Gallo Valentina, Alessi Eva, Montilla Simona, Altamura Gianluca, Traversa Giuseppe, Trotta Francesco
Italian Medicines Agency, Rome, Italy.
Front Med (Lausanne). 2022 Dec 21;9:1055359. doi: 10.3389/fmed.2022.1055359. eCollection 2022.
This investigation aimed to guarantee the principles of transparency in public administration; to inform citizens about the time to patient access to reimbursed medicines; to assess the duration of the P&R process for the first time in the period 2018-2020; and to evaluate whether and how the SARS-CoV-2 (COVID-19) pandemic affected the P&R activity. This study analyzed the timelines of pricing and reimbursement procedures submitted in Italy by the pharmaceutical marketing authorization holder (MAH) from 2018 to 2020.
The analysis was run through an AIFA web-based platform that collects data about P&R procedures for each step of the Italian Price and Reimbursement (P&R) procedure, including dates of the Technical Scientific Committee (CTS) and Price and Reimbursement Committee (CPR) meetings from January 2018 to December 2020. On this basis, four indicators were developed relating to the completion time of each stage of the P&R negotiation process and were defined in terms of days. In this regard, descriptive analyses, graphical boxplots, and survival curves (Kaplan-Meier) were carried out, studying these indicators in relation to the typology of pharmaceutical procedures.
Overall, in the period 2018-2020, 57.1% of the 2,445 procedures entered were represented by the Off-patent pharmaceuticals procedures (generics, biosimilars, copies, and/or parallel trade). In 2020, the overall process duration for Off-patent pharmaceuticals procedures was equal to 129.8 average days [95% CI: (122.3-137.2)], with a median value of 108.0, whereas for In-patent pharmaceuticals procedures, it was equal to 283.1 average days [95% CI: (267.8-298.5)], with a median value of 284.0. Over time, the trend of the entire duration of the P&R process tended to decrease. In terms of estimated timing for the conclusion of each stage of the P&R negotiation process, the difference between Off-patent and In-patent pharmaceutical procedures was statistically significant by the Log-Rank test.
This is the first study to examine the time of the P&R process in Italy, from MAH submission to the publication of the final decision in the Italian Official Journal. The time span considered is 3 years, including the first year of the COVID-19 pandemic. Compared to European average times, in Italy, the time necessary for evaluation, authorization for reimbursement, and definition of the price of a medicine can be considered satisfactory.
本调查旨在确保公共行政的透明度原则；告知公民患者获得报销药品的时间；首次评估2018 - 2020年期间定价与报销流程的持续时间；并评估严重急性呼吸综合征冠状病毒2（SARS-CoV-2，即新冠病毒）大流行是否以及如何影响定价与报销活动。本研究分析了2018年至2020年期间药品上市许可持有人（MAH）在意大利提交的定价和报销程序的时间线。
分析通过意大利药品管理局（AIFA）基于网络的平台进行，该平台收集意大利定价与报销（P&R）程序每个步骤的相关数据，包括2018年1月至2020年12月技术科学委员会（CTS）和定价与报销委员会（CPR）会议的日期。在此基础上，制定了四个与P&R谈判过程各阶段完成时间相关且以天数定义的指标。就此，进行了描述性分析、图形箱线图分析和生存曲线（Kaplan-Meier）分析，研究这些指标与药品程序类型的关系。
总体而言，在2018 - 2020年期间，录入的2445个程序中有57.1%为专利过期药品程序（仿制药、生物类似药、仿制品和/或平行进口药）。2020年，专利过期药品程序的总体流程持续时间平均为129.8天[95%置信区间：（122.3 - 137.2）]，中位数为108.0天，而专利药品程序的总体流程持续时间平均为283.1天[95%置信区间：（267.8 - 298.5）]，中位数为284.0天。随着时间推移，P&R流程的整个持续时间趋势呈下降趋势。就P&R谈判过程各阶段的估计完成时间而言，专利过期药品程序和专利药品程序之间的差异经对数秩检验具有统计学意义。
这是第一项研究意大利从MAH提交到最终决定在意大利官方公报上公布期间P&R流程时间的研究。所考虑的时间跨度为3年，包括新冠疫情大流行的第一年。与欧洲平均时间相比，在意大利，评估、报销授权和药品定价所需的时间可以认为是令人满意的。
