Abstract：
BACKGROUND: Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability.
OBJECTIVE: We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.
METHODS: A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.
RESULTS: Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).
CONCLUSIONS: There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.
OBJECTIVE: We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe.
METHODS: A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs.
RESULTS: Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01).
CONCLUSIONS: There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.
摘要：
背景：欧洲肿瘤药物的报销过程发生在一个复杂的决策过程中，成员国之间存在差异。国家之间的区别引发了社会辩论，因为有必要平衡获得药品和卫生系统的可持续性。
目的：我们旨在审查与欧洲肿瘤药物的报销决定或卫生技术署推荐相关因素的证据。
方法：从开始到2023年8月，在两个数据库中进行了系统的文献检索。成对地进行筛选和数据提取。
结果：纳入了13篇文章，涵盖了来自11个国家的数据。七篇文章表明，具有成本效益的（C-E）药物和较低的成本效益增量比（ICER）具有较高的报销可能性。疾病的严重程度可能会影响财务协议的报销决定。临床结果的改善，显著的临床获益(p<0.01)或总生存期增加(p<0.05)呈正相关.孤儿药物指定的影响因国家而异，但积极的决定通常是在特定条件下实现的。临床和C-E不确定性经常导致通过财务协议或基于结果的条件进行报销。社会人口因素：社会医疗保险制度，较高的国内生产总值和较大的老年人口与报销呈正相关(p<0.01)。
结论：需要进一步研究欧洲报销决定的关键决定因素，并开发能够有效解决和克服成本和有效性不确定性的药物获取模型。
目的：我们旨在审查与欧洲肿瘤药物的报销决定或卫生技术署推荐相关因素的证据。
方法：从开始到2023年8月，在两个数据库中进行了系统的文献检索。成对地进行筛选和数据提取。
结果：纳入了13篇文章，涵盖了来自11个国家的数据。七篇文章表明，具有成本效益的（C-E）药物和较低的成本效益增量比（ICER）具有较高的报销可能性。疾病的严重程度可能会影响财务协议的报销决定。临床结果的改善，显著的临床获益(p<0.01)或总生存期增加(p<0.05)呈正相关.孤儿药物指定的影响因国家而异，但积极的决定通常是在特定条件下实现的。临床和C-E不确定性经常导致通过财务协议或基于结果的条件进行报销。社会人口因素：社会医疗保险制度，较高的国内生产总值和较大的老年人口与报销呈正相关(p<0.01)。
结论：需要进一步研究欧洲报销决定的关键决定因素，并开发能够有效解决和克服成本和有效性不确定性的药物获取模型。
