Kawalec Paweł, Tesar Tomas, Vostalova Lenka, Draganic Pero, Manova Manoela, Savova Alexandra, Petrova Guenka, Rugaja Zinta, Männik Agnes, Sowada Christoph, Stawowczyk Ewa, Harsanyi Andras, Inotai Andras, Turcu-Stiolica Adina, Gulbinovič Jolanta, Pilc Andrzej
Health Sciences Faculty, Institute of Public Health, Jagiellonian University Medical College, Kraków, Poland.
Department of Organization and Management in Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
Front Pharmacol. 2017 Dec 18;8:892. doi: 10.3389/fphar.2017.00892. eCollection 2017.
The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries. A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017. The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application. Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.
本研究的目的是回顾中东欧（CEE）部分国家的报销环境以及药品定价和报销要求。2016年11月至2017年3月期间，对来自保加利亚、克罗地亚、捷克共和国、爱沙尼亚、匈牙利、拉脱维亚、立陶宛、波兰、斯洛伐克和罗马尼亚等中东欧国家参与报销事务的专家进行了问卷调查。对报销要求及卫生技术评估（HTA）的影响进行了审查，以比较上述国家的相关问题。还收集了每个指定国家2014年和2015年的报销费用、药品总预算和公共卫生保健总预算数据。问卷通过电子邮件分发，并以相同方式获取反馈数据。如有其他问题，也通过电子邮件提交给受访者。定价和报销数据截至2017年3月有效。调查显示，2014年和2015年（中位数）药品报销费用与公共医疗总支出的比例在0.12至0.21之间。调查还显示，中东欧国家采用的药品定价标准相当相似。外部参考定价和内部参考定价在上述国家都很常见。中东欧地区所有国家的正面报销清单均有效，负面清单很少使用；大多数国家的报销决定会定期修订和更新。共付费用很常见，各国之间和各国国内的报销水平各不相同，范围从20%到100%。风险分担计划经常被采用，尤其是对于创新型昂贵药品。在所有分析的中东欧国家，仿制药替代也是可能的，而有些国家则将其强制化。几乎所有被考虑的中东欧国家都开展了卫生技术评估，提交定价和报销申请时必须提供HTA档案。中东欧地区的定价和报销要求相当相似，尽管也发现了一些差异。在所考虑的国家中，HTA评估普遍被使用。
