02 Kristensen 20121123 Bosnia Herzegovina€¦ · Kristensen_FB_20121123 Health Technology...

Kristensen FB_Bosnia_Herzegovina_20121123; Sva prava pridržana u skladu sa Zakonom o autorskim i srodnim pravima BiH (Sl.glasnik BiH 63/10) 1

European developments in HTA - Scientific and policy processes leading to a permanent network - Key scientific tools and results coming out of EUnetHTA - Lessons learned and opportunities in national capacity building

Finn Børlum Kristensen, MD, PhD

Director, Secretariat for EUnetHTA Danish Health and Medicines Authority, Copenhagen Adjunct professor, University of Southern Denmark

Chairman, European network for HTA (EUnetHTA) Executive Committee

Kristensen_FB_20121123

Health Technology

• 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



Health Technology Assessment

• 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



• The aim of HTA 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



HTA is context specific

Globalize the evidence, localize the decision

J.M. Eisenberg


Informing policy

Health Economics


Outcomes Research

Evidence

Health Policy



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

HTA

Priority-setting and decision-making

Advising, recommending

HTA

Priority-setting and decision-making


HPV and cancer • Should Human Papilloma Virus (HPV) vaccination be reimbursed?

• Should HPV vaccination be introduced into the public childhood vaccination programme (0-17 years)?



Kristensen FB_Macedonia_20110921



Conclusions of HTAs of human papillomavirus vaccination from

six agencies - and related policy decisions

Country

Organisation Conclusion Policy decision Austria Ludwig Boltzmann Institut Vaccination offers only limited reduction

in morbidity and mortality in girls at substantial costs

Included in the vaccination scheme for girls and boys from 9-17 years but no reimbursement

Belgium Belgian Health Care Knowledge Centre

Vaccination is cost effective for 12 year old girls only if no booster required; otherwise questionable

Flanders (about 60 % of the population): General vaccination of 12 year-old girls. Wallonia: Partial reimbursement

Denmark National Board of Health Vaccination is cost effective for 12 year old girls

Free to all 12 year old girls in general vaccination programme

Ireland Health Information and Quality Authority

Vaccination is cost effective for 12 year old girls

General vaccination of all 12 year-old girls

Norway Norwegian Knowledge Centre for the Health Services

Vaccination is cost effective for 11-12 year old girls

Free to all 12 year old girls in general vaccination programme

Sweden Swedish Council on Technology Assessment in Health Care

Scientific evidence insufficient for conclusion

Free to all 10-12 year-old girls in general vaccination programme

Kristensen FB Gerhardus A. Analysis. BMJ 2010;341: 1029-31


EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012

Can we work together at the European level?

Yes, because • We know what the others do • We trust each other • We use same templates and methodology • We use same language


EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 13 13

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

2006-08 EUnetHTA

Project

2005 Call for project

proposals

2009 Call for Joint

Action

2008 - 11 Draft Cross Border

Healthcare Directive Article on HTA network

2011 - 13 CBHC Directive Expert Group

for HTA network

implementation

2014+ European

network for HTA

Legal basis:

Cross Border Healthcare Directive

Financial support:

1) EU Budget 2) Member

States

2009 EUnetHTA

Collaboration

2010 -12 EUnetHTA

JA

2012 -15 EUnetHTA

JA 2

2011 Call for Joint

Action

Health Programme

Legislation

2011 CBHC

Directive now

decided

DG R&I

2011 FP7-Health 2012-Innovation-1 New methodologies

for HTA

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

EUnetHTA Objectives 2005

The general objective: To establish an effective and sustainable European Network

for Health Technology Assessment – EUnetHTA - that informs policy decisions

The general strategic objective of the Network: To connect public national/regional HTA agencies,

research institutions and health ministries, enabling effective exchange of information support to policy decisions by the Member States


EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu Joint Action 2010–2012 15

The general objective: To put into practice an effective and sustainable

HTA collaboration in Europe Focus on HTA in Europe to facilitate efficient use of resources available for HTA create a sustainable system of HTA knowledge

sharing, and promote good practice in HTA methods and processes

EUnetHTA Joint Action 1: 2010-12


Health Technology Life-cycle

Use

of t

echn

olog

y in

heal

th ca

re

Time line of innovation

Experi-mental

Investiga-tional

Nearly established Established

Technology Basic research

Applied research

Obsolete???

Additional data

collection

Early scientific advice

HTA / REA

Rapid REA



Tools and instruments for European HTA collaboration

• HTA Core Model Online • EUnetHTA Planned and Ongoing Projects Database • EUnetHTA Evidence database on new technologies (EVIDENT

Database) • EUnetHTA Adaptation Toolkit • EUnetHTA Contact Database • EUnetHTA Work Rooms • EUnetHTA e-meeting facility • EUnetHTA Document Repository • EUnetHTA News Aggregator

– Public Site News – Partner Public Site News – Euroscan Recently added new technologies – INAHTA Publications


The HTA Core Model

ONTOLOGY Questions that an HTA

should answer

METHODOLOGICAL GUIDANCE

How to answer the questions

REPORTING STRUCTURE

How to present the answers



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 aspects 8. Social aspects 9. Legal aspects

Domains of the HTA Core Model RAP I D

F U L L

Scope


Domains

1. Health problem and current use of the technology

2. Description and technical characteristics

3. Safety 4. Clinical effectiveness 5. Costs and economic

evaluation 6. Ethical analysis 7. Organisational aspects 8. Social aspects 9. Legal aspects

Clinical effectiveness:

Topics • Mortality

• Morbidity

• Function

• HRQL

• Patient satisfaction

• Change-in-management



Domain: Clinical effectiveness:

Topic: Mortality

Issues: •What is the effect of the intervention on overall mortality?

•What is the effect of the intervention on the mortality caused by the target disease?

•What is the effect of the intervention on the mortality due to other causes than the target disease? •etc


Domain: Clinical effectiveness

Topic: Morbidity

Issues: •How does the intervention modify the progression of disease? •How does the intervention modify the severity and frequency of symptoms and findings? •How does the technology modify the effectiveness of subsequent interventions? •etc



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 the major life areas? •Who are the important others that the use of the technology may affect in addition to the patient? •What kind of support and resources are needed or might be released as the technology is put to use? •etc


H T

A

C o

r e

M o

d e

l

Domain 4

Domain 3

Domain 2

Domain 1

HTA Core Model® and its application

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

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

LOCAL REPORTING* 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

AE = Assessment element

Structured information for Rapid HTA

Structured information for REA

AE

AE

AE

AE

AE

AE

AE

AE

*) e.g. Full HTA, Rapid HTA, REA



Tools already developed Model for Rapid REA of Pharmaceuticals

1st version 2nd version

HTA Core Model Model for Rapid REA

Health problem and current use of technology

Health problem and current use of technology

Description and technical characteristics of the technology

Description and technical characteristics of the technology

Safety SafetyEffectiveness EffectivenessCost and economic considerations

Cost and economic considerations

Ethical analysis Ethical analysis Ethical analysis

Organisational analysis Organisational analysis Organisational analysis

Social aspects Social aspects Social aspectsLegal aspects Legal aspects Legal aspects

SafetyEffectivenessCost and economic considerations

Model for Rapid REA

Health problem and current use of technologyDescription and technical characteristics of the technology

Replaced by checklist





POP database development

Objectives: • facilitating collaboration

among European HTA agencies • reduce duplication of work



POP Statistics: quarterly updates

9th (May/June 2012) POP Request Out of 59 EUnteHTA JA partners: • 37 responded and entered projects into

the database • 5 responded but DID NOT feed the

database • 17 did not respond at all (29%) • Total number of projects: 1266 • Alert (SAME) topics: 150 (12%) • Similar projects (within alert topics): 390 • Access-rights: 42 partners

10th (Sept/Oct 2012) POP Request Out of 55 EUnteHTA JA partners: • 31 responded and entered projects into

the database • 12 responded but DID NOT feed the

database • 12 did not respond at all (29%) • Total number of projects: 1259 • Alert (SAME) topics: 143 (11%) • Similar projects (within alert topics): 394 • Access-rights: 43 partners

Currently the POP database contains: 1260 planned, ongoing and recently published projects

– from 43 EUnetHTA JA partners – from 24 countries


Focus on HTA in Europe to • strengthen the practical application of tools and

approaches to cross-border HTA collaboration • achieve a better understanding for the European

Commission and Member States of ways to establish a sustainable structure for HTA work in the EU

• produce recommendations regarding the design and management of the future EU HTA cooperation

EUnetHTA Joint Action 2: 2012-15



Stakeholder Forum

Plenary Assembly (policy setting)

Secretariat

reporting control

reporting control

reporting support/control

coordination / exchange of info

Determine activities

Work Package

EU

Institutions

info

Executive Committee (strategic planning of activities)

Work Package

Work Package

Work Package

Work Package

Work Package

Work Package

Work Package

info


– EPARs improvement project (collaboration)

– Early dialogue, HTA-EMA Parallel scientific advice (coordination)

– Guidelines (coordination)

– Rapid HTA, pilots, future developments (coordination)

– Post-licensing studies (collaboration) • database, common core protocol

Cooperation between EUnetHTA and EMA



Composition of the Stakeholder Forum

Payers

Providers

Patients / citizens Industry

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