20151020-21Health Technology Assessment (HTA)

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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EUnetHTA

European network for

Health Technology Assessment

Health Technology Assessment (HTA) – A structured

process of applied research to inform policies and

decisions in healthcare

Conference: Putting Science into Standards – evidence-based quality

assurance – an example for breast cancer

Joint Research Centre, ISPRA, Italy,October 22, 2015

Finn Børlum Kristensen, MD, PhD

Professor, Health Services Research & Health Technology

Assessment, University of Southern Denmark

Director, EUnetHTA Secretariat

Danish Health Authority (EUnetHTA Coordinator),

Copenhagen, Denmark

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 2

HTA’s contribution to quality

improvement

• While quality assurance or development is about doing things right health technology assessment (HTA) is about doing the right things.

• The origins of HTA are Evidence Based Medicine, health policy analysis, and health economics.

• EUnetHTA was established to create an effective and sustainable network for HTA across Europe


An example of an HTA

An example of an HTA of prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX )

• http://www.eunethta.eu/outputs/prognostic

-tests-breast-cancer-recurrence-ptbcr

• http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Production%20of%20Core%20HTA%20Information_Comprehensive%20HTA_Activity%20Station%20poster.pdf

http://www.eunethta.eu/outputs/prognostic-tests-breast-cancer-recurrence-ptbcr












http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Production of Core HTA Information_Comprehensive HTA_Activity Station poster.pdf






What is Healthcare 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

INAHTA


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


HTA aim

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


Eclectic (multidisciplinary)

Four main streams of applied research methodology have contributed to the development of HTA

- policy analysis

- evidence based medicine

- health economic evaluation

- social and humanistic sciences


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

HTA

Priority-setting

and

decision-making

Advising,

recommending

HTA

Priority-setting

and

decision-making

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Scope of EUnetHTA’s work

EUnetHTA supports collaboration between European

HTA organisations that brings added value at the

European, national and regional level through

- facilitating efficient use of resources available for HTA

- creating a sustainable system of HTA knowledge sharing

- promoting good practice in HTA methods and processes

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HTA and context

Globalize the evidence, localize the decision

J.M. Eisenberg

Locate the decision, globalise the evidence, localise the reporting

EUnetHTA

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The Domains of the HTA Core Model®

- assessing dimensions of value

HTA Core Model DOMAINS

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. Patient and social aspects

9. Legal aspects

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SCOPE

Rap

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Reli

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Health Technology Life-cycle


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Early scientific

advice

Rapid

REA

Additional

data

collection

HTA / REA

Use o

f te

chnolo

gy in h

ealth c

are

Time line of innovation


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Description

The EUnetHTA Planned and

Ongoing Projects (POP) database

allows EUnetHTA Partners

and Associates to share information

on planned, ongoing or recently

published projects of participating

agencies and identify similar

projects through a matching system

provided by the online database

The POP Database


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Purpose

To facilitate

collaboration

among

European HTA

agencies and

reduce

duplication of

work


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Development

9 Methodological Guidelines for Rapid

REA of Pharmaceuticals developed in

JA1 and revised in JA2 to include

medical devices plus 5 new for HTA

Content

Guidelines on methodological

challenges that are encountered by

health technology assessors while

performing a rapid relative effective-

ness assessments and HTA

Primary Aim

To help the assessors of evidence

interpret and process the data that are

presented to them as part of an HTA..

14 Methodological Guidelines for HTA and Rapid Relative Effectiveness Assessment

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• 15 joint full HTAs and REAs

• 20+ early dialogues (incl. SEED Project)

EUnetHTA Joint Assessments and early scientific advice (early dialogues)


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EUnetHTA Partners and

Associates in JA2

44 Partner organisations

designated by EU Member

States

Large number of regional

agencies and non-for-profit

organisations that produce

or contribute to HTA

*) Norway participates in the

Third EU Health Programme

(2014-2020)

EU Participants* in EUnetHTA


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• GBA, IQWIG, DIMDI, Medical Valley - EMN, Germany • HAS, France • NICE, NETSCC, HIS, United Kingdom • AGENAS, AIFA, ASSR, Veneto Region, Gemelli Hospital, Italy • ISCIII, AETSA, AQuAS, Avalia-T, IACS, OSTEBA, SESCS,

UETS, Spain • AOTMiT, Poland • NSPH MPD, Romania • ZIN, Netherlands • KCE, INAMI, Belgium • INFARMED, Portugal • SBU, TLV, Sweden • LBI, HVB, GÖG, UMIT, Austria • THL, FIMEA, Finland • AAZ, CHIF, Croatia • NHS, Latvia • DHA, Denmark (Coordinator), CFK, Central Region, KORA

Some of the Partner Organisations

in Joint Action 2 (2012-15), e.g.

NCHTA, Russia, as a

Collaborating Partner,

has paid a keen interest

to the activities of

EUnetHTA since 2010


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• HTA is very valuable for the healthcare system

• HTA is driven by policy needs – clarifying options

and consequences for the decision-making (by

politicians, competent authorities)

• Establishment of HTA is a complex process and

needs permanent operational support

• Implementation of an HTA system takes

substantial time

International experience from the last few decades

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“The Union shall support and facilitate cooperation

and the exchange of scientific information among Member States

within a voluntary network connecting national authorities or bodies

responsible for health technology assessment designated by the

Member States… That network shall be based on the principle

of good governance including transparency, objectivity,

independence of expertise, fairness of procedure

and appropriate stakeholder consultations”

Article 15 of the Directive 2011/24/EU on cross-border health care


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2013+ HTA Network

The timeline of reaching a sustainable and permanent HTA network in Europe

European network for Health Technology Assessment | JA2 2012-2015 |

www.eunethta.eu

20

2005 Call for

project

proposals

2009 Call for joint

action

2011 Call for

joint

action

2006-2008 EUnetHTA

Project

2009 EUnetHTA

Collaboration

2008-2011 Draft Cross Border

Healthcare Directive.

Article 15 on HTA network

2011-12 CBHC

Directive

now

decided

2013 EU Cooperation

on HTA

Implementing

Decision

2016-2019 Financial support

HTA (JA3)

2011 FP7-Health

2012-Innovation-1

New methodologies for HTA

(example INTEGRATE-HTA)

Legislation

DG R&I

Health

Programme

2010-2012 EUnetHTA

JA

2016-2019 EUnetHTA

Scientific and technical

cooperation (JA3)

Horizon 2020

Calls

Health Care

2012-2015 EUnetHTA

JA2

2020- Permanent

collabor-

ation


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Thank you for your attention

This presentation arises from the EUnetHTA

Joint Action 2 which has received funding

from the European Union, in the framework

of the Health Programme

21 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

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20151020-21Health Technology Assessment (HTA)