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研究生： 林佳諭
Lin, Jia-Yu
論文名稱： 運用多準則決策分析法進行以實證為基礎的價值評估：以轉移性結腸直腸癌之既有標靶藥品為例
Evidence-Based Value Assessment on Targeted Therapies for Metastatic Colorectal Cancer Treatment: Application of Multi-Criteria Decision Analysis
指導教授： 徐之昇
Hsu, Jason C.
共同指導教授: 林鵬展
Lin, Peng-Chan
學位類別： 碩士
Master
系所名稱： 醫學院 - 臨床藥學與藥物科技研究所
Institute of Clinical Pharmacy and Pharmaceutical sciences
論文出版年： 2017
畢業學年度： 105
語文別： 中文
論文頁數： 233
中文關鍵詞： 價值評估 、多準則決策分析法 、層級分析法 、轉移性結腸直腸癌 、標靶藥物
外文關鍵詞： Metastatic colorectal cancer, Targeted therapy, Value assessment, Multi-criteria decision analysis, Analytic hierarchy process
相關次數： 點閱：153  下載：5 
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    • 研究背景
    藥物價值評估為一多層面的考量，針對不同類型的決策者更動其功能及應用，針對藥物納入保險給付決策，考量層面涵蓋臨床、經濟及社會。為擴大公民參與，從藥物專家決策模式改由多元組成成員的全民健康保險藥物給付項目及支付標準共同擬訂會議，針對臨床需求、藥物之預算衝擊等考量評估後，決定是否納入健保給付。然而該多元組成的利益團體代表對於健保收載藥物與否之著眼點可能有所差異，並且尚無一系統性決定的收載原則，故如何將多元面向準則的衡量應用於藥物價值評估及決定給付與否，有必要進行深入分析及探討。另外，結腸直腸癌之發生人數為目前國人十大癌症中最多的癌症，其發生率和死亡率近年來維持著穩定且居高不下的趨勢。轉移性結腸直腸癌除了透過手術及使用化學治療藥物，可考慮搭配標靶藥物進行治療。本研究目的依序有三項：(1) 初步建構一套多元面向藥物價值的評估準則與模型；(2) 分析不同類型的健保給付決策者及臨床專家對於衡量面向及準則之間的差異；(3) 運用上述模型進行轉移性結腸直腸癌既有標靶藥物之完整價值評估。

    研究方法
    本研究利用多準則決策分析法 (Multi-criteria decision analysis，MCDA) 評估Bevacizumab，Cetuximab，Panitumumab，Aflibercept與Regorafenib等五個治療轉移性結腸直腸癌的標靶藥物。參考 MCDA 的執行步驟逐步進行：
    (1) 建立決策內容、(2) 建構相關評估準則、(3) 決定各評估準則的權重、(4) 統整藥物於各準則的表現資訊、(5) 標靶藥物於各準則的評分、(6) 計算各標靶藥物的整體分數、(7) 處理不確定性並進行敏感性分析，以及(8) 詮釋相關數據並公佈結果。經專家效度評估後，MCDA 模型中包括三個面向與九個準則：(1)臨床面向中包含「相對療效」、「相對安全性」及「方便性與生活品質」準則；(2)經濟面向中包含「成本效益」、「病患人數」和「藥品費用」準則；(3)社會面向有「創新程度」、「社會關注及病人需求」和「其他國家納入保險給付與否」準則。本研究透過訪談式問卷調查，分別蒐集標靶藥物於各面向準則的表現資訊與面向及準則之權重。面向與準則的權重資訊部分，其訪談對象與人數組成係參考專家會議和共同擬訂會議成員類型，共 30 位受訪者；標靶藥物的表現資訊部分與結腸直腸癌外科醫師、血液腫瘤科醫師及癌症臨床藥師等共 10 位臨床專家進行訪談。最後計算各標靶藥物於不同面向與準則的整體分數，以及進行敏感性分析，以評估研究結果的穩固性 (Robustness)。

    研究結果
    經過資料蒐集和分析後，本研究重要結果如下：(1) 整體而言，以臨床面向權重最高；(2) 依不同受訪者屬性區分後，健保署代表較重視臨床與經濟面向；(3) 整體來看，臨床面向中，「相對療效」準則的權重最高；經濟面向中，「成本效益」準則最受重視；社會面向中，側重「社會關注及病人需求」準則；(4) 打破面向框架進行準則之間的比較後，整體以「相對療效」準則權重最高，且依不同受訪者屬性分析後，部分準則之權重略有不同；(5) 針對既有轉移性結腸直腸癌標靶藥物進行各準則之價值評估，整體價值由高至低依序為：Cetuximab （總分分數67.332），Bevacizumab （66.086），Panitumumab （64.06），Aflibercept （57.846），Regorafenib （56.732）；倘若以病友團體代表及藥廠的權重分數傾向來分析，不影響整體之藥物評估結果。(6)針對調整社會面向權重之敏感性分析，Bevacizumab及Regorafenib易受影響，但不影響整體之藥物評估結果。

    結論
    本研究建議健保署應建立「多元面向準則」、「多觀點」且「整合性評估」的評估機制全面地分析藥物價值。多元面向準則的建立會增加評估的完整性，以利於提供完整的藥物價值評估結果；權重的整合評估透過考量決策者的偏好程度，以獲得貼近實際評估情形的資訊進行分析；納入多觀點的建議能夠輔助決策者檢視其他需求及考量。

    Health technology assessment (HTA) is a comprehensive assessment of the clinical, economic, and social issues. Many countries established organizations of HTA to evaluate drug information by evidence-based approach. Multi-criteria decision analysis (MCDA), a structured approach that supports decision-makers to assess and compare multiple options among multiple dimensions and criteria, which can be applied in evaluation of insurance coverage and reimbursement. This study aims to establish a decision-making model with multiple criteria for appraisal and reimbursement, to compare viewpoints toward various dimensions and criteria from different stakeholders, and to evaluate the five targeted therapies for metastatic colorectal cancer. Criteria selection, weights and other information about the criteria and performances of targeted therapies were obtained by medical expert interview and questionnaire analysis. We interviewed 30 stakeholders for weighting of criteria and interviewed 10 clinical experts for scoring of options. This study found that most of the stakeholders take “clinical value” (especially “comparative effectiveness”) as the most important dimension (criteria). Overall, cetuximab has the highest value, followed by bevacizumab and panitumumab. This study is a pilot study, which use MCDA to conduct a comprehensive value assessment. The variations of weightings for dimensions and criteria from different stakeholders are reported. Both overall and specific performance of targeted therapies by dimensions, criteria and stakeholders are also evaluated. The findings of this study will be a base for developing further useful decision models to evaluate the comprehensive value of medicine in the future.

    中文摘要 i Extracted Abstract iv 目錄 viii 表目錄 xii 圖目錄 xvii 第一篇、運用多準則決策分析法進行以實證為基礎的價值評估： 以轉移性結腸直腸癌之既有標靶藥物為例 1 第一章、緒論 1 第一節、研究背景與動機 1 第二節、研究目的與重要性 4 第二章、文獻回顧 5 第一節、價值評估 5 一、價值定義 5 二、價值評估功能 5 三、藥物價值評估之學術探討 7 第二節、藥物價值評估方法 9 一、價值評估之類型與方法 9 二、多準則決策分析法 14 三、層級分析法 26 第三節、藥物納入醫療保險給付之決策考量 33 一、國外藥物納入醫療保險給付之決策考量 33 二、台灣藥物納入給付流程之歷程演進 37 三、醫療科技評估報告內容項目 42 第四節、轉移性結腸直腸癌 44 一、結腸直腸癌之流行病學與危險因子 44 二、轉移性結腸直腸癌簡介 45 三、標靶藥物治療 46 四、既有標靶藥物之醫療科技評估報告回顧 48 第三章、研究方法 72 第一節、研究架構 72 第二節、轉移性結腸直腸癌既有標靶藥物之多準則決策分析 73 一、建立決策內容 Defining the decision problem 73 二、建構相關評估準則 Selecting and structuring criteria 73 三、決定各評估準則的權重 Weighting criteria 77 四、統整藥物於各準則的評分資訊 Measuring performance 79 五、標靶藥物於各準則的評分 Scoring alternatives 84 六、計算各標靶藥物的整體分數 Calculating aggregate scores 85 七、處理不確定性並進行敏感性分析 Dealing with uncertainty 85 八、詮釋相關數據並公佈結果 Interpretation and reporting the results 86 第四章、研究結果 87 第一節、評估面向與評估準則之權重 87 一、評估面向與評估準則之專家效度分析結果 87 二、評估面向之權重 87 三、個別面向中，各評估準則之權重 90 四、在不考慮評估面向的框架下，所有評估準則之權重 105 第二節、既有標靶藥物之整體價值評分 113 一、評分資訊問卷之專家效度評估 113 二、各標靶藥物於各準則之評分 113 三、標靶藥品之整體價值結果 113 四、敏感性分析 (Sensitivity analysis) 116 第五章、研究討論 120 第一節、多面向藥物價值評估 120 第二節、多觀點藥物價值評估 121 第三節、整合性藥物價值評估 125 第四節、面向與評估準則之權重 126 第五節、既有標靶藥物之整體價值評分 132 第六節、訪談對象開放性建議 139 第七節、研究優勢、限制與未來研究方向建議 147 第六章、結論與建議 149 第二篇、臨床藥事服務：成大醫院免疫檢查哨抑制劑使用療效及安全性之病歷回顧 150 第一章、服務背景 150 第二章、目的與重要性 156 第三章、方法 157 第四章、服務結果 159 第一節、研究對象基本特性 159 第二節、免疫檢查哨抑制劑處方情形 164 第三節、藥物治療效果 168 第四節、不良事件發生情形 170 第五章、討論與建議 178 第六章、結論 188 參考文獻 189 附錄 201 附錄一：新藥價值評估問卷內容 201 附錄二：新藥價值評估相關研究結果 205 附錄三：醫療科技評估執行方法建議 207 附錄四：2013及2014年十大癌症發生率及死亡率 214 附錄五：既有轉移性結腸直腸癌標靶藥物之現行健保規範 218 附錄六：結腸直腸癌既有標靶藥品評估準則之權重調查問卷 221 附錄七：結腸直腸癌既有標靶藥品評分問卷 223 表目錄 表2-1-1新藥價值評估研究結果之重要面向及主要考量因素 8 表2-2-1價值評估方法之操作特性 12 表2-2-2量化評估方法之整體特性 13 表2-2-3 EVIDEM架構之評估準則及評分尺度 16 表2-2-4多準則決策分析應用之類型、決策對象及應用案例等內容彙整 20 表2-2-5 MCDA執行步驟及相關說明 22 表2-2-6 AHP方法要素間評估尺度說明 29 表2-2-7隨機指標對照表 31 表2-3-1歐洲國家藥物納入保險給付之考量決策 34 表2-3-2新藥分類 38 表2-3-3參考品核價原則 39 表2-3-4新藥類型及核價方式 39 表2-3-5共同擬定會議代表之成員背景與人數 40 表2-3-6醫療科技評估報告內容主要項目 43 表2-4-1 TFDA 予以藥物許可證時間點及標靶藥物作用機轉 47 表2-4-2標靶藥物於健保給付後臨床上治療情境之選擇 52 表2-4-3標靶藥物於健保給付後臨床上治療情境之詳細用藥選擇 52 表2-4-4政府主管機關許可適應症 53 表2-4-5轉移性結腸直腸癌既有標靶藥物之成分、劑型、使用劑量及用法 55 表2-4-6加拿大、澳洲、英國及蘇格蘭醫療科技評估報告建議收載內容彙整 56 表2-4-7美國FDA目標適應症之核准使用情形 57 表2-4-8歐洲藥物管理局及美國食品藥物管理局之適應症彙整 59 表2-4-9標靶藥物臨床試驗療效結果整理 62 表2-4-10標靶藥品臨床試驗安全性結果 65 表2-4-11健保收載標靶藥品之第一至五年財務衝擊狀況彙整 69 表2-4-12標靶藥物獲得保險給付之國家 70 表2-4-13標靶藥品之國際藥價與國內健保藥價* 71 表3-2-1問卷內容效度評估專家姓名及專長領域 74 表3-2-2問卷各準則衡量方式 76 表3-2-3各評估準則、資料來源、其他假設情形及計算方式 80 表3-2-4各準則之評分標準 84 表4-1-1整體評估面向之權重 88 表4-1-2不同受訪者屬性之面向權重 89 表4-1-3整體及受訪者屬性對各面向權重之變異程度情形 89 表4-1-4整體於臨床面向中評估準則之權重 91 表4-1-5整體於經濟面向中評估準則之權重 91 表4-1-6整體於社會面向中評估準則之權重 92 表4-1-7健保署代表於臨床面向中評估準則之權重 93 表4-1-8健保署代表於經濟面向中評估準則之權重 93 表4-1-9健保署代表於社會面向中評估準則之權重 93 表4-1-10食品藥物管理署代表於臨床面向中評估準則之權重 94 表4-1-11食品藥物管理署代表於經濟面向中評估準則之權重 95 表4-1-12食品藥物管理署代表於社會面向中評估準則之權重 95 表4-1-13專家學者代表於臨床面向中評估準則之權重 96 表4-1-14專家學者代表於經濟面向中評估準則之權重 96 表4-1-15專家學者代表於社會面向中評估準則之權重 97 表4-1-16病友團體代表於臨床面向中評估準則之權重 98 表4-1-17病友團體代表於經濟面向中評估準則之權重 98 表4-1-18病友團體代表於社會面向中評估準則之權重 98 表4-1-19醫師代表於臨床面向中評估準則之權重 99 表4-1-20醫師代表於經濟面向中評估準則之權重 100 表4-1-21醫師代表於社會面向中評估準則之權重 100 表4-1-22藥師代表於臨床面向中評估準則之權重 101 表4-1-23藥師代表於經濟面向中評估準則之權重 101 表4-1-24藥師代表於社會面向中評估準則之權重 102 表4-1-25醫院代表於臨床面向中評估準則之權重 103 表4-1-26醫院代表於經濟面向中評估準則之權重 103 表4-1-27醫院代表於社會面向中評估準則之權重 103 表4-1-28業界代表於臨床面向中評估準則之權重 104 表4-1-29業界代表於經濟面向中評估準則之權重 105 表4-1-30業界代表於社會面向中評估準則之權重 105 表4-1-31整體及不同受訪者屬性對評估準則之權重衡量狀況 111 表4-2-1標靶藥物於各準則下之評估分數 114 表4-2-2標靶藥物之整體價值結果 115 表5-1-1特定評估準則考量之權重加總 120 表5-1-2特定評估準則考量之藥物價值評估結果 121 表5-4-1評估準則之專家建議事項及研究者回覆內容 127 表5-4-2權重比較之專家建議事項及研究者回覆內容 128 表5-5-1標靶藥品評估之專家建議事項及研究者回覆內容 133 表5-6-1預算衝擊之分析架構 140 表5-6-2訪談對象之開放性建議及研究者建議 144 表2-1-1-1 TFDA 對於免疫檢查哨抑制劑之核准適應症 151 表2-1-1-2非第一線使用檢查哨抑制劑之非小細胞肺癌免疫檢查哨抑制劑臨床試驗療效及收案病患特性 153 表2-1-1-3非第一線使用檢查哨抑制劑之非小細胞肺癌免疫檢查哨抑制劑臨床試驗安全性結果 155 表2-4-1-1研究對象基本特性 159 表2-4-1-2研究對象基本特性（生化檢驗數值） 160 表2-4-1-3研究對象基本特性（血液及核醫免疫檢驗數值） 161 表2-4-1-4研究對象之共病症 162 表2-4-1-5研究對象之長期合併用藥 163 表2-4-2-1使用適應症情形 165 表2-4-2-2單一用藥處方型態 166 表2-4-2-3 Nivolumab 合併用藥處方型態 167 表2-4-2-4 Pembrolizumab 合併用藥處方型態 167 表2-4-2-5 Nivolumab 及 Ipilimumab 合併用藥處方型態 168 表2-4-3-1肺癌病人基因相關檢測特性 169 表2-4-3-2整體及肺癌病患之整體存活期及無惡化存活期中位數 169 表2-4-4-1血中肌酸酐增加之發生率及嚴重程度 170 表2-4-4-2 AST 增加之發生率及嚴重程度 171 表2-4-4-3 ALT 增加之發生率及嚴重程度 171 表2-4-4-4總膽色素增加之發生率及嚴重程度 172 表2-4-4-5低血鈉之發生率及嚴重程度 172 表2-4-4-6血鉀濃度異常之發生率及嚴重程度 173 表2-4-4-7低白蛋白血症之發生率及嚴重程度 174 表2-4-4-8血小板減少之發生率及嚴重程度 175 表2-4-4-9免疫相關藥物不良事件類型及發生比率 176 表2-4-4-10藥物不良事件類型及發生比率 176 表2-5-1-1非鱗狀非小細胞肺癌病患使用研究藥物前之治療情形 178 表2-5-1-2本研究結果與已接受治療之非小細胞肺癌臨床試驗結果比較表 179 表2-5-1-3投藥後至第一次免疫相關不良事件之發生時間 180 表2-5-1-4投藥後至第一次非免疫相關不良事件之發生時間 180 表2-5-1-5肝炎帶原及感染者之不良反應類型及發生比率 182 表2-5-1-6 FDA 核准 Nivolumab 的使用情形 183 表2-5-1-7 FDA 核准 Pembrolizumab 的使用情形 184 表2-5-1-8 FDA 核准 Ipilimumab 的使用情形 184 表2-5-1-9免疫檢查哨抑制劑 TFDA 核准適應症及使用劑量 185 表2-5-1-10目前單獨使用 Nivolumab 和 Nivolumab 與 Ipilimumab 併用執行中的臨床試驗 186 表2-5-1-11目前 Pembrolizumab 執行中的臨床試驗案 187 附錄表1 2013年十大癌症（不含原位癌）發生率（每十萬人口） 214 附錄表2 2014年十大癌症（不含原位癌）發生率（每十萬人口） 215 附錄表3 2013年十大癌症死亡率（每十萬人口） 216 附錄表4 2014年十大癌症死亡率（每十萬人口） 217 圖目錄 圖1-1-1結腸直腸癌之標準化發生率和死亡率趨勢圖 2 圖2-1-1評估面向及重要考量因素之重要性高低 8 圖2-2-1價值評估方法架構及類別 11 圖2-2-2成對比較矩陣A 29 圖2-2-3行向量平均值標準化法計算公式 30 圖2-2-4一致性指標相關計算公式 31 圖2-2-5一致性比率計算公式 31 圖2-3-1藥物納入保險給付流程 33 圖2-3-2藥物納入健保給付評估流程圖 42 圖2-4-1結腸直腸癌之五年內存活率 45 圖2-4-2美國國家癌症資訊網 (NCCN) 2017 年第 1 版治療指引建議 48 圖3-1-1研究流程圖 72 圖3-2-1評估面向及準則架構樹狀圖 75 圖3-2-2評估面向及準則權重之訪談對象組成及人數 78 圖3-2-3面向及準則的權重評估方式 79 圖3-2-4標靶藥物評分結果之訪談對象組成及人數 85 圖4-1-1整體評估面向之權重分佈 87 圖4-1-2不同受訪者屬性之面向權重分佈 88 圖4-1-3整體各面向中評估準則之權重分佈 91 圖4-1-4健保署代表於各面向中評估準則之權重分佈 92 圖4-1-5食品藥物管理署代表於各面向中評估準則之權重分佈 94 圖4-1-6專家學者代表於各面向中評估準則之權重分佈 96 圖4-1-7病友團體代表於各面向中評估準則之權重分佈 97 圖4-1-8醫師代表於各面向中評估準則之權重分佈 99 圖4-1-9藥師代表於各面向中評估準則之權重分佈 101 圖4-1-10醫院代表於各面向中評估準則之權重分佈 102 圖4-1-11業界代表於各面向中評估準則之權重分佈 104 圖4-1-12整體於考量面向權重後各評估準則之權重分佈 106 圖4-1-13健保署代表於考量面向權重後各評估準則之權重分佈 106 圖4-1-14食品藥物管理署代表於考量面向權重後各評估準則之權重分佈 107 圖4-1-15專家學者代表於考量面向權重後各評估準則之權重分佈 107 圖4-1-16病友團體代表於考量面向權重後各評估準則之權重分佈 108 圖4-1-17醫師代表於考量面向權重後各評估準則之權重分佈 108 圖4-1-18藥師代表於考量面向權重後各評估準則之權重分佈 109 圖4-1-19醫院代表於考量面向權重後各評估準則之權重分佈 109 圖4-1-20業界代表於考量面向權重後各評估準則之權重分佈 110 圖4-2-1標靶藥物之整體價值結果 115 圖4-2-2臨床面向權重之敏感性試驗 117 圖4-2-3經濟面向權重之敏感性試驗 117 圖4-2-4社會面向權重之敏感性試驗 118 圖4-2-5相對療效準則權重之敏感性試驗 118 圖4-2-6安全性準則權重之敏感性試驗 119 圖4-2-7成本效益準則權重之敏感性試驗 119 圖5-1-1特定評估準則考量之藥物價值評估結果 120 圖5-2-1病友團體及藥廠代表與其他受訪者之評估面向權重分佈 122 圖5-2-2病友及藥廠代表與其他受訪者之臨床面向內準則權重分佈 122 圖5-2-3病友及藥廠代表與其他受訪者之經濟面向內準則權重分佈 122 圖5-2-4病友及藥廠代表與其他受訪者之社會面向內準則權重分佈 123 圖5-2-5其他受訪者之評估準則權重分佈 123 圖5-2-6病友及藥廠代表之評估準則權重分佈 123 圖5-2-7其他受訪者之藥物價值評估結果 124 圖5-2-8病友及藥廠代表之藥物價值評估結果 124 圖5-3-1未進行權重整合之藥物價值評估結果 125 圖2-1-1-1免疫檢查哨抑制劑之作用機轉及藥物分類 150 圖2-1-1-2鱗狀細胞之非小細胞肺癌病患PD-L1表現量 152 圖2-1-1-3非鱗狀細胞之非小細胞肺癌病患PD-L1表現量 152 附錄圖1臨床效益面向中不同受訪者屬性對重要考量因素之差異 205 附錄圖2社會影響及經濟效益面向中不同受訪者屬性對重要考量因素之差異 205 附錄圖3病人考量面向中不同受訪者屬性對重要考量因素之差異 206 附錄圖4醫療可行性面向中不同受訪者屬性對重要考量因素之差異 206

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