Table of Contents
Executive Summary
Balancing supply and demand: an introduction to pharmacoeconomics
Regulatory trends in pharmacoeconomics
Applications of pharmacoeconomics across the value chain
Case studies: proving value for money to decision-makers
Chapter 1 Balancing supply and demand: an introduction to pharmacoeconomics
Summary
Background to health technology assessment
- Report scope
Pharmacoeconomics
- Definition of pharmacoeconomics
- A fourth hurdle to new product launch
- Affordability: a efifth barrier' to entry?
- Pharmacoeconomic analysis methods
- Cost-benefit analysis
- Cost-effectiveness analysis
- Cost-utility analysis
- Cost-minimization analysis
- Study perspective and type of cost
Drivers and resistors of pharmacoeconomics
- Drivers
- Resistors
Chapter 2 Regulatory trends in pharmacoeconomics
Summary
Introduction
Influential regulatory environments
- International regulatory framework
- Australia
- Overview of the Australian healthcare system
- Mandatory pharmacoeconomic requirements
- A multi-committee affair
- A fourth hurdle to commercialization
- Impact on the pharmaceutical industry
- Canada
- Overview of the Canadian healthcare system
- Pharmacoeconomic requirements
- Impact on the pharmaceutical industry
- UK
- Overview of the UK healthcare system
- National Institute for Clinical Excellence
- NICE guidelines
- Impact on the pharmaceutical industry
- US
- Overview of the US healthcare system
- Economic considerations
The wider pharmacoeconomic environment - major international trends
- Conceptual and methodological bases
- Objectives of economic appraisal
- Pharmacoeconomic study type and timeline
- Outcome variable
- Type of costs
- Organization of pharmacoeconomic assessment
- Government body
- Preparation of initial assessment
- Selection of products
- Outcomes
Chapter 3 Applications of pharmacoeconomics across the value chain
Summary
Introduction
Pharmacoeconomics in R&D
- Typical use of pharmacoeconomics in R&D
- Investment
- Timing
- Role in portfolio management and stop-go decisions
- Incorporating pharmacoeconomics into clinical trial design
- Phase III pharmacoeconomic studies - design considerations
- Phase IV studies - demonstrating value in the real world
- Advantages of early pharmacoeconomic assessments
- Early assessment of market potential and risk
- Identification of unmet economic needs
- Better study preparation
- Informed stop-go decisions
- Barriers to early pharmacoeconomic assessments
- Benefits of pharmacoeconomic studies in late stage R&D
Pharmacoeconomics in pricing and reimbursement
- The reimbursement process
- Inadequate commitment of time and resources
- Benefits of early pharmacoeconomic assessments
- Barriers to improvement
- Inadequate level, integration and distribution of expertise
- Lack of acceptance by internal decision-makers
- Overcoming barriers: the value of external expertise
Pharmacoeconomics in marketing
- Promoting to different audiences
- Physicians
- Payors
- Patients
- Presenting pharmacoeconomic data - new marketing strategies
Chapter 4 Case studies: proving value for money to decision-makers
Summary
Introduction
Impact of pharmacoeconomic appraisals - NICE' s assessments of CNS disorders
- COX-II inhibitors in osteoarthritis and rheumatoid arthritis
- NICE' s recommendations
- Impact on the COX-II market
- Implications for development-stage COX-II inhibitors
- Beta interferon and glatiramer acetate for multiple sclerosis
- NICE' s recommendations
- Industry response
- Wider implications of the epayments by result' scheme
- Atypical neuroleptic antipsychotics in schizophrenia
- NICE' s recommendations
- Impact on the antipsychotic market
- Implications for development stage antipsychotics
Herceptin tests reactions to a new era of innovative therapies
- Efficacy
- Side effects
- Impact on payors
- Pricing and reimbursement hurdles
- The North American experience
- The Australian experience
- The UK experience
- Patient advocacy: fueling high prices-
Strategic responses to unfavorable reimbursement decisions
- Option 1: working with decision-makers to improve reimbursement status
- Lilly secures Medicare reimbursement for Xigris
- Option 2: applying pressure by lobbying to improve reimbursement
- Amgen lobbies for Aranesp to be reimbursed
- Option 3: brokering deals with decision-makers and payors
Chapter 5 Appendix
References
Index
List of Figures
- Figure 1.1: Decision patterns in cost-effectiveness analyses 26
- Figure 1.2: Parameters influencing pharmacoeconomic studies 27
- Figure 1.3: Major drivers of and resistors to the wider use of
pharmacoeconomics 31
- Figure 1.4: Growth in pharmaceutical expenditure per capita in real terms,
1990-2001 (1990=100) 32
- Figure 1.5: Pharmaceutical R&D investment in Europe, the US and Japan,
1990-2002 36
- Figure 2.6: The aim of international health technology assessment
organizations - consensus 42
- Figure 2.7: The four hurdles to successful new product commercialization
in Australia 46
- Figure 2.8: Total and pharmaceutical related NICE appraisals per year,
2000-03 59
- Figure 2.9: Recommendations arising from NICE' s first 50 technology
appraisals 60
- Figure 2.10: The roles of NICE and CHI/CHAI 61
- Figure 2.11: Economic content in US pharmaceutical product advertisements
71
- Figure 3.12: Benefits of early integration of pharmacoeconomics into
R&D 93
- Figure 3.13: The reimbursement decision process 99
- Figure 3.14: Industry attitudes: commitment of time and resources to
reimbursement issues 100
- Figure 3.15: Industry attitudes: optimal time to address reimbursement
issues 101
- Figure 3.16: Early stage economic value considerations 104
- Figure 3.17: Internal organization of pharmacoeconomic expertise:
centralized versus distributed approaches 106
- Figure 3.18: Use of external expertise in health economic assessments 108
- Figure 3.19: Relative importance of different stakeholders as targets for
pharmacoeconomic marketing data 110
List of Tables
- Table 1.1: Relative pros and cons of major methods of pharmacoeconomic
analysis 24
- Table 2.2: Adoption of economic evaluation in healthcare decision-making
in selected major economies 40
- Table 2.3: International variability in costs included in pharmacoeconomic
analyses 76
- Table 2.4: Achievement of pharmacoeconomic objectives 79
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