HTA collaboration in Europa - European Health … · European network for Health Technology...

European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

HTA collaboration in Europapast, present and future perspectives

European network for Health Technology Assessment

Wim Goettsch, EUnetHTA JA3 directorate, Zorginstituut Nederland

EFHG Outcomes Event, Vienna, June 28, 2017

European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu2

Content presentation

• Overview of current activities in Europa

• EUnetHTA

• Structural HTA collaboration after 2020

• Conclusion

EU cooperation on HTA

3

Current EU cooperationon HTA

• Cooperation beyond 2020

• Inception Impact Assessment

• Description of the status quo

• Options for the future

Policy and strategic cooperation

Art 15 Directive 2011/24

Set up October 2013

Multiannual work programme

Permanent

HTA Network

Scientific and technical cooperation

Started in the 1990's, later EUnetHTA

Now Joint Action 3 – 2016 – 2020

EUnetHTAJoint

Action

New HTA Initiative

Synergy and complementarity


EUnetHTAHistorical timeline

2006 2016

EUnetHTA

Collaboration

EUnetHTA

Project Joint Action 1 Joint Action 2 Joint Action 3

InceptionPutting into

practice

Strengthening

practical

application

Turning pilots

into standard

practice


Project Coordinator:

Dutch National Health Care

Institute (ZIN)

EUnetHTA JA3 (2016-2020)

Aims to build a sustainable model

for the scientific and technical

cooperation on Health Technology

Assessment (HTA) in Europe

81 partners consisting of national,

regional and non-for-profit agencies

that produce or contribute to HTA


Organisational and Governance Structure

DG SANTE and CHAFEA

WP2

Dissemination

WP3

Evaluation

WP4

Joint Production

WP5

Evidence

Generation

WP6

Quality

Management

WP7

Implementation

Lead:

AETS-ISCIII

Lead:

TLV

Lead:

NIPHNO

Co-lead:

LBI

ZIN

Lead:

HAS

Co-lead:

GBA

Lead:

IQWiG

Co-lead:

KCE

Lead:

NICE

Co-lead:

Agenas

WP1 Network Coordination - Dutch Health Care Institute

EU

netH

TA

Assem

bly

Executiv

e B

oard

Spain Sweden Norway Austria* Netherlands Germany

United Kingdom Belgium Croatia Cyprus Czech Republic Denmark

Finland France Greece Hungary Ireland Latvia

Malta Poland Portugal Romania Slovakia Slovenia

Italy Estonia Lithuania Bulgaria Switzerland *HVB, LBI, GOEG, UMIT

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiNlsvxtMjNAhXmJJoKHaswDCIQjRwIBw&url=https://en.wikipedia.org/wiki/Flag_of_Europe&bvm=bv.125596728,d.bGs&psig=AFQjCNG9GIhqShF5SNo_zMLIS5IIenYC1w&ust=1467123920159026

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwip8eOwt8jNAhVBCZoKHasvDTYQjRwIBw&url=https://wiki.hattrick.org/wiki/Espa%C3%B1a&bvm=bv.125596728,d.bGs&psig=AFQjCNEh9eg2UK9e2CvACqKkkSqc3EEx3A&ust=1467124653382360

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiV1fePuMjNAhXhJ5oKHQ2uBCcQjRwIBw&url=https://en.wikipedia.org/wiki/File:Flag_of_Sweden.svg&psig=AFQjCNFDmp8W_RkDASVQO1p9PdF2zz3KPw&ust=1467124853488317

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjSp9DxuMjNAhXjDpoKHdADBTYQjRwIBw&url=http://flaglane.com/download/norwegian-flag/&bvm=bv.125596728,d.bGs&psig=AFQjCNExoiCBUaEfq5cM4Kppa39aNHAR-A&ust=1467125032345745

http://www.crwflags.com/fotw/images/a/at_govt.gif

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjx4p2zucjNAhXrFJoKHYfmBTIQjRwIBw&url=https://nl.wikipedia.org/wiki/Vlag_van_Nederland&psig=AFQjCNGiO7bcMcZE4oZIyeumbfS3oJIvbA&ust=1467125195826555

http://www.google.nl/url?sa=i&rct=j&q=&source=imgres&cd=&cad=rja&uact=8&ved=0ahUKEwiL_Lf8ucjNAhWEHpoKHSdIAA8QjRwIBw&url=https://nl.wikipedia.org/wiki/Vlag_van_Frankrijk&psig=AFQjCNFAGM7EAHMVNgdBo9mdhqUGdLR0jg&ust=1467125350856430

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjisbiVusjNAhWjE5oKHZ93Dh0QjRwIBw&url=https://en.wikipedia.org/wiki/Flag_of_Germany&psig=AFQjCNGBA7yJF6xVzNO-mJ8EwBOyV9k7xw&ust=1467125402187452

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjisbiVusjNAhWjE5oKHZ93Dh0QjRwIBw&url=https://en.wikipedia.org/wiki/Flag_of_Germany&psig=AFQjCNGBA7yJF6xVzNO-mJ8EwBOyV9k7xw&ust=1467125402187452

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiy2eqNu8jNAhVGSZoKHTUADkUQjRwIBw&url=http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&ved=0ahUKEwjT24yEu8jNAhVBDJoKHaJzDQ8QjRwIBw&url=http://www.mapsofworld.com/flags/belgium-flag.html&bvm=bv.125596728,d.bGs&psig=AFQjCNHWTxr7TvIPwJv5MT2n99upY7z4_w&ust=1467125633586210&bvm=bv.125596728,d.bGs&psig=AFQjCNHWTxr7TvIPwJv5MT2n99upY7z4_w&ust=1467125633586210

http://www.google.nl/url?sa=i&rct=j&q=&source=imgres&cd=&cad=rja&uact=8&ved=0ahUKEwiwgMCOvMjNAhVQSZoKHQA4BNgQjRwIBw&url=https://nl.wikipedia.org/wiki/Vlag_van_het_Verenigd_Koninkrijk&psig=AFQjCNEkE9Rdyoja-snWOwje8ovLI1jP_w&ust=1467125925518524

http://www.google.nl/url?sa=i&rct=j&q=&source=imgres&cd=&cad=rja&uact=8&ved=0ahUKEwjmnaejvMjNAhXDFywKHYtiBygQjRwIBw&url=https://nl.wikipedia.org/wiki/Vlag_van_Itali%C3%AB&psig=AFQjCNHyjvgbR55OuI4n-P2eflwUaYrqlQ&ust=1467125969165402

https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjx4p2zucjNAhXrFJoKHYfmBTIQjRwIBw&url=https://nl.wikipedia.org/wiki/Vlag_van_Nederland&psig=AFQjCNGiO7bcMcZE4oZIyeumbfS3oJIvbA&ust=1467125195826555


WP4 Joint Production

• To produce 43 rapid REA on other technologies and 37 on pharmaceuticals

• Two assessments on oncology products (midostaurin, regofarenib) are ongoing

• To provide a system for topic selection and prioritization

WP5 Evidence Generation

• To conduct Early Dialogues (joint HTA or parallel/joint with regulators)

• Early Dialogue WP (HAS, G-BA, NICE, AIFA (RER), NIPN, RIZIV/ZIN) has started

• One joint parallel regulatory/HTA process will start this year

• To link additional data collection to on-going activities

WP6 Quality Management

• To provide quality management for EUnetHTA joint products

WP7 National implementation and impact

• To facilitate the uptake of joint products at the national/local level

Summary of select activities in JA3

7


HTA in the life cycle of technologies

Presenting and

discussing

requirements

studies in ED*Additional data

collection

Comparative or full HTA / REA

Use o

f te

chnolo

gy in h

ealth c

are

Time line of innovation

Collecting evidence in

development

Preparing submission

files for EMA and HTA

HTA

Technology

Producers

*Early dialogue

Stakeholders

Assessment for

market authorization

Rapid

REA


EunetHTAStakeholders

Patients & Consumers

Regulators

Technology Producers

Payers/

Decision-makers

Providers

Research & Academia


Stakeholder Involvement in JA3

1. Strategic involvement• Stakeholder pool in the HTA Network

• Participation in the EUnetHTA Forum (Sept 14, 2017 (yearly

interactions)

2. Participation in Work Packages• Information/knowledge on specific technical questions

• Interaction on the level of specific activities like the Early dialogues

and Joint Assessments (WP4)

• Interaction on the level of methodologies, guidelines and procedures

3. Structural collaboration with EMA• One process for parallel early dialogue/scientific advice

• Information sharing during REA and assessment for market

authorization

• Collaboration on additional data collection

European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu June 12, 2013 11

Example: Rapid REA (Pharma)

Sco

pin

gA

sse

ss

men

t

Structural EU HTA collaboration after 2020

EU initiative on HTA - Policy options*

Option 1 Option 2 Option 3 Option 4 Option 5

Status quo –voluntary cooperation

Long-term voluntary cooperation (beyond 2020)

Cooperation through the collection, sharing and use of common tools and data

Cooperation on production of joint REA (relative effectiveness assessments) reports

Cooperation on production of joint Full HTA reports (REA+economic)

Non-legislative / voluntary Legislative / voluntary + mandatory

*Inception Impact assessment available at: http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdf

Policy options*

ScopeCoordination/

secretariatFunding

mechanism+ Issues to be addressed


• Clear pathway from EUnetHTA JA3 to sustainable

collaboration after 2020• Work according to a life-cycle approach

• Joint REAs and parallel regulatory/HTA ED move out of pilot phase

• Full interaction with stakeholders is pursued including interaction with the

final decision makers/payers in order to increase implementation

• Results consultation on post2020 scenario show preference for options 3/4• Cooperation to joint REA is voluntary but uptake is mandatory in case of participation

• Relevance for developments in Austria • European HTA collaboration will link to regional activities such as BeneluxA

• Regional horizon scanning could also have additional value for European

collaboration

• Implementation of the EUnetHTA joint products in Austrian practice will have

a focus in the coming period

Conclusions

13


Thank youAny Questions?

HTA collaboration in Europa - European Health … · European network for Health Technology...

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