HTA - what is it about/ what for MTV speciallgekursus i - - PowerPoint PPT Presentation

HTA presentation Zagreb, Croatia 20100119

MTV – speciallægekursus i samfundsmedicin

HTA - what is it about/ what for

• and HTA in European context

Finn Boerlum Kristensen, MD, PhD

Chairman, European Network for HTA, EUnetHTA Executive Committee Director, EUnetHTA Coordinating Secretariat, National Board of Health Adjunct professor, University of Southern Denmark

HTA presentation Zagreb, Croatia 20100119

W hat 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 assessm ent 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

HTA presentation Zagreb, Croatia 20100119

Technology ”diffusion”

Use of technology in health care Time line of innovation

Experi- mental Investiga- tional Nearly established Established Technology Basic research Applied research Obsolete? ? ?

HTA presentation Zagreb, Croatia 20100119

Acceleration / deceleration of technology ”diffusion”

Use of technology in health care Time line of innovation

Experi- mental Investiga- tional Nearly established Established Technology Basic research Applied research Obsolete? ? ?

HTA presentation Zagreb, Croatia 20100119

Policy making paradigm HTA-paradigm

Decision Decision-

• making domain

making domain

including regulation including regulation

Research domain Research domain

Planning /policy question HTA- questions HTA project Summary

• f the

assessment

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

HTA presentation Zagreb, Croatia 20100119

” The four boxes” - the Danish model

Technology

• Area of application
• Effectiveness
• Risk assessment

Patient

• Psychological

aspects

• Social aspects
• Ethical aspects

Organisation

• Structure
• Staff
• Environment

Econom y

• Social and health

economic appraisal

• Operational

economic appraisal

HTA presentation Zagreb, Croatia 20100119

HTA-report Organ- isation Synthesis Eco- nomy Patient Techn-

• logy

HTA-questions

Evidence, analysis

Policy-questions

HTA presentation Zagreb, Croatia 20100119

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, particularly EUR-ASSESS and ECHTA/ECAHI

• Promote the wide scope

and multidisciplinary nature

• f HTA

Social aspects

HTA presentation Zagreb, Croatia 20100119

HTA as an input to priority-setting and decision-making

DACEHTA

HTA Priority-setting and decision-making

HTA presentation Zagreb, Croatia 20100119

HTA as an input to priority-setting and decision-making

DACEHTA

HTA Priority-setting and decision-making Advising, recommending

HTA presentation Zagreb, Croatia 20100119

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

Joint Action

A total of 33 government appointed

• rganisations from 23 EU Member

States and Norway and a large number of relevant non-for-profit

• rganisations that produce or

contribute to HTA

HTA presentation Zagreb, Croatia 20100119

EUnetHTA | European network for Health Technology Assessment | 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 presentation Zagreb, Croatia 20100119

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

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 focused and seek to achieve best value

• Despite its policy goals, HTA must always be

firmly rooted in research and the scientific method

EUnetHTA

HTA presentation Zagreb, Croatia 20100119

EUnetHTA | European network for Health Technology Assessment

64 Partners

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

• Final Technical Report published by DG SANCO on

http://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

HTA presentation Zagreb, Croatia 20100119

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

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

HTA presentation Zagreb, Croatia 20100119

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

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

HTA presentation Zagreb, Croatia 20100119

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, particularly EUR-ASSESS and ECHTA/ECAHI

• Promote the wide scope

and multidisciplinary nature

• f HTA

Social aspects

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

HTA presentation Zagreb, Croatia 20100119

H T A C o r e M o d e l s

Domain 4 Domain 3 Domain 2 Domain 1

The Core HTA Structure

i.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 of Structured HTA Information CORE HTA

Summary of key findings

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

LOCAL REPORT

AE 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

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

HTA presentation Zagreb, Croatia 20100119

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

• Established by 25 Founding Partners from

15 countries (13 EU Member States, Norway, Switzerland)

• The partnership will be expanded with HTA
• rganisations 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 +

HTA presentation Zagreb, Croatia 20100119

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

Stakeholder Forum

Plenary Assembly (policy setting)

Secretariat

reporting control reporting control reporting support/control coordination / exchange of info Determine activities

Work Package Work Package Work Package Work Package Work Package Work Package EPSCO WG on Public Health

EMEA

info

Executive Committee (strategic planning of activities)

info

DG Ent WG Clinical Investigation and Evaluation

HTA presentation Zagreb, Croatia 20100119

EUnetHTA | European network for Health Technology Assessment

• A total of 33 government appointed
• rganisations 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

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Austria LBI-HTA, Ludwig Boltzman Institute, HTA – Austria HVB, Hauptverband der Österreichischen Sozialversicherungsträger(Association of Austrian Social Insurance Institutions) – Austria GÖG-Gesundheit Österreich GmbH/Geschäftsbereich BIQG- Bundesinstitut für Qualität im Gesundheitswesen – Belgium KCE, Belgian Health Care Knowledge Centre

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Bulgaria National Center of Public Health Protection – Czech Republic Ministry of Health – Denmark NBoH, National Board of Health – Denmark SDU, Centre for Applied Health Services Research and Technology Assessment, University of Southern Denmark – Estonia UTA, Department of Public Health, University of Tartu

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Finland THL, National Institute for Health and Welfare – France HAS, Haute Autorité de Santé – Germany DIMDI, Deutsches Institut für Medizinische Dokumentation und Information – Germany IQWIG, Institute for Quality and Efficiency in Health Care – Greece NSPH, National School of Public Health

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Hungary ESKI, National Institute for Strategic Health Research – Hungary EMKI, Institute for Healthcare Quality Improvement and Hospital Engineering – Ireland HIQA, Health Information and Quality Authority – Italy AGE.NA.S, Agenzia Nazionale per i Servizi Sanitari Regionali – Italy AIFA, Italian Medicines Agency – Italy Regione Veneto

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Latvia Centre of Health Economics – Lithuania VASPVT, State Health Care Accreditation Agency – Malta SSD/MSOC, Ministry for Social Policy, Strategy and Sustainability Division – Netherlands CVZ, Health Care Insurance Board – Norway NOKC, Norwegian Knowledge Center for the Health Services

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

– Poland AHTAPol, Agency for Health Technology Assessment – Portugal INFARMED, National Authority of Medicines and Health Products – Slovenia IPH-RS, Institute of Public Health of the Republic of Slovenia – Spain Ministry of Health – Spain ISCIII, Instituto De Salud Carlos III – Sweden SBU, Swedish Council on Technology Assessment in Health Care

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA associated partners

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

HTA presentation Zagreb, Croatia 20100119

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

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

HTA presentation Zagreb, Croatia 20100119

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

Pharm aceutical Forum 2 0 0 7 Recom m endations

• Decisions on reim bursem ent on national level
• Relative effectiveness assessm ent ( REA) vs cost-

effectiveness assessm ent ( CEA)

• Exchange of REA criteria/ inform ation
• I m plem entation of agreed good practice

principles for REA

• More effectively done by existing netw orks

HTA presentation Zagreb, Croatia 20100119

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

EUnetHTA Relative effectiveness

• f pharm aceuticals
• I ntegration of REA of pharm aceuticals in the scope
• f EUnetHTA JA
• Using e.g. inform ation from database of

prospectively collected inform ation on real-life effectiveness of technologies ( EUnetHTA W P7 strand A lead by HAS)

• Based on the definitions of the Pharm aceutical

Forum

• Relative effectiveness can be defined as the extent to

w hich an intervention does m ore good than harm com pared to one or m ore intervention alternatives for achieving the desired results w hen provided under the usual circum stances of health care practice.

HTA presentation Zagreb, Croatia 20100119

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

I ndependently but linked!

• Exchange of inform ation w ith EMEA
• EPARs and NPARs further contribute to REA
• Receive inform ation necessary for REA in a transnational

collaboration by HTA bodies in MS

• DG Enterprise W G on Clinical I nvestigation Evaluation
• Cooperation w ith MEDEV organisations
• Outside EU w ith organisations like AHRQ ( USA) ,

CADTH/ CEDAC ( Canada) , PBAC ( Australia)

• Stakeholders using the EUnetHTA stakeholders forum

HTA presentation Zagreb, Croatia 20100119

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

A stepw ise approach

• Exploratory Phase ( m eetings, use of already available

inform ation) and identification and role of various actors ( Regulatory bodies…)

• I dentification of needed im provem ents for REA,

review of available m ethods, tools and potential gaps

• Proposed m odel for REA of pharm aceuticals,

consistent w ith the EUnetHTA “core HTA m odel”

• Applicability/ adaptation to the context : pilot testing

in the context of STA/ MTA

• Modification of the m odel/ toolbox

HTA presentation Zagreb, Croatia 20100119

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

Relevant issues (examples)

• General issues

– Guideline available? – STA vs MTA – Assessm ent vs appraisal – Clinical effectiveness vs risk/ benefit – I ntegration REA in CEA?

• Methodological issues

– Com parative treatm ent – Clinical endpoints vs surrogate m arkers – I ndirect com parisons – subpopulations

HTA presentation Zagreb, Croatia 20100119

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

Objectives in 2 0 0 9 -2 0 1 2

• Establish a W G and organise a group m eeting ( 2 0 0 9 )
• I nitiate ( 2 0 0 9 ) and report on exploratory phase,

including a review of available solutions ( 2 0 1 0 )

• Proposal of relevant tools and m ethods ( 2 0 1 0 -2 0 1 1 )
• Definition of a fram ew ork for RE assessm ent ( 2 0 1 1 )
• Pilot testing ( end 2 0 1 1 ) and adjustm ent of toolbox
• n the basis of the results of the pilots ( 2 0 1 1 -2 0 1 2 )

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

HTA presentation Zagreb, Croatia 20100119

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

New Technologies General objective

To support collaboration on new technologies and to contribute 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)

HTA presentation Zagreb, Croatia 20100119

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

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

HTA presentation Zagreb, Croatia 20100119

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

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)

HTA presentation Zagreb, Croatia 20100119

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

Deliverables – Stream B

• Electronic, web-based database on
• ngoing/ 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...

HTA presentation Zagreb, Croatia 20100119

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

Stakeholder Forum

Plenary Assembly (policy setting)

Secretariat

reporting control reporting control reporting support/control coordination / exchange of info Determine activities

Work Package Work Package Work Package Work Package Work Package Work Package EPSCO WG on Public Health

EMEA

info

Executive Committee (strategic planning of activities)

info

DG Ent WG Clinical Investigation and Evaluation

HTA presentation Zagreb, Croatia 20100119

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

Use of technology in health care Time line of innovation

Experi- mental Investiga- tional Nearly established Established Technology Basic research Applied research

Alert MI NI

Rapid Performance evaluation BROAD HTA Policy making

Political decision making / regulation

Obsolete? ? ? Policy making Policy making Policy making

Clinical Decision making Clinical Decision making Clinical Decision making

HTA presentation Zagreb, Croatia 20100119

HTA presentation Zagreb, Croatia 20100119

Global organisations