Brief introduction to eunethta and its tools Marianne Klempb · A brief introduction to EUnetHTA...
Transcript of Brief introduction to eunethta and its tools Marianne Klempb · A brief introduction to EUnetHTA...
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A brief introduction toEUnetHTA and its Tools
Marianne Klemp / NOKC / research directorThird WP2 Face to Face Training Course for EUnetHTA stakeholders, Brussels, 23rd of April2015
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
2004 The European Commission and the Council of Ministers targetHealth Technology Assessment (HTA) as “a political priority”,recognising “(…) an urgent need for establishing a sustainableEuropean network on HTA”
2005 Call for project proposal answered by a group of 35 organisationsthroughout 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 Timelineof EUnetHTA
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EUnetHTA Joint Action 2 (2012-2015)Objectives
• To achieve a better understanding for the European Commissionand Member States of ways to establish a sustainable structurefor the HTA work in the EU
• To produce recommendations regarding the design andmanagement of the future EU HTA cooperation
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Total budget: € 9,428,550
• To strengthen the practical application of toolsand approaches to cross-border HTA collaboration
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EUnetHTA Joint Action 2 (2012-2015)Work Packages
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WP1Coordination &
Sustainablenetwork
Implementation
WP2Dissemination &Capacity Building
WP3Evaluation &
Data Collectionon cost-
effectiveness
WP4Testing
collaborativeproduction
of HTAinformation
WP5Applyingthe HTA
Core Modelfor Rapid
Assessment
WP6Information
ManagementInfrastructureand Services
(IMIS)
WP7Methodologydevelopmentand evidence
generation
WP8Maintenanceof HTA Core
Modelinfrastructure
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• Recommendations on the implementation of sustainableEuropean network for HTA
• Full Core HTAs
• Pilot rapid assessments
• Methodological guidelines and templates to support productionof core HTA information and rapid assessments
• Guidelines and pilots to improve quality and adequacy of initialand 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 assessmentof the impact on secondary users of HTA information
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EUnetHTA Joint Action 2 (2012-2015)Planned deliverables
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Project JA1 JA2
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Establishment Putting intopractice
Strengtheningpractical
application
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Organisational andGovernance Structure
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Plenary Assembly
EU
Insti
tuti
on
s
ExecutiveCommittee
StakeholderForum
The Secretariat
WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8
SAGs
EUnetHTA Organigram
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Composition of theStakeholder Forum
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PayersPatients/
ConsumersIndustry Providers
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To provide stakeholders withthe opportunity
• to participate as stakeholderrepresentatives in the EUnetHTAJoint Actions
• to observe and comment on theEUnetHTA Joint Action work
• to provide advice to overarchinggovernance questions in the JointActions, and
• to bring forward specific themes andconcerns considered relevant by thestakeholders' constituencies inline with the aims of the EUnetHTAJoint Actions
Purpose of theStakeholder Forum
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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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EUnetHTA Output
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Health TechnologyLife-cycle
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Early scientificadvice
RapidREA
Additionaldata
collection
HTA / REA
Use
ofte
chnolo
gy
inhealth
care
Time line of innovation
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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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The HTACore Model®
Description
The HTA Core Model® is amethodological framework forshared production and sharing ofHTA information.
Purpose
To enable production of highquality HTA information in astructured format to support theproduction of local (national orregional) HTAs and reuse ofexisting information.
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The Domains of theHTA Core Model®
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Core HTA Structure
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The POP Database
Description
The EUnetHTA Planned and Ongoing Projects(POP) database allows EUnetHTA Partnersand Associates to share information on planned,ongoing or recently published projects ofparticipating agencies and identify similar projectsthrough a matching system providedby the online database.
Purpose
To facilitatecollaborationamong EuropeanHTA agencies andreduce duplicationof work.
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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 25countries
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
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The EVIDENTDatabase
Description
The EVIDENT Database enables sharingearly information on evidence gapsidentified during the production of HTAreports and consequent recommendations/ requests for additional data collection.
It also contains information onreimbursement / coverage andassessment status of promisingtechnologies in Europe.
Purpose
To reduce redundancy,promote generationof further evidenceand facilitate Europeancollaboration in thedomain.
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The EVIDENT DatabaseOnline
Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml
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9 Methodological Guidelinesfor Rapid REA
Development
9 Methodological Guidelines for RapidREA of Pharmaceuticals developed inJA1 by WP5.
Content
Guidelines on methodologicalchallenges that are encountered byhealth technology assessors whileperforming a rapid relativeeffectiveness assessment ofpharmaceuticals.
Primary Aim
To help the assessors of evidenceinterpret and process the data that arepresented to them as part of a REA.
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9 Methodological Guidelinesfor Rapid REA
Endpoints used for REAof 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 mostappropriate comparator(s)
7.Direct and indirect comparison
Levels of evidence
8.Internal validity
9.Applicability of evidence in thecontext of a relative effectivenessassessment
Link to the guidelines:
http://www.eunethta.eu/eunethta-guidelines
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• 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 transferableinformation contributing to HTAs in European countries
EUnetHTA hasfacilitated…
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Thank you
This presentation arises from the EUnetHTA
Joint Action 2 which has received fundingfrom the European Union, in the frameworkof the Health Programme