Brief introduction to EUnetHTA and its Tools, Marianne Klemp, NOKC
Presentation from the 3rd face to face training course for EUnetHTA Stakeholders organised by EUnetHTA JA2 WP2; April 23rd, 2015, Brussels.
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Brief introduction to EUnetHTA and its tools
1. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
A brief introduction to
EUnetHTA and its Tools
Marianne Klemp / NOKC / research director
Third WP2 Face to Face Training Course for EUnetHTA stakeholders, Brussels, 23rd of April
2015
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
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3. 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
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Total budget: € 9,428,550
• To strengthen the practical application of tools
and approaches to cross-border HTA collaboration
4. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA Joint Action 2 (2012-2015)
Work Packages
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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
5. 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
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EUnetHTA Joint Action 2 (2012-2015)
Planned deliverables
6. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Project JA1 JA2
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Establishment Putting into
practice
Strengthening
practical
application
7. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Organisational and
Governance Structure
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Plenary Assembly
EUInstitutions
Executive
Committee
Stakeholder
Forum
The Secretariat
WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8
SAGs
EUnetHTA Organigram
8. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Composition of the
Stakeholder Forum
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Payers
Patients/
Consumers
Industry Providers
9. 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
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10. 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
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11. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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EUnetHTA Output
12. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Health Technology
Life-cycle
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Early scientific
advice
Rapid
REA
Additional
data
collection
HTA / REA
Useoftechnologyinhealthcare
Time line of innovation
13. 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
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14. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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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.
15. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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The Domains of the
HTA Core Model®
16. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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Core HTA Structure
17. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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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.
18. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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POP Statistics:
Quarterly Updates
In the third quarter of 2014, the POP Database contained: 1,249 planned,
ongoing and recently published projects from 47 EUnetHTA JA partners and 25
countries
2014 Q3 POP Request
Out of 70 EUnetHTA JA partners:
• Response rate: 64 %
• Total number of projects: 1,266
• Alert (SAME) topics: 88 (7 %)
• Similar projects (within alert topics): 208
• Access-right: 45 partners
2014 Q4 POP Request
Out of 71 EUnetHTA JA partners:
• Response rate: 70 %
• Total number of projects: 1,249
• Alert (SAME) topics: 103 (8 %)
• Similar projects (within alert topics): 203
• Access-right: 50 partners
19. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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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.
20. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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The EVIDENT Database
Online
Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml
21. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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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
effectiveness 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.
22. European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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9 Methodological Guidelines
for Rapid REA
Endpoints used for REA
of pharmaceuticals
1.Clinical endpoints
2.Composite endpoints
3.Surrogate endpoints
4.Safety
5.Health-related quality of life
Comparators and comparisons
6.Criteria for the choice of the most
appropriate comparator(s)
7.Direct and indirect comparison
Levels of evidence
8.Internal validity
9.Applicability of evidence in the
context of a relative effectiveness
assessment
Link to the guidelines:
http://www.eunethta.eu/eunethta-
guidelines
23. 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…
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24. 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