EU cooperation on HTA Flora Giorgio DG SANCO ( eHealth and HTA) Sum - PowerPoint PPT Presentation

EMA-HTA parallel scientific advice Session 1 W hy this is needed and W hat/ W here do w e w ant to get to EU cooperation on HTA Flora Giorgio DG SANCO ( eHealth and HTA)

Sum m ary - EU Cooperation on HTA • Yesterday • Today • Tomorrow

EU cooperation on HTA- How did we get there* Health Programme 2014-2020 2005 2009 2011 Financial support Call for Call for joint Call for project action joint HTA proposals action 2009 2010-2012 2012-2015 2016-2020 2006-2008 EUnetHTA EUnetHTA EUnetHTA EUnetHTA EUnetHTA Collaboration JA JA2 Scientific and Project technical cooperation Legislation 2008-2011 2011-12 2013 2013+ Draft Cross Border CBHC Directive EU HTA Network Healthcare Directive. now decided Cooperation Article 15 on HTA network on HTA Implementing Decision DG R&I 2011 FP7-Health Horizon 2020 2012-Innovation-1 Calls New methodologies for HTA Health Care * Adapted from slide of Prof. Finn Børlum Kristensen - Thanks European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 3

EU Cooperation in HTA - today • HTA Netw ork (art 15 Directive 2011/ 24)– strategic level (1 st meeting 16 October 2013)  MS representatives (mainly MoH); EMA associated • EUnetHTA (Joint Action HP)– scientific level – on-going until October 2015  HTA doers (mainly HTA Agencies) • Two levels in synergy and complementary • Involvement of stakeholders - both @ strategic level and scientific level

EU cooperation on HTA- results • EU HTA community built up  more trust between HTA doers. • Common HTA methodologies have been produced  joint piloting are on-going. • IT tools and training facilities are in place  for common use and sharing

EU cooperation in HTA – W here do w e w ant to go - HTA Netw ork MW P* ( I ) • Adoption of a long term vision on HTA cooperation and priorities for next phase of scientific cooperation (JA 3): • Scope of technologies (pharma, MD, complex interventions) • Scope of HTA: clinical versus other domains • Scope of interventions (from single technologies to micro/ intermediate/ macro issues) • Sustainable and cost/ effective cooperation mechanism * Multiannual Work Programme adopted by the HTA Network on 16 October 2013

EU cooperation in HTA – W here do w e w ant to go - HTA Netw ork MW P ( I I ) • Reflection paper on synergies between HTA and regulatory process  2 nd half 2015 Defragmentation ; cost-effectiveness • EUnetHTA pilots on early dialogues • EMA early dialogues • EC funded tender "SEEDS" 10 pilots on early dialogues (pharma + MD) • EMA-EUnetHTA Joint workplan

EU cooperation in HTA – W here do w e w ant to go - HTA Netw ork MW P* ( I I I ) • Reflection paper on conditions to facilitate take up and re-use at national level of joint HTA production including information and joint assessments  1 st half 2015 • Lessons from pilots • More "pilots" in the next phase of scientific cooperation

Conclusions • New phase of EU cooperation on HTA • Increase synergies/ defragmentation • Share common vision • Build on achievements

Thank you flora.giorgio@ec.europa.eu http:/ / ec.europa.eu/ health/ technolog y_ assessm ent/ policy/ index_ en.htm