Lamivudine與Entecavir用於治療B型肝炎病人之成本效果分析

研究目的本研究將探討B型肝炎患者接受抗病毒藥物Lamivudine及Entecavir治療之成本效果分析，主要研究目的為: 一、比較B型肝炎患者接受口服抗病毒藥物Lamivudine及Entecavir治療之病人特質與就醫醫院特質之差異。二、比較B型肝炎患者接受口服抗病毒藥物Lamivudine及Entecavir治療之成本差異。三、比較B型肝炎患者接受口服抗病毒藥物Lamivudine及Entecavir治療之效果差異。四、 B型肝炎患者接受口服抗病毒藥物Lamivudine及Entecavir治療之成本效果分析。研究方法本研究為一回溯性世代研究，採次級資料進行分析。以回溯性方式分析國家衛生研究院提供的醫事機構基本資料檔(HOSB)、承保資料檔(ID)、住院醫療費用清單明細檔(DD)、住院醫療費用醫令清單明細檔（DO）、門診處方治療明細檔（CD）、及門診處方醫令明細檔(OO)，以2006年1月至2010年12月期間診斷為B型肝炎門診病人為基礎，並以行政院衛生署中央健康保險局公告網站藥品醫令代碼，選擇以口服抗病毒藥物治療「干安能(lamivudine)醫令代碼A043302100」，及「貝樂克(entecavir)醫令代碼0.5mg/B024469100」為研究樣本，分析這兩種治療於B型肝炎患者的成本效果。由於兩組比較研究可能會受到潛在干擾因子的影響，爲減少偏差，經由傾向分數配對(PSM, propensity score matching)，以平衡兩組干擾因子的差異。統計分析採用統計套裝軟體SPSS 19中文版，進行描述性及推論性統計卡方檢定、獨立樣本t檢定。研究結果本研究探討慢性B型肝炎患者接受抗病毒藥物Lamivudine及Entecavir治療之成本效果比較，整體而言，台灣地區慢性B型肝炎患者接受口服抗病毒藥物干安能(lamivudine)及貝樂克(entecavir)治療共1280人，本研究結果顯示罹患慢性B型肝炎患者年齡大多數介於35~64歲，且以男性佔多數。又以接受治療的醫院層級而言，顯示大多數B型肝炎患者皆以醫學中心為選擇治療的醫療院所，其次才是區域醫院。而以兩種治療方式之成本比較，以每人治療18個月直接醫療成本相較，貝樂克治療之成本低於干安能（p＝0.0171）；而以效果而言，兩組治療方式的病人皆以門診治療追蹤為主，故結果顯示兩組治療病人門診次數上統計分析無顯著差異（p＝0.1155），但以實際計算平均門診次數上，干安能治療病人門診次數較貝樂克病人多。又以干安能與貝樂克治療之成本效果分析結果，C/E值於總醫療費用顯示貝樂克治療低於干安能，故以成本/效果值而言，貝樂克治療為最佳方案；以遞增成本效果比值ICER而言，顯示貝樂克治療的成本較低，但效果也較差；又以兩種治療方案ICER值皆小於3倍的國民生產毛額則為1,810,101元，故皆具有成本效果。故本研究結果顯示慢性B型肝炎患者選擇以貝樂克治療較干安能治療具成本效果。結論與建議本研究比較兩種治療方式之成本、效果及成本效果之差異，發現兩種治療方式之成本部份，平均總醫療費用相差9.3萬，顯示以貝樂克治療方式之成本低於以干安能治療方式；又以成本效果分析結果顯示，選擇以貝樂克治療較干安能治療具成本效果。以2003年10月行政院衛生署中央健康保險局開辦的「全民健康保險加強慢性B型及C型肝炎治療試辦計畫」，在陸續擴大給付條件後，隨著臨床專科醫師的判斷建議、加上政策推動下，接受治療的族群逐漸上升。本研究結果顯示口服抗病毒藥物確實在成本效果上皆有經濟效益，將此結論提供給有關單位利用，作為醫療資源參考，以訂定更合宜的給付標準。

關鍵字

慢性B型肝炎； lamivudine ； entecavir ；成本效果分析

並列摘要

Purposes This study will examine the cost-effectivness analysis of two antiviral drugs, Lamivudine and Entecavir, the main research objectives are: 1. Examine the characteristics of hepatitis B patients receiving oral antiviral Lamivudine versus Entecavir therapy and compare the differences in medical hospital characteristics. 2. Evaluate the costs of oral antiviral Lamivudine and Entecavir in patients with chronic hepatitis B 3. Compare the effectiveness of oral antiviral treatment of Lamivudine and Entecavir in patients with chronic hepatitis B 4. Evaluate the cost-effectiveness of Lamivudine and Entecavir in patients with chronic hepatitis B Methods This study was a retrospective cohort study using secondary data for cost-effectiveness analysis. The secondary data were provided by the database of National Health Research Institute including basic profile medical institutions (HOSB), coverage data file (ID), inpatient medical expenses detailed file list (DD), inpatient medical expenses medical orders inventory detail file (DO), outpatient prescription medications detail file (CD), and outpatient prescription medical orders detail file (OO) from January 2006 to December 2010. Outpatients diagnosed with chronic hepatitis B were selected, but excluding chronic hepatitis C, HIV (acquired immunodeficiency syndrome) and multiple sclerosis patients. We selected two oral antiviral therapy "Zeffix ( lamivudine): Physician Order Code A043302100 "and" Baraclude (entecavir) :Physician Order Code 0.5m g/B024469100 ", using the pharmaceuticals physician order code announced by the Bureau of National Health Insurance website, then analyzed the cost-effectiveness of these two treatments in patients with Chronic hepatitis B. Because of the two groups may be impacted by the potential confounding factors, the propensity score matching (PSM) method was used for reducing bias and balancing the differences between the two groups. Statistical analyses such as chi-square test, independent sample t-test. were performed using SPSS statistical package release 19. The cost/effect ratio and ICER (incremental cost effectiveness ratio) were also used for the economic evaluation. Results In this study, cost-effectiveness analysis of lamivudine and entecavir treatment in patients with chronic hepatitis B, overall, Our results showed that there were 1280 patients with chronic hepatitis B in Taiwan receiving oral antiviral lamivudine and entecavir treatment, mainly in the 35-64 year-old age group and most of them are male. Most of these patients received treatment in major medical centers, then regional hospital. According to our results of the cost-effectiveness analysis, we found that there is statistical significance in the difference of medication costs between these two drugs, the cost of lamivudine is lower than the cost of entecavir（p＝0.0171）. According to projections based on outpatient visits frequency, there were no significant differences（p＝0.1155）,but actual accounting visits frequency average is the lamivudine more than the entecavir. Finally, the C/E of the total medical costs showed entecavir is lower than lamivudine. That’s mean entecavir is the best choice；the ICER of the total medical costs and the effect showed that entecavir is lower than lamivudine. Both treatments in terms of ICER were less than 3 times GDP NT1,810,101, that means both of entecavir and lamivudine are cost effective. Conclusions and suggestions This study compared the medical cost, effectiveness and cost-effectiveness between two medications, and found a discrepancy of 93,000 NTD in total medical costs between these two medications, and also found a significant difference in the duration of hospitalization. The cost-effectiveness analysis showed that both treatments are cost-effective, entecavir showed the costs less than lamivudine. There is a steady increasing number of patients receiving medical treatments using antiviral medications, since the Chronic hepatitis B and C treatment pilot project announced by the National health Council in October 2003. The pilot project was later reformed and expanded on its conditions to include more patients. There were even more patients since the policy reform, along with the professional opinion from the clinical specialist. The results indicated that oral antiviral medications were clinically significant in both cost and effectiveness, and this conclusion will be provided to the relevant units utilized as a medical resource reference to stipulate more expedient payment standard.