Skoupá Jana
CZECHTA Institute o.p.s., Prague, The Czech Republic.
Value Health Reg Issues. 2017 Sep;13:55-58. doi: 10.1016/j.vhri.2017.08.002. Epub 2017 Sep 9.
The legal background of the current pharmaceutical pricing and reimbursement (P&R) setting in the Czech Republic is based on Act 48/1997. Since 2008, the P&R process has been coordinated by the State Institute for Drug Control, which is the main stakeholder in the decision-making process; marketing authorization holders and insurance funds (IFs) also participate.
To present a general overview of the current Czech health care system and its P&R principles.
The study used publicly available sources concerning health care, mainly acts related to public health care and public health care insurance, public notices related to P&R setting, and statistical data.
Regulation covers P&R. The official price represents the highest exfactory price, which cannot be exceeded. It is calculated as the mean of the three lowest prices in the European Union reference basket. Reimbursement is based on the lowest price per daily dose across the whole European Union. For reimbursement, products can be clustered into jumbo groups (mutually interchangeable), stated by law. In each group, reimbursement is set at the lowest price of any substance within the group. For highly innovative drugs a temporary reimbursement can be granted for a period of 3 years. During the administrative proceeding, efficacy, safety, cost-effectiveness, and budget impact are assessed. The cost-effectiveness principles are aligned with the guidelines of the National Institute for Health and Clinical Care Excellence, preferring cost-utility analyses. The willingness-to-pay threshold has been implicitly set at 3 times the gross domestic product per capita. Products exceeding this threshold are subject to further risk-sharing negotiations. Budget impact is becoming increasingly important mainly for IFs. The IFs have recently introduced their own methodology, which allows only products with a budget impact in the range of CZK16 to CZK48 million (CZK = Czech koruna; ∼€600,000 to €1.8 million) to enter the system. Products exceeding this budget impact have to negotiate risk-sharing schemes, mainly further discounts and/or budget caps.
The Czech pricing and reimbursement system is rather complex, taking into account clinical evidence, cost-effectiveness and budget impact. The strict regulations are a result of financial scarcity.
捷克共和国当前药品定价与报销（P&R）体系的法律背景基于第48/1997号法案。自2008年以来，P&R流程由国家药品控制研究所协调，该研究所是决策过程中的主要利益相关者；营销授权持有人和保险基金（IFs）也参与其中。
概述当前捷克医疗保健系统及其P&R原则。
该研究使用了有关医疗保健的公开可用来源，主要是与公共医疗保健和公共医疗保险相关的法案、与P&R设定相关的公告以及统计数据。
法规涵盖P&R。官方价格代表最高出厂价，不得超过该价格。它是根据欧盟参考篮子中三个最低价格的平均值计算得出的。报销基于整个欧盟每日剂量的最低价格。对于报销，产品可依法分为大型组（可相互替代）。在每个组中，报销设定为该组内任何物质的最低价格。对于高度创新的药物，可给予为期3年的临时报销。在行政程序中，会评估疗效、安全性、成本效益和预算影响。成本效益原则与国家卫生与临床优化研究所的指南一致，更倾向于成本效用分析。支付意愿阈值已隐含设定为人均国内生产总值的3倍。超过该阈值的产品需进行进一步的风险分担谈判。预算影响对IFs来说变得越来越重要。IFs最近引入了自己的方法，该方法仅允许预算影响在1600万至4800万捷克克朗（CZK = 捷克克朗；约60万至180万欧元）范围内的产品进入该系统。超过此预算影响的产品必须谈判风险分担方案，主要是进一步的折扣和/或预算上限。
捷克的定价和报销系统相当复杂，并考虑了临床证据、成本效益和预算影响。严格的法规是资金短缺的结果。
