Cost-Effective Healthcare Solutions: The Strategic Impact of Pharmacoeconomics in Key Markets

Executive Summary
Why did the NHS need to be NICE?
Role models for NICE
The UK: NICE in action
Global perspective: pharmacoeconomics in healthcare policy
Current and future scope of pharmacoeconomics in major markets

Chapter 1 Why did the NHS need to be NICE?
Summary
The National Health Service: supply and demand
The 'third way'
Clinical governance
Cost and efficacy
No management
Active management
Case study: Aricept
Case Study: Viagra
Case study: beta interferon

Chapter 2 Role models for NICE
Summary
The increasing use of pharmacoeconomics
Prototypes provided by Australia and Canada
Pharmacoeconomics in Australia
The Australian pharmacoeconomic guidelines
Australian guidelines: a fourth hurdle
The commercial impact of the Australian guidelines on the pharmaceutical industry
Implications for the global pharmaceutical industry
Pharmacoeconomics in Canada
The role of pharmacoeconomics in Canada
The CCOHTA guidelines
The commercial impact of the CCOHTA evaluations on the pharmaceutical industry
Implications for the global pharmaceutical industry
Two different ways of using pharmacoeconomics
Pharmacoeconomic guidelines and hurdles in Europe
The fourth hurdle comes to Finland
The Netherlands move towards a fourth hurdle
Similarities to the Australian and Canadian use of pharmacoeconomics
UK: the implementation of NICE
The commercial implications of NICE on the pharmaceutical industry
Similarities to the Canadian use of pharmacoeconomics
The publication of guidelines in Italy
Additional EU countries introduce pharmacoeconomic guidelines
The changing use of pharmacoeconomics in Europe
Pharmacoeconomics in the rest of the world
Pharmacoeconomics unlikely to be introduced in Japan in near future
Pharmacoeconomics in the US
The use of pharmacoeconomics by public healthcare funding bodies
The use of pharmacoeconomics by private healthcare providers
Future developments in the use of pharmacoeconomics in the US
Australian or Canadian style use of pharmacoeconomics in the US?
Conclusions

Chapter 3 The UK: NICE in action
Summary
The reality of NICE: Quality of care or rationing of resources?
Implementing clinical governance: hospital-based healthcare professionals
Implementing clinical governance: primary healthcare professionals
Implementing clinical governance: NHS Boards
Implementing clinical governance: the pharmaceutical industry
Implementing clinical governance: patients
Relenza, the first in the firing line?
The case
The appraisal
The verdict
Implications for Glaxo Wellcome
Repercussions
Conclusion
Market implications
Implications for pharmaceutical companies

Chapter 4 Global perspective: Pharmacoeconomics in healthcare policy
Summary
The changing environment of health and healthcare
Evaluating the cost of healthcare
Phase I and II
Phase III
Drug approval
Sales and marketing
Current use of pharmacoeconomics
Issues in pharmacoeconomics
The use of pharmacoeconomics: implications in major markets
The US healthcare system
Medicare and Medicaid
Private heath insurance
Indemnity insurance
Self-insured employers
Preferred provider organization
Health maintenance organization
The application of pharmacoeconomics in the US
Public healthcare payers
Private healthcare payers
Potential applications of pharmacoeconomics in the US
Public healthcare payers
Private healthcare payers
Implications for pharmaceutical companies
The Japanese healthcare system
The application of pharmacoeconomics in Japan
The role of pharmacoeconomics in reimbursement pricing
Submission of pharmacoeconomic data for pricing
Implications for pharmaceutical companies
The German healthcare system
Reimbursement for in-patients
Reimbursement for out-patients
Reimbursement in primary care
The application of pharmacoeconomics in Germany
Implications for pharmaceutical companies
The French healthcare system
The application of pharmacoeconomic data for pricing and reimbursement
Reimbursement listing of new drugs
Pricing
Implications for pharmaceutical companies
Pricing
Reimbursement
Conclusion

Chapter 5 Current and future scope of pharmacoeconomics in major markets
Summary
Inter-country comparisons
High acceptance and high regulation of pharmacoeconomic practices
High acceptance and low regulation of pharmacoeconomic practices
Low acceptance and low regulation of pharmacoeconomic practices
Pharmaceutical Industry perspective
Advantages
Readier identification of the value of an innovative compound
Pharmacoeconomics as a fundamental and integrated method within the decision-making process
A strengthening of corporate focus and strategy
The provision of a level playing field
Disadvantages
Lost revenues through increased time to market
Different strategies for different countries
Restricted freedom in marketing products
The need to be prepared
Clarification and focus
A lack of flexibility
Inter-country commercial comparisons

Chapter 6 Appendix
Primary research methodology
Data research methodology
Index

List of Figures
Figure 1.1: The organization of the NHS following the 1990 Health Act
Figure 1.2: The organization of the NHS following the 1999 Health Act
Figure 1.3: Drug reimbursement management criteria in the NHS, pre-NICE
Figure 2.4: The four hurdles of drug approval in Australia
Figure 2.5: Different uses of pharmacoeconomics in Australia and Canada
Figure 2.6: The application of pharmacoeconomics in Europe
Figure 3.7: The NICE appraisal cycle
Figure 3.8: The clinical audit cycle
Figure 3.9: The NICE appraisal process
Figure 3.10: Probability cascade for outcomes of Relenza/Tamiflu's NICE appraisal in 2000
Figure 3.11: Schematic of Relenza's sales following four possible appraisal outcomes
Figure 3.12: The effect of possible outcomes of Relenza/Tamiflu's NICE appraisal on sales of Relenza
Figure 5.13: The use and acceptance of pharmacoeconomics, 1999
Figure 5.14: Commercial implications of pharmacoeconomics in pricing and reimbursement processes, 2000
Figure 5.15: Commercial implications of pharmacoeconomics in pricing and reimbursement processes, 2005
Figure 6.16: Reuters Business Insight Healthcare's six-step research methodology

List of Tables
Table 1.1: Reimbursement status of Aricept amongst selected UK health authorities, June 1997
Table 3.2: Advantages of Tamiflu over Relenza
Table 4.3: The potential use of pharmacoeconomics throughout the product life cycle
Table 4.4: The ASMR scale rating the medical benefit of new drugs in France