Impact of Pharmacogenomics on Public Healthcare Policy:
Educating patients, payors and healthcare providers
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| Overview: | |
| During the last fifteen years tremendous advances have been made in deciphering the genetic coding of a variety of species from invertebrates, vertebrates and finally man through the formal initiation of the Human Genome Project in October 2000 and its completion in 2003. This information has helped to increase our understanding of how genetics has a pivotal role in the predisposition of many diseased states, the progression of a course of a disease, as well as a patient’s response to a drug, or lack of it. Now in the 21st Century there is a growing trend towards the development of personalized medicine – the right drug for the right individual. | |
| Keywords: ADRs, Cost Effectiveness, DME, Efficacy & Safety, Haplotype analysis, Incentives, IP, IVD, Personalized medicine, Pharmacodynamics, Pharmacogenomics, Pharmacogenetics, Regulation, Reimbursement, SNP | |
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By Dr Cheryl L Barton / Publication Date: 26th March 2008
Contents:
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 Tables:
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