关键词: CEE drug policy pharmaceutical regulation pricing reimbursement

来  源:   DOI:10.3389/fphar.2017.00892   PDF(Sci-hub)

Abstract:
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.
摘要:
目标:本研究的目的是审查部分中欧和东欧(CEE)国家药品的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,对来自中东欧国家的参与报销事宜的专家进行了问卷调查: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。对卫生技术评估(HTA)的报销要求和影响进行了审查,以比较上述国家的问题。对于每个指定的国家,报销费用的数据,药品预算总额,还收集了2014年和2015年的公共医疗保健总预算。问卷通过电子邮件分发,反馈数据以相同的方式获得。其他问题,如果有的话,还通过电子邮件提交给受访者。定价和报销数据于2017年3月有效。结果:调查显示,2014年和2015年药品报销费用与公共医疗总支出的关系范围为0.12至0.21(中位数)。它还透露,药品的定价标准,受雇于中东欧国家,非常相似。外部参考定价和内部参考定价在上述国家很常见。积极的偿还清单在中欧和东欧地区的所有国家都有效,很少使用负面决定;大多数国家定期修订和更新偿还决定。共付额很普遍,国家内部和国家之间的可用报销水平不同,范围从20%到100%。风险分担方案经常被使用,尤其是在创新的情况下,昂贵的药物。在所有分析过的中东欧国家中,通用替代也是可能的,虽然有些人是强制性的。HTA在几乎所有考虑过的中东欧国家都进行了,HTA档案必须提交定价和报销申请。结论:尽管确定了一些差异,但中东欧地区的定价和报销要求非常相似。HTA评估通常在所考虑的国家中使用。
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