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研究生:章法瑜
研究生(外文):Fa-Yu Chang
論文名稱:新複方藥品納入健保給付對藥品市場影響之探討- 以降血糖藥品 Avandamet®為例
論文名稱(外文):The Impact of New Fixed-Dose Combination on Anti-Diabetic Pharmaceutical Market: The Case of Avandamet®
指導教授:黃文鴻黃文鴻引用關係蔡憶文蔡憶文引用關係
指導教授(外文):Weng-Foung HuangYi-Wen Tsai
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:衛生福利研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2015
畢業學年度:103
語文別:中文
論文頁數:76
中文關鍵詞:複方藥品市場規模安全警示thiazolidinediones
外文關鍵詞:Fixed-dose combinationMarket scaleSafety warningThiazolidinediones
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研究目的
複方藥品是由兩種或兩種以上活性成分組成的單一製劑,在單方藥品市場亦屬新藥。但過去鮮少針對新複方藥品上市後對於藥品市場的影響進行研究,故本研究以thiazolidinedione(TZD)類別的口服降血糖複方藥品Avandamet®為例,探討新複方藥品納入健保給付,對既有TZD藥品rosiglitazone(Avandia®+Avandamet®)市場規模之助益與對競爭藥品pioglitazone (Actos®)市場的影響。

研究方法
本研究採回溯性縱貫性研究,使用2002至2006年全民健康保險資料庫之糖尿病特殊需求檔,以單一醫事機構為市場單位,建立每月TZD藥品處方資料,分別以藥品用量(DDD)與費用支出作為市場規模指標。以Piecewise linear regression分析Avandamet®於2004年8月納入健保給付與2005年2月安全警示後,既有藥品rosiglitazone與競爭藥品pioglitazone的市場規模成長趨勢變化。並以Fractional logit regression統計模型分析rosiglitazone市場佔率的趨勢改變。

研究結果
Avandamet®納入健保給付前,rosiglitazone (用量:coefficient=0.036)與pioglitazone(用量:coefficient=0.045)市場規模均呈正向成長,rosiglitazone的TZD市場佔率呈現下降趨勢(用量:coefficient=-0.032,marginal effect=-0.0064)。Avandamet®納入健保給付後,rosilgitazone(用量:coefficient=-0.042)與pioglitazone(用量:coefficient=-0.122)市場規模則均呈負向成長,rosiglitazone的TZD市場佔率成長趨勢比前一階段顯著上升(coefficient=0.070,marginal effect=0.014)。Rosiglitazone安全警示出現後,rosiglitazone市場規模成長趨勢無顯著改變(用量:coefficient=-0.008),pioglitazone市場規模成長顯著上升(用量:coefficient=0.09),造成rosiglitazone的TZD市場佔率顯著下降(coefficient=-0.08,marginal effect=-0.016)。

結論
Avandamet®納入我國健保給付後,rosiglitazone與pioglitazone市場規模成長趨勢皆下降,rosiglitazone的TZD市場佔率則上升。Rosiglitazone安全警示出現後,rosiglitazone市場規模成長趨勢並無明顯改變,pioglitazone市場規模趨勢上升,rosiglitazone的TZD市場佔率成長趨勢下降。

Background
Fixed-dose combination (FDC) is a formulation including two or more active pharmaceutical ingredients (APIs) in a single pill. It is a new kind of drug in the market of free-combination drugs. However, there is hardly any study which investigated the impact of a FDC on the pharmaceutical market. Therefore, this study used Avandamet® as an example to explore the impact of a FDC on the pharmaceutical market. We examined the change in the market of rosiglitazone (Avandia®+ Avandamet®) and pioglitazone (Actos®) after the introduction of Avandamet® into the market because all of these three drugs belong to the thiazolidinedione (TZD) class.

Method
In this retrospective longitudinal study, each hospital was viewed as a microcosm of the market. Taiwan National Health Insurance database (years 2002~2006) was used to construct monthly profiles of TZDs. Defined daily dose (DDD) and expenses were considered as the indexes of the market scale. Piecewise linear regression was used to analyze the growth trend of rosiglitazone and pioglitazone market after Avandamet® was listed as an insurance-covered medicine by National Health Insurance (NIH) in August 2004 and also after safety warning for rosiglitazone showed up in February 2005. In addition, fractional logit model was used to analyze the growth trend of the market share of rosiglitazone.

Results
Before Avandamet® was listed as an insurance-covered medicine by NIH, both of rosiglitazone (DDD: coefficient=0.036) and pioglitazone (DDD: coefficient=0.045) markets were increasing, and the market share of rosiglitazone was showing a descending trend (coefficient=-0.032, marginal effect=-0.0064). After Avandamet® was introduced into the market, both of rosiglitazone (DDD: coefficient=-0.042) and pioglitazone (DDD: coefficient=-0.122) market growth trends decreased, and the market share trend of rosiglitazone rose significantly (coefficient=0.070, marginal effect=0.014). After the safety warning for rosiglitazone came out, there was no significant change in rosiglitazone (coefficient=-0.008) market, but pioglitazone (coefficient=0.09) market showed a significant rise, which made the market share trend of rosiglitazone significantly decline (coefficient=-0.08, marginal effect=-0.016).

Conclusion
After Avandamet® was listed as an insurance-covered medicine by NIH, both rosiglitazone and pioglitazone market trends decreased, and the market share trend of rosiglitazone increased. After the safety warning for rosiglitazone showed up, the growth trend of rosiglitazone market didn’t change, but that of pioglitazone market increased, making the market share trend of rosiglitazone decline.
目錄
論文電子檔著作權授權書………………………………………………………I
論文審定同意書………………………………………………………………………II
致謝……………………………………………………………………………………………III
中文摘要……………………………………………………………………………………IV
Abstract…………………………………………………………………………………VI
目錄………………………………………………………………………………………VIII
表目錄…………………………………………………………………………………………X
圖目錄………………………………………………………………………………………XI
第一章 緒論………………………………………………………………………………………1
第一節 研究緣起…………………………………………………………………………1
第二節 研究目的及問題…………………………………………………………5
第三節 研究重要性……………………………………………………………………6
第四節 名詞定義…………………………………………………………………………7
第二章 文獻探討………………………………………………………………………………8
第一節 口服降血糖藥品特性…………………………………………………8
第二節 口服降血糖藥品之合併治療…………………………………16
第三節 複方藥品………………………………………………………………………19
第四節 我國藥品市場特性……………………………………………………22
第五節 文獻總結………………………………………………………………………24
第三章 研究設計與方法……………………………………………………………25
第一節 研究設計………………………………………………………………………25
第二節 研究架構………………………………………………………………………26
第三節 研究假說………………………………………………………………………27
第四節 研究期間與研究對象………………………………………………28
第五節 資料來源………………………………………………………………………29
第六節 研究變項及操作型定義…………………………………………30
第七節 資料處理流程……………………………………………………………34
第八節 統計分析………………………………………………………………………36
第四章 研究結果……………………………………………………………………………39
第一節 描述性統計結果…………………………………………………………39
第二節 推論性統計結果…………………………………………………………55
第五章 討論………………………………………………………………………………………63
第一節 政策介入與資訊衝擊對TZD市場之影響……………63
第二節 研究限制…………………………………………………………………………69
第六章 結論與建議…………………………………………………………………………70
第一節 結論…………………………………………………………………………………70
第二節 建議…………………………………………………………………………………71
參考文獻…………………………………………………………………………………………………72


表目錄
表1-1 我國TZD原廠藥品之比較…………………………………………………………………3
表1-2 我國口服降血糖原廠藥品健保給付價格(初次核價)……………3
表2-1 口服降血糖藥品特性…………………………………………………………………………11
表2-2 我國TZD類藥品健保給付價格 (2002.02~2006.11)………13
表2-3 2000~2009年單方藥品健保申報金額排行………………………………14
表2-4 2000~2009年我國兩種口服降血糖藥品合併治療趨勢………17
表2-5 我國納入健保給付之口服降血糖複方藥品………………………………18
表2-6 我國納入健保給付之TZD類藥品劑型…………………………………………20
表3-1 研究變項與操作型定義……………………………………………………………………32
表4-1 研究對象之醫事機構特性………………………………………………………………41
表4-2 研究期間TZD類藥品與整體口服降血糖藥品市場規模………42
表4-3 研究期間醫事機構整體TZD市場規模………………………………………44
表4-4 研究期間開立rosiglitazone與pioglitazone的醫事機構家數……45
表4-5 研究期間醫事機構整體TZD用量(DDD):層級別…………………47
表4-6 研究期間醫事機構整體TZD藥品費用支出:層級別……………48
表4-7 研究期間醫事機構整體TZD用量(DDD):權屬別…………………50
表4-8 研究期間醫事機構整體TZD藥品費用支出:權屬別……………50
表4-9 研究期間醫事機構整體TZD用量(DDD):分局別…………………52
表4-10 研究期間醫事機構整體TZD藥品費用支出:分局別……………53
表4-11 研究期間rosiglitazone市場規模趨勢…………………………………57
表4-12 研究期間pioglitazone市場規模趨勢……………………………………59
表4-13 研究期間rosiglitazone市場規模的TZD佔率……………………61
表5-1 採用pioglitazone之醫事機構特性(2002.11)…………………64


圖目錄
圖1-1 我國TZD類藥品市場………………………………………………………………………………4
圖2-1 2000~2008年我國口服降血糖單方藥品申報金額趨勢…………15
圖2-2 降血糖藥品合併治療建議流程…………………………………………………………16
圖2-3 Avandamet®之特性及市場與政策影響因素………………………………24
圖3-1 研究期間之三個階段……………………………………………………………………………25
圖3-2 研究架構……………………………………………………………………………………………………26
圖3-3 資料處理流程示意圖……………………………………………………………………………35


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