藥事經濟學導論
Introduction to Pharmacoeconomics
學期
110-2
學分
2
學分
當期課號
D101
永久課號
A7249
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 YN514 2 節連堂 |
8 16:30–17:20 |
* 根據陽明交大上課時間表所列
概述
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。
教學方式
先修科目或先備能力: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。 課程概述與目標: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。
評分方式
1.學期作業、考試、評量:閱讀資料報告佔20%,出席及課堂討論20%,期末筆試60%。 2.教學方法及教學相關配合事項(如助教、網站或圖書及資料庫等) (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514教室),本課程授課方式採現場實體與視訊同步。
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 | PE and Policy/1. The Pharmaceutical Industry (p.23~58) 1.Chart Pact: Biopharmaceuticals in Perspective. 2.Genia Long. The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development. 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 5.Global Medicine Spending and Usage Trends ~Outlook to 2025. IQVIA Institute, April 2021. 6.Preview 2021 Outlook to 2026, 14th Edition. Evaluate, July 2021.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 | 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)校際活動週 (放假一天) |
| 第 8 週 | 民族掃墓節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.Caleb J. Scheckel and S. Vincent Rajkumar. Generics and Biosimilars: Barriers and Opportunities. Mayo Clinic Proc.2021; 96(12):2947-2957.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.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):621-634.14.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 | 期末測驗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 | 特別演講:怎麼評估生技投資計畫期末測驗 |
| 第 18 週 | 特別演講:怎麼評估生技投資計畫 |
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)