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Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review

机译:中欧和东欧国家的药品法规:最新评论

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摘要

>Objectives: 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.>Methods: 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.>Results: 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.>Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.
机译:>目标:本研究的目的是审查中欧和东欧(CEE)某些国家/地区的药品报销环境以及定价和报销要求。>方法:在2016年11月至2017年3月期间对来自CEE国家/地区的报销事宜的专家进行了基于基础的调查: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。对报销要求及其对卫生技术评估的影响进行了审查,以比较上述国家中的问题。对于每个指定的国家,还收集了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。通过电子邮件分发问卷,并以相同方式获取反馈数据。如有其他问题,也将通过电子邮件发送给受访者。定价和报销数据在2017年3月有效。>结果:调查显示,2014年和2015年,药物报销成本与公共医疗总支出的关系在0.12到0.21之间(中值)。它还显示,中东欧国家采用的药品定价标准非常相似。在上述国家中,外部参考价和内部参考价很普遍。正向报销清单在中东欧地区的所有国家均有效,很少使用负向清单;大多数国家都定期修订和更新报销决定。共付额很普遍,各国之间和国家之间可用的报销水平有所不同,范围从20%到100%。经常使用风险分担计划,特别是在创新,昂贵的药物中。在所有分析过的中欧和东欧国家,通用替代也是可能的,尽管有些强制性替代。 HTA在几乎所有考虑的CEE国家中进行,HTA档案必须提交定价和报销申请。>结论:CEE区域的定价和报销要求非常相似,尽管已发现一些差异。 HTA评估通常在相关国家/地区使用。

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