. The HTA Core Model Online®
Access to the HTA Core Model®:
European network for Health Technology Assessment | JA |

34. The POP Database Description
The EUnetHTA Planned and Ongoing Projects (POP) database allows EUnetHTA Partners and Associates to share information on planned, ongoing or recently published projects of participating agencies and identify similar projects through a matching system provided by the online database.
Purpose
To facilitate collaboration among European HTA agencies and reduce duplication of work.
European network for Health Technology Assessment | JA |

35. The POP Database Online
10 November, 2018
The POP Database Online
Picture and text
Access to the POP Database :
European network for Health Technology Assessment | JA |

36. POP Statistics: Quarterly Updates
In the second quarter of 2015, the POP Database contained: 1,068 planned, ongoing and recently published projects from 43 EUnetHTA JA partners and 26 countries
2015 Q1 POP Request
Out of 69 EUnetHTA JA partners:
Response rate: 65 %
Total number of projects: 1,314
Alert (SAME) topics: 103 (8 %)
Similar projects (within alert topics): 251
Access-right: 47 partners
2015 Q1 POP Request
Out of 69 EUnetHTA JA partners:
Response rate: 57 %
Total number of projects: 1,068
Alert (SAME) topics: 100 (9 %)
Similar projects (within alert topics): 244
Access-right: 43 partners

37. The EVIDENT Database Description
10 November, 2018
The EVIDENT Database
Description
The EVIDENT Database enables sharing early information on evidence gaps identified during the production of HTA reports and consequent recommendations / requests for additional data collection.
It also contains information on reimbursement / coverage and assessment status of promising technologies in Europe.
Purpose
To reduce redundancy, promote generation of further evidence and facilitate European collaboration in the domain.
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38. The EVIDENT Database Online
Access to the EVIDENT Database:
European network for Health Technology Assessment | JA |

39. 9 Methodological Guidelines for Rapid REA
Development 9 Methodological Guidelines for Rapid REA of Pharmaceuticals developed in JA1 by WP5.
Content Guidelines on methodological challenges that are encountered by health technology assessors while performing a rapid relative effective- ness assessment of pharmaceuticals.
Primary Aim To help the assessors of evidence interpret and process the data that are presented to them as part of a REA.
European network for Health Technology Assessment | JA |

40. 9 Methodological Guidelines for Rapid REA
Endpoints used for REA of pharmaceuticals
Levels of evidence
Internal validity
Clinical endpoints
Applicability of evidence in the context of a relative effectiveness assessment
Composite endpoints
Surrogate endpoints
Safety
Link to the guidelines
Health-related quality of life
guidelines
Comparators and comparisons
Criteria for the choice of the most appropriate comparator(s)
Direct and indirect comparison
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41. External Collaboration
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42. EUnetHTA-EMA Collaboration
10 November, 2018
EUnetHTA-EMA Collaboration
To identify opportunities for and undertake specific steps to improve the efficiency of the process and conditions for patients’ timely access to an effective medicine.
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European network for Health Technology Assessment | JA |

43. EUnetHTA-EMA Collaboration
10 November, 2018
EUnetHTA-EMA Collaboration
Scientific advice/early dialogues involving regulators and HTAs
Scientific and methodological guideline development
Post-licensing (post-authorisation) data generation
Availability of clinical study data
Orphan medicinal products
Cooperation in specific pilot projects of EUnetHTA JA2
Conferences, workshops and seminars/meetings
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European network for Health Technology Assessment | JA |

44. EUnetHTA-FP7 Projects Collaboration
AdHopHTA (Adopting Hospital Based Health Technology Assessment in EU)
Advance-HTA (Advancing and strengthening the methodological tools and practices relating to the application and implementation of Health Technology Assessment)
Integrate-HTA (Integrated health technology assessment for evaluating complex technologies)
MedTecHTA (Methods for Health Technology Assessment of Medical Devices: a European Perspective)
European network for Health Technology Assessment | JA |

45. EUnetHTA-FP7 Projects Collaboration
Objective:
To identify opportunities for developing alliances with contributing fields of research in order to support a stronger and broader evidence base for HTA
European network for Health Technology Assessment | JA |

46. EU Joint Actions PARENT and EUCERD
PARENT: The Cross Border PAtient REgistries iNiTiative
EUCERD: The European Union Committee of Experts on Rare Diseases
Objective:
To facilitate timely information flow and input between EUnetHTA the current EU initiatives in the areas of patient registries and rare diseases
European network for Health Technology Assessment | JA |

47. EUnetHTA-HTAi Collaboration
Subjects of EUnetHTA-HTAi Collaboration
HTAi Glossary
HTAi Vortal
Objective:
To support the latest developments and new / regional HTA terminology are reflected in the global efforts to streamline HTA glossaries (through the HTAi Glossary).
To provide a structured access to information of interest about Health Technology Assessment
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48. General Information about HTA
European network for Health Technology Assessment | JA |

49. Definition of Health Technology
Health technology is the application of scientific knowledge in health care and prevention
Examples of Health Technology
Diagnostic and treatment methods
Medical equipment
Pharmaceuticals
Rehabilitation and prevention methods
Organisational and support systems within which health care is provided
European network for Health Technology Assessment | JA |

50. Definition of HTA
Health technology assessment (HTA) is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology, in a systematic, transparent, unbiased, robust manner.
Its aim is to inform the formulation of safe, effective health policies that are patient focused and seek to achieve best value.
Despite its policy goals, HTA must always be firmly rooted in research and the scientific method.
European network for Health Technology Assessment | JA |

51. Health Technology Life-cycle
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Health Technology Life-cycle
HTA / REA
Use of technology in health care
Early scientific advice
Rapid REA
Additional data collection
Graphics slides
Time line of innovation
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52. Abbreviations HTA Health Technology Assessment JA Joint Action DG R&I
Directorate-General for Research and Innovation
CBHC
Cross-border Healthcare
FP7
The Seventh Framework Programme
REA
Relative effectiveness assessment
IMS
Information Management and Services
IMIS
Information Management Infrastructure and Services
SAG
Stakeholder Advisory Group WP
Work Package
POP
The EUnetHTA Planned and Ongoing Projects database
EVIDENT
The Evidence database on new technologies
HTAi
Health Technology Assessment International
November 10, 2018
European network for Health Technology Assessment | JA |

53. Thank you Any questions?
10 November, 2018
Thank you
Any questions?
This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme
European network for Health Technology Assessment | JA |