表紙
市場調查報告書
商品編碼
931799

製藥產業的健康科技評估:主要的決策事項檢討

Health Technology Assessment in Pharma: A Review of Major Decisions

出版日期: | 出版商: BCC Research | 英文 82 Pages | 訂單完成後即時交付

價格
  • 全貌
  • 簡介
  • 目錄
簡介

本調查的目標,是提供北美,歐洲,亞太地區醫療保健科技的認證流程相關資訊。

本報告以製藥產業中健康科技評估所扮演的角色與其功能為焦點,提供醫療保健科技評估趨勢,帶給藥價設定與給付的重要性,主要企業的簡介相關彙整。

第1章 簡介

第2章 健康科技評估的簡介

  • 簡介
  • 技術評估的原點
  • 基本的概念
  • 健康科技
  • 健康科技的類別
  • 目的或用途
  • 擴散階段
  • 健康科技評估
  • 健康科技評估的目的

第3章 對製藥產業的健康科技評估的看法

  • 健康科技評估和效率
  • 成本推動因素
  • 運用上的障礙

第4章 全球健康科技評估組織概要

  • 歐洲
  • 英國(英格蘭,威爾斯)
  • 蘇格蘭
  • 德國
  • 法國
  • 義大利
  • 北美
  • 美國
  • 加拿大
  • 亞太地區
  • 日本
  • 中國
  • 澳洲

第5章 Daratumumab

  • 概要
  • 科學性摘要
  • 藥效學和作用機制
  • 為了評估安全性和有效性臨床實驗
  • 疾病的背景

第6章 Tildrakizumab

第7章 Durvalumab

第8章 Abemaciclib

第9章 Ocrelizumab

第10章 結論

目錄
Product Code: PHM228A

Highlights:

The goal of this study is to provide information on the global health technology approval process in North America, Europe and the Asia-Pacific region. The study emphasizes the role of HTA and its function and technology process in the pharmaceutical industry. The report also elaborates on recent HTA approvals and their significance on pricing and reimbursement.

Report Scope:

The current report provides details about HTA processes in countries such as U.S., Canada and U.K. This report highlights information and insights on the molecules which were recently approved in terms of regulatory and reimbursement decisions. The report includes policies, country-specific HTA activities, drug overviews, mechanisms of action, disease backgrounds, clinical evidence on safety and efficacy, regulatory scenarios, and HTA evaluation details.

Report Includes:

  • 45 tables
  • A detailed outlook on the HTA process and its approvals in major pharma industries
  • Insights into the recent HTA submissions to HTA agencies by top pharmaceutical manufacturers
  • Discussion on how HTA helps in the development of safe, and effective health policies, thereby benefitting both patient and health care providers
  • Information about the medical, social, economic and ethical issues related to the use of a health technology
  • Company profiles of market-leading players, including Janssen Pharmaceuticals Inc., Merck & Co. Inc., AstraZeneca PLC, Eli Lilly and Co., and Hofmann-La Roche Inc.

Table of Contents

Chapter 1: Introduction

  • Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Analyst's Credentials
  • BCC Custom Research
  • Related BCC Research Reports

Chapter 2: Introduction to Health Technology Assessment

  • Introduction
  • Origins of Technology Assessment
  • Fundamental Concepts
    • Health Technology
    • Health Technology Categories
    • Purpose or Application
    • Stage of Diffusion
  • Health Technology Assessment
    • Purposes of HTA

Chapter 3: Pharmaceutical Industry's Perspective on HTA

  • HTA and Efficiency
  • HTA: A Cost Driver
  • Implementation Barriers

Chapter 4: Overview of Global HTA Organizations

  • HTA in Europe
    • United Kingdom (England and Wales)
    • Scotland
    • Germany
    • France
    • Italy
  • HTA in North America
    • U.S.
    • Canada
  • HTA in the Asia-Pacific Region
    • Japan
    • China
    • Australia

Chapter 5: Daratumumab (Darzalex)

  • Overview of Daratumumab
  • Scientific Summary
    • Pharmacodynamics and Mechanism of Action
    • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
    • Multiple Myeloma: Disease Overview
    • Staging and Prognosis
    • Signs and Symptoms
  • Regulatory Milestones
  • Technology Assessment Decisions
    • NICE U.K.
    • SMC Scotland
    • Haute de sante (HAS) France
    • CADTH (pCODR) Canada
  • Company Profile
    • JANSSEN PHARMACEUTICALS INC.

Chapter 6: Tildrakizumab (Ilumya)

  • Overview of Tildrakizumab
  • Scientific Summary
    • Pharmacodynamics and Mechanism of Action
    • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
    • Psoriasis: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
    • NICE U.K.
    • SMC Scotland
    • Company Profile
    • MERCK AND CO. INC.

Chapter 7: Durvalumab (Imfinzi)

  • Overview of Durvalumab
  • Scientific Summary
    • Pharmacodynamics and Mechanism of Action
    • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
    • Non-small Cell Lung Cancer: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
    • NICE U.K.
    • SMC Scotland
    • CADTH (pCODR) Canada
    • HAS France
  • Company Profile
    • ASTRAZENECA PLC

Chapter 8: Abemaciclib (Verzenio)

  • Overview of Abemaciclib
  • Scientific Summary
    • Pharmacodynamics and Mechanism of Action
    • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
    • Breast Cancer: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
    • NICE U.K.
    • SMC Scotland
    • CADTH (pCODR) Canada
    • HAS France
  • Company Profile
    • ELI LILLY AND CO.

Chapter 9: Ocrelizumab (Ocrevus)

  • Overview of Ocrelizumab
  • Scientific Summary
    • Pharmacodynamics and Mechanism of Action
    • Clinical Trials to Assess Safety and Efficacy
  • Disease Background
    • Multiple Sclerosis: Disease Overview
  • Regulatory Milestones
  • Technology Assessment Decisions
    • NICE U.K.
    • SMC Scotland
    • CADTH Canada
    • HAS France
  • Company Profile
    • HOFFMANN-LA ROCHE INC.

Chapter 10: Conclusion

List of Tables

  • Table 1: Types of Health Technologies, by Category
  • Table 2: Types of Health Technologies, by Application
  • Table 3: Types of Health Technologies, by Stage of Diffusion
  • Table 4: National Healthcare Spending in Germany, by Sector/ Services, 2015-2017
  • Table 5: Key Organizations Involved in the Reimbursement of Pharmaceuticals and Medical Devices in France
  • Table 6: Key Organizations Involved in the Reimbursement of Pharmaceuticals in the U.S.
  • Table 7: Public Health Insurance Programs in the U.S.
  • Table 8: National Healthcare Expenditures in Canada, 2010-2019
  • Table 9: National Healthcare Expenditures of Canada, by Sector/Service, 2017
  • Table 10: Trends in Japanese Healthcare Expenditures, 1995-2016
  • Table 11: National Healthcare Expenditures in Japan, by Sector/Service, 1995-2014
  • Table 12: Distribution Shares of Healthcare Spending on Pharmaceuticals in China, 2017
  • Table 13: Trends in the Number of Medicines Included in Previous National Essential Medicines Lists, 1982-2009
  • Table 14: National Health Expenditures in Australia, by Sector/Service, 2017-2018
  • Table 15: Key U.S. Clinical Trials on Daratumumab
  • Table 16: Multiple Myeloma International Staging System
  • Table 17: Regulatory Milestones of Daratumumab, 2013-2015
  • Table 18: NICE Technology Assessment of Daratumumab
  • Table 19: SMC Technology Assessment of Daratumumab
  • Table 20: HAS Technology Assessment of Daratumumab
  • Table 21: CADTH-pCODR Technology Assessment of Daratumumab
  • Table 22: Key U.S. Clinical Trials on Tildrakizumab
  • Table 23: Tildrakizumab Regulatory Milestones
  • Table 24: NICE Technology Assessment of Tildrakizumab
  • Table 25: SMC Technology Assessment of Tildrakizumab
  • Table 26: Key U.S. Clinical Trials on Tildrakizumab
  • Table 27: Regulatory Milestones of Durvalumab
  • Table 28: NICE Technology Assessment of Durvalumab
  • Table 29: SMC Technology Assessment of Durvalumab
  • Table 30: CADTH-pCODR Technology Assessment of Durvalumab
  • Table 31: HAS Technology Assessment of Durvalumab
  • Table 32: Key U.S. Clinical Trials on Abemaciclib
  • Table 33: Regulatory Milestones of Abemaciclib
  • Table 34: NICE Technology Assessment of Abemaciclib
  • Table 35: SMC Technology Assessment of Abemaciclib
  • Table 36: CADTH-pCODR Technology Assessment of Abemaciclib
  • Table 37: HAS Technology Assessment of Abemaciclib
  • Table 38: Key U.S. Clinical Trials on Ocrelizumab
  • Table 39: Incidence and Prevalence of Multiple Sclerosis Cases, by Country, 2016
  • Table 40: Regulatory Milestones of Ocrelizumab
  • Table 41: NICE Technology Assessment of Ocrelizumab
  • Table 42: SMC Technology Assessment of Ocrelizumab
  • Table 43: CADTH Technology Assessment of Ocrelizumab
  • Table 44: HAS Technology Assessment of Ocrelizumab

List of Figures

  • Figure 1: Shares of Healthcare Expenditures in the U.K., by Sector, 2017
  • Figure 2: IQWiG Technology Assessment Process
  • Figure 3: IQWiG Conclusions on the Benefits of Assessments
  • Figure 4: Shares of National Healthcare Expenditures in the U.S., by Sector, 2018
  • Figure 5: Schematic of the Reimbursement Process in the U.S.
  • Figure 6: Features of the Asia-Pacific Market
  • Figure 7: Shares of Drugs Listed in the National Formulary of China, by Therapeutic Area, 2017
  • Figure 8: Management of Advanced Non-small Cell Lung Cancer and Expected Outcomes