1. HTA in Poland Wojciech Matusewicz, Ph.D., M.D. – Director Iga Lipska, M.D. – Head of HTA Department Agency for Health Technology Assessment in Poland AHTAPol

2. 1.Poland and Polish health care system 2.AHTAPol legal basis 3.AHTAPol tasks and activities 4.AHTAPol analytic team 5.Drug reimbursement / HTA

3. Poland

4. Polish health care system Centralised Health insurance system - taxes National Health Fund (NHF) 16 regional branches NHF concludes contracts with health service providers NHF budget for 2009 is 56,8 billion PLN (14 billion EURO) Drug reimbursement - 7,3 billion PLN (12,9%) Therapeutic drug programs - 1,3 billion PLN (2%) Total public spending about 4% GDP.

5. AHTAPol - Legal basis Created in 2005 (Ordinance by MoH Sept 2005) The possible lowest legal act So far updated every year: June 2006 Sept 2007 Sept 2008 Steps undertaken to prepare the Law on AHTAPol establishment The Bill prepared and submitted for Parliament work Planned to come into force in 2009 (June?)

6. AHTAPol – tasks and activities Still a lot of discussions Which activities should be performed by this institution Which model of the Agency should be implemented Light Heavy (limitations) Mixed International collaboration! EUnetHTA, INAHTA, HTAi, ISPOR, GIN Drug reimbursement list (Transparency Directive!) Therapeutic programmes Non – drug technologies

7. AHTAPol - tasks and activities

8. Horizon scanning/new and emerging technologies Early warning/awarness system Stakeholders’ involvement Screenning programmes Education in HTA Cascading/distance learning programmes Registries Clinical Practise Guidelines Eastern Dimension Capacity Building AHTAPol – FUTURE tasks and activities

9. AHTAPol - Analytic team Build a strong team - one of the biggest tasks for a new institution Motivation system created to maintain people working in Agency Continuous trainings International collaboration Professional development Money, money, money… Maybe not only : )) Salaries - public administration v. private sector

10. AHTAPol - Analytic team POSSIBILITIES EU funded project 2 million EURO Twinning project Poland - France (Oct 2006 - Apr 2008) 2 Components: Institutional - proposals of structural and procedural improvements for AHTAPol and other institutions Trainings in EBM and HTA DOERS – about 30 people USERS – about 300 people Training for trainers – about 15 people trainned 7 internships 2 months longCORE of THE TEAM 1 internship 6 months long

11. AHTAPol - Analytic team

12. Drug reimbursement / HTA Drug reimbursement list Therapeutic programmes Revision of applications Submitted by the industry Assessment of analysis in terms of credibility and quality Clinical effectiveness Cost effectiveness Budget impact analysis Consultative Council (CC) – the role

13. CC recommendation types “Finance” “Finance temporarily, provided that the data are gathered to a final decision” ”Finance provided that some precisely criteria are met or in particular indications” “Finance provided that a cost-effective way of financing was assured” “Not to finance” “Increase financing” “Decrease financing” ”Not to change financing”

14. HTA in decision making process Assessment and Appraisal Completely separated processes Assessment/Revision of industry submission – by Analytic Team Appraisal – by Consultative Council CC recommendation Decision making – Ministry of Health

15. Thank you for your attention Questions???