Evidence-Based Medicine - Current Use and Future Impact on Global Clinical and Reimbursement Practices

Table of Contents

1 Methodology and Executive Summary

• 1.1 Report Objectives
• 1.2 Report Methodology
• 1.3 Executive Summary
  • 1.3.1 EBM and Pharmaceutical Reimbursement
  • 1.3.2 Future of EBM

2 Evidence-Based Medicine - Overview

• 2.1 Definitions
• 2.2 Types of Evidence-Based Medicine
• 2.3 Methodology Used by Evidence-Based Medicine
• 2.4 History of Evidence-Based Medicine
• 2.5 Impact on Policy-Formation
  • 2.5.1 Depth of Reimbursement
  • 2.5.2 Breadth of Reimbursement

3 Evidence-Based Medicine - Classification and Recommendations

• 3.1 Overview
• 3.2 US Preventive Services Task Force Stratification System
• 3.3 UK Stratification Systems

4 Evidence-Based Medicine - Advantages and Limitations

• 4.1 Advantages
• 4.2 Limitations

5 Evidence-Based Medicine - Current Trends

• 5.1 Healthcare on the Global Level
• 5.2 EBM and Pharmaceutical Reimbursement
• 5.3 EBM Case Studies - Therapeutic Areas
  • 5.3.1 Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS)
  • 5.3.2 Alzheimer' s Disease
  • 5.3.3 Cardiovascular Disease
  • 5.3.4 Inflammatory Disease
  • 5.3.5 Breast Cancer

6 EBM Case Studies - Countries

• 6.1 EBM Case Studies - Australia
  • 6.1.1 Regulatory Environment
  • 6.1.2 The Role of Evidence-Based Medicine
  • 6.1.3 Examples of Evidence-Based Medicine in Reimbursement
  • 6.1.4 Future Developments
• 6.2 EBM Case Studies - Canada
  • 6.2.1 Regulatory Environment
  • 6.2.2 The Role of Evidence-Based Medicine
  • 6.2.3 Examples of Evidence-Based Medicine in Reimbursement
  • 6.2.4 Future Developments
• 6.3 EBM Case Studies - United Kingdom
  • 6.3.1 Regulatory Environment
  • 6.3.2 Health Insurance
  • 6.3.3 The Role of Evidence-Based Medicine
  • 6.3.4 Examples of Evidence-Based Medicine in Reimbursement
  • 6.3.5 Future Developments

7 Discussion of Evidence-Based Medicine in Clinical and Reimbursement Practices of Other Major Markets

• 7.1 Germany
  • 7.1.1 Regulatory Environment
  • 7.1.2 Health Insurance
  • 7.1.3 The Role of Evidence-Based Medicine
  • 7.1.4 Future Developments
• 7.2 Japan
  • 7.2.1 Regulatory Environment
  • 7.2.2 Health Insurance
  • 7.2.3 The Role of Evidence-Based Medicine
  • 7.2.4 Future Developments
• 7.3 United States
  • 7.3.1 Regulatory Environment
    • 7.3.1.1 Regulatory Environment - Pricing
    • 7.3.1.2 Regulatory Environment - Reimbursement
  • 7.3.2 Health Insurance
    • 7.3.2.1 Medicare
    • 7.3.2.2 Medicaid
  • 7.3.3 The Role of Evidence-Based Medicine
    • 7.3.3.1 The Role of Evidence-Based Medicine: Case Study - Cox-2 Class
  • 7.3.4 EBM and Federal Agencies
  • 7.3.5 EBM and Individual States
  • 7.3.6 EBM and Insurance Companies
  • 7.3.7 ' Pay-for-Performance' Schemes
  • 7.3.8 ' Risk-Sharing' Schemes
  • 7.3.9 EBM and Managed Care
  • 7.3.10 Barriers to EBM' s Application
  • 7.3.11 Future Developments
    • 7.3.11.1 Demand for Individualized Care
    • 7.3.11.2 EBM and Pharmaceutical Reimbursement
    • 7.3.11.3 Lessons Learned
    • 7.3.11.4 Lessons from Elsewhere
    • 7.3.11.5 Striking the Right Balance

8 The Future of Evidence-Based Medicine

• 8.1 Developments Driving Wider Application of EBM
  • 8.1.1 Epidemiology and Demographics
  • 8.1.2 Biotechnology and Biogenerics
  • 8.1.3 Orphan Drugs
  • 8.1.4 Health Economics
  • 8.1.5 The Need for Cost-Containment in Pharmaceutical Reimbursement
  • 8.1.6 Practical Benefits of Standardized Procedures
  • 8.1.7 Drug Lifecycle Management
  • 8.1.8 Countries Following Suit of Trend-Setters
• 8.2 Developments Hampering Wider Application of EBM
  • 8.2.1 Compliance with Guidelines
  • 8.2.2 Information Overload
  • 8.2.3 Lack of Public Funding for Medical Research
  • 8.2.4 Demand for Tailor-Made Medicine
• 8.3 The End Result - Application of EBM

9 Conclusions and Recommendations

10 Appendix

• 10.1 Glossary of Terms
• 10.2 EBM Resources
• 10.3 Select EBM Guidelines
  • 10.3.1 Agency for Healthcare Research and Quality (AHRQ)
  • 10.3.2 National Institute of Clinical Excellence (NICE)
  • 10.3.3 National Breast and Ovarian Cancer Centre (NBOCC)
• 10.4 Evidence-Based Medicine Databases

Tables

• Table 2.1 EBM Process
• Table 3.1 Classification of Evidence
• Table 3.2 Ratings of Diagnostic and Prognostic Articles
• Table 4.1 Arguments Used by Critics and Supporters of EBM
• Table 5.1 Table Overview of Pricing and Reimbursement Measures in Select EU Countries
• Table 5.2 Global Pharmaceutical Sales, 1999 - 2006
• Table 5.3 Global Pharmaceutical Sales by Region, 2006
• Table 5.4 Global Pharmaceutical Sales by Select Countries
• Table 5.5 PE Guidelines around the World
• Table 5.6 Epidemic Profiles
• Table 5.7 Cost-Effectiveness of Care and Treatment for HIV/AIDS
• Table 5.8 Cost-Effectiveness of HIV Interventions
• Table 5.9 Cost-Effectiveness by Epidemic Profile
• Table 6.1 Recent Reimbursement Recommendations by NICE
• Table 7.1 Examples of Pharmaceuticals Granted Usefulness Premiums
• Table 7.2 Premium Reimbursement Categories and Rates
• Table 7.3 Main Types of Health Insurance in the USA
• Table 7.4 Avoidable Death and Medical Costs Due to Unexplained Variations n Care
• Table 7.5 Select Health Insurance Companies in the US
• Table 7.6 From Managed Care to Care Management
• Table 7.7 Main Obstacles to EBM' s Application
• Table 8.1 Drivers and Constraints of EBM
• Table 8.2 Select Orphan Drugs

Graphs

• Graph 5.1 Public Share of Total Expenditure on Health, 2005
• Graph 5.2 Health Expenditure per Capita, Public and Private, 2005
• Graph 7.1 Public Share of Total Expenditure on Health, 2005
• Graph 7.2 Public Share of Expenditure on Medical Services and Pharmaceuticals, 2005
• Graph 7.3 Out-of-Pocket and Private Health Insurance spending as a Share of Total Health Expenditure, 2005
• Graph 7.4 Total Health Expenditure as a Share of GDP, 2005
• Graph 7.5 Coverage by Type of Health Insurance
• Graph 8.1 Global Burden of Non-Communicable Diseases

Figures

• Figure 8.1 Global Population by Age