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癌治療における薬価設定と償還 - 新薬の高額な薬価設定が正当であることの証左を求める支払い者側圧力により製薬企業はリスクシェアリング方式に向かう

Pharmaceutical Pricing and Reimbursement in Oncology - Payer Pressure to Justify Premium Pricing of Novel Agents, Pushing Companies to Risk-Sharing Modalities

発行 GBI Research 商品コード 246717
出版日 ページ情報 英文 64 Pages
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癌治療における薬価設定と償還 - 新薬の高額な薬価設定が正当であることの証左を求める支払い者側圧力により製薬企業はリスクシェアリング方式に向かう Pharmaceutical Pricing and Reimbursement in Oncology - Payer Pressure to Justify Premium Pricing of Novel Agents, Pushing Companies to Risk-Sharing Modalities
出版日: 2012年07月10日 ページ情報: 英文 64 Pages
概要

当レポートは、世界主要7カ国の医療システムならびに薬価設定および償還プロセスに関して包括的に精査を行ったもので、これら各国で用いられている様々な法規制メカニズムについて詳細な分析を加えています。また薬剤についての重要な変化や癌治療関連薬に関する最近の薬価設定および償還制度について詳しく取り上げ、さらに将来に対する影響を分析しており、概略下記の構成でお届けいたします。

第1章 目次

第2章 癌治療における薬価設定と償還 - イントロダクション

第3章 癌治療における薬価設定と償還 - 概要

  • 抗癌薬の発達
  • 市場アクセスおよび抗癌薬における医療経済の役割
    • 欧州における抗癌薬関連法規
    • 病院予算ならびに患者の薬剤へのアクセス性
    • 数多く出現する新治療に対しての革新的戦略を用いた支払者側からの管理
    • リスクシェアリング契約についての米国と欧州との比較
  • 抗癌薬に対する償還制度に関する米国と欧州との間の差異
  • 米国におけるコスト正当化の手法

第4章 癌治療における薬価設定と償還 - 米国

  • イントロダクション
  • 規制機関
  • 動向
    • 米国における癌診療と費用
    • 2020年までの癌治療費用 - 2010年から27%もの増加となる可能性あり
    • 処方薬の償還 - 抗癌薬は第4ティア以下に類別
    • 医療支出制御のための戦略
    • 経口分子標的抗癌剤が癌治療の次期パラダイムに
    • 経口抗癌剤における償還の問題
    • 経口抗癌剤パリティ法

第5章 癌治療における薬価設定と償還 - 欧州主要5カ国

  • イタリア
  • スペイン
  • ドイツ
  • フランス
  • 英国

第6章 癌治療における薬価設定と償還 - 日本

  • イントロダクション
  • 規制機関
  • 動向
    • 日本では高齢癌患者に対する医療費は異なる
    • 薬剤の承認適応症外使用に対しては条件付きで償還が認められる
    • 市場で上位を占める抗癌薬の薬価設定システムの変化
    • 健康保険新薬リストにはエーザイの乳癌治療薬ハラヴェンが掲載

第7章 癌治療における薬価設定と償還 - 付録

付表

付図

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目次
Product Code: GBIHC203MR

Summary

GBI Research, leading business intelligence provider, has released its latest research report, entitled "Pharmaceutical Pricing and Reimbursement in Oncology - Payer Pressure to Justify Premium Pricing of Novel Agents, Pushing Companies to Risk-Sharing Modalities". It provides a comprehensive overview of the healthcare system, and the pricing and reimbursement processes in the top seven countries of the world, with a detailed analysis of the different regulatory mechanisms used in these countries. The report closely scrutinizes the major pharmaceutical changes and oncology-related pricing and reimbursement in these countries in the recent past and their impact in the near future. The countries analyzed in the report are the US, the top five European countries of the UK, France, Italy, Germany and Spain; and Japan.

Cancer is considered to be one of the most feared diseases, a cure for which has so far eluded researchers all over the world. However, new lines of therapeutics Vascular Endothelial Growth Factor (VEGF) inhibitors and Epidermal Growth Factor Receptor (EGFR) inhibitors are expected to make a significant impact on patient survival. However, progress in patient survival and other benefits are accompanied by premium prices, which has necessitated the creation of several agencies responsible for making decisions pertaining to pricing and reimbursement for cancer drugs in many countries of the world in order to contain costs related to cancer treatment. The report on "Pharmaceutical Pricing and Reimbursement in Oncology " delves into these recent changes in pricing and reimbursement mechanisms that are often targeted at expensive cancer drugs.

Scope

  • Detailed study of the healthcare systems and roles of the key players in the respective pharmaceutical systems of the top seven countries of the world - the US, the UK, France, Germany, Italy, Spain and Japan.
  • Analysis of the major pricing and reimbursement mechanisms in each country.
  • Key trends that follow from the recent changes brought about in pricing and reimbursement mechanisms.
  • Analysis of the possible major challenges brought about by the enactment of changes in the pricing and reimbursement scene in the countries covered in the report.
  • Particular focus on pricing and reimbursement in oncology.

Reasons to buy

  • Build an understanding of the oncology-related key pricing and reimbursement mechanisms in the top seven countries of the world.
  • Optimize your investment through identification and understanding of the changes in oncology drugs' regulatory mechanisms and in the pricing and reimbursement scenario for the countries covered in the report.
  • Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in the pricing and reimbursement scene for the countries covered.

Table of Contents

1 Table of Contents 6

  • 1.1 List of Tables 7
  • 1.2 List of Figures 8

2 Pricing and Reimbursement in Oncology - Introduction 9

3 Pricing and Reimbursement in Oncology - Overview 10

  • 3.1 Development of Oncology Drugs 13
  • 3.2 Market Access and the Role of Health Economics in Cancer Drugs 14
    • 3.2.1 Regulation of Cancer Drugs in Europe 14
    • 3.2.2 Hospital Budgets and Patient Access to Drugs 14
    • 3.2.3 Payers Managing Influx of New Therapies through Innovative Strategies 15
    • 3.2.4 Risk Sharing Agreements in the US Vis-a-vis Europe 16
  • 3.3 Difference in Reimbursement for Oncology Drugs between the US and Europe 16
  • 3.4 Rationalizing Costs in the US 16

4 Pricing and Reimbursement in Oncology - The US 17

  • 4.1 Introduction 17
  • 4.2 Regulatory Bodies 18
  • 4.3 Trends 19
    • 4.3.1 Oncology Practice and Expenditure in the US 19
    • 4.3.2 Expenditure on Cancer Care Until 2020 - Costs May Increase by 27% from 2010 19
    • 4.3.3 Reimbursement of Prescription Drugs - Oncology Falls under Tier Four 25
    • 4.3.4 Strategies to Control Healthcare Spending 25
    • 4.3.5 Oral Targeted Chemotherapeutics are the Next Paradigm in Cancer Care 26
    • 4.3.6 Reimbursement Issues in Oral Chemotherapeutics 27
    • 4.3.7 Oral Chemotherapy Parity Act 27

5 Pricing and Reimbursement in Oncology - Top Five Countries of Europe 28

  • 5.1 Italy 28
    • 5.1.1 Introduction 28
    • 5.1.2 Regulatory Bodies 29
    • 5.1.3 Trends 29
  • 5.2 Spain 32
    • 5.2.1 Introduction 32
    • 5.2.2 Regulatory Bodies 32
    • 5.2.3 Trends 32
  • 5.3 Germany 35
    • 5.3.1 Introduction 35
    • 5.3.2 Regulatory Bodies 36
    • 5.3.3 Trends 38
  • 5.4 France 40
    • 5.4.1 Introduction 40
    • 5.4.2 Regulatory Bodies 41
    • 5.4.3 Trends 43
  • 5.5 The UK 47
    • 5.5.1 Introduction 47
    • 5.5.2 Regulatory Bodies 48
    • 5.5.3 Trends 49

6 Pricing and Reimbursement in Oncology - Japan 54

  • 6.1 Introduction 54
  • 6.2 Regulatory Bodies 56
  • 6.3 Trends 57
    • 6.3.1 Fee Changes for the Elderly in Japan Suffering from Cancer 57
    • 6.3.2 Off-label Uses of Drugs Agreed to be Given Conditional Reimbursement 57
    • 6.3.3 Changes to Japan's Pricing System for Market Leading Drugs 57
    • 6.3.4 New Medicines Included in NHI List Including Eisai's Breast Cancer Drug Halaven 57

7 Pricing and Reimbursement in Oncology - Appendix 59

  • 7.1 Market Definitions 59
  • 7.2 Abbreviations 59
  • 7.3 Sources 62
  • 7.4 Research Methodology 63
    • 7.4.1 Introduction 63
    • 7.4.2 Regulatory Bodies 63
    • 7.4.3 Key Trends 63
  • 7.5 Contact Us 64
  • 7.6 Disclaimer 64

List of Tables

  • Table 1: Pricing and Reimbursement in Oncology, Estimated Number of New Cases for Major Types of Cancer, Top Seven Countries ('000), 2011 11
  • Table 2: Pricing and Reimbursement in Oncology, Estimated Mortality for Major Types of Cancer, Top Seven Countries ('000), 2011 12
  • Table 3: Pricing and Reimbursement in Oncology, Examples of Innovative Reimbursement Agreements 15
  • Table 4: Pricing and Reimbursement in Oncology, the US, Expenditure for Cancer Care in the Top Five Sites ($bn), 2010 and 2020 21
  • Table 5: Pricing and Reimbursement in Oncology, the US, Expenditure for Cancer Care in Other Sites ($bn), 2010 and 2020 22
  • Table 6: Pricing and Reimbursement in Oncology, Average Retail Coinsurance Rates, the US, By Tier (%), 2011 25
  • Table 7: Pricing and Reimbursement in Oncology, Public Pharmaceutical Expenditure, Pharmacies, 2010-2012 33
  • Table 8: Pricing and Reimbursement in Oncology, Germany, Healthcare Expenditure by Financing Agent, $ per inhabitant, 2007, 2008, 2009 36
  • Table 9: Pricing and Reimbursement in Oncology, France, Types of Treatment and their Reimbursement Levels 41
  • Table 10: Pricing and Reimbursement in Oncology, Market Entry Restrictions for Cancer Drugs, the UK 50
  • Table 11: Pricing and Reimbursement in Oncology, the UK, General Price Changes (%), 2009-2013 52
  • Table 12: Pricing and Reimbursement in Oncology, Healthcare Expenditure, Japan, 2011 54
  • Table 13: Pricing and Reimbursement in Oncology, Trend in Revision Rates of Reimbursement Prices, Japan, 1992-2008 55
  • Table 14: Pricing and Reimbursement in Oncology, Change in Premiums, Japan, 2002-2008 56
  • Table 15: Pricing and Reimbursement in Oncology, List of Drugs Introduced to NHI, Japan, 2011 58

List of Figures

  • Figure 1: Pricing and Reimbursement in Oncology, Estimated Number of New Cases or Major Types of Cancer, Top Seven Countries, ('000), 2015 10
  • Figure 2: Pricing and Reimbursement in Oncology, Estimated Number of New Cases for Major Types of Cancer, Top Seven Countries ('000), 2011 11
  • Figure 3: Pricing and Reimbursement in Oncology, Estimated Mortality for Major Types of Cancer, Top Seven Countries ('000), 2011 12
  • Figure 4: Pricing and Reimbursement in Oncology, the US, Total Healthcare Expenditure vs. Out-of-Pocket Expenditure (%), 2011 18
  • Figure 5: Pricing and Reimbursement in Oncology, the US, Expenditure for Cancer Care ($bn), 2010 and 2020 20
  • Figure 6: Pricing and Reimbursement in Oncology, the US, Expenditure for Cancer Care in the Top Five Indications ($bn), 2010 and 2020 21
  • Figure 7: Pricing and Reimbursement in Oncology, the US, Estimated Cancer Cases, By Sites, Men (%), 2011 23
  • Figure 8: Pricing and Reimbursement in Oncology, the US, Estimated Cancer Cases, By Sites, Women (%), 2011 24
  • Figure 9: Pricing and Reimbursement in Oncology, Total Per-capita Expenditure on Pharmaceuticals, Top Five Countries of Europe and the US, $PPP, 1990-2010 28
  • Figure 10: Pricing and Reimbursement in Oncology, Public Pharmaceutical Expenditure, Pharmacies, Growth Rates (%), 2010-2012 33
  • Figure 11: Pricing and Reimbursement in Oncology, Germany, Healthcare Expenditure by Financing Agent, $ per inhabitant, 2007, 2008, 2009 35
  • Figure 12: Pricing and Reimbursement in Oncology, Germany, Structural Reforms by AMNOG, 2011 38
  • Figure 13: Pricing and Reimbursement in Oncology, European Counties, the US and Japan, Total Healthcare Expenditure vs. Out-of-Pocket Expenditure, 2011 40
  • Figure 14: Pricing and Reimbursement in Oncology, Regulatory Bodies and Functions, France 41
  • Figure 15: Pricing and Reimbursement in Oncology, HTA to P&R Decisions, France 42
  • Figure 16: Pricing and Reimbursement in Oncology, Public and Private Expenditure on Health as % of Total Expenditure on Health, 2011 47
  • Figure 17: Pricing and Reimbursement in Oncology, Life Expectancy at Birth, Males and Females, Japan, 2011 55
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