FfW 2012 Summit_FBK

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    How should HTAs respond to the

    growing burden of Chronic Diseases in

    the working-age population ?Finn Brlum Kristensen, MD, PhD

    Secretariat for EUnetHTA

    Danish Health and Medicines AuthorityChairman, European network for HTA (EUnetHTA) Executive Committee

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    EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    The aim of HTA is to inform theformulation of safe, effective,health policies that are patient

    focused and seek to achieve bestvalue

    HTA must always be firmly rooted

    in research and the scientificmethod

    HTA aim

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    EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    HTA is a multidisciplinary processthat summarises information aboutthe medical, social, economic and

    ethical issues related to the use ofa health technology in asystematic, transparent, unbiased,robust manner

    HTA definition

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    EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    EUnetHTA Joint Action 20102012 | www.eunethta.eu

    European network for HTA

    Joint Actions 2010-15 between EuropeanCommission and EU Member States

    A total of 37 government appointed organisations from 26 EU Member

    States, Norway and Croatia and a large number of regional agencies andnon-for-profit organisations that produce or contribute to HTA

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    EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    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 aspects8. Social aspects

    9. Legal aspects

    Domains of the HTA Core Model

    RAPID

    FULL

    Scope

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    EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    Domains

    1. Health problem and currentuse of the technology

    2. Description and technical

    characteristics

    3. Safety

    4. Clinical effectiveness

    5. Costs and economic

    evaluation

    6. Ethical analysis

    7. Organisational aspects8. Social aspects

    9. Legal aspects

    Clinical effectiveness:

    Topics

    Mortality

    Morbidity

    Function

    HRQL

    Patient satisfaction

    Change-in-management

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    7/12EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    Domain: Clinical effectiveness

    Topic: Morbidity

    Issues:How does the intervention modify the

    progression of disease?

    How does the intervention modify theseverity and frequency of symptomsand findings?

    How does the technology modify theeffectiveness of subsequentinterventions?

    etc

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    8/12EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    Domain: Social aspects

    Topic: Major life areas

    Issues:What kinds of changes does the use of the

    technology generate in the patient's role in themajor life areas?

    Who are the important others that the use of thetechnology may affect in addition to the patient?

    What kind of support and resources are needed ormight be released as the technology is put to use?

    etc

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    9/12EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    Stakeholder

    Forum

    Plenary Assembly

    (policy setting)

    Secretariat

    reporting control

    reporting control

    reporting support/control

    coordination /

    exchange of

    info

    Determine

    activities

    Work

    Package

    EUInstitutions

    info

    Executive Committee

    (strategic planning of activities)

    Work

    PackageWork

    PackageWork

    PackageWork

    PackageWork

    PackageWork

    PackageWork

    Package

    info

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    Composition of the Stakeholder Forum

    PayersProviders

    Patients /citizens Industry

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    11/12EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 20102012

    Directive 2011/24 EU on cross-border healthcare

    Article 15 Cooperation on health technology assessment

    1. The Union shall support and facilitate cooperation and theexchange ofscientific information among Member Stateswithin a voluntary network connecting national authoritiesor bodies responsible for health technology assessment

    designated by the Member States. That network shall bebased on the principle ofgood governance including

    transparency, objectivity, independence of expertise, fairness

    of procedure and appropriate stakeholder consultations

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    12/12EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 201020121212

    The time-line of reaching a sustainable andpermanent HTA network in Europe

    2006-08

    EUnetHTAProject

    2005Call forproject

    proposals

    2009Call forJoint

    Action

    2008 - 11

    Draft Cross BorderHealthcare DirectiveArticle on HTA network

    2011 - 13CBHC DirectiveExpert Group

    for

    HTA networkimplementation

    2014+

    Europeannetwork for

    HTA

    Legal basis:

    Cross BorderHealthcareDirective

    Financialsupport:

    1) EU Budget

    2) MemberStates

    2009EUnetHTA

    Collaboration

    2010 -12

    EUnetHTAJA

    2012 -15

    EUnetHTAJA 2

    2011Call forJoint

    Action

    HealthProgramme

    Legislation2011CBHC

    Directive

    nowdecided

    DG R&I2011 FP7-Health

    2012-Innovation-1New methodologies

    for HTA

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