kce.fgov.be

Federaal Kenniscentrum voor de GezondheidszorgCentre fédéral d’expertise des soins de santé

Belgian Health Care Knowledge Centre

Health Technology Assessmentin Internationaal Perspectief

Raf Mertens, MDGeneral Director KCE

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KCE • Federaal Kenniscentrum voor de Gezondheidszorg Centre fédéral d’expertise des soins de santé

• Opdracht: studies uitvoeren en rapporten maken om de beleidsmakers te adviseren bij hun beslissingen inzake gezondheidszorg en ziekteverzekering. Aanbevelingen formuleren voor goede klinische praktijk.

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Het KCE team

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• Totaal: 55

• Directie: 4 staff: 7

secretariaat: 7 experten: 33

artsen economisten data analysten juridisch experten sociologen statistici ….

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From proposal to published KCE report

Pre-project fiche (PPF)

Project ficheStart of procedures

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Pre-report

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ReportPublication report on website;Press release

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Work programme

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Studyproposal

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Identify team (int or ext) ;if external :Public call for tender

100 – 150 + 40 + 25

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Een paar voorbeelden…• Is Neonatale Screening op Mucoviscidose aangewezen in België?

• Een eerste stap naar het meten van de performantie van het Belgische gezondheidszorgsysteem

• Kosteneffectiviteit van antivirale behandeling voor chronische hepatitis B in België. 

• Gebruik van point-of care systemen bij patiënten met orale anticoagulatie: een Health Technology Assesment

• Terugbetaling van Radioisotopen in België

• Organisatie en financiering van genetische diagnostiek in België

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HSR - GCP - HTA

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International collaborationIn Health Services Research

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International collaborationIn Guidelines Development

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• 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

• Its aim 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

What is HTA ?

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Questions to KCE

• Does A work better than placebo ? → Efficacy • Does A work better than B ?

→ Relative efficacy • … also in real life ?

→ Relative effictiveness • at an acceptable cost ? → Cost-effectiveness

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+IV I

Less Effective More effective More cost More cost

- +Effectiveness

III IILess Effective More effective

Less cost Less cost-

Costs

Cost-effectivenessIncremental cost-effectiveness ratio (ICER)

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Efficacy Effectiveness

Absolute

RelativeVersus best alternative

Versus any alternative

Versus placebo

Nocomparator

Ideal world Real world Real world trial trial no trial

RCT vs. placeboRCT vs. placebo

RCT vs. best alternative - clinical outcomeRCT vs. best alternative - clinical outcome

RCT vs. Any alternative - surrogate marker outcomeRCT vs. Any alternative - surrogate marker outcome

Post marketing studywith comparatorPost marketing studywith comparator

Medical claims dataMedical claims dataAbsolute efficacy

Relative effectiveness

Adapted from :Pharmaceutical forum

(pragmatic trials, effectiveness trias)

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International Network of Agencies for Health Technology Assessment

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European context

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EUnetHTA Joint action

Work Package 4: Core HTAWork Package 5: Relative effectiveness

Duplication of efforts !

avoid

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EUnetHTA Core HTA

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Social aspects

Health problem and current use of technology

Technical characteristics

Ethical analysis

Organisational aspects

Legal aspects

Clinical effectiveness

Costs and economic evaluation

Safety

Domains of HTA

• Identified in previous EU projects, particularlyEUR-ASSESS and ECHTA/ECAHI

• Promote the multidisciplinary nature of HTA

Social aspects

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Clinical effectiveness

TopicsHealth problem and current use of technology

Technical characteristics

Ethical analysis

Organisational aspects

Social aspects

Legal aspects

Costs and economic evaluation

Safety

Topic 1: Mortality

Topic 2: Morbidity

Topic 3 etc…

Clinical effectiveness

Issue 1: What is the effect of the intervention on overall mortality?

Issue 2: What is the effect of the intervention on mortality caused by the target disease?

Issue 3: etc…

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Core HTA Structure

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• WP4 Strand A: HTA Core Model development– Online Tool & Service : production, publication, retrieval of HTA

information– Policies for selecting Core HTA topics, production and publication of

Core HTAs– New application of HTA Core Model on screening– Adaptation processes (building on earlier work EUnetHTA 2006-2008)

• WP4 Strand B: Core HTA production– Production of 2 Core HTAs on jointly selected topics– Definition / testing of collaborative models in producing Core HTAs– Analysis of topic selection processes and stakeholder involvement

among agencies

EUnetHTA JA WP4 Core HTA Key tasks

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Online version available at www.corehta.info

Currently for EUnetHTA member agencies only

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What will HTA Core Model enable?

1. For HTA agencies and professionals– Core HTAs to support local HTAs– Other building blocks for local HTAs– International collaboration (sharing resources, expertise

and methods)– Greater variability of HTA information available (through

reduction of overlapping work)

2. For health care decision-makers– Better informed decisions through improved evidence-

base– Better ROI on HTA through reduced overlapping work in

different countries

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EUnetHTA JA WP6 Information Management System: ObjectivesProvision of a contemporary information management system which ensures

compatibility and interoperability across WPs’

tools to support collaborative HTA

work, and ensure rapid dissemination of HTA results within the JA

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ContextHTA

Glossary

HTAi vortal

HTA database

E-meeting facility

EIFFELPlanned & Ongoing Project (POP)

HTA Core Model

MO site

Public SiteNews

aggregator

Adaptation glossary

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EUnetHTA JA WP6 Information Management System: Key tasks

Some examples…

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Members-Only site

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Tools supporting day to day collaboration

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Collab. toolsCollab. tools

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The future of HTA in Europe

• (draft) Directive on patients’ rights in cross-border healthcare - Article 15 on HTA collaboration• Future role of the European Medicines Agency (EMA)• SANCO work programme and the future of EUnetHTA • Actual, practical collaboration between HTA agencies

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Federaal Kenniscentrum voor de GezondheidszorgCentre fédéral d’expertise des soins de santé

Belgian Health Care Knowledge Centre

Thanks for the attention!

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