The document summarizes the history and objectives of the European network for Health Technology Assessment (EUnetHTA). It began in 2004 when the European Commission recognized the need to establish a sustainable HTA network. This led to the EUnetHTA project in 2006-2008 and subsequent collaborations. The current joint action, EUnetHTA JA2 from 2012-2015, aims to strengthen practical HTA collaboration across Europe and make recommendations for a permanent HTA network. It involves partners from various countries working on HTA tools, reports, and increasing cooperation between stakeholders like HTA agencies and the EMA.
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EUnetHTA Training course for Stakeholders - Brief introduction to EUnetHTA
1. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA –
The European network for
Health Technology Assessment
EUnetHTA Training Course for Stakeholders
Rome, 29 Oct 2014
Marianne Klemp, Research Director, NOKC, Norway
2. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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 (2006-2008)
2009 EUnetHTA Collaboration (2009)
2010 EUnetHTA Joint Action 1 (2010-2012)
2012 EUnetHTA Joint Action 2 (2012-2015)
Historical Timeline
of EUnetHTA
2
3. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
2013+
HTA Network
The timeline of reaching a sustainable
and permanent HTA network in Europe
3
2005
Call for
project
proposals
2009
Call for joint
action
2011
Call for
joint
action
2006-2008
EUnetHTA
Project
2009
EUnetHTA
Collaboration
2008-2011
Draft Cross Border
Healthcare Directive.
Article 15 on HTA network
2011-12
CBHC Directive
now decided
2013
EU
Cooperation
on HTA
Implementing
Decision
2014-2020
Financial support
HTA
2011 FP7-Health
2012-Innovation-1
New methodologies for HTA
Legislation
DG R&I
Health
Programme
2010-2012
EUnetHTA
JA1
2016-2020
EUnetHTA
Scientific and
technical cooperation
Horizon 2020
Calls
Health Care
2012-2015
EUnetHTA
JA2
4. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Joint Action 2 (2012-2015)
Objectives
• 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
4
Total budget: € 9,428,550
• To strengthen the practical application of tools
and approaches to cross-border HTA collaboration
5. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Joint Action 2 (2012-2015)
Work Packages
5
WP1
Coordination &
Sustainable
network
Implementation
WP2
Dissemination &
Capacity Building
WP3
Evaluation &
Data Collection
on cost-
effectiveness
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
6. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
• 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
6
EUnetHTA Joint Action 2 (2012-2015)
Planned deliverables
7. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Project JA1 JA2
7
Establishment Putting into
practice
Strengthening
practical
application
8. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Organisational and
Governance Structure
8
Plenary Assembly
EUInstitutions
Executive
Committee
Stakeholder
Forum
The Secretariat
WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8
SAGs
EUnetHTA Organigram
9. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Composition of the
Stakeholder Forum
9
Payers
Patients/
Consumers
Industry Providers
10. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
Purpose of the
Stakeholder Forum
10
11. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
Purpose of the Stakeholder
Advisory Groups (SAGs)
11
12. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Partners and
Associates in JA2.
Large number of regional
agencies and non-for-profit
organisations that produce
or contribute to HTA
Participants JA2
12
13. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
• 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
EUnetHTA has
facilitated…
13
14. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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
EUnetHTA Tools
14
15. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Health Technology
Life-cycle
15
Early scientific
advice
Rapid
REA
Additional
data
collection
HTA / REA
Useoftechnologyinhealthcare
Time line of innovation
16. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
• 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
EUnetHTA-EMA
Collaboration
16
17. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Thank you
This presentation arises from the EUnetHTA
Joint Action 2 which has received funding
from the European Union, in the framework
of the Health Programme