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標題: | 全民健保體制下癌症創新新藥給付時程與使用量之評估 Dynamic Evaluation of Listing Time and Utilization of Innovative Oncology Drugs under National Health Insurance System in Taiwan |
作者: | Kai-Hsin Liao 廖愷欣 |
指導教授: | 蕭斐元(Fei-Yuan Hsiao) |
關鍵字: | 癌症藥品,藥品使用,給付時程,藥品給付規定,藥品競爭, oncology drugs,drug utilization,listing time,reimbursement criteria,drug competition, |
出版年 : | 2017 |
學位: | 碩士 |
摘要: | 研究背景:近年來全球藥品支出持續攀升,而癌症藥品的支出成長更為顯著。綜觀過去文獻,認為藥品支出上升的主因為新藥的引進與藥品使用量的改變。然而,目前的研究多聚焦於新藥納入給付的當下,忽略了藥品納入給付後的一連串動態變化對藥品使用量的影響,包括與藥品自身相關的內在因素改變(如:藥品給付規定變更)以及與外部環境有關的外在因素介入(如:藥品競爭)。特別是癌症創新新藥,其內在和外在因素的變動極為顯著,但相關的實證資料仍然有限,無法提供癌症創新新藥納入健保後的全面性評估。
研究目的:於台灣全民健康保險系統下,檢視癌症創新新藥之給付時程並探討藥品給付規定變更和藥品競爭與藥品使用量之關聯性。 研究方法:本研究為一回溯性長期追蹤研究,以我國全民健康保險於2007至2013年間收載之癌症創新新藥為研究藥品。在給付時程分析部分,利用公開可取得之官方資料蒐集給付時程相關參數並進行描述性分析。在藥品使用量的分析部分,採用間斷區間時間序列設計,利用台灣全人口之衛生福利資料檔以及癌症登記年報檔取得2009至2014年之每月藥品使用量資料,以推論性統計的方式,分別探討介入因子─藥品使用規定變更以及藥品競爭,對藥品使用量之影響,並以level/trend change表示之。最後,合併兩大介入因子,綜合探討其與藥品使用量之關聯性。 研究結果:符合本研究之癌症創新新藥共計15項,包含14種治療領域,其中最多為治療晚期腎細胞癌之藥品。在給付時程分析部分,癌症創新新藥之健保給付時程(從取得我國藥品許可證至健保給付生效日)中位數為476天(平均值:606.6,標準差:299.0)。其中,曾歷經藥品給付規定變更有10項藥品,自健保給付生效日至藥品給付規定第一次變更,其時程中位數為548天(平均值:551,標準差:416.9)。曾新增適應症有9項藥品,自健保給付生效日至第一次新增適應症之時程中位數為853天(平均值:893.1,標準差:566.9)。而有4項藥品曾變更治療地位,自健保給付生效日至第一次治療地位變更之時程中位數為806天(平均值:1,020.0,標準差:664.9)。 在探討藥品給付規定變更與藥品使用量之關聯性部分,綜合分析10項藥品共計23項藥品給付規定變更的結果顯示,藥品給付規定變更類型中以新增適應症(34.8%)和使用限制變更(34.8%)最多,其次為治療地位變更(17.4%),而多種類型者最少(13.0%)。其中,新增適應症對於藥品使用量的level/trend change影響較顯著,而使用限制變更對藥品使用量的影響最不顯著。 在探討競爭藥品與藥品使用量之關聯性部分,本研究以晚期腎細胞癌作為標的治療領域。於該治療領域中,創新新藥的藥品使用量明顯高於舊有藥品;而創新新藥中又以sunitinib用量最多,temsirolimus用量最少。綜合分析該藥品市場的觀察結果,屬於first competition的競爭關係有3項,其中有2項皆對藥品使用量之level/trend change有顯著的影響。而屬於non-first competition的競爭關係有7項,其中4項對藥品使用量之level/trend change亦有顯著的影響。 最後,針對研究藥品sorafenib,綜合分析藥品使用規定變更以及藥品競爭對其使用量的影響。Sorafenib之藥品給付規定變更對其使用量沒有顯著影響;而屬於first competitor的sunitinib和pazopanib納入健保,則分別使sorafenib使用量之trend change和level change顯著下降。 研究結論:癌症創新新藥納入健保給付後,藥品給付規定變更與藥品競爭之變動極為顯著。在藥品給付規定變更中,以新增適應症對藥品使用量的影響最為顯著。而晚期腎細胞癌領域之藥品競爭無論為first-competition或為non-first competition皆顯著影響藥品使用量。藥品使用情形之評估,建議應以藥品生命週期的長期觀點,並且同時考量藥品給付規定變更以及藥品競爭的變動,以提供更全面、更完整的評估。 Background: Pharmaceutical expenditures, particularly spending on innovative oncology drugs, are increasing dramatically. This rapid growth was largely driven by increasing utilization and the entry of innovative new drugs, as shown in previous studies. Nevertheless, existing studies are mainly limited to the analyses at the time of reimbursement of new drug without taking into account the dynamic changes resulted from numerous endogenous (such as the expansion of indications) and exogenous factors (such as drug competitions) after the reimbursement of new drug. Objectives: To fill the current knowledge gap, the aims of this study were to investigate the listing time of innovative oncology drugs and to evaluate the effects of endogenous factors (reimbursement criteria changed) and exogenous factors (drug competitions) on utilization of innovative oncology drugs at and after the time of reimbursement under National Health Insurance (NHI) System in Taiwan. Methods: This is a retrospective longitudinal study covering 15 innovative oncology drugs reimbursed by the NHI between 2007 and 2013. Data sources for the timing of reimbursement were retrieved from publicly-available data. Monthly data (January 2009 to December 2014) of the consumption (volume) of studied drugs were obtained from National Health Insurance Research Database (NHIRD). Descriptive analyses were used to examine the listing time of innovative oncology drugs and interrupted time series analyses were used to evaluate the effects of reimbursement criteria changed and drug competition on utilization of innovative oncology drugs. Results: Among 15 innovative oncology drugs, there were 10 drugs with reimbursement criteria changed. We found that the average time from marketing authorization to reimbursement was 607 days (median: 476, SD: 299.0) and the time from reimbursement to first reimbursement criteria changed was 551 days (median: 548, SD: 416.9). The average time from reimbursement to first indication expansion and to line of therapy changed were 893 days (median: 853, SD: 566.9) and 1,020 days (median: 806, SD: 665), respectively. For endogenous factors (reimbursement criteria changed), segmented regression analyses showed statistically significant level or trend change of drug volume after indication expansion. However, there was no significant change in drug volume after restriction changed. For exogenous factors (drug competition), we found that both first competition and non-first competition were significantly associated with level or trend change of drug volume. Taking sorafenib as an example to examine both the impacts of endogenous and exogenous factor on drug volume after reimbursement, we found that the drug volume was not significantly changed after line of therapy changed (endogenous). However, the reimbursement of first competitors were significantly associated with a lower level or trend change of volume sorafenib consumed. Conclusions: In Taiwan, after drug reimbursement, the utilization of innovative oncology drugs changed dramatically. This was largely driven by indication expansion and new drug competition. Our findings suggest that drug utilization evaluation should take into account both endogenous and exogenous factors. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/67019 |
DOI: | 10.6342/NTU201703110 |
全文授權: | 有償授權 |
顯示於系所單位: | 臨床藥學研究所 |
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