藥事經濟學導論
Introduction to Pharmacoeconomics
| 節 | 週二 |
|---|---|
7 15:30–16:20 | 藥事經濟學導論 YN514 2 節連堂 |
8 16:30–17:20 |
* 根據陽明交大上課時間表所列
以閱讀、討論指定教材與文獻資料為主,由老師依課程進度授課,每一階段再由同學依照閱讀書籍的章節或文獻資料做綜合報告,並提出討論問題題綱,供為討論的基礎。修課同學無論負責報告與否,均應於上課前依課程進度閱讀指定書籍。為確認選課同學的課前閱讀,老師上課時得提出問題,指定學生回答。
「藥事經濟導讀」是結合藥學與醫療經濟的課程,對象為不具備藥學領域知識背景,或是雖具有藥學背景、但是對醫療經濟領域不熟悉的公共衛生、衛生福利或醫務管理研究所的研究生,本課程與生技製藥產業的關連至為密切,亦與健保體制下台灣的生技產業發展及經營環境議題相關。 近年來因健康照護、智財權保護以及生物科技的進步,分別對各國藥品管理政策以及製藥產業產生相當大的衝擊,「藥事經濟」在課程上分別從宏觀面與微觀面設計。前者與醫藥產業政策層面息息相關,後者則偏重特定的藥品相關議題與可供研究領域進行探討。本課程設計係以研究生或大學高年級學生關注生技製藥產業政策者為對象,故導讀內容偏重生技製藥產業政策面的論述文章、相關智財權概念與實務,以及新興生物科技藥品管理與發展趨勢的簡介;微觀面則聚焦於藥事經濟相關研究議題,本課程另開有針對博士班學生的藥事經濟特論與藥事經濟研究兩門進階課程,預定下學年繼本學期課程開設藥事經濟特論。藥事經濟研究則視博士班學生修業需要開課。 本課程設計以導讀與搜尋相關知識的方式安排,使選課學生逐漸對製藥產業及其市場生態、健保體制與藥品管理政策相關領域,建立完整的基礎概念,並培養從中尋求研究主題的興趣。 本課程內容以導讀製藥產業政策與經濟面的教材與文獻資料為主,以教師授課及學生討論為輔。第一階段以藥事經濟的基礎概念與製藥產業為導向,涵蓋我國、日本、歐盟與全球製藥產業之探討為閱讀基礎 。第二階段則以特定領域的議題,包含智財權法律實務,經濟評估方法以及生物科技藥品的管理與發展作為課堂討論的基礎。學生選修本課程,除需按課程進度閱讀資料與參與討論外,並需選擇題材,進行文獻探討之口頭報告,本課程並有期末考試。
| 週次 | 主題 |
|---|---|
| 第 1 週 | 課程簡介與說明,文獻選讀重點 (上課講義) |
| 第 2 週 | PE and Policy/Introduction Glossary and Basic Concept (上課講義) |
| 第 3 週 | PE and Policy/1.The Pharmaceutical Industry (p.23~58) 1.2019 Chart Pact: Biopharmaceuticals in Perspective. 2.Innovation in the Pharmaceutical Pipeline ~ A Multidimensional View |
| 第 4 週 | PE and Policy/2.The Biotechnology Industry 3.Pharmaceutical Product Registration in Taiwan |
| 第 5 週 | PE and Policy/3.Generics and Biosimilars 4.委託研究機構(Contract Research Organization, CRO)的管理 (上課講義) |
| 第 6 週 | PE and Policy/4.The Global Pharmaceutical Industry PE and Policy/5.The Demand for Pharmaceuticals The Global Use of Medicine in 2019 and Outlook to 2023 Forecasts and Areas to Watch. IQVIA Institute, January 2019. 5.World Preview 2019, Outlook to 2024, 12th Edition. Evaluate, June 2019. |
| 第 7 週 | 校際活動週 (放假一天) |
| 第 8 週 | PE and Policy/7.Pharmaceutical Prices (p.193~219) PE and Policy/8.Economic Evaluation of New Drugs (p.220~24^) 藥事經濟研究基本概念 (上課講義) |
| 第 9 週 | PE and Policy/9.Pricing Pharmaceuticals in a World Environment (p.247~268) 7.Biosimilar Action Plan: Balancing Innovation and Competition. USFDA, August 2018. 8.Alessandra Ferrario and colleagues. Strategies to achieve fairer prices for generic and biosimilar medicines. BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.l5444 (Published 13 January 2020) |
| 第 10 週 | 9.Joy Li-Yueh Lee, Michael A. Fischer, William H. Shrank, Jennifer M. Polinski, Niteesh K. Choudhry: A systematic review of reference pricing: Implications for US prescription drug spending. The American Journal of Managed Care 2012; 18(11):e430-e437. 10.Olivier J. Wouters, Panos G. Kanavos and Martin McKee. Comparing generic drug markets in Europe and the United States: Prices, volumes, and spending. The Milbank Quarterly 2017, 95(3): 554-601. |
| 第 11 週 | 11.Ravi Gupta, Thomas J Bollyky, Matthew Cohen, Joseph S Ross, Aaron S Kesselheim: Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. BMJ 2018;360:k831. 12.Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures. DHHS, United States, October 25, 2018. |
| 第 12 週 | 13.全民健康保險藥品給付項目與支付標準 |
| 第 13 週 | 14.Steven G Morgan, Hannah S Bathula and Suerie Moon. Pricing of pharmaceuticals is becoming a major challenge for health systems. BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.l4627 (Published 13 January 2020) 15.Mi Tang, Peipei Song, Jiangjiang He. Progress on drug pricing negotiations in China. BioScience Trends. 2019; 13(6):464-468. |
| 第 14 週 | 16.Market review – European Biosimilar Medicines Market Policy Review. Medicines for Europe 2017. 17.Evelien Moorkens, Arnold G. Vulto, Isabelle Huys, Pieter Dylst, Brian Godman, Simon Keuerleber: Policies for biosimilar uptake in Europe: An overview. PlosOne, December 28, 2017. Available from: https://doi.org/10.1371/journal.pone.0190147 |
| 第 15 週 | PE and Policy/11.Patent Protection (p.303~321) 18.Orphan Drugs in the United States: Providing context and Cost. INQUIVA Institute, October 2017. 19.Orphan Drugs in the United States: Exclusivity, Pricing and Treated Populations. INQUIVA Institute, December 2018. |
| 第 16 週 | PE and Policy/11.Patent Protection (p.303~321) 18.Orphan Drugs in the United States: Providing context and Cost. INQUIVA Institute, October 2017. 19.Orphan Drugs in the United States: Exclusivity, Pricing and Treated Populations. INQUIVA Institute, December 2018. |
| 第 17 週 | 期末測驗 |
| 第 18 週 | 特別演講:怎麼評估生技投資計畫 |
指定教科書: Stuart O. Schweitzer & Z. John Lu: Pharmaceutical Economics and Policy ~Perspectives, Promises, and Problems (3rd Edition), Oxford University Press 2018. (簡稱為PE and Policy) 指定參考資料: 1.Chart Pact: Biopharmaceuticals in Perspective. Washington, D.C.: Pharmaceutical Research and Manufacturers of America, 2019 Summer. 2.Genia Long and Justin Works: Innovation in the Pharmaceutical Pipeline ~ A Multidimensional View. The Analyst Group, Washington, D.C.: Pharmaceutical Research and Manufacturers of America, January 2013. 3.Pharmaceutical Product Registration in Taiwan (黃老師上課講) 4.楊健明博士: 委託研究機構(Contract Research Organization, CRO)的管理(楊博士上課講義) 5.The Global Use of Medicine in 2019 and Outlook to 2023 Forecasts and Areas to Watch. IQVIA Institute, January 2019. 6.World Preview 2019, Outlook to 2024, 12th Edition. Evaluate, June 2019. 7.Biosimilar Action Plan: Balancing Innovation and Competition. USFDA, August 2018. 8.Alessandra Ferrario and colleagues. Strategies to achieve fairer prices for generic and biosimilar medicines. BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.l5444 (Published 13 January 2020) 9.Joy Li-Yueh Lee, Michael A. Fischer, William H. Shrank, Jennifer M. Polinski, Niteesh K. Choudhry: A systematic review of reference pricing: Implications for US prescription drug spending. The American Journal of Managed Care 2012; 18(11):e430-e437. 10.Olivier J. Wouters, Panos G. Kanavos and Martin McKee. Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending. The Milbank Quarterly 2017, 95(3): 554-601. 11.Ravi Gupta, Thomas J Bollyky, Matthew Cohen, Joseph S Ross, Aaron S Kesselheim: Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. BMJ 2018;360:k831. 12.Comparison of U.S. and International Prices for Top Medicare Part B Drugs by Total Expenditures. DHHS, United States, October 25, 2018 (Available form: https://aspe.hhs.gov/system/files/pdf/259996/ComparisonUSInternationalPricesTopSpendingPartBDrugs.pdf 13.衛生福利部中央健康保險署:全民健康保險藥品給付項目與支付標準。 14.Steven G Morgan, Hannah S Bathula and Suerie Moon. Pricing of pharmaceuticals is becoming a major challenge for health systems. BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.l4627 (Published 13 January 2020) 15.Mi Tang, Peipei Song, Jiangjiang He. Progress on drug pricing negotiations in China. BioScience Trends. 2019; 13(6):464-468. 16.Market review – European Biosimilar Medicines Market Policy Review. Medicines for Europe 2017. 17.Evelien Moorkens, Arnold G. Vulto, Isabelle Huys, Pieter Dylst, Brian Godman, Simon Keuerleber: Policies for biosimilar uptake in Europe: An overview. PlosOne, December 28, 2017. Available from: https://doi.org/10.1371/journal.pone.0190147 18.Orphan Drugs in the United States: Growth Trends in Rare Disease Treatments. INQUIVA Institute, October 2018. 19.Orphan Drugs in the United States: Exclusivity, Pricing and Treated Populations. INQUIVA Institute, December 2018.