Abstract

The inappropriate use of antibiotics is a primary cause of the ongoing increase in drug resistance amongst pathogenic bacteria. The resulting decrease in the efficacy of antibiotics threatens the ability to combat infectious diseases. Rapid, point-of-care tests to identify pathogens and better target the appropriate treatment could greatly improve the use of antibiotics, yet few such tests are available or being developed, despite the rapid pace of medical innovation. Clearly, something is inhibiting the much-needed development of new and more convenient diagnostic tools.

This study delineates priorities for developing diagnostics to improve antibiotic prescription and use, in order to manage and curb the expansion of drug resistance. It calls for new approaches, particularly in the provision of diagnostic devices, and, in doing so, outlines some of the inadequacies in health, science and policy initiatives that have led to the dearth of such devices. The authors make the case that innovation is clearly and urgently needed, not only in the technology of diagnosis but also in public policy and medical practice to support the availability and use of better diagnostic tools.

This book explores the complexities of the diagnostics market from the perspective of both supply and demand, unearthing interesting bottlenecks: some obvious, some more subtle. It calls for a broad, multifaceted policy response, and an overhaul of current practice, so that the growth of bacterial resistance can be stemmed.

Contents

• Acknowledgements
• List of abbreviations
• 1. Introduction
• 2. Background
  • 2.1. Trends in the use and misuse of antibiotics
  • 2.2. Trends in the prevalence of resistance
• 3. Overview of the diagnostics market
  • 3.1. Introduction
  • 3.2. Shape and size of the market
  • 3.3. Recent trends in the market
  • 3.4. Exhibits: examples of recent breakthroughs in diagnostic development
• 4. Supply-side bottlenecks inhibiting development of priority diagnostics
  • 4.1. Introduction
  • 4.2. Drivers of resource allocation decisions by developers and prospective diagnostic developers
  • 4.3. Scientific and technical barriers
• 5. Reimbursement-related signals received from procurement and reimbursement agencies
  • 5.1. Introduction
  • 5.2. Background: reimbursement in the United States
  • 5.3. Coverage: determining clinical utility
  • 5.4. Background: overview of reimbursement of diagnostics in the United Kingdom and Europe
  • 5.5. Implications of being tied to indication
  • 5.6. Variation across countries
  • 5.7. Reimbursement case study
• 6. Regulation
  • 6.1. Introduction
  • 6.2. History of medical device regulation
  • 6.3. Evolving needs for medical device regulation
  • 6.4. Overview of regulatory processes for market entry in Europe and the United States
  • 6.5. United States current regulatory structures/frameworks
  • 6.6. EU current regulatory structures/framework
  • 6.7. Reform under way in the United States
  • 6.8. Reforms under way in Europe
  • 6.9. Industry stakeholder involvement in European regulatory reforms
  • 6.10. Evaluation of communication pathways between regulator and industry
  • 6.11. FDA flexibility in antibiotic approval/trial design which may influence uptake of diagnostics
  • 6.12. Flexibility in clinical trial requirements for antibiotic development
  • 6.13. Regulatory comparison United States/EU
  • 6.14. Harmonization of the diagnostics regulatory pathway in the United States and EU
  • 6.15. Industry perspectives on harmonization
  • 6.16. Stakeholder perception of overall regulatory processes for diagnostics
• 7. Intellectual property challenges
  • 7.1. Introduction
  • 7.2. History
  • 7.3. Patent-related bottlenecks to diagnostic development
• 8. Demand-side issues
  • 8.1. Introduction: complexity in demand expression
  • 8.2. Engagement to improve developer understanding of demand
  • 8.3. Determinants of and barriers to uptake of new POC diagnostics
  • 8.4. Diagnostic and clinical guidelines
  • 8.5. Prescribing culture
  • 8.6. Patient barriers
• 9. Economic evaluation: the limited evidence base affecting both supply and demand for new diagnostics
  • 9.1. Introduction
  • 9.2. Background: economic evaluation and cost–effectiveness
  • 9.3. Background: economic evaluation in the United States
  • 9.4. Background: summary of the evidence from economic evaluations of rapid POC diagnostics
  • 9.5. Challenges in making the “business case” for new diagnostics
  • 9.6. Need for greater role of public sector in setting format priorities
  • 9.7. Cost–effectiveness evidence in reimbursement decisions
  • 9.8. Technical matters surrounding published cost–effectiveness studies of rapid POC diagnostics
• 10. Underlying and purpose-driven health system incentives affecting demand for diagnostics
  • 10.1. Introduction
  • 10.2. Reimbursement
  • 10.3. Organization of budgets
  • 10.4. Group purchasing
  • 10.5. Performance assessment
  • 10.6. Public performance monitoring
  • 10.7. Financial penalties for poor performance
  • 10.8. Financial bonuses for positive performance
• 11. Co-development of antibiotics and diagnostics for bacterial infection
  • 11.1. Introduction
  • 11.2. Potential of co-development
  • 11.3. Background: the nature and underlying differences in the market for antibiotics and diagnostics
  • 11.4. Considerations for co-development strategies
• 12. Policy response
  • 12.1. Rationale for intervention in the diagnostics market
  • 12.2. Initiatives to support diagnostics development
  • 12.3. Final recommendations
• Appendix A. Summary of studies on the cost–effectiveness of POCTs to diagnose sepsis
• Appendix B. Summary of studies on the cost–effectiveness of POCTs to diagnose UTI
• Appendix C. Streptococcal pharyngitis cost–effectiveness studies
• Appendix D. United Kingdom HGC recommendations 2010
• Appendix E. Recommendations of the SACGHS to the United States DHHS in 2010 report
• References

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