塗藥球囊導管與傳統球囊導管用於治療下肢動脈粥樣硬化患者之成本效果分析

Abstract

【研究目的】 以衛生福利部中央健康保險署之觀點，使用馬可夫模型評估使用塗藥球囊導管(drug-coated balloon, DCB)及傳統球囊導管(uncoated balloon, UCB)用於治療下肢動脈粥樣硬化(lower-limb atherogenesis)患者之成本效果分析(cost-effectiveness analysis, CEA)。 【研究背景】 使用塗藥球囊導管進行經皮穿刺血管腔內整形術可降低下肢動脈粥樣硬化患者再介入性治療率，並延長其再介入性治療時間。迄今為止，僅有針對美國、德國、英文、義大利及瑞士政府觀點之塗藥球囊導管成本效果分析研究，對於塗藥球囊導管在我國之成本效果尚未知。 【研究方法】 根據IN.PACT SFA II臨床試驗獲得之臨床結果，再透過我國全民健康保險研究資料庫得到我國在治療下肢動脈粥樣硬化之醫療費用，來進行週期(cycles)長度為一個月、期間(time horizon)為兩年之馬可夫模型模擬。 【研究結果】 儘管使用塗藥球囊導管進行經皮穿刺血管腔內整形術之費用會因特材費用較高，但因其再介入性治療率較低，在兩年追蹤後，塗藥球囊導管之總醫療費用會比傳統球囊導管低約新台幣30,000元，並可增加約0.01年之生活品質校正生命年。增額成本效益比值(ICER)顯示DCB為具有優勢(dominant)的介入。使用塗藥球囊導管治療下肢動脈粥樣硬化患者具有成本效果的機率在閾值為一個人均國內生產毛額（新臺幣801,037元）及三個人均國內生產毛額（新臺幣2,403,111元）時，分別為83.5%及90.6%。 【結論】 對於下肢動脈粥樣硬化患者來說，使用塗藥球囊導管進行經皮穿刺血管腔內整形術為效果較佳、成本較低之策略。與過去美國、英國、德國、義大利及瑞士經濟評估結果相同，塗藥球囊導管較傳統球囊導管為具有優勢(dominant)之治療策略。

[Objective] The aim of this study was to use Markov model simulation to evaluate the cost-effectiveness of using drug-coated balloon (DCB) versus un-coated balloon (UCB) in percutaneous transluminal angioplasty (PTA) from the perspective of Taiwan National Health Insurance Administration, Ministry of Health and Welfare (the third pay payer). [Background] Using DCBs in PTA can reduce the rate of target lesion revascularizations (TLR) and extend the time of revascularizations of patients with lower-limb atherogenesis. Recent researches have reported the cost-effectiveness of using DCB versus UCB in PTA based on the views of the US, Germany, UK, Italian and Swiss governments. However, the cost-effectiveness of DCB angioplasty in Taiwan is unknown. [Methods] Cost-effectiveness was assessed as cost per quality-adjusted life-year (QALY) gained using a Markov model on the basis of empirical data from the IN.PACT SFA II trial and costs from National Health Insurance Reasearch Database. The cycle of the Markov model was one month long and the time horizon was two years. [Results] Initial costs were higher with using DCBs than UCBs in PTA, driven by higher costs of DCB itself. However, due to lower TLR, total medical costs of using DCBs were $30,000 per patient lower than patients treated with UCBs, whereas QALYs were about 0.01 greater with using DCBs than using UCBs in PTA after 24 months. Thus, the ICER showed that DCB was a dominant invervention. The probability that using DCBs is cost-effective compared with using UCBs was 83.5% using a threshold of 1 GDP ($801,037) per QALY gained and 90.6% at a threshold of 3 GDPs ($2,403,111) per QALY gained. [Conclusions] For patients with lower-limb atherogenesis, using DCBs in PTA is associated with better 2-year outcomes and lower costs compared with using UCBs in PTA. With similar results of the past cost-effectiveness analysis in the United States, United Kingdom, Germany, Italy, and Switzerland, the results of this study suggest that using DCBs is a dominant intervention compared with UCBs for treating PTA.