PDF(Pubmed)
Abstract：
BACKGROUND: International guidelines recommend ivosidenib followed by modified FOLFOX (mFOLFOX) for advanced intrahepatic cholangiocarcinoma (ICC) with isocitrate dehydrogenase 1 (IDH1) mutations. Taiwan National Health Insurance covers only fluorouracil/leucovorin (5-FU/LV) chemotherapy for this ICC group, and there has been no prior economic evaluation of ivosidenib. Therefore, we aimed to assess ivosidenib\'s cost-effectiveness in previously treated, advanced ICC-presenting IDH1 mutations compared with mFOLFOX or 5-FU/LV.
METHODS: A 3-state partitioned survival model was employed to assess ivosidenib\'s cost-effectiveness over a 10-year horizon with a 3% discount rate, setting the willingness-to-pay threshold at 3 times the 2022 GDP per capita. Efficacy data for Ivosidenib, mFOLFOX, and 5-FU/LV were sourced from the ClarIDHy, ABC06, and NIFTY trials, respectively. Ivosidenib\'s cost was assumed to be NT$10,402/500 mg. Primary outcomes included incremental cost-effectiveness ratios (ICERs) and net monetary benefit. Deterministic sensitivity analyses (DSA) and probabilistic sensitivity analyses (PSA) were employed to evaluate uncertainty and explore price reduction scenarios.
RESULTS: Ivosidenib exhibited ICERs of NT$6,268,528 and NT$5,670,555 compared with mFOLFOX and 5-FU/LV, respectively, both exceeding the established threshold. PSA revealed that ivosidenib was unlikely to be cost-effective, except when it was reduced to NT$4,161 and NT$5,201/500 mg when compared with mFOLFOX and 5-FU/LV, respectively. DSA underscored the significant influence of ivosidenib\'s cost and utility values on estimate uncertainty.
CONCLUSIONS: At NT$10,402/500 mg, ivosidenib was not cost-effective for IDH1-mutant ICC patients compared with mFOLFOX or 5-FU/LV, indicating that a 50-60% price reduction is necessary for ivosidenib to be cost-effective in this patient group.
METHODS: A 3-state partitioned survival model was employed to assess ivosidenib\'s cost-effectiveness over a 10-year horizon with a 3% discount rate, setting the willingness-to-pay threshold at 3 times the 2022 GDP per capita. Efficacy data for Ivosidenib, mFOLFOX, and 5-FU/LV were sourced from the ClarIDHy, ABC06, and NIFTY trials, respectively. Ivosidenib\'s cost was assumed to be NT$10,402/500 mg. Primary outcomes included incremental cost-effectiveness ratios (ICERs) and net monetary benefit. Deterministic sensitivity analyses (DSA) and probabilistic sensitivity analyses (PSA) were employed to evaluate uncertainty and explore price reduction scenarios.
RESULTS: Ivosidenib exhibited ICERs of NT$6,268,528 and NT$5,670,555 compared with mFOLFOX and 5-FU/LV, respectively, both exceeding the established threshold. PSA revealed that ivosidenib was unlikely to be cost-effective, except when it was reduced to NT$4,161 and NT$5,201/500 mg when compared with mFOLFOX and 5-FU/LV, respectively. DSA underscored the significant influence of ivosidenib\'s cost and utility values on estimate uncertainty.
CONCLUSIONS: At NT$10,402/500 mg, ivosidenib was not cost-effective for IDH1-mutant ICC patients compared with mFOLFOX or 5-FU/LV, indicating that a 50-60% price reduction is necessary for ivosidenib to be cost-effective in this patient group.
摘要：
背景：国际指南推荐ivosidenib，然后用改良FOLFOX（mFOLFOX）治疗具有异柠檬酸脱氢酶1（IDH1）突变的晚期肝内胆管癌。台湾国民健康保险仅涵盖该ICC组的氟尿嘧啶/亚叶酸（5-FU/LV）化疗，并没有事先对伊沃西德尼进行经济评估。因此,我们的目的是评估ivosidenib在先前治疗中的成本效益，与mFOLFOX或5-FU/LV相比，晚期ICC呈递IDH1突变。
方法：采用3状态分区生存模型，以3％的折现率评估ivosidenib在10年内的成本效益。将支付意愿门槛设定为2022年人均GDP的3倍。Ivosidenib的疗效数据，mFOLFOX,5-FU/LV来自ClaridHy，ABC06和NIFTY试验，分别。Ivosidenib的成本假定为新台币10,402/500毫克。主要结果包括增量成本效益比（ICER）和净货币收益。采用确定性敏感性分析（DSA）和概率敏感性分析（PSA）来评估不确定性并探索降价方案。
结果：Ivosidenib的ICER分别为新台币6,268,528和新台币5,670,555，而mFOLFOX和5-FU/LV，分别,都超过了既定的门槛。PSA透露，ivosidenib不太可能具有成本效益，除了与mFOLFOX和5-FU/LV相比，它减少到新台币4,161元和新台币5,201/500毫克，分别。DSA强调了ivosidenib的成本和效用值对估计不确定性的重大影响。
结论：以新台币10,402元/500毫克，与mFOLFOX或5-FU/LV相比，Ivosidenib对IDH1突变ICC患者的成本效益不佳，这表明，在该患者组中，要使ivosidenib具有成本效益，必须将价格降低50-60％。
方法：采用3状态分区生存模型，以3％的折现率评估ivosidenib在10年内的成本效益。将支付意愿门槛设定为2022年人均GDP的3倍。Ivosidenib的疗效数据，mFOLFOX,5-FU/LV来自ClaridHy，ABC06和NIFTY试验，分别。Ivosidenib的成本假定为新台币10,402/500毫克。主要结果包括增量成本效益比（ICER）和净货币收益。采用确定性敏感性分析（DSA）和概率敏感性分析（PSA）来评估不确定性并探索降价方案。
结果：Ivosidenib的ICER分别为新台币6,268,528和新台币5,670,555，而mFOLFOX和5-FU/LV，分别,都超过了既定的门槛。PSA透露，ivosidenib不太可能具有成本效益，除了与mFOLFOX和5-FU/LV相比，它减少到新台币4,161元和新台币5,201/500毫克，分别。DSA强调了ivosidenib的成本和效用值对估计不确定性的重大影响。
结论：以新台币10,402元/500毫克，与mFOLFOX或5-FU/LV相比，Ivosidenib对IDH1突变ICC患者的成本效益不佳，这表明，在该患者组中，要使ivosidenib具有成本效益，必须将价格降低50-60％。
