Pharmacogenetics: Opportunities and Challenges for Health Innovation

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12 Nov 2009
9789264076808 (PDF) ;9789264076792(print)

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Pharmacogenetics helps us understand the relationship between an individual’s genetic make-up and the way medicines work for each person. This book reviews the use of pharmacogenetics across all stages of the health innovation cycle from research through to uptake by doctors and patients. It focuses on how to optimise the use of pharmacogenetics to deliver effective innovations for public health, and design policies that enhance their economic and social benefits. The book argues for large-scale studies to validate the biomarkers that underpin pharmacogenetics and policies to share the cost and risk of using  pharmacogenetics to improve the use of existing  medicines. Governments and others need to align regulatory, reimbursement and other incentives and work  with industry to measure better the impacts of pharmacogenetics. Health systems need to take positive steps to adapt to the use of pharmacogenetics and ensure that health professionals receive adequate training.
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  • Acronyms
  • Executive Summary
    Pharmacogenetics offers new ways of understanding how drugs work and how this affects both the safety and efficacy of drugs in individuals. The potential opportunities are considerable. In drug development, pharmacogenetics shows great potential for improving the efficiency of the drug discovery process, particularly for identifying and validating new drug targets. It is expected to improve the translation of early-stage projects into medicines that meet public health needs. In clinical care, pharmacogenetics may enable doctors to prescribe more effective interventions and improve their use of evidence-based medicine. It can help identify those individuals most likely to benefit from a therapy, thereby optimising treatment strategies for both common and complex disorders. It may also enable preventive interventions.
  • Introduction to the Policy issues
    This chapter serves as a general introduction to the issues raised by the potential adoption of pharmacogenetics in drug development and delivery, including its economic implications, which are examined in greater detail in the rest of the report.
  • The Supporting Infrastructures for Pharmacogenetics
    This chapter reviews the technologies and infrastructures that will accompany the use of pharmacogenetics and argues for a better integration of new scientific and technological advances in target identification and validation. A major section focuses on biomarkers and offers an overview of the potential applications of genetics-based biomarkers. The chapter also considers the information systems that must be in place to support the clinical application of pharmacogenetics.
  • Pharmacogenetics and Drug Development
    This chapter examines the application of pharmacogenetics to drug development. It explains why there has been a recent slowdown in discovery and development of new medicines and how pharmacogenetics may help address this problem. It discusses how application of genetic biomarkers will affect drug development. Such an approach can, in principle, reduce the costs of clinical trials for prospective medicines while increasing the probability that potential products might reach the market.
  • Business Models for Pharmacogenetics
    This chapter discusses the challenges posed by pharmacogenetics to established "big pharma" business models in the pharmaceutical and diagnostics and device industries. It considers the viability of current business models and the financial incentives of different types of firms.
  • Physician and Patient Demand for Pharmacogenetics
    This chapter reviews current evidence of physicians’ attitudes to pharmacogenetics. It also covers patients’ perspectives and possible ethical and equity issues, particularly those concerning developing countries. It closes with consideration of the opportunities and challenges for incorporating pharmacogenetics in clinical care as well as potential organisational and system-wide hurdles. This will necessarily create both technical and educational challenges for health professionals. Successful integration of pharmacogenetics will depend upon appropriate infrastructure and trained personnel.
  • Regulatory Authorities and Reimbursement Mechanisms
    This chapter looks at the role of regulators and reimbursement systems in facilitating the uptake of pharmacogenetics by health-care systems. Regulators and coverage policies will be strong factors in the rate of diffusion of pharmacogenetics. Reimbursement policies and cost-containment strategies for drug and test-use policies and clinical guidelines will be very important. The challenges for payers and the trade-offs they may have to make are also considered.
  • Conclusions
    While research in pharmacogenetics is proceeding rapidly, at the start of 2009 there were only just over a dozen pharmacogeneticsbased products on the market. A number of scientific, economic and regulatory challenges need to be overcome if pharmacogenetics is to be taken up more widely within health-care systems. It is not yet clear to the private sector what business models will deliver acceptable returns on investment. In the public sector, governments have a number of levers which they could use to create an "enabling" environment for pharmacogenetics, while continuing to provide the necessary checks and balances.
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