Impact Of Pharmacogenomics On Public Healthcare Policy: Educating Patients, Payors And Healthcare Providers

Published by: Business Insights

Published: Mar. 1, 2008 - 171 Pages

Table of Contents

Impact of Pharmacogenomics on Public Healthcare Policy

Executive Summary

Pharmacogenomics defined

Application & implementation of PGx by the industry

Pharmacogenomic strategies, alliances & licensing opportunities

Pharmacogenomic regulation & implementation

Reimbursement - coverage, coding & payment

Future challenges and opportunities

Chapter 1 Pharmacogenomics defined

Summary

Introduction

What is pharmacogenomics & pharmacogenetics?

Why is pharmacogenomics important?

Rising R&D costs

Long development times

High risk drug development

Current pharmacogenomic environment

PGx testing for targeted therapies

PGx diagnostics to improve safety

Conclusions

Chapter 2 Implementation of PGx by the industry

Summary

Introduction

Current applications

Efficacy studies

Safety and toxicity studies

Dosing studies

Implications

Target identification

Pre-clinical development

Clinical development

Phase 4 development

Conclusions

Chapter 3 Pharmacogenomic strategies, alliances and licensing opportunities

Summary

Introduction

Pharmaceutical strategies to PGx

AstraZeneca

Bayer Schering Pharma

Eli Lilly

GlaxoSmithKline

Pfizer

Roche

Conclusions- Pharma PGx strategies

Biotech strategies to PGx

Amgen

Genentech

Millennium Pharmaceuticals

Conclusions- Biotech PGx strategies

Diagnostic strategies to PGx

Clinical Data

Dako

Diaceutics

Genomic Health

Genzyme Genetics

Monogram Biosciences

Conclusions- Diagnostic PGx strategies

Interactions between stakeholders

Consortia

Intellectual property

IP conclusions

Conclusions

Chapter 4 Adoption of pharmacogenomics by regulators

Summary

Introduction

Regulators: US, Europe and Japan

USA

Europe

Japan

Global PGx harmonization: ICH

In vitro diagnostics

The US

Europe

PGx guidance on IVD devices

Conclusions

Chapter 5 PGx and Health Economics

Summary

Introduction

Reimbursement criteria

Coverage

Coding

Payment

Reimbursement drivers

Reimbursement in the US

Reimbursement in Europe

Eligibility of coverage

Medical support for PGx coverage

Dx coding

Payment and pricing

Case study 1: DPD testing

Cost-effectiveness of PGx

Commercially viable PGx testing

Case Study 2: HLA B*5701 testing

Industry incentives

Conclusions

Chapter 6 Future challenges and opportunities

Summary

Introduction

Challenges

Opportunities

Market trends

Market sales

Conclusions

Chapter 7 Appendix

Acknowledgements

Acronyms

Bibliography

Glossary

Index

List of Figures

Figure 1.1: A genomic timeline

Figure 1.2: The concept of pharmacogenetics

Figure 1.3: Costs, time and success rates associated with drug development

Figure 1.4: R&D costs savings following the application of pharmacogenetics

Figure 1.5: R&D time savings following the application of genomics technologies in drug discovery

Figure 2.6: Applications of PGx/biomarkers in drug development timelines

Figure 2.7: Applications of new technologies to develop new medicines

Figure 2.8: Response rates to current medicines

Figure 2.9: Factors affecting efficacy and outcome of drug treatment

Figure 2.10: Response rates to Iressa

Figure 2.11: US Reported Adverse Drug Reactions (1995-2001)

Figure 2.12: Relationship of drugs, disease, genes and gene products

Figure 2.13: Roche AmpliChip CYP450 array technology

Figure 2.14: Dose response curves to A) penicillin and B) 6MP

Figure 2.15: Warfarin mode of action, metabolism and inter-individual variation

Figure 3.16: Pharmacodynamic biomarkers for dose-selection

Figure 3.17: PGx and biomarkers to aid decision making

Figure 3.18: Bayer’s high tech research platform

Figure 3.19: Obesity patients stratified according drug response and weight loss/weight gain

Figure 3.20: Pfizer- Applying PGx

Figure 3.21: Genotyping an integral part of diagnosis and treatment

Figure 3.22: Roche -Pharmaceuticals’ and diagnostics’ approach

Figure 3.23: Amgen - PGx approach in R&D and Drug Therapy

Figure 3.24: Genentech - development history of Herceptin/HercepTest

Figure 3.25: Genentech - multiple targeted cancer therapy

Figure 3.26: Millennium - molecular classifiers of Velcade response

Figure 3.27: Millennium - Survival classifiers stratifies risk groups

Figure 3.28: Diaceutics Library - Rationale for its CMR model

Figure 3.29: Genomic Health Product Pipeline 2008-2009

Figure 3.30: Genzyme Genetics Product Pipeline 2008-2009

Figure 3.31: Monogram Biosciences molecular diagnostics approach

Figure 4.32: The organization of the Interdisciplinary Pharmacogenomic Review Group (IPRG)

Figure 4.33: FDA’s voluntary PGx submission pathway

Figure 4.34: The organization of the EMEA

Figure 5.35: CMS a dominant third-party payor A) 2002A and B) 2008E

Figure 5.36: Roche - US & EU approval & reimbursement of new tests

Figure 6.37: Market trends and drivers for the industry

Figure 6.38: Challenges in PGx

Figure 6.39: Opportunities in PGx

Figure 6.40: Key stakeholder in PGx

Figure 6.41: Future PGx Landscape

Figure 6.42: Future PGx Landscape

Figure 6.43: PGx Sales Forecasts 2005-2015

List of Tables

Table 1.1: PGx - Gene Association Studies

Table 1.2: Targeted Oncology Products and PGx based tests

Table 1.3: PGx tests to aide prescription and reduce the risk of ADRs

Table 2.4: Patient stratification for Herceptin trials

Table 2.5: Drug withdrawals 1996-2004

Table 2.6: PharmGKB Knowledge Base annotated PGx genes

Table 2.7: Warfarin dosage versus genetic variant

Table 2.8: Disease-associated alleles underlie complex disease phenotypes

Table 3.9: SNP Coverage per candidate gene

Table 3.10: Recent strategic alliances and collaborations in PGx

Table 3.11: PGx driven consortia

Table 5.12: PGx Dx value based pricing

Table 5.13: Types of economic evaluations in health care

Table 5.14: Assessment of the potential cost-effectiveness of PGx interventions

Table 5.15: Potential cost-effective PGx applications

Abstract

• 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.

• 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.

• 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.

• 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?

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