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研究生:鍾佳容
研究生(外文):Chia-Jung Chung
論文名稱:台灣新藥創新延遲之研究
論文名稱(外文):Innovation Lag of New Drugs in Taiwan
指導教授:黃文鴻黃文鴻引用關係
指導教授(外文):Weng-Foung Huang
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:2004
畢業學年度:92
語文別:中文
論文頁數:91
中文關鍵詞:創新延遲上市延遲給付延遲藥物延遲
外文關鍵詞:innovational lagmarketing lagreimbursement lagdrug lag
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新藥核准時間(the timing of new drug approvals)意味國家整體的健康狀態、健康支出,甚至有社會平等意含。如何在藥品安全性與民眾用藥可近性之間取得平衡,也成為各國衛生政策分析者關注之焦點。由於藥物延遲(drug lag)通常僅著重在新藥,因此又稱「創新延遲(innovational lag)」,健保上路後,創新延遲可再細分兩段:上市延遲(marketing lag)與給付延遲(reimbursement lag),如此才能追溯國人用藥之可近性問題。因此本研究目的:1.台灣新藥創新延遲趨勢;2.台灣新藥創新延遲與OECD(美、加、歐盟、日本)國家比較;3.了解台灣新藥上市延遲情況及其相關屬性;4.了解台灣新藥健保給付延遲情況及其相關屬性。
本研究採回溯性研究,以中央健保局1996年藥事小組成立後,至2002年所有納入健保給付之新藥為樣本,共347個品項,以此為基準,蒐集各國新藥審核上市時間、屬性資料、生產國、納入給付時間與納入給付時藥價等。資料蒐集來自健保局、衛生署、各國相關網站或機構等地。本研究以SPSS統計軟體進行頻率分析、相關性檢定、ANOVA、Mann-Whitney、K-W、複回歸等。國際比較部分,透過藥物延遲指標(drug lag index)與國家配對比較來看台灣在美、加、歐盟、日本等國的延遲程度如何。
研究主要發現台灣創新性藥品仰賴國外進口輸入,集中在英、美、德、法、日等強調研發製藥的國家。且引進較多me too 藥品,breakthrough最少。療效別來看,屬神經系統用藥、全身性抗感染劑、抗腫瘤等最多。台灣上市延遲長達30.48個月,生產國別、ATC治療別皆會影響;給付延遲部分,若單就1996年後才核准上市之藥品,平均11.67個月;1996年前就上市之藥品,平均20.11個月;綜合兩者之給付延遲為13.27個月,僅ATC治療別有影響,藥價沒有影響。國際比較部分,上市延遲最短為美國(5.55個月),其次歐盟(8.20個月)、加拿大(17.95個月),台灣最長(30.48個月);若就新藥延遲指標來看,美國(0.14)最小、歐盟(0.21)、加拿大(0.45)、台灣(0.76)最大。配對比較發現,雖然各國與台灣都有各自領先的藥品,不過國外都佔多數且領先較久。
由本研究發現,台灣創新延遲嚴重,建議衛生主管機關應能重視該議題,並檢討新藥申請程序、繼續加強研發能力、減少me too藥品上市、多一些breakthrough藥品、加強上市後監視系統等,以縮短我國創新延遲。
The timing of new drug approvals has significant implications on health expenditures, social equity, and population health status of any country. It’s very important for policy- makers to balance drug safety and public accessibility to innovations. The issue of ‘drug lag’ usually focuses on new drugs, which is also called ‘innovational lag’. The innovational lag can be divided into two stages: marketing lag in product approvals and reimbursement lag in NHI reimbursement. Examination of innovation lags can understand if there are drug accessibility problems in the patients. The objectives of this study were to explore the trend of innovational lag in Taiwan, to compare the innovational lag with mainly OECD countries (included US, EU, Canada, and Japan), and to identify the factors contributing to the marketing lag and the reimbursement lag.
The study is a retrospective study based on 347 new drugs reimbursed by NHI from 1996~2002. The variables for analysis include: approval time for marketing of each country, the level of innovation, the country of origins, lead time from market approval to reimbursement by NHI, price of NHI reimbursement, etc. Data resources are from NHI, Department of Health, websites-related or organizations of each country. This study used SPSS for statistical analysis for frequency distribution, correlation, ANOVA, Mann-Whitney test, Kruskal-Wallis test, and multiple regressions. International comparisons were made based on drug lag index among studied countries.
Most innovational drugs in Taiwan are originated from foreign countries particularly England, US, German, France, Japan, etc. There was more me too new drugs than breakthrough new drugs. According to the therapeutic classification, the top three drug categories are nervous system agents, general anti-infective agents, and anticancer agents. On the average, there was a marketing lag of 30.48 months depending on source of origin and ATC, while reimbursement lag was 11.67 months in Taiwan. For new drugs that were marketed prior to 1996, the average reimbursement lag was 13.27 months, while the average reimbursement lag for those marketed after 1996 was 20.11 months. Comparing the results internationally, US had the shortest marketing lag (5.55 months), followed by EU (8.20 months), Canada (17.95 months), Taiwan (30.48 months). When examined by drug lag index, US has the smallest drug lag index (0.14), followed by EU (0.21), Canada (0.45), Taiwan (0.76). On paired country comparison basis, each foreign country had some drugs approved earlier than other countries, but most foreign countries lead Taiwan in terms of products and length of marketing lag.
We found the marketing lag of new drugs was quite serious in Taiwan. We suggest that responsible government agency should pay attention to the issues and to reexamine the process of New Drug Applications (NDAs). It is also suggested that the government responsible agencies should continue to improve the R&D capabilities of local industry, to contain the approvals of me too new drugs, to encourage more breakthrough drugs into the market, and to strengthen the post-marketing surveillances, etc. to narrow innovational lag of new drugs in Taiwan.
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