課程名稱 |
健康科技:價值評估與准入 Health Technology: Value Assessment and Access |
開課學期 |
112-1 |
授課對象 |
公共衛生學院 全球衛生碩士學位學程 |
授課教師 |
賴育宏 |
課號 |
MGH7054 |
課程識別碼 |
853EM0540 |
班次 |
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學分 |
1.0 |
全/半年 |
半年 |
必/選修 |
選修 |
上課時間 |
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上課地點 |
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備註 |
本課程以英語授課。本課程為週末工作坊形式。上課日期:2023年10月29日及11月04日。教室:公衛215室 總人數上限:50人 |
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課程簡介影片 |
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核心能力關聯 |
核心能力與課程規劃關聯圖 |
課程大綱
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課程概述 |
Health technologies compromises medical products, procedures, devices, diagnostics, and public health programmes. Value needs to be addressed and assessed along the clinical development that lays out evidence generation strategy and market access.
In this intensive module, we will:
‧ Address the value and the context from various stakeholders in the process for introducing a new medical product (medicine or medical devices) to a targeted market.
‧ Emphasizes the methodology of assessment used and referenced by companies and national regulatory & reimbursement agencies to inform government policy, clinical and public health practice.
‧ Understand the regulatory processes and requirements as determinants for pharmaceuticals and medical devices; reimbursement decisions by payers or out-of-pocket payment are also major factors for the uptake of a new product, increasingly based on health technology assessment.
‧ Understand the processes and the role of decisions makers to introduce a new product or technology but also along the life cycle. |
課程目標 |
1. Apply ethical approaches in global health research and practice (GH-2)
2. Apply monitoring and evaluation techniques to global health programs, policies, and outcomes (GH-3)
3. Explain the social, political and economic determinants of health and how they contribute to population health and health inequities (D17-10) |
課程要求 |
This course gives a high priority to interaction between the participant and the academic staff, and amongst participants. It is understood that students may have different learning styles and may come from different cultural backgrounds, but all students are encouraged to participate actively. |
預期每週課後學習時數 |
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Office Hours |
另約時間 備註: By appointment either physically or virtually between 30 October and 3 November. A 30-mins group appointment with the instructor before the group presentation is highly recommended but not require.d |
指定閱讀 |
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參考書目 |
1. del Llano-Senaris JE, Campillo-Artero C (Eds). Health Technology Assessment and Health Policy Today: A Multifaceted View of Their Unstable Crossroads. Springer: Switzerland, 2015.
2. Lou J et al (2020). Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward. International Journal of Technology Assessment in Health Care 1-7 https://doi.org/10.1017/S0266462320000628.
3. Nairismagi, M., Yau, A., and Lai, A. (2019) Spend less to combat cancer better? Critique on cost-effectiveness of tumour genomic profiling, Asia-Pacific Biotech News, 23(11), 30-34.
4. Lai, A., and M., Nairismagi, (2018) Clinical utility of and access to cancer molecular diagnostics in Asia, Asia-Pacific Biotech News, 22(6), 32-36.
5. Health Technology Assessment International (HTAi) Vortal http://vortal.htai.org/.
6. International Network of Agencies for Health Technology Assessment (INAHTA). HTA Tools and Resources http://www.inahta.org/hta-tools-resources/.
7. Health Technology Assessment database http://www.crd.york.ac.uk/CRDWeb/. |
評量方式 (僅供參考) |
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週次 |
日期 |
單元主題 |
Week 1-1 |
29 Oct |
Theme 1: Value & Context
Health Technology Assessment: introduction of values, policy context, landscape & trend
Reading:
• Chapter 1 Health Technology Assessment and its Interface with Regulation, Policy and Management by Michael Drummond. In: Health Technology Assessment and Health Policy Today: A Multifaceted View of Their Unstable Crossroads. Springer: Switzerland (2015)
Video:
• HTA: Why, How, and So What by Dr Chris Henshall & Dr. Cliff Goodman, The Lewin Group USA 2016 (4:29 – 19:16) (https://www.youtube.com/watch?v=4GaMl-47yuA)
• Intro to HTA (efficacy, safety and quality) by Anne Willemsen EUnetHTA, view from European Medicines Agency, 2022 (15mins) (https://www.youtube.com/watch?v=aehXYIYFCLU) |
Week 1-2 |
29 Oct |
Theme 1: Value & Context
Evidence synthesis: real world data, sources, evidence hierarchy, and methodology; appraisal of primary and secondary research: industry perspective
Reading:
• Chapter 3 Evidence review, appraisal and synthesis in formulary management. In: Formulary
Management: A Practical Guide (2014)
• Chapter 3 Measuring effectiveness by Yabroff & Mandelblatt. In: Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Oxford: Oxford University Press, 2nd edition (2003)
Video:
• Early Engagement with Health Technology Assessment: Its Role in Evidence Generation by Ailish Higgins, National Institute for Health and Care Excellence (NICE) 2015, 25mins (https://www.labtube.tv/video/MTA0MTAx)
• A case of HTA for evidence-based decision-making, Changi General Hospital Singapore by Dr. Pwee Keng Ho, 2021 (16:06 – 29:39) (https://www.youtube.com/watch?v=ofZQA8AJ6fU) |
Week 1-3 |
29 Oct |
Theme 2: Value & Assessment
Assessment – Cost & Effectiveness; Cost & Benefit (risk)
Reading:
• Chapter 4 Evidence review, appraisal and synthesis in formulary management. In: Formulary Management: A Practical Guide (2014)
• Chapter 2 Basic types of economic evaluation. In: Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press, 4th edition (2015)
• Chapter 2 Study Design by Farnham & Haddix. In: Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Oxford: Oxford University Press, 2nd edition (2003)
Video:
• Health Economic Evaluation Basics: Putting a price tag on health 2021 (8mins) (https://www.youtube.com/watch?v=cUgkWYeRsJk)
• Goal and purpose of HTA by Dr. David Danko, Janssen, 2017 view from a pharma company (9mins) (https://www.youtube.com/watch?v=4GaMl-47yuA)
Reference:
• Nairismagi, M., Yau, A., and Lai, A. (2019) Spend less to combat cancer better? Critique on cost-effectiveness of tumour genomic profiling, Asia-Pacific Biotech News, 23(11), 30-34 |
Week 1-4 |
29 Oct |
Theme 2: Value & Assessment (Real world consideration)
Special lecture
• Topic: HTA view from the Government: Rationale, Approach and Practice; Ethical considerations
• Speaker: Prof. Jasmine Pwu (Chief Executive Officer, Data Science Center, Fu Jen Catholic University; Former Director, National Hepatitis C Program Office, MoHW Taiwan; Former Director, Division of HTA, Center for Drug Evaluation)
• Profile: https://www.linkedin.com/in/raoh-fang-jasmine-pwu-8031869/details/experience/
Reading:
• Lou J et al (2020). Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward. International Journal of Technology Assessment in Health Care 1-7 https://doi.org/10.1017/S0266462320000628 |
Week 2-1 |
4 Nov |
Theme 2: Value & Assessment
Assessment – Budget Impact Analysis
Reading:
• Chapter 4 Evidence review, appraisal and synthesis in formulary management. In: Formulary Management: A Practical Guide (2014)
• Sullivan SD et al. (2014) Budget Impact Analysis – Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Forace. Value in Health 17: 5-14
Video:
• How to do a Cost-Benefit Analysis (4:17) (https://www.youtube.com/watch?v=CYY_qs2lDnQ)
• HTA: Why, How, and So What by Dr Chris Henshall & Dr. Cliff Goodman, The Lewin Group USA 2016 (QALY & clinical added benefit systems (23:54 – 38:30) (https://www.youtube.com/watch?v=4GaMl-47yuA) |
Week 2-2 |
4 Nov |
Theme 3: Access & Affordability
Payer and financing models; Pricing & Reimbursement
Reading:
• Verghese NR. et al (2019) Government pharmaceutical pricing strategies in the Asia-Pacific region: an overview. Journal of Market Access & Health Policy, 7:1, DOI: 10.1080/20016689.2019.1601060
Reference:
• Lai, A., and M., Nairismagi, (2018) Clinical utility of and access to cancer molecular diagnostics in Asia, Asia-Pacific Biotech News, 22(6), 32-36. |
Week 2-3 |
4 Nov |
Theme 3: Access & Affordability (Real world consideration)
Special lecture by Ms. Lillian Wang
Senior Director, Market Access, Japan, Asia & Pacific
Edwards Lifesciences
Profile: https://www.linkedin.com/in/lillian-yujen-wang/
Topic: HTA view from the Industry: Rationale, Approach and Practice
Reference:
• Petcharapiruch S. & Wong C. (2020) The Evolving Health Technology Assessment for Medical Devices and Diagnostics in the Asia Pacific Region and Key Considerations for Value Assessment Frameworks. IQVIA. |
Week 2-4 |
4 Nov |
Group presentation
Each group has 30 mins for a presentation plus Q&A
Team Project: choose a country in Asia, search for its HTA system, pick out a health technology, and present how such health technology is introduced (evaluated and accessed) and paid (reimbursed)
Course Wrap-up & revision & feedback: take home message |
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