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EUnetHTAEuropean network for Health Technology Assessment

DATABASES, REGISTRIES AND OTHER DATA CAPTURE TOOLS: HOW CAN WE AVOID MULTIPLICITY AND CREATE AN INTEGRATED DATA-CAPTURE APPROACH ALONG THE PRODUCT DEVELOPMENT CYCLE?

The HTA perspectiveDIA, Vienna March 26, 2014

Finn Børlum Kristensen, MD, PhDDirector, EUnetHTA SecretariatDanish Health and Medicines Authority (EUnetHTA Coordinator)Copenhagen, Denmark

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Disclaimer

• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated

• These PowerPoint slides are copyright of the European network for Health Technology Assessment. Reproduction is permitted provided the source is acknowledged.

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

National, regional agencies,

universities, hospitals and non-

for-profit research organisations

38 Associated Partner

organisations designated by

Member States

30 Collaborating Partners

contribute in kind

Participants in EUnetHTA JA 2 2014

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• Germany, IQWIG,DIMDI• France, HAS• UK, NICE, NETSCC• Italy, AGENAS, AIFA, ASSR Emilia Romagna, Veneto Region• Spain, ISCIII, AETSA, OSTEBA, Avalia-T, AQuAS• Croatia, AAZ• Poland, AHTAPOL• Austria, LBI, HVB, GÖG• Netherlands, CVZ• Belgium, KCE• Portugal, INFARMED• Sweden, SBU, TLV• Norway, NOKC• Finland, THL, FIMEA• Denmark, DHMA (Coordinator), CFK Region Midt

Some of the Partner Organisationsin Joint Action 2 (2012-15), e.g.

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

• EUnetHTA specific

• National registries and databases in national HTA

• Parent

• EMA and ENCePP

• Standardisation and harmonisation

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This presentation

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Health Technology Life-cycle

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Early scientific advice

RapidREA

Additionaldata

collection

HTA / REA

Use

of

tech

nolo

gy in

hea

lth c

are

Time line of innovation

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

• Early scientific advice to technology sponsors (drugs, devices)

• Guidelines on assessing outcomes, diagnostics, and economic

evaluation

• Additional data collection

• Moving to joint production through piloting

• Aligning HTA and regulatory needs

• Appropriate stakeholder involvement

Specific initiatives along the lifecycle taken up within European HTA cooperation

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Description

The EVIDENT Database enables sharing early information on evidence gaps identified during the production of HTA reports and consequent recommendations / requests for additional data collection.

It also contains information on reimbursement / coverage and assessment status of promising technologies in Europe.

The EVIDENT Database

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Purpose

To reduce redundancy, promote generation of further evidence and facilitate Europeancollaboration in the domain.

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

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The EVIDENT Database Online

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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. Social aspects

9. Legal aspects

SCOPE

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Rel

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imel

y, t

ran

spar

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

• Cross Border PAtient REgistries iNiTiative (PARENT), is a Joint Action under the EU's Health Programme 2008-2013.

• Overall objective: To support member states in developing comparable and coherent patient registries in fields of identified importance (e.g. chronic diseases, rare diseases, medical technology)

• Aim. To rationalize and harmonize the development and governance of patient registries, thus enabling analyses of secondary data for public health and research purposes

• EUnetHTA is a member of the JA’s Associated Projects Group

• Read more at http://www.patientregistries.eu/

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Parent Joint Action

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• Opportunities, specific steps to improve the efficiency of the process and conditions for patients’ timely access to an effective medicine

• A three-year Workplan is being implemented

EUnetHTA-EMA Collaboration

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HTA 2.0 Europe

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Thank you for yourattention

This presentation arises from the EUnetHTA Joint Action 2 which has received funding from the European Union, in the framework of the Health Programme