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Impact of Pharmacogenomics on Public Healthcare Policy

Immense advances in genetic code decipherment over the last decade have recently led to personalized medicine, or ‘the right drug for the right person’, becoming an achievable concept. Pharmacogenomics (PGx) embodies the principles of personalized medicine by combining pharmacology with genetic information to improve drug safety and efficiency. The pharma industry is currently applying PGx throughout its R&D processes to enhance decision making, streamline clinical trial design and reduce drug failures and product withdrawals. Companies are also attempting to increase the impact of PGx by engaging in strategic alliances and collaborations. However, it is crucial that governments and regulators provide sufficient rewards for developers if innovation in this field to continue. This can be achieved by establishing suitable incentives, regulatory frameworks and reimbursement environments.
Impact of Pharmacogenomics on Public Healthcare Policy: Educating patients, payors and regulators is a new report published by Business Insights that examines how PGx implementations can help to improve efficiency and productivity within the industry, across the fields of pharma, biotech and diagnostics. The PGx strategies of major companies are profiled and recent alliances and licensing opportunities are highlighted. This report discusses how reimbursement issues may influence the uptake of PGx and assesses major regulatory issues in Europe, Japan and the US. The current market trends, future challenges and opportunities facing PGx are also investigated.
Discover the potential value of pharmacogenomic tests and products to your R&D program, identify the latest regulatory and reimbursement issues and benchmark PGx implementation strategies with this report.

Top five reasons to order your copy today
• Identify how companies are implementing PGx technologies with this report’s analysis of key strategies, alliances and licensing opportunities for major pharma, biotech and diagnostics companies.
• Discover how PGx can create cost-savings through improved decision-making and reduced development times by examining the challenges and opportunities facing this technology and assessing the realistically attainable benefits.
• Understand the latest reimbursement issues influencing coverage, coding and payment in the PGx field by using this report’s profile of key reimbursement drivers and analysis of the cost-effectiveness and commercial viability of PGx tests and technologies.
• Assess the extent to which changes in the regulatory landscape may influence future applications of PGx with this report’s analysis of influential white papers currently under review and major developments in the regulatory environments of Europe, Japan and the US.
• Evaluate stakeholder importance in the uptake of PGx products and tests and understand how education and patient consent will affect PGx utilization in the drive towards personalized medicine.
Some key findings from this report...
• Pharmacogenomics (PGx) can improve drug safety and efficiency to increase success rates in pharma R&D. Although the biotech and diagnostic industries have been quick to adopt this technology, the pharma industry has been the slowest to realize the potential benefits.
• Regulators in the US, Europe and Japan are beginning to engage in the collection, submission and analysis of PGx data through a newly established regulatory framework. However, there are concerns that regulations that may stifle innovation in this rapidly evolving field.
• Pharma, biotech and diagnostics companies have adopted a variety of PGx strategies in their R&D programs, and in some cases have active companion diagnostic programs that run in parallel.
• The pharma industry continues to fight for cost-effectiveness and fair reimbursement in PGx tests and products. PGx testing is generally not mandatory prior to drug prescription and approval does not currently guarantee reimbursement.
• The patent landscape will become more complex as companies seek to develop personalized medicines in an effort to improve the proprietary status of approved and novel drugs.

Key issues examined in this report...
• Productivity improvements. PGx technologies aim to alleviate the current productivity crisis in the biopharma industry, specifically in terms of regulatory approvals, reimbursement, containment of R&D costs and accurate stratification of patient populations.
• Industrial consolidation. Reductions in productivity have been one of the key factors driving consolidation within the pharma industry. The application of new technologies such as PGX testing and patient stratification is helping to address this issue.
• Go/no-go decision-making. The additional information and resources associated with PGx applications can be used to make go/no-go decisions earlier in the drug development process, reducing the financial liability of potential drug failures.
• Toxicology and safety. Effective PGx implementations can result in the earlier identification of toxicology and safety issues in late-stage R&D. Clinical trials can then be adapted to reposition the drug candidate, significantly reducing the prospect of negative publicity.

Your questions answered...
• What is PGx and how is it being applied in the industry?
• Which of the leading companies adopting PGx and how are they applying it to their development programs?
• What are the opportunities and challenges facing PGx?
• Which strategies are diagnostic companies using to develop PGx tests?
• What reimbursement hurdles do PGx tests and products have to overcome in order to reach the market?
• How is the r evolution of PGx changing the reimbursement environment?
• How will regulatory frameworks provide incentives for the adoption of PGx technologies in the future?
• What is the current IP landscape within the PGx field?

Table of Contents
Impact of Pharmacogenomics on Public Healthcare Policy
Executive Summary 10
Pharmacogenomics defined 10
Application & implementation of PGx by the industry 11
Pharmacogenomic strategies, alliances & licensing opportunities 11
Pharmacogenomic regulation & implementation 12
Reimbursement - coverage, coding & payment 13
Future challenges and opportunities 14
Chapter 1 Pharmacogenomics defined 18
Summary 18
Introduction 19
What is pharmacogenomics & pharmacogenetics? 20
Why is pharmacogenomics important? 21
Rising R&D costs 21
Long development times 22
High risk drug development 24
Current pharmacogenomic environment 25
PGx testing for targeted therapies 25
PGx diagnostics to improve safety 26
Conclusions 26
Chapter 2 Implementation of PGx by the industry 30
Summary 30
Introduction 31
Current applications 32
Efficacy studies 34
Safety and toxicity studies 40
Dosing studies 46
Implications 51
Target identification 51
Pre-clinical development 53
Clinical development 53
Phase 4 development 54
Conclusions 54
Chapter 3 Pharmacogenomic strategies, alliances and licensing opportunities 58
Summary 58
Introduction 59
Pharmaceutical strategies to PGx 59
AstraZeneca 59
Bayer Schering Pharma 62
Eli Lilly 63
GlaxoSmithKline 66
Pfizer 70
Roche 72
Conclusions- Pharma PGx strategies 77
Biotech strategies to PGx 78
Amgen 78
Genentech 80
Millennium Pharmaceuticals 81
Conclusions- Biotech PGx strategies 85
Diagnostic strategies to PGx 85
Clinical Data 86
Dako 88
Diaceutics 89
Genomic Health 91
Genzyme Genetics 93
Monogram Biosciences 95
Conclusions- Diagnostic PGx strategies 97
Interactions between stakeholders 98
Consortia 100
Intellectual property 101
IP conclusions 102
Conclusions 103
Chapter 4 Adoption of pharmacogenomics by regulators 106
Summary 106
Introduction 107
Regulators: US, Europe and Japan 107
USA 107
Europe 111
Japan 113
Global PGx harmonization: ICH 114
In vitro diagnostics 115
The US 115
Europe 116
PGx guidance on IVD devices 116
Conclusions 118
Chapter 5 PGx and Health Economics 122
Summary 122
Introduction 123
Reimbursement criteria 124
Coverage 124
Coding 124
Payment 124
Reimbursement drivers 126
Reimbursement in the US 128
Reimbursement in Europe 129
Eligibility of coverage 130
Medical support for PGx coverage 132
Dx coding 133
Payment and pricing 135
Case study 1: DPD testing 136
Cost-effectiveness of PGx 137
Commercially viable PGx testing 139
Case Study 2: HLA B*5701 testing 142
Industry incentives 142
Conclusions 144
Chapter 6 Future challenges and opportunities 146
Summary 146
Introduction 147
Challenges 148
Opportunities 150
Market trends 151
Market sales 154
Conclusions 155
Chapter 7 Appendix 158
Acknowledgements 158
Acronyms 159
Bibliography 162
Glossary 164
Index 169
List of Figures
Figure 1.1: A genomic timeline 19
Figure 1.2: The concept of pharmacogenetics 20
Figure 1.3: Costs, time and success rates associated with drug development 21
Figure 1.4: R&D costs savings following the application of pharmacogenetics 22
Figure 1.5: R&D time savings following the application of genomics technologies in drug discovery 23
Figure 2.6: Applications of PGx/biomarkers in drug development timelines 32
Figure 2.7: Applications of new technologies to develop new medicines 33
Figure 2.8: Response rates to current medicines 35
Figure 2.9: Factors affecting efficacy and outcome of drug treatment 36
Figure 2.10: Response rates to Iressa 38
Figure 2.11: US Reported Adverse Drug Reactions (1995-2001) 40
Figure 2.12: Relationship of drugs, disease, genes and gene products 42
Figure 2.13: Roche AmpliChip CYP450 array technology 45
Figure 2.14: Dose response curves to A) penicillin and B) 6MP 47
Figure 2.15: Warfarin mode of action, metabolism and inter-individual variation 49
Figure 3.16: Pharmacodynamic biomarkers for dose-selection 60
Figure 3.17: PGx and biomarkers to aid decision making 61
Figure 3.18: Bayer’s high tech research platform 62
Figure 3.19: Obesity patients stratified according drug response and weight loss/weight gain 68
Figure 3.20: Pfizer- Applying PGx 70
Figure 3.21: Genotyping an integral part of diagnosis and treatment 73
Figure 3.22: Roche –Pharmaceuticals’ and diagnostics’ approach 76
Figure 3.23: Amgen – PGx approach in R&D and Drug Therapy 79
Figure 3.24: Genentech – development history of Herceptin/HercepTest 80
Figure 3.25: Genentech – multiple targeted cancer therapy 81
Figure 3.26: Millennium – molecular classifiers of Velcade response 83
Figure 3.27: Millennium – Survival classifiers stratifies risk groups 84
Figure 3.28: Diaceutics Library - Rationale for its CMR model 90
Figure 3.29: Genomic Health Product Pipeline 2008-2009 92
Figure 3.30: Genzyme Genetics Product Pipeline 2008-2009 94
Figure 3.31: Monogram Biosciences molecular diagnostics approach 96
Figure 4.32: The organization of the Interdisciplinary Pharmacogenomic Review Group (IPRG) 108
Figure 4.33: FDA’s voluntary PGx submission pathway 109
Figure 4.34: The organization of the EMEA 112
Figure 5.35: CMS a dominant third-party payor A) 2002A and B) 2008E 125
Figure 5.36: Roche - US & EU approval & reimbursement of new tests 132
Figure 6.37: Market trends and drivers for the industry 147
Figure 6.38: Challenges in PGx 148
Figure 6.39: Opportunities in PGx 150
Figure 6.40: Key stakeholder in PGx 152
Figure 6.41: Future PGx Landscape 153
Figure 6.42: Future PGx Landscape 154
Figure 6.43: PGx Sales Forecasts 2005-2015 155
List of Tables
Table 1.1: PGx - Gene Association Studies 25
Table 1.2: Targeted Oncology Products and PGx based tests 26
Table 1.3: PGx tests to aide prescription and reduce the risk of ADRs 28
Table 2.4: Patient stratification for Herceptin trials 37
Table 2.5: Drug withdrawals 1996-2004 41
Table 2.6: PharmGKB Knowledge Base annotated PGx genes 43
Table 2.7: Warfarin dosage versus genetic variant 50
Table 2.8: Disease-associated alleles underlie complex disease phenotypes 52
Table 3.9: SNP Coverage per candidate gene 69
Table 3.10: Recent strategic alliances and collaborations in PGx 99
Table 3.11: PGx driven consortia 100
Table 5.12: PGx Dx value based pricing 136
Table 5.13: Types of economic evaluations in health care 138
Table 5.14: Assessment of the potential cost-effectiveness of PGx interventions 140
Table 5.15: Potential cost-effective PGx applications 141