藥價及償付：美國、歐洲、日本的市場策略

Abstract

The global pharmaceutical pricing and reimbursement environment is notoriously complex and continuously changing. Pharma companies must implement strategic pricing assessments across global markets and product lifecycle phases in order to develop effective pricing policies. By incorporating such assessments into portfolio evaluations and lifecycle planning, companies can enhance their understanding of potential price profiles for individual drugs and optimise future returns. ' Pharmaceutical Pricing and Reimbursement' is a new report published by Business Insights that examines the tactical importance of price optimization throughout the product lifecycle. The key issues affecting pricing and reimbursement disciplines are identified and the market environments of individual countries are assessed. This report will also detail the global and lifecycle pricing strategies of new and established drugs, including actionable recommendations and detailed case studies, and provide forecasts for future pricing scenarios in major markets.

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