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

Report 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.

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

1.1 List of Tables

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

1.2 List of Figures

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