乌克兰药品的外部参考定价:最新趋势

L. Kucherenko, EF I. V. Nizhenkovska A, EF N. V. Sholoiko A, CE L. O. Hala A, CE N. O. Datsiuk A, Л. І. Кучеренко, І. В. Ніженковська, Н. В. Шолойко, Л. О. Гала, Н. О. Дацюк
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引用次数: 0

摘要

与前一年相比,乌克兰国家预算中的医疗支出份额有所下降,这与安全和国防部门的资金增加有关。就国内生产总值而言,医疗保健支出已降至 2.8%,与 2019 年的数字相符。这些情况表明了合理利用预算的重要性,包括有效调节药品价格。合理使用医疗预算的关键因素之一是制定和实施外部参考定价(ERP)。制定和实施完善的药品外部参考定价政策有助于改善患者获得基本药物(EMs)的机会。本研究的目的是分析乌克兰实施外部参考定价的现状,并提出改进这一政策的建议。材料和方法。在研究过程中,对 ERP 现行监管框架进行了分析,并根据 Sullivan、Kanavos & Kalo 于 2015 年提出的 ERP 14 项最佳实践原则,对乌克兰的 ERP 实施情况进行了评估。结果。乌克兰对《国家基本药物目录》(NEML)和 "廉价药物 "计划中的药物实施了ERP。乌克兰卫生部(MoH)已批准了由国家预算资金购买并受价格监管的药品边际批发价格登记册。目前,该登记册包括 1239 种药品,其中 1233 种来自 NEML,6 种经过了卫生技术评估 (HTA)。约 58% 的药品通过企业资源规划(ERP)确定了价格,24% 的药品受内部参考定价(IRP)监管,近 18% 的药品有申报价格。这表明药品价格监管方法缺乏统一性,需要进一步改进。根据最新更新的《国家医疗保障计划报销药品登记册》,共有 486 种药品,其中包括 72 种胰岛素和 21 种免疫抑制剂(184 种药品为自费药品)。在国家医疗保障计划和 "负担得起的药品 "计划中,对药品的价格管理采用了不同的方法,包括不同的参照国和价格计算算法。根据 Sullivan、Kanavos & Kalo 于 2015 年提出的 14 项企业资源规划最佳实践原则,对乌克兰企业资源规划系统的实施情况进行了评估,结果显示现行政策并未遵守所有原则。结论。分析表明,国家药品采购清单和 "负担得起的药品 "计划对药品定价采取了不同的方法,这表明有必要统一不同清单的定价政策。采用统一的肯定列表有助于改进定价政策和提高资源利用效率。收集、传播和交流药品价格数据对于支持定价透明度及其控制至关重要。定期监测市场价格有助于确保定价政策得到遵守,并在出现违规情况时采取适当措施。在乌克兰实施统一的药品定价监管政策是实现欧洲一体化和遵守国际标准的重要一步。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
External reference pricing for medicines in Ukraine: latest trends
Compared to the previous year, the share of healthcare expenditure in the state budget of Ukraine has decreased, which is associated with increased funding for the security and defense sector. In terms of gross domestic product, healthcare spending has reduced to 2.8 %, which corresponds to the figures for 2019. These circumstances indicate the importance of proper budget utilization, including effectively regulating medicine prices. One of the key elements of rational healthcare budget usage is the development and implementation of external reference pricing (ERP). A well-formulated and implemented ERP policy for pharmaceuticals contributes to improving patient access to essential medicines (EMs). The aim of this study is to analyze the current status of ERP implementation in Ukraine and provide recommendations for improving this policy. Materials and methods. During the research process, an analysis of the ERP’s current regulatory framework was conducted, and ERP implementation in Ukraine was assessed according to adherence to the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015. Results. In Ukraine, ERP has been introduced for medicines from the National Essential Medicine Lists (NEML) and the “Affordable Medicines” program. The Ministry of Health (MoH) of Ukraine has approved a Register of marginal wholesale prices for medicines purchased with state budget funds and subject to price regulation. Currently, the register includes 1239 medicinal products, of which 1233 are from NEML and 6 have undergone Health Technology Assessment (HTA). Approximately 58 % of medicines have a set price through ERP, 24 % are regulated by internal reference pricing (IRP), and nearly 18 % have declared prices. This indicates a lack of uniformity in approaches to price regulation for medicines and requires further improvements. According to the latest update of the Register of medicines for reimbursement under the state medical guarantees program, there are 486 medicines, including 72 insulins and 21 immunosuppressive medicines (184 medicines are provided with co-payment). Different approaches, including different reference countries and price calculation algorithms, are applied for the price regulation of medicines in NEML and the “Affordable Medicines” program. An assessment of the implementation of the ERP system in Ukraine based on the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015 showed that the current policy does not adhere to all principles. Conclusions. The analysis revealed different approaches to pricing for medicines NEML and the “Affordable Medicines” program, indicating the need for harmonizing pricing policies for different lists. The adoption of a unified positive list can contribute to improving pricing policies and efficient resource utilization. Collecting, disseminating, and exchanging data on drug prices is crucial to support transparency in pricing and its control. Regular monitoring of prices in the market will help ensure compliance with pricing policies and take appropriate measures in case of violations. The implementation of a unified pricing regulation policy for medicines in Ukraine is an important step towards European integration and compliance with international standards.
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