Brief introduction to eunethta and its tools Marianne Klempb · A brief introduction to EUnetHTA and its Tools Marianne Klemp / NOKC / research director Third WP2 Face to Face Training

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

A brief introduction toEUnetHTA and its Tools

Marianne Klemp / NOKC / research directorThird WP2 Face to Face Training Course for EUnetHTA stakeholders, Brussels, 23rd of April2015


2004 The European Commission and the Council of Ministers targetHealth Technology Assessment (HTA) as “a political priority”,recognising “(…) an urgent need for establishing a sustainableEuropean network on HTA”

2005 Call for project proposal answered by a group of 35 organisationsthroughout Europe

2006 EUnetHTA Project (2006-2008)

2009 EUnetHTA Collaboration (2009)

2010 EUnetHTA Joint Action 1 (2010-2012)

2012 EUnetHTA Joint Action 2 (2012-2015)

Historical Timelineof EUnetHTA

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EUnetHTA Joint Action 2 (2012-2015)Objectives

• To achieve a better understanding for the European Commissionand Member States of ways to establish a sustainable structurefor the HTA work in the EU

• To produce recommendations regarding the design andmanagement of the future EU HTA cooperation

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Total budget: € 9,428,550

• To strengthen the practical application of toolsand approaches to cross-border HTA collaboration


EUnetHTA Joint Action 2 (2012-2015)Work Packages

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WP1Coordination &

Sustainablenetwork

Implementation

WP2Dissemination &Capacity Building

WP3Evaluation &

Data Collectionon cost-

effectiveness

WP4Testing

collaborativeproduction

of HTAinformation

WP5Applyingthe HTA

Core Modelfor Rapid

Assessment

WP6Information

ManagementInfrastructureand Services

(IMIS)

WP7Methodologydevelopmentand evidence

generation

WP8Maintenanceof HTA Core

Modelinfrastructure


• Recommendations on the implementation of sustainableEuropean network for HTA

• Full Core HTAs

• Pilot rapid assessments

• Methodological guidelines and templates to support productionof core HTA information and rapid assessments

• Guidelines and pilots to improve quality and adequacy of initialand additional evidence generation

• Upgraded and updated application package of HTA Core Model

• Report on yearly training courses on EUnetHTA tools and methodology

• Report on evaluation of project completion including assessmentof the impact on secondary users of HTA information

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EUnetHTA Joint Action 2 (2012-2015)Planned deliverables


Project JA1 JA2

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Establishment Putting intopractice

Strengtheningpractical

application


Organisational andGovernance Structure

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Plenary Assembly

EU

Insti

tuti

on

s

ExecutiveCommittee

StakeholderForum

The Secretariat

WP1 WP2 WP3 WP4 WP5 WP6 WP7 WP8

SAGs

EUnetHTA Organigram


Composition of theStakeholder Forum

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PayersPatients/

ConsumersIndustry Providers


To provide stakeholders withthe opportunity

• to participate as stakeholderrepresentatives in the EUnetHTAJoint Actions

• to observe and comment on theEUnetHTA Joint Action work

• to provide advice to overarchinggovernance questions in the JointActions, and

• to bring forward specific themes andconcerns considered relevant by thestakeholders' constituencies inline with the aims of the EUnetHTAJoint Actions

Purpose of theStakeholder Forum

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

EUnetHTA Partners and

Associates in JA2.

Large number of regional

agencies and non-for-profit

organisations that produce

or contribute to HTA

Participants JA2

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EUnetHTA Output


Health TechnologyLife-cycle

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Early scientificadvice

RapidREA

Additionaldata

collection

HTA / REA

Use

ofte

chnolo

gy

inhealth

care

Time line of innovation


EUnetHTA HTA Core Model Online

EUnetHTA Planned and Ongoing Projects Database (POP)

EUnetHTA Evidence database on new technologies (EVIDENT)

EUnetHTA Adaptation Glossary & Toolkit

EUnetHTA Contact Database

EUnetHTA Intranet Groups

EUnetHTA E-meeting facility

EUnetHTA News Aggregator

EUnetHTA Tools

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The HTACore Model®

Description

The HTA Core Model® is amethodological framework forshared production and sharing ofHTA information.

Purpose

To enable production of highquality HTA information in astructured format to support theproduction of local (national orregional) HTAs and reuse ofexisting information.


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The Domains of theHTA Core Model®


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Core HTA Structure


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The POP Database

Description

The EUnetHTA Planned and Ongoing Projects(POP) database allows EUnetHTA Partnersand Associates to share information on planned,ongoing or recently published projects ofparticipating agencies and identify similar projectsthrough a matching system providedby the online database.

Purpose

To facilitatecollaborationamong EuropeanHTA agencies andreduce duplicationof work.


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POP Statistics:Quarterly Updates

In the third quarter of 2014, the POP Database contained: 1,249 planned,ongoing and recently published projects from 47 EUnetHTA JA partners and 25countries

2014 Q3 POP Request

Out of 70 EUnetHTA JA partners:

• Response rate: 64 %

• Total number of projects: 1,266

• Alert (SAME) topics: 88 (7 %)

• Similar projects (within alert topics): 208

• Access-right: 45 partners

2014 Q4 POP Request

Out of 71 EUnetHTA JA partners:

• Response rate: 70 %

• Total number of projects: 1,249

• Alert (SAME) topics: 103 (8 %)

• Similar projects (within alert topics): 203

• Access-right: 50 partners


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The EVIDENTDatabase

Description

The EVIDENT Database enables sharingearly information on evidence gapsidentified during the production of HTAreports and consequent recommendations/ requests for additional data collection.

It also contains information onreimbursement / coverage andassessment status of promisingtechnologies in Europe.

Purpose

To reduce redundancy,promote generationof further evidenceand facilitate Europeancollaboration in thedomain.


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The EVIDENT DatabaseOnline

Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml


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9 Methodological Guidelinesfor Rapid REA

Development

9 Methodological Guidelines for RapidREA of Pharmaceuticals developed inJA1 by WP5.

Content

Guidelines on methodologicalchallenges that are encountered byhealth technology assessors whileperforming a rapid relativeeffectiveness assessment ofpharmaceuticals.

Primary Aim

To help the assessors of evidenceinterpret and process the data that arepresented to them as part of a REA.


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9 Methodological Guidelinesfor Rapid REA

Endpoints used for REAof pharmaceuticals

1.Clinical endpoints

2.Composite endpoints

3.Surrogate endpoints

4.Safety

5.Health-related quality of life

Comparators and comparisons

6.Criteria for the choice of the mostappropriate comparator(s)

7.Direct and indirect comparison

Levels of evidence

8.Internal validity

9.Applicability of evidence in thecontext of a relative effectivenessassessment

Link to the guidelines:

http://www.eunethta.eu/eunethta-guidelines


• increased collaboration between European HTA organisations

• practical efforts in improving efficient use of resources available for HTA

• the creation of a sustainable system of HTA knowledge sharing

• the promotion of good practice in HTA methods and processes

• the basis for delivery of reliable, timely, transparent and transferableinformation contributing to HTAs in European countries

EUnetHTA hasfacilitated…

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Thank you

This presentation arises from the EUnetHTA

Joint Action 2 which has received fundingfrom the European Union, in the frameworkof the Health Programme

Documents

Brief introduction to eunethta and its tools Marianne Klempb · A brief introduction to EUnetHTA and its Tools Marianne Klemp / NOKC / research director Third WP2 Face to Face Training