HTA cooperation in the EUHTA cooperation in the EULessons learntLessons learnt

Anders Lamark Tysse

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Presentation outline

Commission goals on HTAEU initiatives on HTALessons learntThe way forward

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Commission goalson HTA

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Commission’s overall goalson HTA

HTA= patients’ satisfaction, costscontainment, reward for innovation

All health technologies should becovered: prevention andrehabilitation, vaccines,pharmaceuticals and devices,medical and surgical procedures…and the health care systems

Overall goals (2)

Provide decision makers, healthprofessionals and managers,patients with robust scientificevidence on technologies

Reduce duplication of work for MS

Reduce the national hurdles tomarket access faced after licensing

Support MS with little HTA capacity5

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EU initiativeson HTA

On-going initiatives on HTA

2006-2008: EUnetHTA project

2008: Ministerial Pharma forum

2010: 1st joint action on HTA

2010: CAVOD initiative

2010: Pilot on multi-stakeholders’dialogue

2010: Pharmacovigilence directive

2010: Collaboration with academics7

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1st Joint Action EC/MS EunetHTA

Period: 2010-2012, 24 MS

Budget: 6 Mio € (50 % supported by EU)

EUnetHTA’s objectives:To further develop the ”core HTA” methods

To develop specific methods on relativeeffectiveness assessment of pharmaceuticals+ improvement of EPAR’s

To conduct horizon scanning of new tech.

To set up an information managementsystem + long term business model

To set up a policy on stakeholder’sinvolvement

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Lessons learnt

Lessons learnt (1)

Building a network takes time

Governance and cooperationstructures

Defining areas of cooperation andmethodolical approach

Much duplication of work takingplace

Strong stakeholder interest10

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Lessons learnt (2)

Need for more knowledge to test thepossibilities of joint/coordinatedEuropean HTA production

Need to increase capacity at stakeholderlevel, particularly patients and healthprofessionals

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2nd Joint Action 2012/ 2014?

Overall objective: need for betterknowledge/ feedback on opportunitiesand limitations to joint HTA productionProduction of joint HTA’s + core HTA’s

Early assessments of pharma + MDHead to head comparisonsMultiple technologies HTA’s…

Increase capacities of stakeholdersTest real life governance of thecooperation + collect info on costs andorganisational mattersTotal budget: up to 7 Mio €

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The way forward

On-going initiatives on the “HTAenvironment”HTA is part of the overall EC’sobjective of “responsible innovation”

2010: EU 2020 strategy’s flagshipson innovation and digital agenda

2010: preparation of the next EUCohesion Policy + FP8

2010: launch of revision of theTransparency + Data Protectiondirectives 14

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The proposed directive on cross-border health care (CBHC)

Art. 14 ➱ From project-based topermanent cooperation on HTA“The Union shall support and facilitatecooperation and the exchange of scientificinformation among Member States within avoluntary network connecting nationalauthorities or bodies responsible for healthtechnology assessment designated by theMember States.The members of the network shall participateand contribute to the network’s activitiesaccording to the legislation of the MemberState where they are established”.

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The CBHC (2)

Art. 13 Cooperation on eHealth: overallobjectives

Emergency careContinuity of careSupport to innovation

3 concrete areas of work at EU level:Data to be included in patients summaries; (to beshared between health professionals to enablecontinuity of care and patient safety across borders)Collection of medical information for public health andresearch;Identification & authentication measures to facilitatetransferability of data in cross-border healthcare.

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State of play of the directive

First reading finished in EP and Council;2nd reading autumn 2010

The issues at stake on HTA cooperation

Scope of the work: relative efficacy versuseffectiveness?

How binding should the conclusions be?

How much money are MS/ industry ready toput? Impact on the HTA production?

Degree of stakeholders’ involvement?

Decision making process

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Governance of the cooperation

What is taken for granted is:

MS HTA bodies will do the work

HTA process should remain separate fromthe regulatory process

Reflection process on the structure:

EC/ MS coordination and hosting

Decision making process/ CAVOD may help

Capacity to cover all and cross technologies

Build on existing synergies, expertise andother regulatory requirements (PRAC)

Cost/ efficiency of the structure itself

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Conclusions

HTA part of the overall EU strategyon innovation

There is a strong added value inconsidering HTA at EU level:

Pooling of expertise

Minimised duplication of efforts

Final objective is not harmonisationof the decisions. But somestandardisation may be agreedbetween MS.

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Conclusions (2)

Stakeholders’ involvement is a keysuccess factor of cooperation at EU level

All actors involved need to explore newways of working together.Defragmentation is needed.

A sustainable cooperation is needed.Long term solutions are currently beingevaluated.

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Further information

www.eunethta.eu

http://ec.europa.eu/health/index_en.htm

http://phis.goeg.at http://ppri.oebig.at

http://ec.europa.eu/enterprise/sectors/healthcare/process_on_corporate_responsibility/index_en.htm