藥事經濟學導論
Introduction to Pharmacoeconomics
學期
111-2
學分
2
學分
當期課號
130707
永久課號
MDHW30022
開課單位
衛生福利研究所
授課教師
蔡憶文、黃文鴻、楊健明
校區
陽明
類別
選修
上課時間表
| 節 | 週二 |
|---|---|
7 15:30–16:20 | 藥事經濟學導論 YN613 2 節連堂 |
8 16:30–17:20 |
* 根據陽明交大上課時間表所列
概述
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。
先修科目
授課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;對生技製藥產業有興趣的其他領域高年級學生或研究生,亦為本課程的授課目標族群。
教學方式
(1) 選課學生一學期請假或缺課不得超過三次,否則無法給予學期分數。 (2) 上課時間與地點:每週星期二 15:30 - 17:20 (陽明大學護理館613教室),本課程授課方式採現場實體與視訊同步。
評分方式
閱讀資料報告佔20%,出席及課堂討論20%,期末筆試60%。
週次計畫
| 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 | 和平紀念日連假 |
| 第 4 週 | PE and Policy/1. The Pharmaceutical Industry 1. Chart Pact: Biopharmaceuticals in Perspective. Genia Long. The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development. 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 4. Global Medicine Spending and Usage Trends ~Outlook to 2025. IQVIA Institute, April 2021. 5. Preview 2021 Outlook to 2026, 14th Edition. Evaluate, July 2021. |
| 第 7 週 | PE and Policy/7. Pharmaceutical Prices (p.193~219) PE and Policy/8. Economic Evaluation of New Drugs (p.220~246) 藥事經濟研究基本概念 (上課講義) |
| 第 8 週 | 民族掃墓節 |
| 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. Caleb J. Scheckel and S. Vincent Rajkumar. Generics and Biosimilars: Barriers and Opportunities. Mayo Clinic Proc.2021; 96(12):2947-2957. |
| 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. Paul Declerck, Romano Danesi, Danielle Petersel, Ira Jacobs. The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. Drugs (2017) 77:671–677. 15. Elena Wolf Holz, Klara Tiitso, Camille Vleminckx and Martina Weise. Evolution of the EU Biosimilar Framework: Past and Future. BioDrugs. 2019 Dec;33(6):621-634. |
| 第 14 週 | 16. Market review – European Biosimilar Medicines Market Policy Review. Medicines for Europe 2020. 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 | 期末測驗 |
| 第 17 週 | 特別演講:怎麼評估生技投資計畫期末測驗 |
| 第 18 週 |
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)
Office Hours
- 地點
- 上課教室
- 時間
- 每周上課前半小時,亦可另約時間
- 聯絡方式
- hwf8011@nycu.edu.tw