Pharmaceutical Pricing Strategies: Price optimization, reimbursement and regulation in Europe, US and Japan

Maximizing prices and securing reimbursement status for a product is increasing in importance, as pharmaceutical companies seek to ensure that they achieve a high return on investment from current and future drugs in light of a sustained R&D productivity shortfall and a wave of impending blockbuster patent expiries. Pharmaceutical Pricing Strategies: Price optimization, reimbursement and regulation in Europe, US and Japan, is a report which will help you create an effective pricing policy, in the midst of continued regulatory uncertainty, stagnant R&D and the continued cost-containment efforts of healthcare payors. This report will provide detailed analysis of the key issues and market environments making up the pricing landscape, and enable you to conduct pricing and reimbursement evaluations for products throughout the development lifecycle. Gain a detailed understanding a drug's potential price profile and optimize future returns by including these assessments in portfolio evaluations and lifecycle planning, with the help of this report.
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Pharmaceutical pricing strategies
Executive Summary
The importance of price optimization
Pricing and reimbursement in North America
Pricing and reimbursement in Europe
Pricing and reimbursement in Japan and the rest of the world
Pricing strategies for new drugs
Pricing strategies for established drugs

hapter 1 The importance of price optimization

Summary
Introduction
Maximizing return on investment
R&D productivity shortfall
Key patent expiries
Healthcare cost containment
Cost-containment initiatives
Cost containment in pharmaceutical expenditure
Key issues
Price optimization
Reimbursement regulations
Reference pricing
Pharmacoeconomic evaluations
Parallel imports
Generic substitution
Hot topics
US reimportation
Medicare Drug Benefit
EU enlargement
Price harmonization
Pricing and reimbursement hurdles

Chapter 2 Pricing and reimbursement in North America

Summary
Introduction
US pricing regulations
Medicare
Medicaid
Private healthcare
Recent developments in the US
The 2003 Medicare Prescription Drug Act
Expanded access…
Improved drug compliance…
Higher utilization…
Price comparison tool…
Medicare drug benefit formularies…
Medicaid budget crisis
Price controls in Maine?
Florida’s Medicaid drug rebates
Pharmacoeconomics in the US
Pharmacoeconomics in public healthcare provision
Pharmacoeconomics in private healthcare provision
Managed care pharmacoeconomic submissions
Future use of pharmacoeconomics in the US
Parallel imports in the US
Developments in cross-border trade
Reimportation task force report…
State-level action…
Generic substitution in the US
The Waxman-Hatch Act
Pediatric exclusivity provisions
Anti-competition agreements
Delaying tactics and 180-day exclusivity
Biogenerics
Trends in generic usage
‘March-in’ law…
Future pricing scenarios in the US
Best case pricing scenario
Worst case pricing scenario
Most likely pricing scenario
Canadian pricing regulations
Federal measures
Provincial measures
Driving down prices
Reimportation

Chapter 3 Pricing and reimbursement in Europe

Summary
Introduction
European pricing regulations
France
Recent developments…
Germany
Recent developments…
Italy
Recent developments…
Spain
Recent developments…
The UK
Recent developments…
Pharmacoeconomics in Europe
France
Germany
Italy
Spain
UK
Parallel importing in Europe
Penetration of parallel imports
Price differentials…
Initiatives to encourage use of parallel imports…
Ability to obtain a license to import products…
Regulations and key legal decisions
Merck versus Stephar…
Bayer (Adalat)…
Bristol-Myers Squibb versus Paranova…
The Silhouette case…
The Maglite case…
The Davidoff case…
Recent developments
GSK’s supply restriction in Greece…
Lack of regulatory framework in France…
Novo Nordisk’s supply of Actrapid Novolet in Spain…
Pfizer’s direct distribution to pharmacies in Spain…
Generic substitution in Europe
The mutual recognition procedure
Future changes in European generics legislation
Government initiatives encouraging generic uptake
EU accession
Drug pricing policies and reimbursement post-accession
Parallel trade post-accession
Generics post-accession
Future pricing scenarios in Europe
Best case pricing scenario
Worst case pricing scenario
Most likely pricing scenario

Chapter 4 Pricing and reimbursement in Japan and the rest of the world

Summary
Introduction
Japanese pricing regulations
Recent developments
Pharmacoeconomics in Japan
Parallel importing in Japan
Generic substitution in Japan
Future pricing scenarios in Japan
Best case pricing scenario
Worst case pricing scenario
Most likely pricing scenario
Australian pricing regulations
Benchmark pricing
Cost plus method
Average monthly treatment cost
Prices for new items
Chinese pricing regulations

Chapter 5 Pricing strategies for new drugs

Summary
Introduction
Pricing strategies in early-stage development
Therapy area analysis
Epidemiology analysis
Treatment delivery analysis
Market needs analysis
Pricing analysis
Cost analysis
Economic analysis
Decision-maker analysis
Market research
Initial assessment of drug candidates
Pricing strategies in mid stage development
Evaluating opportunities
Case study: Aventis appeal against NICE…
Improving product value
Case study: Johnson & Johnson’s Concerta…
Pricing strategies in late stage development
Sub-population analysis
Choosing outcomes
Case study: Merck’s Zocor (simvastatin)…
Patient reported outcomes
Case study: Pfizer’s Viagra…
Head-to-head trials
Phase III pharmacoeconomic studies
Phase IV studies
Pricing strategies for new product approvals
Submission dossiers
Identifying key decision makers
Failure to secure reimbursement
Working with decision makers…
Case study – Eli Lilly’s Xigris…
Applying pressure through lobbying…
Case study – Amgen’s Aranesp…
Brokering deals…
Case study – Celebrex in France…
External support
EU launch order
First choice countries…
Second choice countries…
Third choice countries…
Fourth choice countries…
Global price optimization

Chapter 6 Pricing strategies for established drugs

Summary
Introduction
Strategic pricing of reformulations
Benchmarking relative pricing
Patient expansion strategies
Patient switching and generic defence strategies
Generic defence reformulations
Strategic pricing at patent expiry
US patent expiry
European patent expiry

Chapter 7 Appendix

Glossary
Sources
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Table 1.1: Number of NDAs and NMEs approved by the FDA, 1990-2004 22
Table 1.2: R&D expenditure within the US and abroad by PhRMA members, 1980-2004 24
Table 1.3: Trends in healthcare spending as a proportion of GDP between 1970 and 2002 28
Table 2.4: Future pricing scenarios in the US 88
Table 3.5: Use of economic evaluations in different European countries 123
Table 3.6: Generic substitution in across European countries 144
Table 3.7: Future pricing scenarios in Europe 151
Table 4.8: Co-payments for drugs/services in Japan 158
Table 4.9: Classification for price premium (Japanese healthcare system) 159
Table 4.10: Future pricing scenarios in Japan 165
Table 6.11: Calculating relative pricing – Prozac 20mg versus Prozac Weekly 223

Figure 1.1: Declining trend in number of NDAs and NMEs approved, 1995-2004 23
Figure 1.2: Rise in the cost of drug development, 1975-2000 25
Figure 1.3: US patent expiries for top ten selling drugs, 2004 27
Figure 1.4: Trends in healthcare spending as a proportion of GDP between 1998 and 2002 29
Figure 1.5: Pharmaceutical expenditure as a share of total healthcare expenditure in 2002 30
Figure 1.6: Key drivers and resistors of pharmacoeconomics 41
Figure 2.7: Average branded drug prices in selected countries compared with the US 58
Figure 2.8: Distribution of 2003 Medicare drug expenditure 59
Figure 2.9: Average annual growth rates of total Medicaid spending, 1995-2002 64
Figure 2.10: Drivers and resistors of parallel imports into the US 75
Figure 3.11: External reference pricing in Europe, 2004 99
Figure 3.12: The NICE appraisal cycle 129
Figure 5.13: Stop-go decision portfolio review phase IIa 189
Figure 5.14: Use of economic evaluation 193
Figure 5.15: Optimal country-by-country sequence launch for entry into the EU-15 countries 214
Figure 5.16: Global pricing and the interaction between countries 218
Figure 6.17: Comparative analysis by strategic type – relative average US pricing four quarters following launch for 25 reformulations 224
Figure 6.18: Relative average US pricing – patient switching versus generic defense 228
Figure 6.19: Relative average US pricing 12 quarters following launch in patient switching reformulations 229
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