PDF(Pubmed)
Abstract：
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.
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.
摘要：
背景：新抗癌药物的报销时间（TTR）在不同国家之间存在差异，并导致不平等的获得。我们旨在调查新的抗癌药物的TTR，并探讨影响七个高收入欧洲国家报销过程的因素。
方法：我们从2016年到2021年对具有欧盟市场准入（EU-MA）和人用医药产品委员会的积极意见的抗癌药物进行了回顾性案例研究，并随后获得了国家报销批准（NRA）。德国国家卫生技术评估(HTA)和报销网站，法国,英国,荷兰,比利时,挪威和瑞士被用来识别TTR，定义为从EU-MA到NRA的时间。此外,我们调查了药物-，country-,潜在影响TTR的指标和药物相关因素。
结果：确定了35种药物，其TTR范围为-81天至2320天（中位数为407天）。在数据截止时，16（46%）在所有七个国家得到了报销。总的来说,最短的TTR在德国(中位数为3天，所有药品报销<5天)。在满足EU-MA（欧盟透明度指令）后，欧洲共同体理事会规定的180天的时间限制，德国100％的包含药品，51%在法国29%在英国和荷兰，14%在瑞士，挪威为6%，比利时为3%。不同国家的TTR差异有统计学意义(P<0.001)。在多变量分析中，与较短的TTR相关的因素是较高的国内生产总值(GDP)，缺乏预评估程序和大型制药公司的提交。
结论：七个高收入欧洲国家之间的抗癌药物的TTR差异很大，导致了获取不平等。在探索的药物中-，country-,与指标和制药相关的因素，我们发现高GDP，缺乏预评估程序和大型制药公司提交的报告与较短的TTR有关.
方法：我们从2016年到2021年对具有欧盟市场准入（EU-MA）和人用医药产品委员会的积极意见的抗癌药物进行了回顾性案例研究，并随后获得了国家报销批准（NRA）。德国国家卫生技术评估(HTA)和报销网站，法国,英国,荷兰,比利时,挪威和瑞士被用来识别TTR，定义为从EU-MA到NRA的时间。此外,我们调查了药物-，country-,潜在影响TTR的指标和药物相关因素。
结果：确定了35种药物，其TTR范围为-81天至2320天（中位数为407天）。在数据截止时，16（46%）在所有七个国家得到了报销。总的来说,最短的TTR在德国(中位数为3天，所有药品报销<5天)。在满足EU-MA（欧盟透明度指令）后，欧洲共同体理事会规定的180天的时间限制，德国100％的包含药品，51%在法国29%在英国和荷兰，14%在瑞士，挪威为6%，比利时为3%。不同国家的TTR差异有统计学意义(P<0.001)。在多变量分析中，与较短的TTR相关的因素是较高的国内生产总值(GDP)，缺乏预评估程序和大型制药公司的提交。
结论：七个高收入欧洲国家之间的抗癌药物的TTR差异很大，导致了获取不平等。在探索的药物中-，country-,与指标和制药相关的因素，我们发现高GDP，缺乏预评估程序和大型制药公司提交的报告与较短的TTR有关.
