研發決策之藥劑經濟學分析 是由出版商Business Insights在2011年10月所出版的。
這份英文市場調查報告書包含Pages: 87 價格從美金3835起跳。
製藥公司無論是哪種新藥，必須於考量其報酬決策時，一開始便要探討其健康技術評估之潛在要件。透過認識病患觀點、治療異質性、尚未滿足需求、環境條件現況，評論新產品上市前之成本效益等。美國於醫療改革過程中，討論治療費用及其成本效益之頻率增加，另外，其食品和藥物管理局（FDA）及疾病控制和預防中心（CMS）也發表將同時協助審查之方針。
本報告為，確認醫療藥物產業於評估健康技術之充足數據蒐集，並徹底探討研發決策之藥劑經濟學分析，以下列摘要形式闡述。
實施概要
- 定義藥劑經濟學（藥理經濟學）
- 醫療藥物開發支援決策之藥劑經濟學分析
- 藥價定價及報酬支援研究
- 基於價值之藥劑開發今後趨勢
關於作者
定義藥劑經濟學
- 摘要
- 定義藥劑經濟學
- 健康技術評估
- 評估數值
- 醫療藥物開發之藥劑經濟學
醫療藥物開發支援決策之藥劑經濟學分析
- 摘要
- 簡介
- MATCH（Mobilising Advanced Technologies for Care at Home）計畫
- Headroomz方式
- 健康經濟（HE：Health Economic）評估工具
- 貝葉斯決策理論之資訊價值
- 最佳化組合
- 結論
藥價定價及報酬支援研究
- 摘要
- 認識藥劑開發初期之經濟學分析
- 疾病成本研究
- 流行病學研究
- 病患觀點
- 測定公用事業
- 將健康經濟學納入第3階段之研究設計
- 許可後研究及數據分析
- 觀察研究
- 實用之臨床實驗
- 支援健康技術評估之數據合成
- 比較有效性研究成本
- 結論
基於價值之藥劑開發今後趨勢
- 摘要
- 跨越管轄權之健康技術評估要件整合
- 利益關係人間對話（歐洲）
- 英國國家衛生和臨床醫療研究所（NICE：National Institute for Health and Clinical Excellence）之科學建言
- 利益關係人間對話
- 成本效益及美國保健制度
- 最小化成本效益
- 全球規模開發
- 展望
附錄
Description
INTRODUCTION
This report gives in depth analysis of the ways in which the pharmaceutical industry can ensure that it collects sufficient data to support health technology assessments for new products and how it can apply economic analyses to support decision making during the R&D process.
FEATURES AND BENEFITS
- Understand the importance of health technology assessment in reimbursement decisions and how to optimize data to get a positive outcome.
- Compare different methods that use health economics early in product development and can enable decisions to be made that will reduce R&D costs.
- Understand how trials can be designed to provide good evidence to support positive reimbursement decisions.
- Understand the impact of increasing interaction between the various stakeholders in the reimbursement decision making process.
- Discover the views of experts in the field of pharmacoeconomics including the Associate Director of the Scientific Advice Programme at NICE.
HIGHLIGHTS
Pharma companies should think earlier about potential HTA requirements for any new drug. Understanding patient perspectives, existing practice, including treatment heterogeneity, unmet needs, and the costs associated with a condition will help to frame discussions of cost-effectiveness lbefore a new product comes to market.
Phase III trials can be designed in such a way as to provide data that supports positive reimbursement decisions. Studies that provide evidence to support reimbursement will typically include a comparator, be longer, include a broader patient population, and realistic outcome measures.
In the light of healthcare reform in the US, discussion of the costs - and cost-effectiveness - of treatment will be raised more and more frequently. The FDA and Centers for Medicaid and Medicare Services have announced their intention to work together to explore a parallel review process.
YOUR KEY QUESTIONS ANSWERED
- How are HTAs impacting on the reimbursement decisions made by payers worldwide, and how can I influence these decisions positively?
- How can I use pharmacoeconomic analysis to support intelligent R&D go/no-go decision making?
- How can I design clinical trials in such a way as to provide good data to support positive reimbursment decisions?
- How can I use the Headroom Approach, the Health Economic Evaluation Tool, and Bayesian decision theory to analyze my R&D projects?
- How will the closer integration of the various stakeholders in the approval and reimbursement process impact drug approval and reimbursement?
Table of Contents
Executive Summary
- Defining pharmacoeconomics
- Pharmacoeconomic analysis to support decision making in drug development
- Studies to support pricing and reimbursement
- Future directions for value-based drug development
About the authors
Defining pharmacoeconomics
- Summary
- Defining pharmacoeconomics
- Health Technology Assessment
- National authorities
- Global collaboration for HTA
- Assessing value
- Pharmacoeconomics in drug development
Pharmacoeconomic analysis to support decision making in drug development
- Summary
- Introduction
- The MATCH project
- The Headroom Approach
- The Health Economic (HE) Evaluation Tool
- Bayesian decision theory and the value of information
- Portfolio optimization
- Conclusions
Studies to support pricing and reimbursement
- Summary
- Understanding pharmacoeconomics in early drug development
- Cost-of-illness studies
- Epidemiological studies
- Patient perspectives
- Measuring utility
- Including health economics in Phase III study designs
- Comparators
- Study design
- Endpoints
- Post-approval studies and data analyses
- Observational studies
- Pragmatic clinical trials
- Data synthesis to support HTA
- Costs of comparative effectiveness research
- Conclusion
Future directions for value-based drug development
- Summary
- Harmonization of HTA requirements across jurisdictions
- Multi-stakeholder dialogue in Europe
- The NICE Scientific Advice process
- Multi-stakeholder dialogue
- Cost-effectiveness and the US healthcare system
- Minimizing the gap between efficacy and effectiveness
- Progressive approvals
- Pharmacogenomics
- Prescribers and patients
- Global development teams
- Future directions
Appendix
- Research methodology
- Acknowledgements
- Abbreviations
- Glossary
- References
