Villa Federico, Jommi Claudio, Altamura Gianluca, Antignani Sara, Cangini Agnese, Fortino Ida, Melazzini Mario, Trotta Francesco, Tafuri Giovanni
Agenzia Italiana del Farmaco (AIFA), Roma.
SDA Bocconi School of Management, Milano.
Recenti Prog Med. 2020 Feb;111(2):65-69. doi: 10.1701/3309.32795.
Italy was used as a case study to investigate the determinants of the difference between the price proposal for medicines submitted by the industry and the final negotiated price (∆P). Data was gathered through the information system used by Italian Medicines Agency (AIFA) and the time-frame for this analysis is 2013-2017. Factors influencing the delta price were analyzed through a regression analysis. Forty four orphan drugs and 89 new other molecular entities obtained reimbursement in the period considered. Following the negotiation process, prices proposed by Marketing Authorization Holders (MAH) were lowered during the negotiation process 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 (FB) 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 target population), others were more surprising (e.g. a significant price reduction for "innovative" drugs). The implementation of FB agreements, which often rely on confidential arrangements, was one of the determinants with higher impact on price reduction.
意大利被用作案例研究，以调查制药行业提交的药品价格提案与最终谈判价格之间差异（∆P）的决定因素。数据通过意大利药品管理局（AIFA）使用的信息系统收集，分析的时间范围是2013年至2017年。通过回归分析对影响差价的因素进行了分析。在考虑的时间段内，有44种孤儿药和89种其他新分子实体获得了报销。经过谈判过程，营销授权持有人（MAH）提出的价格在谈判过程中平均分别降低了25.1%和28.6%，孤儿药和其他分子的降价幅度分别为25.1%和28.6%。创新药物的降价幅度更高（-32.2%）。与更大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册；ii）谈判基于财务的（FB）管理进入协议；iii）目标人群超过20,000名患者；iv）预计国家卫生服务支出超过2亿欧元。一些变量对差价的影响是可预测的（例如，对于预期预算影响较高且目标人群较大的药物），其他一些则更令人惊讶（例如，“创新”药物大幅降价）。通常依赖保密安排的FB协议的实施是对降价影响较大的决定因素之一。
