晚期肺腺癌具有EGFR基因變異者之一線治療策略成本效用分析

隨著現代癌症治療標靶藥物發展的日新月異，如何在最少的健保預算下增加晚期非小細胞肺癌EGFR陽性無法手術的病人，最多的無惡化存活期（(Progression Free Survival, PFS)、較佳的生活品質校正年(quality adjusted life-years, QALYs)並增進健保資源的永續經營。本研究利用經濟評估的方法比較晚期非小細胞肺癌具有EGFR基因變異者之一線治療策略成本效用分析。方法:由2014年至2017年全民健康保險資料庫及國民健康署癌症登記表全人口檔獲得晚期非小細胞肺癌具有EGFR基因變異者之真實資料，分析病人在接受三種標靶藥物Gefitinib、Erlotinib及Afatinib，三種一線不同治療策略的無惡化存活期與整體存活期(Overall Survival, OS)，並利用文獻回顧取得在不同治療策略下病人的效用值(Utility)，比較在三種一線治療標靶藥物治療下的存活情形與成本差異，進行成本效用分析及多維敏感度分析，計算其品質校正人年。結果:與Gefitinib相比Erlotinib的ICER值為新台幣697,318元、Afatinib的ICER值為新台幣1,787,675。成本效果接受曲線(CEAC)結果顯示使用Erlotinib在願付價格為新台幣960,650元時具有成本效益的機率為50.1%，隨著願付金額的上升，使用Erlotinib治療策略的成本效益機率越高。Afatinib在一倍GDP(新台幣800,542元)時，具有成本效益的機率為40.8%，在願付價格為新台幣1,761,192元時具有成本效益的機率為50.1%。隨著願付金額的上升，使用Afatinib治療策略的成本效益機率越高。結論:使用Erlotinib及Afatinib治療非小細胞肺癌EGFR陽性病人與Gefitinib相比當願付價格越高時，具有成本效益的機率越高。

關鍵字

晚期非小細胞肺癌；標靶藥物；成本效益評估； EGFR陽性

並列摘要

Objective: With the Pharmaceutical industry developed, cancer patients have more treatment choices to cope with the disease. In Taiwan, we have the National Health Insurance (NHI) which can ensure the insured that who have catastrophic illness can be taken good care of .But with limited resource, how to increase the QALY of patients and keep sustainable operation of NHIis issue. In this study, we did the cost-utilities analysis for first line treatments Gefitinib,Erlotinib and Afatinib with advanced (III IV) stage EGFR positive in non-small cell lung cancer (NSCLC) patients in Taiwan. To find out which first line target therapy treatment provide the patients more quality adjusted life-years (QALYs) and enhance the sustainable for National Health Insurance. Methods: The resource of data is from National Health Insurance Database and Taiwan's national cancer registry database between 2014 to 2017.We compared the difference of the overall survival (OS) ,progression free survival (PFS) and cost. The Wilcoxon rank-sum test, generalized estimating equation (GEE), Cox proportional hazards regression and Kaplan-Meier survival curve were used to compare the difference in the clinical outcomes and medical expenditures (cost).Incremental cost-effectiveness ratio (ICER) and quality adjusted life-years (QALYs) were calculated in the cost-utility analysis. This study also used the one-way sensitivity analysis and non-parametric bootstrap to discuss the distribution of ICER. Results: In the cost-utility analysis of the first-line treatment strategy for patients with advanced non-small cell lung cancer with EGFR mutation positive, compare to Gefitinib the ICER of Erlotinib and Afatinib are NTD697, 318 NTD1, 787,675 per QALY. In the CEAC, it would be 50.1% more cost effective of Erlotinib than Gefitinib with the WTP NTD 960,650. Afatinib would be 50.1% more cost effective than Gefitinib with the WTP NTD 1,761,192. Conclusions: As trategies of the first line treatments on advanced stage EGFR positive in non-small cell lung cancer in Taiwan, Erlotinib and Afatinib would be more cost effectiveness to Gefitinib with the higher WTP.