20151020-21health technology assessment (hta)
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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EUnetHTA
European network for
Health Technology Assessment
Health Technology Assessment (HTA) – A structured
process of applied research to inform policies and
decisions in healthcare
Conference: Putting Science into Standards – evidence-based quality
assurance – an example for breast cancer
Joint Research Centre, ISPRA, Italy,October 22, 2015
Finn Børlum Kristensen, MD, PhD
Professor, Health Services Research & Health Technology
Assessment, University of Southern Denmark
Director, EUnetHTA Secretariat
Danish Health Authority (EUnetHTA Coordinator),
Copenhagen, Denmark
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 2
HTA’s contribution to quality
improvement
• While quality assurance or development is about doing things right health technology assessment (HTA) is about doing the right things.
• The origins of HTA are Evidence Based Medicine, health policy analysis, and health economics.
• EUnetHTA was established to create an effective and sustainable network for HTA across Europe
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 3
An example of an HTA
An example of an HTA of prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX )
• http://www.eunethta.eu/outputs/prognostic
-tests-breast-cancer-recurrence-ptbcr
• http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Production%20of%20Core%20HTA%20Information_Comprehensive%20HTA_Activity%20Station%20poster.pdf
What is Healthcare Technology ?
• Healthcare technology is defined as prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained
INAHTA
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HTA definition
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
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 6
HTA aim
The aim of HTA 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 | JA2 2012-2015 | www.eunethta.eu
Eclectic (multidisciplinary)
Four main streams of applied research methodology have contributed to the development of HTA
- policy analysis
- evidence based medicine
- health economic evaluation
- social and humanistic sciences
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
HTA as an input to priority-setting and decision-making
HTA
Priority-setting
and
decision-making
Advising,
recommending
HTA
Priority-setting
and
decision-making
8
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Scope of EUnetHTA’s work
EUnetHTA supports collaboration between European
HTA organisations that brings added value at the
European, national and regional level through
- facilitating efficient use of resources available for HTA
- creating a sustainable system of HTA knowledge sharing
- promoting good practice in HTA methods and processes
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
HTA and context
Globalize the evidence, localize the decision
J.M. Eisenberg
Locate the decision, globalise the evidence, localise the reporting
EUnetHTA
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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. Patient and social aspects
9. Legal aspects
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SCOPE
Rap
id
RE
A
Co
mp
reh
en
siv
e/
Fu
ll H
TA
Reli
ab
le, ti
me
ly,
tra
nsp
are
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in
form
ati
on
Va
lue
??
?
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Health Technology Life-cycle
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12
Early scientific
advice
Rapid
REA
Additional
data
collection
HTA / REA
Use o
f te
chnolo
gy in h
ealth c
are
Time line of innovation
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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
The POP Database
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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Purpose
To facilitate
collaboration
among
European HTA
agencies and
reduce
duplication of
work
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Development
9 Methodological Guidelines for Rapid
REA of Pharmaceuticals developed in
JA1 and revised in JA2 to include
medical devices plus 5 new for HTA
Content
Guidelines on methodological
challenges that are encountered by
health technology assessors while
performing a rapid relative effective-
ness assessments and HTA
Primary Aim
To help the assessors of evidence
interpret and process the data that are
presented to them as part of an HTA..
14 Methodological Guidelines for HTA and Rapid Relative Effectiveness Assessment
14
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• 15 joint full HTAs and REAs
• 20+ early dialogues (incl. SEED Project)
EUnetHTA Joint Assessments and early scientific advice (early dialogues)
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EUnetHTA Partners and
Associates in JA2
44 Partner organisations
designated by EU Member
States
Large number of regional
agencies and non-for-profit
organisations that produce
or contribute to HTA
*) Norway participates in the
Third EU Health Programme
(2014-2020)
EU Participants* in EUnetHTA
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
• GBA, IQWIG, DIMDI, Medical Valley - EMN, Germany • HAS, France • NICE, NETSCC, HIS, United Kingdom • AGENAS, AIFA, ASSR, Veneto Region, Gemelli Hospital, Italy • ISCIII, AETSA, AQuAS, Avalia-T, IACS, OSTEBA, SESCS,
UETS, Spain • AOTMiT, Poland • NSPH MPD, Romania • ZIN, Netherlands • KCE, INAMI, Belgium • INFARMED, Portugal • SBU, TLV, Sweden • LBI, HVB, GÖG, UMIT, Austria • THL, FIMEA, Finland • AAZ, CHIF, Croatia • NHS, Latvia • DHA, Denmark (Coordinator), CFK, Central Region, KORA
Some of the Partner Organisations
in Joint Action 2 (2012-15), e.g.
NCHTA, Russia, as a
Collaborating Partner,
has paid a keen interest
to the activities of
EUnetHTA since 2010
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• HTA is very valuable for the healthcare system
• HTA is driven by policy needs – clarifying options
and consequences for the decision-making (by
politicians, competent authorities)
• Establishment of HTA is a complex process and
needs permanent operational support
• Implementation of an HTA system takes
substantial time
International experience from the last few decades
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“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”
Article 15 of the Directive 2011/24/EU on cross-border health care
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2013+ HTA Network
The timeline of reaching a sustainable and permanent HTA network in Europe
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www.eunethta.eu
20
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
2016-2019 Financial support
HTA (JA3)
2011 FP7-Health
2012-Innovation-1
New methodologies for HTA
(example INTEGRATE-HTA)
Legislation
DG R&I
Health
Programme
2010-2012 EUnetHTA
JA
2016-2019 EUnetHTA
Scientific and technical
cooperation (JA3)
Horizon 2020
Calls
Health Care
2012-2015 EUnetHTA
JA2
2020- Permanent
collabor-
ation
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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Thank you for your attention
This presentation arises from the EUnetHTA
Joint Action 2 which has received funding
from the European Union, in the framework
of the Health Programme
21 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
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