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Pharmaceutical Pricing And Reimbursement: Strategies For Market Access Across The Us, Europe, Japan And Other Key Geographies

Published by: Business Insights

Published: Nov. 1, 2007 - 143 Pages


Table of Contents



Pharmaceutical Pricing and Reimbursement

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

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.

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