Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.
Department of Pharmacy, National Taiwan University Hospital, Taipei, Taiwan.
Clin Transl Sci. 2020 Nov;13(6):1288-1297. doi: 10.1111/cts.12829. Epub 2020 Jul 16.
Healthcare expenditure on pharmaceuticals, especially innovative oncology drugs, is escalating. Current knowledge on this topic is largely limited to studies conducted upon reimbursement of new drugs. We investigated how endogenous factors (e.g., changed reimbursement criteria, such as an expanded indication) and exogenous factors (e.g., competing drugs) affect the level and trends of innovative oncology drug utilization in the Taiwan National Health Insurance (NHI) system, both upon reimbursement and afterward. This retrospective longitudinal study analyzed monthly data (January 2009 to December 2014) from the NHI Research Database on the consumption (prescribing volume) of 15 innovative oncology drugs reimbursed by the NHI between 2007 and 2013. Effects of endogenous and exogenous factors on drug utilization were evaluated using interrupted time series analyses. In segmented regression analyses, changed drug prescribing volume after the indication expanded (endogenous factor) was statistically significant; however, drug volume did not change significantly after prescription restrictions changed. First-competitors and non-first-competitors (exogenous factors) were significantly associated with drug prescription levels or utilization rates. Taking sorafenib as an example, the post-reimbursement drug prescribing volume did not change significantly after its therapy line changed (endogenous factor), whereas the reimbursement of first-competitors (exogenous factor) was significantly associated with a lower level or usage rate of sorafenib. Utilization of innovative oncology drugs in Taiwan changed dramatically after NHI reimbursement, driven largely by expanded indications and new competitors. Drug utilization evaluations should investigate both endogenous and exogenous factors.
医疗保健在药品上的支出,特别是创新型肿瘤药物,正在不断增加。目前,该主题的知识主要限于对新药报销的研究。我们研究了内在因素(例如,扩大适应证等报销标准的变化)和外在因素(例如,竞争药物)如何影响台湾全民健康保险(NHI)系统中创新型肿瘤药物的使用水平和趋势,包括报销前后。这项回顾性纵向研究分析了 NHI 研究数据库中 2007 年至 2013 年间 15 种创新型肿瘤药物的每月数据(2009 年 1 月至 2014 年 12 月),这些药物均由 NHI 报销。使用中断时间序列分析评估内在和外在因素对药物使用的影响。在分段回归分析中,适应证扩大后的药物处方量变化(内在因素)具有统计学意义;然而,处方限制改变后药物量没有显著变化。第一竞争药物和非第一竞争药物(外在因素)与药物处方水平或使用率显著相关。以索拉非尼为例,治疗方案改变后,药物报销后处方量无明显变化(内在因素),而第一竞争药物的报销(外在因素)与索拉非尼的使用率或使用率呈负相关。在 NHI 报销后,台湾的创新型肿瘤药物的使用发生了巨大变化,主要是由于适应证的扩大和新的竞争药物的出现。药物利用评估应同时考虑内在和外在因素。