Pharmaceutical Pricing and Reimbursement: Strategies for market access across the US, Europe, Japan and other key geographies

Table of Contents

Executive Summary

• An introduction to price optimization
• Pricing and reimbursement in North America
• Pricing and reimbursement in Europe
• Pricing and reimbursement in Japan and the rest of the world
• Global pricing strategies
• Lifecycle pricing strategies

Chapter 1 An introduction to price optimization

• Summary
• Introduction
• Delivering a return on investment
• Sustained R&D productivity shortfall
• Impending blockbuster patent expiries
• Healthcare cost containment
• Cost-containment initiatives
• Pharmaceutical spend cost containment
• Key issues impacting on pricing
• Pharmaceutical price optimization
• Pricing and reimbursement regulations
• Reference pricing
• Pharmacoeconomic evaluations
• Parallel imports and reimportation
• Generic substitution
• Global versus lifecycle pricing

Chapter 2 Pricing and reimbursement in North America

• Summary
• Introduction
• US pricing regulations
• Medicare
• Medicaid
• Private healthcare
• Pharmacoeconomics
• Generic substitution
• Recent developments in the US
• Medicare Part B revisions
• Medicare Part D - one year on
• Average manufacturer price
• Re-importation in decline
• Follow-on biologics
• Reverse payments to generic companies
• 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
• Common drug review expansion
• Patented Medicine Price Review Board progress

Chapter 3 Pricing and reimbursement in Europe

• Summary
• Introduction
• European pricing regulations
• French pricing regulations
• State of the industry
• Recent developments in France
• Parallel trade
• Generic substitution
• German pricing regulations
• State of the industry
• Recent developments in Germany
• The Statutory Health Insurance Competition Enhancement law
• Italian pricing regulations
• State of the industry
• Recent developments in Italy
• Regional cost-containment
• 2007 Finance Law
• Spanish pricing regulations
• State of the industry
• Recent developments in Spain
• Regional cost-containment
• Modified reference price system
• Anti-parallel trade strategies
• UK pricing regulations
• Recent developments in the UK
• The future of the PPRS
• Risk sharing schemes
• Declining parallel trade
• Expanding the NICE remit
• 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 in Japan
• Biennial price cut
• Generic substitution introduced
• 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
• Recent developments in Australia
• Pharmaceutical Benefits Scheme reform
• Chinese pricing regulations
• Recent developments in China
• New drug pricing procedures
• Price cuts
• Generic prescribing

Chapter 5 Global pricing strategies

• Summary
• Introduction
• Local optimization
• Market access and reimbursement
  • Free price markets
  • Orphan drugs
• Pharmacoeconomic evaluations
• Global coordination
• Launch sequence
  • EU launch order
• Optimal price differentials
• Implementing global pricing strategies

Chapter 6 Lifecycle pricing strategies

• Summary
• Introduction
• Launch phase pricing considerations
• Submission dossiers
• Identifying key decision makers
• Failure to secure reimbursement
  • Working with decision makers
  • Applying pressure through lobbying
  • Brokering deals
• Patent protected phase pricing considerations
• Case study: the respiratory market
• Innovative pricing strategies
• Patent expiry phase pricing considerations
• Price changes
  • US patent expiry
  • European patent expiry
• Case study: generic simvastatin
• Biosimilar pricing
• Implementing lifecycle pricing strategies

Chapter 7 Appendix

• Glossary
• Sources

List of Figures

• Figure 1.1: Declining trend in number of NDA and NME approvals, 1997-2006
• Figure 1.2: Rise in the cost of drug development, 1975-2001
• Figure 1.3: US patent expiries for top ten selling drugs, 2006-2011
• Figure 1.4: Trends in healthcare spending as a proportion of GDP, 1970-2005
• Figure 1.5: Pharmaceutical expenditure as a share of total healthcare expenditure in 2005
• Figure 2.6: Source of prescription drug expenditures, 2005-2006
• Figure 2.7: Canadian cross border internet pharmacy sales, 2002-2006
• Figure 2.8: Compensatory final settlements (reverse payments), 2004-2006
• Figure 3.9: Average ex-factory drug prices in key European markets, 2005
• Figure 4.10: NHI price cuts by therapeutic class, 2006
• Figure 5.11: Market share for new products launched in last five years, 2005
• Figure 5.12: External reference pricing in Europe, 2007
• Figure 5.13: Global pricing and the interaction between countries
• Figure 5.14: Global pricing strategies
• Figure 6.15: Leading respiratory drugs by global sales, 2006
• Figure 6.16: Lifecycle pricing strategies

List of Tables

• Table 1.1: Number of NDA and NME approvals by the FDA, 1990-2006
• Table 1.2: R&D expenditure within the US and abroad by PhRMA members, 1980-2006
• Table 1.3: Trends in healthcare spending as a proportion of GDP, 1970-2005 (%)
• Table 2.4: Future pricing scenarios in the US
• Table 3.5: Future pricing scenarios in Europe
• Table 4.6: Co-payments for drugs/services in Japan
• Table 4.7: Classification for price premium (Japanese healthcare system)
• Table 4.8: Future pricing scenarios in Japan