Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy; Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Largo Guido Donegani, 2 - 28100, Novara, Italy.
Italian Medicines Agency (AIFA), Via del Tritone, 181 - 00187, Rome, Italy; Utrecht University, Heidelberglaan 8, 3584 CS Utrecht, NL.
Health Policy. 2019 Jun;123(6):595-600. doi: 10.1016/j.healthpol.2019.03.009. Epub 2019 Apr 13.
The aim of this paper is to investigate the determinants of the difference between the price proposal submitted by the industry and the final negotiated price. We used Italy as a case-study.
Data were gathered through the information system used by Italian Medicines Agency. The time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis.
44 orphan drugs and 89 new other molecular entities obtained reimbursement in the last five years. Following the negotiation process, prices were lowered by 25.1% and 28.6% on average for orphan drugs and other molecules respectively. The price reduction was higher for innovative drugs (-32.2%). Statistically significant determinants associated to higher price reduction were: i) the implementation of a product specific monitoring registry, ii) the negotiation of a financial-based Managed Entry Agreement, iii) a target population larger than 20,000 patients, iv) an expected National Health Service expenditure larger than €200 million.
The impact of some variables on the delta price was predictable (e.g. for drugs with an expected higher budget impact and a larger population target), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of financial-based agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.
本文旨在研究产业界提交的价格建议与最终谈判价格之间存在差异的决定因素。我们以意大利为例进行了研究。
通过意大利药品管理局使用的信息系统收集数据。本分析的时间范围为 2013 年至 2017 年。通过回归分析对影响差价的因素进行了分析。
在过去的五年中，有 44 种孤儿药和 89 种新的其他分子实体获得了报销。经过谈判过程，孤儿药和其他分子的平均价格分别降低了 25.1%和 28.6%。创新药物的降价幅度更高（-32.2%）。与更高的降价幅度相关的具有统计学意义的决定因素包括：i）实施特定产品监测登记，ii）谈判财务型管理准入协议，iii）目标人群大于 20,000 名患者，iv）预期国家卫生服务支出大于 2 亿欧元。
一些变量对差价的影响是可以预测的（例如，对于预期预算影响更大且目标人群更大的药物），而其他变量则更令人惊讶（例如，“创新”药物的大幅降价）。基于财务的协议的实施，这通常依赖于保密安排，是对降价影响较大的决定因素之一。
