Geenen Joost W, Jut Mark, Boersma Cornelis, Klungel Olaf H, Hövels Anke M
Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands.
Health-Ecore, Zeist, The Netherlands.
J Mark Access Health Policy. 2019 Nov 30;8(1):1697558. doi: 10.1080/20016689.2019.1697558. eCollection 2020.
: In many countries, Budget Impact (BI) informs reimbursement decisions. Evidence has shown that decision-makers have restricted access based on high BI estimates but studies show that BI estimates are often inaccurate. : To assess the accuracy of BI estimations used for informing access decisions on oncology drugs in the Netherlands. Oncology products for which European Medicines Agency Marketing Authorisation was granted between 1-1-2000 and 1-10-2017 were selected. Observed BI data were provided by FarmInform. BI estimates were extracted from the reimbursement dossiers of the Dutch Healthcare Institute. Products without an estimated BI in the reimbursement dossier were excluded. Accuracy is defined as the ratio observed BI/estimated BI. General community, the Netherlands. : Ten products were included in the base case analysis. Mean accuracy was 0.64 and observed BI deviated by more than 40% and 100% from the estimated BI for 4 and 5 products, respectively. For all products together, €141 million BI was estimated and €82 million BI was observed, a €59 million difference. : The findings indicate that BI estimates for oncology drugs in the Netherlands are inaccurate. The role and use of BI in reimbursement decisions for these potentially life-saving drugs should therefore be considered carefully, as well as BI estimation methodology.
在许多国家，预算影响（BI）为报销决策提供依据。有证据表明，决策者会基于较高的BI估计来限制药品准入，但研究表明，BI估计往往不准确。：评估用于为荷兰肿瘤药物准入决策提供依据的BI估计的准确性。选择了2000年1月1日至2017年10月1日期间获得欧洲药品管理局上市许可的肿瘤产品。观察到的BI数据由FarmInform提供。BI估计值从荷兰医疗保健研究所的报销档案中提取。报销档案中没有估计BI的产品被排除。准确性定义为观察到的BI/估计的BI的比率。荷兰普通社区。：基础案例分析纳入了10种产品。平均准确性为0.64，分别有4种和5种产品观察到的BI与估计的BI偏差超过40%和100%。所有产品加起来，估计BI为1.41亿欧元，观察到的BI为8200万欧元，相差5900万欧元。：研究结果表明，荷兰肿瘤药物的BI估计不准确。因此，在这些可能挽救生命的药物的报销决策中，应仔细考虑BI的作用和用途，以及BI估计方法。
