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リスク評価・低減戦略(REMS):オピオイド、赤血球生成促進剤、および癌治療薬がREMSを必要とする最重要クラス

Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS

発行 GBI Research 商品コード 200294
出版日 ページ情報 英文 88 Pages
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リスク評価・低減戦略(REMS):オピオイド、赤血球生成促進剤、および癌治療薬がREMSを必要とする最重要クラス Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS
出版日: 2011年05月24日 ページ情報: 英文 88 Pages
概要

疼痛管理におけるオピオイドの有効性や重要性はよく知られていますが、誤用や乱用、中毒、過剰摂取などオピオイドをめぐる重大なリスクも指摘されています。こうしたリスクを最小限に抑えるために、オピオイドはリスク評価・低減戦略(REMS)の対象となっています。REMSとは薬剤のメリットがそのリスクを上回っていることを担保するようFDAが定めたものであり、2008年以降に承認された小分子の3分の1がREMSの対象となっています。REMSの対象となる重要な薬剤クラスには長期作用型オピオイドや赤血球生成促進剤などがあります。

当レポートでは、リスク評価・低減戦略(REMS)の概要と必要性、オピオイドや赤血球生成促進剤におけるREMSの影響、ニッチ市場における機会、および将来の見通しをまとめ、概略以下の構成でお届けします。

第1章 目次

第2章 リスク評価・低減戦略:イントロダクション

第3章 リスク評価・低減戦略:薬剤開発とファーマコビジランス

  • 創薬と薬剤開発
    • 早期段階
    • 第1相
    • 第2相
    • 第3相
    • 登録
    • 第4相
  • ファーマコビジランス
    • 様々な国におけるファーマコビジランス
    • 欧州
    • 米国
  • 市販後調査
    • 市販後調査
    • 有害事象報告システム
    • 薬剤評価・調査センター
  • REMSの必要性
    • 有害事象報告件数
    • 7つの地域における医療費の増加

第4章 リスク評価・低減戦略:概要

  • REMSとは
  • Food and Drug Administration Amendments Act of 2007
  • 承認されたリスク評価・低減戦略:2008~2010年
  • REMS承認
  • REMSの影響
  • 薬剤クラス別REMS
  • REMSとジェネリック医薬品

第5章 オピオイド

  • イントロダクション
  • オピオイドとREMS
  • ケーススタディ

第6章 赤血球生成促進剤

  • 赤血球生成促進剤
  • 薬剤プロファイル
  • その他のケーススタディ

第7章 ニッチ市場における機会

  • REMSと個別化医療
  • REMSとオーファンドラッグ

第8章 電子記録管理とITソリューション

  • EDC
  • ePRO
  • IVRS
  • CDMS
  • 製造・サプライチェーンにおける情報技術

第9章 競合環境

  • Inflexxion, Inc
  • inVentiv Health
  • BioTrak Research

第10章 その他REMSサービスを提供している主な臨床研究機関

第11章 将来見通し

第12章 付録

図表

目次
Product Code: GBIHC087MR

Summary

GBI Research' s research, “Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS”, provides key data, information and analysis on the risk management and mitigation strategies, mandated by the FDA and being implemented by pharmaceutical companies. The report provides information on the Risk Evaluation and Mitigation Strategies (REMS), the reasons why companies implement REMS and the importance of REMS. This report provides comprehensive analysis of REMS approved up to date, components of REMS and safety issues involved in the requirement of REMS using case studies. Also, information on major drug classes that require REMS such as opioids and erythropoesis-stimulating agents in cancer management is also provided in detail. The report also reviews the impact of REMS on various stakeholders including patients, healthcare providers and pharma and biotech industries. Selected REMS consulting companies are covered in the report.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

The increasing number of deaths due to adverse reactions has been alarming and has forced the FDA to implement strict regulatory guidelines for drug use. For every drug approved by the FDA, potential risks or adverse reactions of the drug are communicated to the patients and physicians through product package inserts. However, drug withdrawals such as the highly publicized Vioxx withdrawal in 2004 brought the FDA under scrutiny and highlighted the need for fundamental changes in the system.

Scope

• Analysis and data on REMS, detailed review of the drug development and pharmacovigilence studies, the need for REMS and implementation of the Food and Drug Administration and Amendments Act (FDAAA) by the FDA
• Insight into the number of approved and deemed REMS since the FDAAA came into effect.
• Components of REMS and the increasing complexity of the same.
• Analysis of the safety issues and different therapy areas that have seen REMS approvals.
• Detailed analysis of important drug classes that require REMS including opioids, and erythropoesis-stimulating agents in cancer management.
• Overview of consulting companies that offer risk management services and selected case studies.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -

• Build understanding of REMS for current drugs on the market and the need for REMS for new drugs and the process of submission.
• Develop effective business strategies related to risk mitigation and management of present drugs on the market and drugs in the pipeline that may require REMS.
• Analyze the safety issues and drugs in key therapy areas that require REMS and develop effective strategies to prevent a drug’s withdrawal from the market.
• Identify the key consulting companies that offer risk management solutions.
• Identify and understand various IT tools for effective data management and as a result, easy documentation of REMS.

Companies Mentioned

Inflexxion, Inc

inVentiv Health

BioTrak Research

Executive Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS”. It provides key data, information and analysis on the risk management and mitigation strategies, mandated by the FDA and being implemented by pharmaceutical companies. The report provides information on the Risk Management and Mitigation Strategies (REMS), the reasons why companies implement REMS and the importance of REMS. This report provides comprehensive analysis of REMS approved up to date, components of REMS and safety issues involved in the requirement of REMS using case studies. The report also provides information on major drug classes that require REMS such as opioids and erythropoesis-stimulating agents in cancer management. It also reviews the impact of REMS on various stakeholders including patients, healthcare providers and pharma and biotech industries. Major REMS consulting companies are covered in the report.

It is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

Risk Evaluation and Mitigation Strategies (REMS) to Ensure Safe Use of Opioids

Importance and efficacy of opioids in pain management is well known and acknowledged by organizations such as the American Pain Society (APS), American Academy of Pain Medicine (AAPM) and World Health Organization (WHO). However, nonmedical use including misuse, abuse, addiction and overdose are some of the significant risks associated with opioids. Opioid prescription drug abuse has shown an alarming increase over the last few years. Number of hydrocodone and oxycodone prescriptions increased from approximately 141 million in 2004 to 179 million in 2009.

In an effort to minimize these risks, opioids are made available through REMS. REMS ensure that opioids’ benefits outweigh its safety risks and that healthcare professionals are aware will allow appropriate patients continued access to opioids. A class wide REMS for long-acting opioids has been suggested by the FDA but the design remains to be specified.

Risk Evaluation and Mitigation Strategies, Opioids, 2010

Source: GBI Research, Drug Abuse Warning Network

REMS Elements such as ETASU have seen increased implementation in the recent past

Since the introduction of the Food and Drug Administration Amendments Act (FDAAA), the FDA approved 23 REMS in 2008, 72 REMS in 2009 and 63 REMS in 2010.

Risk Evaluation and Mitigation Strategies, Requirement of additional REMS component, 2008-2010

Source: GBI Research, US FDA, ParagonRx REMS Hub, REMSadvisor.com

Approximately 65% of all the approved REMS (since 2008) required a medication guide. However, medication guide-only REMS have decreased and components such as ETASUs and implementation systems have become key elements of REMS. ETASUs may be required if the drug is associated with serious adverse events and the medication guide/

In an interview with GBI Research (April 2011), David Kirk, Commercial Development Director for ParagonRx, said “One of three small molecules approved since 2008 have required REMS. MedGuide-only REMS have decreased as a percentage of total REMS approved in each year.”

FDA mandates REMS for Erythropoiesis-Stimulating Agents (ESAs)

ESAs are indicated for the treatment of anemia resulting from chronic kidney failure, chemotherapy, Human Immunodeficiency Virus (HIV) infection, and are also used to reduce the number of blood transfusions during and after certain major surgeries. ESAs are associated with an increase in risk of tumor growth and reduction in survival rate in patients with cancer who use ESAs. Studies have also shown that ESAs can increase the risk of heart attack, heart failure, stroke, or blood clots in patients who use these drugs for other conditions.

ESAs included in the REMS program are Amgen’s Epogen (epoetin alfa), Procrit (epoetin alfa), and Aranesp (darbepoetin alfa).The ESA APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe use of ESAs) Oncology program, launched on March 24, 2010, was developed by Amgen in collaboration with Centocor Ortho Biotech Products for healthcare professionals who prescribe ESAs to patients with cancer. All ESAs are required to be prescribed with REMS to ensure their safe use.

Risk Evaluation and Mitigation Strategies, Erythropoiesis-Stimulating Agents, 2010

Source: GBI Research, Amgen press releases, REMSadvisor.com

Table of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Risk Evaluation and Mitigation Strategies - Introduction 9
2.1 GBI Research Report Guidance 10
3 Risk Evaluation and Mitigation Strategies - Drug Development and Pharmacovigilance 11
3.1 Drug Discovery and Development 11
3.1.1 Early Stage Drug Discovery 11
3.1.2 Phase I 12
3.1.3 Phase II 12
3.1.4 Phase III 12
3.1.5 Registration 12
3.1.6 Phase IV 13
3.2 Pharmacovigilance 14
3.2.1 Pharmacovigilance in Different Countries 14
3.2.2 Pharmacovigilance in Europe 14
3.2.3 Pharmacovigilance in the US 15
3.3 Post Marketing Research and Surveillance 15
3.3.1 Post marketing Surveillance 16
3.3.2 Adverse Event Reporting System (AERS) 17
3.3.3 Center for Drug Evaluation and Research (CDER) 17
3.4 Need for REMS 18
3.4.1 Number of Adverse Events Reports 18
3.4.2 Increase in healthcare costs in top seven geographies 19
4 Risk Evaluation and Mitigation Strategies - Overview 20
4.1 What are REMS? 20
4.1.1 RiskMAPs and REMS 20
4.1.2 Components of REMS 21
4.2 Food and Drug Administration Amendments Act (FDAAA) of 2007 22
4.2.1 Prescription Drug User Fee Amendments, 2007 22
4.2.2 Medical Device User Fee Amendments, 2007 22
4.2.3 Pediatric Research Equity Act, 2007 22
4.2.4 Best Pharmaceuticals for Children Act, 2007 22
4.3 Approved Risk Evaluation and Mitigation Strategies - 2008-2010 23
4.3.1 FDA Approved REMS, 2008 27
4.3.2 FDA Approved REMS, 2009 29
4.3.3 FDA Approved REMS, 2010 33
4.4 Deemed REMS Approvals 37
4.5 Implications of REMS 38
4.6 REMS by Drug Class 39
4.7 REMS and Generics 40
5 Risk Evaluation and Mitigation Strategies - Opioids 41
5.1 Introduction 41
5.2 Opioids and REMS 41
5.3 Case Studies - Opioids 44
5.3.1 Oxycodone 45
5.3.2 Embeda 46
5.3.3 Exalgo 46
5.3.4 Onsolis 47
6 Risk Evaluation and Mitigation Strategies - Erythropoiesis-Stimualting Agents 50
6.1 Erythropoiesis-Stimulating Agents (ESAs) 50
6.2 ESA Drug Profiles 51
6.2.1 Epogen 51
6.2.2 Aranesp 53
6.2.3 Procrit/Eprex 55
6.3 Risk Evaluation and Mitigation Strategies - Other Case Studies 58
6.3.1 Accutane (Isotretinoin) - iPLEDGE Program 58
6.3.2 Tysabri (Natalizumab) - TOUCH Program 59
6.3.3 Nplate (romiplostim) - NEXUS Program 60
7 Risk Evaluation and Mitigation Strategies - Opportunities in Niche Markets 61
7.1 REMS and Personalized Medicine 61
7.2 REMS and Orphan Drugs 62
8 Risk Evaluation and Mitigation Strategies - Electronic Record Maintenance and IT Solutions 64
8.1 Electronic Data Capture (EDC) 64
8.1.1 Cost Saving Scenario in EDC 65
8.1.2 Case Studies 66
8.2 Electronic Patient Report Outcome System (ePRO) 67
8.2.1 Cost Saving Scenario with eDiaries 69
8.3 Interactive Voice Response Systems (IVRS) 70
8.4 Clinical Data Management Systems (CDMS) 71
8.5 Information Technology in the Manufacturing & Supply Chain 72
8.5.1 E-Pedigree Solutions 72
8.5.2 Track and Trace Solutions 73
8.5.3 Product Callback Management 74
8.5.4 Sample Distribution Management 74
9 Risk Evaluation and Mitigation Strategies - Competitive Landscape 75
9.1 Inflexxion, Inc 75
9.1.1 Business Description 75
9.1.2 Snapshot 75
9.2 inVentiv Health 76
9.2.1 Business Description 76
9.2.2 ParagonRx 76
9.2.3 Snapshot 77
9.3 BioTrak Research 78
9.3.1 Business Description 78
9.3.2 Snapshot 78
9.3.3 REMS Solutions - Case Study 79
10 Other Major Clinical Research Organizations offering REMS services 80
10.1 PRA International 80
10.1.1 Business Description 80
10.1.2 Services Offered 80
10.2 Covance 81
10.2.1 Business Description 81
10.2.2 Services Offered 81
10.3 Kendle International Inc. 82
10.3.1 Business Overview 82
10.3.2 Services Offered 82
10.4 Pharmaceutical Product Development 82
10.4.1 Business Description 82
10.4.2 Services Offered 82
11 Risk Evaluation and Mitigation Strategies - The Future 84
12 Appendix 85
12.1 Market Definitions 85
12.2 Abbreviations 85
12.3 Research Methodology 86
12.3.1 Coverage 86
12.3.2 Secondary Research 87
12.3.3 Primary Research 87
12.4 Expert Panel Validation 87
12.5 Contact Us 88
12.6 Sources 88
12.7 Disclaimer 88

List of Tables

Table 1: Risk Evaluation and Mitigation Strategies, List of FDA Approved REMS, 2008 27
Table 2: Risk Evaluation and Mitigation Strategies, List of FDA Approved REMS, 2009 29
Table 3: Risk Evaluation and Mitigation Strategies, List of FDA Approved REMS, 2010 33
Table 4: Risk Evaluation and Mitigation Strategies, Deemed REMS, 2010 37

List of Figures

Figure 1: Risk Evaluation and Mitigation Strategies, Stages of Drug Development, 2011 13
Figure 2: Risk Evaluation and Mitigation Strategies, Post Marketing Surveillance System , 2011 16
Figure 3: Risk Evaluation and Mitigation Strategies, System of safety data gathering, 2011 16
Figure 4: Risk Evaluation and Mitigation Strategies, Number of Adverse Events in the US, 2000-2011 18
Figure 5: Risk Evaluation and Mitigation Strategies, Healthcare Expenditure 1998-2008 19
Figure 6: Risk Evaluation and Mitigation Strategies, Components of REMS 21
Figure 7: Risk Evaluation and Mitigation Strategies, REMS Approvals (2008-2010) 23
Figure 8: Risk Evaluation and Mitigation Strategies, Components of REMS, 2008-2010 24
Figure 9: Risk Evaluation and Mitigation Strategies, Requirement of additional REMS component, 2008-2010 25
Figure 10: Risk Evaluation and Mitigation Strategies, Safety Issues, 2008-2010 25
Figure 11: Risk Evaluation and Mitigation Strategies, Components of REMS, 2008 28
Figure 12: Risk Evaluation and Mitigation Strategies, Components of REMS, 2009 32
Figure 13: Risk Evaluation and Mitigation Strategies, Components of REMS, 2010 36
Figure 14: Risk Evaluation and Mitigation Strategies, Implications for Stakeholders 38
Figure 15: Risk Evaluation and Mitigation Strategies, Important Drug Classes Requiring REMS 39
Figure 16: Risk Evaluation and Mitigation Strategies, Number of ED Visits Due To Drug Abuse in the US, 2004 and 2008 42
Figure 17: Risk Evaluation and Mitigation Strategies, Number of Opioid drug prescriptions (in million), 1991-2009 43
Figure 18: Risk Evaluation and Mitigation Strategies, Number of Emergency Department Visits in the US, 2004-2008 43
Figure 19: Risk Evaluation and Mitigation Strategies, Opioids, 2011 44
Figure 20: Risk Evaluation and Mitigation Strategies, Onsolis, 2011 49
Figure 21: Risk Evaluation and Mitigation Strategies, Erythropoiesis-Stimulating Agents, 2011 50
Figure 22: Risk Evaluation and Mitigation Strategies, Accutane Case Study, 2011 58
Figure 23: Risk Evaluation and Mitigation Strategies, Tysabri Case Study, 2011 59
Figure 24: Risk Evaluation and Mitigation Strategies, Nplate, Case Study, 2011 60
Figure 25: Risk Evaluation and Mitigation Strategies, Electronic Data Capture through e-CRF, 2009 64
Figure 26: Risk Evaluation and Mitigation Strategies, EDC System- Cost Saving Scenario, 2009 65
Figure 27: Risk Evaluation and Mitigation Strategies, EDC Cost Saving in Clinical Trials - By Therapy , 2009 66
Figure 28: Risk Evaluation and Mitigation Strategies, Cost Saving Scenario of ePRO Solutions, 2009 68
Figure 29: Risk Evaluation and Mitigation Strategies, Case Study of ePRO Solutions, 2009 69
Figure 30: Risk Evaluation and Mitigation Strategies, Integration of IVR with other Systems, 2009 70
Figure 31: Risk Evaluation and Mitigation Strategies, Clinical Data Management Flow, 2009 71
Figure 32: Risk Evaluation and Mitigation Strategies, Paper Based Pedigree in a Pharmaceutical Supply Chain 72
Figure 33: Risk Evaluation and Mitigation Strategies, Inflexxion, Snapshot, 2011 75
Figure 34: Risk Evaluation and Mitigation Strategies, inVentiv health, Snapshot, 2011 77
Figure 35: Risk Evaluation and Mitigation Strategies, BioTrak Research, Snapshot, 2011 78
Figure 36: Risk Evaluation and Mitigation Strategies, BioTrak Research, Case Study, 2011 79
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