MTV –HsTpAe c-iawllhæagte iksu itrsus ab oi usat/mwfhunatd sformedicin -and HTA...

HTA presentation Zagreb, Croatia 20100119

MTV – speciallægekursus i samfundsmedicinHTA - what is it about/what for

- and HTA in European contextFinn Boerlum Kristensen, MD, PhD

Chairman, European Network for HTA, EUnetHTA Executive CommitteeDirector, EUnetHTA Coordinating Secretariat, National Board of Health

Adjunct professor, University of Southern Denmark


What is HTA

• 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

• Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology

INAHTA


Technology ”diffusion”

Use

of t

echn

olog

y in

hea

lth c

are

Time line of innovation

Experi-mental

Investiga-tional

Nearly established Established

TechnologyBasic research

Appliedresearch

Obsolete???


Acceleration / deceleration of technology ”diffusion”

Use

of t

echn

olog

y in

hea

lth c

are


Experi-mental

Investiga-tional



Appliedresearch

Obsolete???


Policy making paradigm

HTA-paradigm

DecisionDecision--making domainmaking domainincluding regulationincluding regulation

Research domainResearch domain

Planning /policy

question

HTA-questions

HTA project

Summary of the assessment

Based on Kristensen FB et al. Seminars in Colon and Rectal Surgery, 2002; 13: 96 – 103


”The four boxes” - the Danish model

Technology

Ø Area of application Ø Effectiveness Ø Risk assessment

Patient

Ø Psychological aspects Ø Social aspects Ø Ethical aspects

Organisation

Ø Structure Ø Staff Ø Environment

Economy

Ø Social and health economic appraisal Ø Operational

economic appraisal


HTA-report

Organ-isation

Synthesis

Eco-nomy

PatientTechn-ology

HTA-questions

Evidence,analysis

Policy-questions


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 wide scope and multidisciplinary nature of HTA Social aspects


HTA as an input to priority-settingand decision-making

DACEHTA

HTA

Priority-settinganddecision-making


HTA as an input to priority-settingand decision-making

DACEHTA

HTA

Priority-settinganddecision-making

Advising,recommending


EUnetHTA | European network for Health Technology Assessment | www.eunethta.net

Joint ActionA total of 33 government appointed organisations from 23 EU Member States and Norway and a large number of relevant non-for-profit organisations that produce or contribute to HTA

http://www.eunethta.net



Strategic position

• All activities of the EUnetHTA Collaboration arise from the premise that its outputs will be used to inform but not mandate the content of national / regional / institutional HTA reports




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

• Its aim is to inform the formulation of safe, effective, health policies that are patient focusedand seek to achieve best value

• Despite its policy goals, HTA must always be firmly rooted in research and the scientific method

EUnetHTA



EUnetHTA | European network for Health Technology Assessment

64 Partners55 Partners from 29 countries (21 EU Member States) including 9 International Partner Organisations

• Final Technical Report published by DG SANCO onhttp://ec.europa.eu/health/ph_systems/docs/eunethta_report_en.pdf

• Fourteen scientific articles now published in Int J Technol Assess Health Care, 2009: 25 (Suppl. 2) January 2010

EUnetHTA Project 2006-08

http://ec.europa.eu/health/ph_systems/docs/eunethta_report_en.pdf



What did we do differently?

• Focus on methodology but ALSO on a working process (i.e. developing practical tools)

• Orientation towards results and continuity

• Strong emphasis on the management and organisational support structures for co-operation




What did we do differently?

• Stakeholder involvement, openness to dialogue and inclusiveness

• Attention to the policy processes in European healthcare

• Continuous attention to delivering a unique and added value to partners and users



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 wide scope and multidisciplinary nature of HTA Social aspects




H T

A

C o

r e

M o

d e

l s

Domain 4

Domain 3

Domain 2

Domain 1

The Core HTA Structurei.e. HTA Core Models and their applications

AE AE

AE AE

AE

AE AE

AE

AE

AE

AE

AE

AE

AE AE

AE

AE

AE

AE

AE

Pool ofStructured HTA Information CORE HTA

Summary of key findings

Takes into account local epidemiology, resources, values, etc.

LOCAL REPORTAE AE

AE

AE

AE AE

AE

AE

AE

AE

AE

AE AE

AE

AE

AE

AE

AE

INFO

INFO

INFO

AE = Core element

AE = Non-core element

INFO = Locally produced information that does not follow HTA Core model structure

AE = assessment element





•Established by 25 Founding Partners from 15 countries (13 EU Member States, Norway, Switzerland)•The partnership will be expanded with HTA organisations from European countries that are government nominated•Relevant non-for-profit organisations that produce or contribute to HTA and will be actively involved and provide scientific input can become EUnetHTA Associates

EUnetHTA Collaboration 2008 +




Stakeholder Forum

Plenary Assembly(policy setting)

Secretariat

reporting control

reporting control

reporting support/control

coordination /exchange of info

Determineactivities

Work Package

Work Package

Work Package

Work Package

Work Package

Work Package

EPSCO WG on Public Health

EMEA infoExecutive Committee (strategic

planning of activities)info

DG Ent WG Clinical Investigation and

Evaluation



EUnetHTA | European network for Health Technology Assessment

•A total of 33 government appointed organisations from 23 EU Member States and Norway (”Associated Partners”)•Relevant non-for-profit organisations that produce or contribute to HTA and will be actively involved and provide scientific input (”Collaborating Partners”)

EUnetHTA Joint Action 2010-2



EUnetHTA associated partners

– AustriaLBI-HTA, Ludwig Boltzman Institute, HTA– AustriaHVB, Hauptverband der Österreichischen

Sozialversicherungsträger(Association of Austrian Social Insurance Institutions)

– AustriaGÖG-Gesundheit Österreich GmbH/Geschäftsbereich BIQG-

Bundesinstitut für Qualität im Gesundheitswesen – Belgium KCE, Belgian Health Care Knowledge Centre





– BulgariaNational Center of Public Health Protection– Czech RepublicMinistry of Health – DenmarkNBoH, National Board of Health– Denmark SDU, Centre for Applied Health Services Research and Technology

Assessment, University of Southern Denmark– EstoniaUTA, Department of Public Health, University of Tartu





– FinlandTHL, National Institute for Health and Welfare– FranceHAS, Haute Autorité de Santé– GermanyDIMDI, Deutsches Institut für Medizinische Dokumentation und

Information– GermanyIQWIG, Institute for Quality and Efficiency in Health Care– GreeceNSPH, National School of Public Health





– HungaryESKI, National Institute for Strategic Health Research– HungaryEMKI, Institute for Healthcare Quality Improvement and Hospital

Engineering– IrelandHIQA, Health Information and Quality Authority– Italy

AGE.NA.S, Agenzia Nazionale per i Servizi Sanitari Regionali– ItalyAIFA, Italian Medicines Agency – ItalyRegione Veneto





– LatviaCentre of Health Economics– Lithuania

VASPVT, State Health Care Accreditation Agency– MaltaSSD/MSOC, Ministry for Social Policy, Strategy and Sustainability

Division– NetherlandsCVZ, Health Care Insurance Board – Norway

NOKC, Norwegian Knowledge Center for the Health Services





– Poland AHTAPol, Agency for Health Technology Assessment – PortugalINFARMED, National Authority of Medicines and Health Products– SloveniaIPH-RS, Institute of Public Health of the Republic of Slovenia– SpainMinistry of Health– SpainISCIII, Instituto De Salud Carlos III – SwedenSBU, Swedish Council on Technology Assessment in Health Care





– United Kingdom

NETSCC, NIHR Evaluation Trials and Studies Coordinating Centre– United KingdomNICE, National Institute for Health and Clinical Excellence




EUnetHTA Joint Action 2010-12

• Coordination• Core HTA including adaptation• Relative Effectiveness Assessment (REA) of

Pharmaceuticals• New Technologies. Facilitating Evidence

Generation and Collaboration on (Pre-coverage) Assessments

• Strategy development (Business model for sustainability including capacity building to do HTA)

• Information management system• Communication• Evaluation




Pharmaceutical Forum 2007Recommendations

• Decisions on reimbursement on national level

• Relative effectiveness assessment (REA) vs cost-effectiveness assessment (CEA)

• Exchange of REA criteria/information

• Implementation of agreed good practice principles for REA

• More effectively done by existing networks




EUnetHTA Relative effectivenessof pharmaceuticals

• Integration of REA of pharmaceuticals in the scope of EUnetHTA JA

• Using e.g. information from database of prospectively collected information on real-life effectiveness of technologies (EUnetHTA WP7 strand A lead by HAS)

• Based on the definitions of the Pharmaceutical Forum

• Relative effectiveness can be defined as the extent to which an intervention does more good than harm compared to one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of health care practice.




Independently but linked!

• Exchange of information with EMEA• EPARs and NPARs further contribute to REA• Receive information necessary for REA in a transnational

collaboration by HTA bodies in MS

• DG Enterprise WG on Clinical Investigation Evaluation

• Cooperation with MEDEV organisations

• Outside EU with organisations like AHRQ (USA), CADTH/CEDAC (Canada), PBAC (Australia)

• Stakeholders using the EUnetHTA stakeholders forum




A stepwise approach

• Exploratory Phase (meetings, use of already available information) and identification and role of various actors (Regulatory bodies…)

• Identification of needed improvements for REA, review of available methods, tools and potential gaps

• Proposed model for REA of pharmaceuticals, consistent with the EUnetHTA “core HTA model”

• Applicability/ adaptation to the context : pilot testing in the context of STA/MTA

• Modification of the model/toolbox




Relevant issues (examples)• General issues

– Guideline available?– STA vs MTA– Assessment vs appraisal– Clinical effectiveness vs risk/benefit – Integration REA in CEA?

• Methodological issues– Comparative treatment– Clinical endpoints vs surrogate markers– Indirect comparisons– subpopulations




Objectives in 2009-2012

• Establish a WG and organise a group meeting (2009)

• Initiate (2009) and report on exploratory phase, including a review of available solutions (2010)

• Proposal of relevant tools and methods (2010-2011)

• Definition of a framework for RE assessment (2011)

• Pilot testing (end 2011) and adjustment of toolbox on the basis of the results of the pilots (2011-2012)

Deliverable : Adjusted Model/toolbox for REA, consistent with Core HTA Model




New TechnologiesGeneral objective

To support collaboration on new technologies and tocontribute to reduce duplication of work by:

• exchanging information on and developing tools to facilitate evidence generation (stream A)

• effectively exchanging information on assessments of new health technologies (stream B)




Stream A - objectives• To implement a structured way to exchange and share

information on technologies entering use outside experimental context and requiring additional evidence generation

• To define an agreed dataset of interest to exchange useful information on prospective data collection

• To develop criteria to select new technologies for additional evidence generation




Deliverables – Stream A• Operational web-based toolkit containing database with

information on evidence generation on new technologies (M33)– IT development, training (all EUnetHTA partner), feedback from

users (all EUnetHTA partners),

• Relevant dataset to exchange information on data collection (M18)– Survey (Partners)

• Criteria to select new technologies for additional evidence generation (M30)– Literature review, survey (Partners)




Deliverables – Stream B• Electronic, web-based database on

ongoing/planned projects• Checklist for collaborations• Quarterly communication protocol of

information flow on ongoing/planned national assessments based on database input, and personal comments of users.

• Survey results/report - the impact of information flow measured by all communication protocols...




Stakeholder Forum

Plenary Assembly(policy setting)

Secretariat

reporting control

reporting control

reporting support/control

coordination /exchange of info

Determineactivities

Work Package

Work Package

Work Package

Work Package

Work Package

Work Package

EPSCO WG on Public Health

EMEA infoExecutive Committee (strategic

planning of activities)info

DG Ent WG Clinical Investigation and

Evaluation



”Diffusion” of technology, HTA modalities,Policy making and Decision making

Use

of t

echn

olog

y in

hea

lth c

are


Experi-mental

Investiga-tional



Appliedresearch

Alert MINIRapid

Performance evaluation

BROAD HTA

Policy makingPoliticaldecisionmaking /regulation

Obsolete???

Policymaking

Policy making

Policy making

ClinicalDecisionmaking




Global organisations

MTV –HsTpAe c-iawllhæagte iksu itrsus ab oi usat/mwfhunatd sformedicin -and HTA...

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