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Health Technology Assessment in Internationaal Perspectief. Raf Mertens, MD General Director KCE. KCE. Federaal K enniscentrum voor de Gezondheidszorg C entre fédéral d’ e xpertise des soins de santé
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Health Technology Assessmentin Internationaal Perspectief Raf Mertens, MD General Director KCE
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.
Het KCE team • artsen • economisten • data analysten • juridisch experten • sociologen • statistici • …. • Totaal: 55 • Directie: 4 staff: 7 secretariaat: 7 experten: 33
From proposal to published KCE report 100 – 150 + 40 + 25 Pre-project fiche (PPF) Study proposal Work programme Identify team (int or ext) ;if external : Public call for tender Evaluation by KCE Validation by Board Publication report on website; Press release Start of procedures Pre-report Project fiche Report Acceptedby Board validation meeting experts meeting experts meeting experts
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 HSR - GCP - HTA
International collaboration In Health Services Research
International collaboration In Guidelines Development
What is HTA ? • 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
Questionsto 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
Cost-effectivenessIncremental cost-effectiveness ratio (ICER) Costs + IV I Less Effective More effective More cost More cost - + Effectiveness III II Less Effective More effective Less cost Less cost -
(pragmatic trials, effectiveness trias) Efficacy Effectiveness Ideal world Real world Real world trial trial no trial Relative Versus best alternativeVersus any alternativeVersus placeboNocomparator RCT vs. best alternative - clinical outcome Relative effectiveness Post marketing studywith comparator RCT vs. Any alternative - surrogate marker outcome RCT vs. placebo Absolute efficacy Medical claims data Absolute Adapted from :Pharmaceutical forum
International Network of Agencies for Health Technology Assessment
EUnetHTA Joint action Work Package 4: Core HTA Work Package 5: Relative effectiveness avoid Duplication of efforts !
Health problem and current use of technology Domains of HTA Technical characteristics Safety • Identified in previous EU projects, particularlyEUR-ASSESS and ECHTA/ECAHI • Promote the multidisciplinary nature of HTA Clinical effectiveness Costs and economic evaluation Ethical analysis Organisational aspects Social aspects Social aspects Legal aspects
Health problem and current use of technology Topics Technical characteristics Safety Clinical effectiveness Topic 1: Mortality Clinical effectiveness Issue 1: What is the effect of the intervention on overall mortality? Costs and economic evaluation Topic 2: Morbidity Ethical analysis Issue 2: What is the effect of the intervention on mortality caused by the target disease? Topic 3 etc… Organisational aspects Social aspects Issue 3: etc… Legal aspects
EUnetHTA JA WP4 Core HTA Key tasks • 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
Online version available at www.corehta.info Currently for EUnetHTA member agencies only
What will HTA Core Model enable? • 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) • For health care decision-makers • Better informed decisions through improved evidence-base • Better ROI on HTA through reduced overlapping work in different countries
EUnetHTA JA WP6 Information Management System: Objectives Provision of a contemporary information management system which ensures compatibility and interoperability across WPs’ tools to support collaborative HTA work, and ensure rapid disseminationof HTA results within the JA 22
Context HTA Glossary EIFFEL Planned & Ongoing Project (POP) HTA Core Model HTA database E-meeting facility Adaptation glossary HTAivortal News aggregator Public Site MO site 23
EUnetHTA JA WP6 Information Management System: Key tasks Some examples… 24
Members-Only site December 2010 25
Tools supporting day to day collaboration Work rooms Collab. tools June 2011 E-meeting Toolbar 26
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 27 27