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表紙:製薬業界におけるヘルステクノロジー評価:主な決定事項レビュー
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製薬業界におけるヘルステクノロジー評価:主な決定事項レビュー

Health Technology Assessment in Pharma: A Review of Major Decisions

出版日: | 発行: BCC Research | ページ情報: 英文 82 Pages | 納期: 即納可能 即納可能とは

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製薬業界におけるヘルステクノロジー評価:主な決定事項レビュー
出版日: 2020年04月08日
発行: BCC Research
ページ情報: 英文 82 Pages
納期: 即納可能 即納可能とは
担当者のコメント
医療技術評価(Health Technology Assessment -HTA)は、医療技術の世界的な普及とその経済効果において昨今承認プロセスの情報を提供するに当たり、その評価の動向を把握することは不可欠となります。ヘルスケア市場動向において長年の調査実績を保有する多くのアナリストを持つBCC Research社より、HTAに着目した最新レポートがリリースされました。
  • 全表示
  • 概要
  • 図表
  • 目次
概要

この調査の目標は、北米、欧州、アジア太平洋地域におけるヘルスケアテクノロジーの承認プロセスに関する情報を提供することです。

当レポートでは、製薬業界におけるヘルステクノロジー評価の役割とその機能に焦点を当て、ヘルスケアテクノロジー評価の動向と、薬価設定と償還に及ぼす重要性、主要企業のプロファイルについてまとめています。

第1章 イントロダクション

第2章 ヘルステクノロジー評価のイントロダクション

  • イントロダクション
  • 技術評価の原点
  • 基本的概念
  • ヘルステクノロジー
  • ヘルステクノロジーのカテゴリー
  • 目的または用途
  • 拡散段階
  • ヘルステクノロジー評価
  • ヘルステクノロジー評価の目的

第3章 製薬業界のヘルステクノロジー評価に対する見方

  • ヘルステクノロジー評価と効率
  • コスト牽引因子
  • 運用上の障壁

第4章 世界のヘルステクノロジー評価組織概要

  • 欧州
  • 英国(イングランド、ウェールズ)
  • スコットランド
  • ドイツ
  • フランス
  • イタリア
  • 北米
  • 米国
  • カナダ
  • アジア太平洋地域
  • 日本
  • 中国
  • オーストラリア

第5章 Daratumumab

  • 概要
  • 科学的サマリー
  • 薬力学と作用機序
  • 安全性と有効性を評価するための治験
  • 疾患の背景

第6章 Tildrakizumab

第7章 Durvalumab

第8章 Abemaciclib

第9章 Ocrelizumab

第10章 結論

図表

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
目次
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

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