台灣新藥創新延遲之研究   全文下載

A Study on Drug Innovation Lag in Taiwan

藥物延遲（drug lag）亦稱為創新延遲（innovational lag），通常再細分為上市延遲（marketing lag）與給付延遲（reimbursement lag）。本研究探討台灣新藥創新延遲的趨勢，並與歐美、加拿大及日本等主要製藥先進國家比較，以瞭解台灣新藥上市延遲情況與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年至2002年間納入健保給付之347個品項新藥為樣本，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，並透過藥物延遲指標（drug lag index）對比台灣與主要國家之延遲程度。本研究以sPss統計軟體進行頻率分析與複回歸等。研究主要發現台灣創新性藥品仰賴國外進口輸入，平均上市延遲時間長達30.5個月；引進的新藥較多類似療效之新藥，突破性新藥最少。上市延遲時間最短為美國（5.6個月），其次歐洲國家（8.2個月）、加拿大（18.0個月），台灣最長（30.5個月）；若就新藥延遲指標來看，美國（0.14）最小、其他依次為歐盟（0.21）、加拿大（0.45）、台灣（0.76）。給付延遲部分平均為衛生署核准上市後11.7個月，僅atC（anatomical therapeutic Chemical）治療別有影響，新藥價格高低則沒有影響。由本研究發現台灣創新延遲情形是項嚴肅的議題，因大部分新藥源自國外，自然影響引進台灣時的創新延遲時間，較率先核准國家平均延遲約30.5個月。雖然新藥的價格與給付延遲並無關連，但在衛生署核准上市後，平均仍須11.7個月才納入健保給付。建議衛生主管機關應重視該議題，重新檢視新藥申請程序與新藥核價機制，將資源集中鼓勵突破性新藥藥品的可近性，減少類似療效藥品上市。

Drug lag, also known as drug innovation lag, can be categorized into marketing lag and reimbursement lag. This study investigates the trend and factors influencing drug innovation lag in Taiwan, and makes a comparison with major countries like USA, Canada, Japan, and Europe on marketing lag. The reimbursement lag in the National Health Insurance (NHI) of Taiwan is also explored. This is a retrospective study covering a total of 347 new drugs that were reimbursed by the Bureau of National Health Insurance (BNHI) from 1996 to 2002. Data collection includes time of regulatory approval, type of innovation, country of origin, and time and price of reimbursement by BNHI. The time of new drug approvals in study countries was obtained from relevant websites for comparison. The drug lag index between Taiwan and study countries was also analyzed. Data were analyzed by SPSS software for frequency distribution and multiple regressions. We found that new drugs are predominantly imported, and predominantly imported, and the average marketing lag was up to 30.5 months in Taiwan. Most of the new drugs were of me-too nature; only very few could be classified as breakthrough new drugs. In terms of marketing lag, USA was the shortest (5.6 months), followed by European countries (8.2 months), Canada (18.0 months), and Taiwan (30.5 months). The reimbursement lag was 11.7 months on average after product license granted by DOH, yet it was not affected by the NHI reimbursement price. The drug lag index from smallest to largest was: the USA (0.14), Europe (0.21), Canada (0.45), and Taiwan (0.76). Drug marketing lag is a serious issue in Taiwan. The average marketing lag of 30.5 months could be attributed to the fact that nearly all new drugs were of foreign origins. The average time after DOH’s regulatory approval to NHI reimbursement was as long as 11.7 months. The government should reexamine the current function of the regulatory and reimbursement systems. More specifically, the health authorities should focus on faster regulatory process for breakthrough medicines instead of approving only “me-too new drugs”.