IMPLEMENTATION OF TRANSPARENT PROCESS OF DRUG REIMBURSEMENT DECISIO N S IN POLAND

1. IMPLEMENTATION OF TRANSPARENT PROCESS OF DRUG REIMBURSEMENT DECISIONS IN POLAND Aleksandra Zagorska, Iga Lipska, Zbigniew Krol Agency for Health Technology Assessment in Poland Artur Falek - Ministry of Health, Poland Phillippe Sauvage, Alexandre Barna Ministry of Health, France Thijs van Ormondt – law expert, Holland

2. Poland in EUfrom 2004

3. Polish reimbursement decision-making process -2006 Failure of full implementation of „Transparency Directive” (89/105/EEC): • Unclear and long decision making process: • Criteria • Deadlines • Information • Lack of appeal proceedings against a decision Lack of experienced staff in newly created HTA Agency

4. EU founded project • EU twinning project signed between Poland and France (from October 2006 to April 2008) • 2 components (institutional and trainings) • During almost 2 years – 68 experts from all over EU came to help establish transparent and clear decision making process • Missions • Workshops • Study visits, trainings, internships

5. Experts missions • Analysis of law regulations, institutions involved, problems • Recommendations in missions’ reports But… no progress • Workshops with decision makers!

6. Workshops • Participants: experts, decision makers, industry, stakeholders • 1st was awareness workshop ! • Ministers confirmed the new bill will be prepared! • Continuation after project in Ministry of Health

7. Workshops 3 groups: • Reimbursement and pricing criteria • Division of responsibilities between institutions involved • Role of stakeholders ( doctors, pharmacists, patients, other institutions)

8. Reimbursement criteria • Impact on public health (health priorities) • Consequences of the disease (severity) • Proven clinical efficacy compared to gold standard; • Proven safety profile compared to gold standard; • Beneficial ratio of health effects vs. costs; • Justification, proven by HTA Agency (AHTAPol) recommendation • Proven accessibility on the market and/or guarantee of supply;

9. Impact of drug on direct costs of treatment; • Number of patient's population to whom the pharmacotherapy may refer; • Criterion of categorization of patients for therapy; • Known annual cost of reimbursement and its potential follow-up in respective years; • Financial feasibility of subject obliged to finance health services from public means

10. Levels of reimbursement

11. Pricing criteria • Reimbursement limits: • Therapeutic group • Generic group (the same active substance) • The limit is the price of DDD of the cheapest drug in the group

12. Setting reimbursement system • Reimbursement application sent to Ministry of Health • New molecules – assessment in AHTAPol • Recommendation of Consultative Council (8 types) • Price negotiations - Negotiation Committee • Final decision - Minister + Reimbursement Committee

13. Results • Law from August 2007 has fully implemented provisions of Transparency Directive related to deadlines of application examination (90 and 180 days). • The bill about reimbursement from October 2008 implements workshops results.

14. Results - AHTAPol Changes in regulations concerning Agency: • The bill gives stable legal framework for Agency (20 Oct 2008) • Stronger and independent position of AHTAPol • New ordinance signed at 10 September 2008: • Regulates tasks of Agency and it’s Consultative Council

15. What to do next? • Act of law concerning Agency has been prepared and will be implemented in January 2009 • New template of reimbursement application still not prepared • Knowledge about HTA and EBM still has to be disseminated

16. Lesson learned: • Good cooperation and dialogue between policy makers and industry is important • Policy makers are aware of importance of transparent and understandable process • Help from experienced countries is indispensible (the same problems, the same solutions)