Php320 - analysis of hta process on the basis of pharmacoeconomic guidelines in central eastern european countries

The aim of this study is to review and comparative analyses of the Pharmacoeconomic Guidelines (PhE-guidelines) for new International Nonproprietary Names (INN) in Central Eastern Europe Countries (CEEC) in order to compare the different parameters and methods, and whether the guidelines are regularly updated. Quantitative descriptive analyses have been applied in evaluating the current HTA-process, based on HTA methodologies/ PhE-guidelines in 10 CEEC: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Lithuania, Latvia, Poland, Slovakia, Slovenia. The parameters and methodologies are summarized through a descriptive study, which examined the historical development of the approved HTA or the PhE-guidelines. The diversity of HTA/ PhE-guidelines or recommendations in the surveyed CEEC prove that some of their published documents are dealing with pricing and reimbursement requirements only (Czech Republic, Slovakia and Slovenia) but the rest of the counties (70%) have HTA methodology/ PhE-guidelines. First in 2002 the Baltic counties have developed the economical evaluation of pharmaceuticals, followed by Poland (in 2010), Croatia (2011), Hungary (2013) and finally Bulgaria in 2015. In Baltic countries, Croatia and Poland (70%) PhE-guidelines are publicly available in English. Many indicators as source of costs, target population, subgroup analysis, systematic review of evidences, modeling, sensitivity analysis-methods, Incremental and budget analysis time horizon are analysed in order to see which indicators are with serious impact. Harmonization of HTA approaches of EU level is needed in the surveyed CEEC in order to precise the related evidence reimbursement requirements for new INN and to make the HTA process more harmonized and transparent for the new INN .