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Impact of Pharmacogenomics on Public Healthcare Policy

Educating Patients, Payors and Healthcare Providers

Publication Date   March 2008
Publisher   Business Insights
Product Type   Report
Pages   171
ISBN Number   not applicable
Product Code   RBI172
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Price £1,995.00

approximately: $3,445 | €2,533

Summary


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?

Content


  • 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