新型抗癌药物的报销时间（TTR）在不同国家之间存在差异，进而导致不平等的获得机会。我们旨在调查新型抗癌药物的报销时间，并探讨影响报销过程的因素，涉及七个高收入的欧洲国家。我们进行了一项回顾性病例研究，调查了2016年至2021年期间获得欧洲联盟市场准入（EU-MA）和人用药品委员会（CHMP）积极意见，并随后获得国家报销批准（NRA）的抗癌药物。我们利用德国、法国、英国、荷兰、比利时、挪威和瑞士的国家健康技术评估（HTA）和报销网站来确定TTR，定义为从EU-MA到NRA所需的时间。此外，我们还研究了可能影响TTR的药物、国家、适应症和制药相关因素。确定了35种药物的TTR，范围从-81天到2320天（中位数为407天）。在截止日期时，16种药物（46%）在所有七个国家都得到了报销。总体上，德国的TTR最短（中位数为3天，所有药物都在5天内得到报销），符合欧洲联盟市场准入后180天的报销时限（欧盟透明指令）的药物在德国的所有纳入药物中的比例为100%，而在法国为51%，在英国和荷兰为29%，在瑞士为14%，在挪威为6%，在比利时为3%。不同国家的TTR之间存在显着差异（P＜0.001）。在多元分析中，与较短TTR相关的因素是更高的国内生产总值（GDP）、缺乏预评估程序以及由大型制药公司提出的提交申请。抗癌药物的TTR在七个高收入的欧洲国家之间有显著差异，导致获得机会的不平等。在探讨的药物、国家、适应症和制药相关因素中，我们发现高GDP、缺乏预评估程序以及由大型制药公司提交申请与较短的TTR有关。版权所有 © 2023作者。Elsevier Ltd.保留所有权利。

Time to reimbursement (TTR) of new anticancer medicines differs between countries and contributes to unequal access. We aimed to investigate TTR of new anticancer medicines and explore factors influencing the reimbursement process in seven high-income European countries.We carried out a retrospective case study of anticancer medicines with European Union Market Access (EU-MA) and a positive Committee for Medicinal Products for Human Use opinion from 2016 until 2021 with subsequent national reimbursement approval (NRA). The National Health Technology Assessment (HTA) and reimbursement websites of Germany, France, UK, the Netherlands, Belgium, Norway and Switzerland were used to identify TTR, defined as time from EU-MA to NRA. Additionally, we investigated medication-, country-, indication- and pharma-related factors potentially influencing TTR.Thirty-five medicines were identified for which TTR ranged from -81 days to 2320 days (median 407 days). At data cut-off, 16 (46%) were reimbursed in all seven countries. Overall, the shortest TTR was in Germany (median 3 days, all medicines reimbursed <5 days). The time limit for reimbursement of 180 days stated by the Council of European Communities after the EU-MA (EU Transparency Directive) was met for 100% of included medicines in Germany, 51% in France, 29% in the UK and the Netherlands, 14% in Switzerland, 6% in Norway and 3% in Belgium. The TTR was significantly different between countries (P < 0.001). In multivariate analysis, factors associated with shorter TTR were higher gross domestic product (GDP), absence of a pre-assessment procedure and submission by a big pharmaceutical company.TTR of anticancer medicines varies significantly between seven high-income European countries and leads to inequality in access. Among explored medication-, country-, indication- and pharma-related factors we found that a high GDP, the absence of a pre-assessment procedure and submission by big pharmaceutical companies were associated with shorter TTR.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.