EUnetHTA - epaccontrol.com · The HTA perspective DIA, Vienna March 26, 2014 Finn Børlum...
Transcript of EUnetHTA - epaccontrol.com · The HTA perspective DIA, Vienna March 26, 2014 Finn Børlum...
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTAEuropean network for Health Technology Assessment
DATABASES, REGISTRIES AND OTHER DATA CAPTURE TOOLS: HOW CAN WE AVOID MULTIPLICITY AND CREATE AN INTEGRATED DATA-CAPTURE APPROACH ALONG THE PRODUCT DEVELOPMENT CYCLE?
The HTA perspectiveDIA, Vienna March 26, 2014
Finn Børlum Kristensen, MD, PhDDirector, EUnetHTA SecretariatDanish Health and Medicines Authority (EUnetHTA Coordinator)Copenhagen, Denmark
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Disclaimer
• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated
• These PowerPoint slides are copyright of the European network for Health Technology Assessment. Reproduction is permitted provided the source is acknowledged.
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
National, regional agencies,
universities, hospitals and non-
for-profit research organisations
38 Associated Partner
organisations designated by
Member States
30 Collaborating Partners
contribute in kind
Participants in EUnetHTA JA 2 2014
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• Germany, IQWIG,DIMDI• France, HAS• UK, NICE, NETSCC• Italy, AGENAS, AIFA, ASSR Emilia Romagna, Veneto Region• Spain, ISCIII, AETSA, OSTEBA, Avalia-T, AQuAS• Croatia, AAZ• Poland, AHTAPOL• Austria, LBI, HVB, GÖG• Netherlands, CVZ• Belgium, KCE• Portugal, INFARMED• Sweden, SBU, TLV• Norway, NOKC• Finland, THL, FIMEA• Denmark, DHMA (Coordinator), CFK Region Midt
Some of the Partner Organisationsin Joint Action 2 (2012-15), e.g.
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• EUnetHTA specific
• National registries and databases in national HTA
• Parent
• EMA and ENCePP
• Standardisation and harmonisation
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This presentation
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Health Technology Life-cycle
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Early scientific advice
RapidREA
Additionaldata
collection
HTA / REA
Use
of
tech
nolo
gy in
hea
lth c
are
Time line of innovation
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• Early scientific advice to technology sponsors (drugs, devices)
• Guidelines on assessing outcomes, diagnostics, and economic
evaluation
• Additional data collection
• Moving to joint production through piloting
• Aligning HTA and regulatory needs
• Appropriate stakeholder involvement
Specific initiatives along the lifecycle taken up within European HTA cooperation
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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.
The EVIDENT Database
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Purpose
To reduce redundancy, promote generation of further evidence and facilitate Europeancollaboration in the domain.
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Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml
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The EVIDENT Database Online
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The Domains of the HTA Core Model®
- assessing dimensions of value
HTA Core Model 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
SCOPE
Rap
id
Fu
ll
Rel
iab
le, t
imel
y, t
ran
spar
ent,
tr
ansf
erab
le H
TA i
nfo
rmat
ion
Val
ue
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?
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• Cross Border PAtient REgistries iNiTiative (PARENT), is a Joint Action under the EU's Health Programme 2008-2013.
• Overall objective: To support member states in developing comparable and coherent patient registries in fields of identified importance (e.g. chronic diseases, rare diseases, medical technology)
• Aim. To rationalize and harmonize the development and governance of patient registries, thus enabling analyses of secondary data for public health and research purposes
• EUnetHTA is a member of the JA’s Associated Projects Group
• Read more at http://www.patientregistries.eu/
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Parent Joint Action
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• Opportunities, specific steps to improve the efficiency of the process and conditions for patients’ timely access to an effective medicine
• A three-year Workplan is being implemented
EUnetHTA-EMA Collaboration
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HTA 2.0 Europe
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Thank you for yourattention
This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme