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This article discusses the implementation of a transparent process for drug reimbursement decisions in Poland. It highlights the challenges faced in the past, the steps taken to improve transparency, and the results achieved. The importance of cooperation between policymakers and industry is emphasized.
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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
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
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
Experts missions • Analysis of law regulations, institutions involved, problems • Recommendations in missions’ reports But… no progress • Workshops with decision makers!
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
Workshops 3 groups: • Reimbursement and pricing criteria • Division of responsibilities between institutions involved • Role of stakeholders ( doctors, pharmacists, patients, other institutions)
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;
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
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
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
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.
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
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
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)