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

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

Evidence-based medicine is defined as an attempt to use standards from scientifically-collected evidence to improve medical practices by assessing risks and benefits of treatments and/or the lack of treatments. The term can be taken to cover a wide variety of recommendations and guidelines, as well as the basis for decisions regarding pharmaceutical reimbursement. This one-of-a-kind report discusses evidence-based medicine in a variety of its guises, illustrating the pervasive nature of evidence-based decisions in healthcare and pharmaceutical environments.

In recent years, evidence-based medicine has emerged as one of the most pertinent topics of discussion within the field of medicine, involving - on the one hand - patients and - on the other - a variety of healthcare policy-makers, practitioners and regulators. In the United Kingdom, evidence-based practice has been implemented in a variety of fields, including adult medicine, child health, surgery, pathology, pharmacotherapy, nursing, general practice, and dentistry, as well as in the field of pharmaceutical reimbursement. Evidence-based medicine has also been practiced by the governments of Canada and Australia for some time, while Germany, Japan and the United States have more recently begun to utilize evidence-based medicine for both private and public reimbursement.

The opening chapters of this report provide a brief history of evidence-based medicine, main definitions and the limitations and advantages of the concept. Subsequent chapters discuss the use and applicability of evidence-based medicine in various therapeutic areas, followed by a discussion of evidence-based medicine in six major global medical and pharmaceutical markets. The first three of these (namely Australia, Canada and the United Kingdom) are seen as pioneers in the utilization of evidence-based medicine, while the other three (namely Germany, Japan and the United States) have more recently become interested in wider applicability of such practices.

The final chapter discusses the future prospects for evidence-based medicine, setting out, on the one hand, the list of factors driving wider application of such practices. On the other, the report analyses a number of constraints to the use of evidence-based medicine, which include a range of practical considerations, such as a lack of time and information overload, as well as more culture-specific resistance to compliance with imposed guidelines.

What questions does this report answer?

• What is the current status of evidence-based medicine in key global markets?
• What are the major drivers of wider application of evidence-based medicine?
• What types of evidence-based medicine strategies are currently in use in various countries around the world?
• What is the anticipated future for evidence-based medicine practices?
• How will the development of expensive new therapeutics stimulate the need for the implementation of evidence-based medicine?

• Discussion of evidence-based medicine in pharmaceutical reimbursement in a number of key global markets
• Discussion of the future of evidence-based medicine in light of medical and scientific developments
• Focused analysis of various evidence-based medicine developments in the US
• Identification of key evidence-based medicine resources
• Contributions from industry experts highlighting country-specific cultural constraints to wider penetration of evidence-based medicine

• The report provides an analytically-focused guide to the global application of evidence-based medicine
• The report provides a comparison of evidence-based medicine and its applicability in different countries
• The report provides a scenario for the future use of evidence-based medicine through the discussion of drivers and constraints
• The report identifies key resources and organizations involved in the formulation of evidence-based medicine policies

• Increasing need for healthcare and pharmaceutical cost-containment in both public and private spheres
• Focus on introduction of standards in healthcare
• Rising involvement of patients in their own healthcare and rising demand for higher quality care
• Increasing use of information technology (IT) in healthcare, which provides easier access to various data and analysis
• Large investments in new medical technologies and pharmaceuticals requiring high prices, rendering publicly-funded pharmaceutical reimbursement highly desirable

• Thorough descriptions of key evidence-based medicine practices in major global medical and pharmaceutical markets
• Discussion of evidence-based medicine’s future from the point of view of medical advances, not just practical considerations
• Analysis of evidence-based medicine from the point of view of pharmaceutical reimbursement
• Critical assessment of evidence-based medicine’s advantages and disadvantages

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