Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006Arrowhead PublishersMarch 1, 2006 209 Pages - SKU: AH1259751 |
Additional Information
Pharmaceutical and Biotech Market Entrance Strategies provides the following:An overview of major market access strategies
In-depth information regarding the pricing environments of the American, European and Japanese pharmaceutical markets, comparing and contrasting their major features with a view to securing the best approach
In-depth information regarding reimbursement environments and market strategies that are most suitable for a particular market
Overview of parallel trade, including major responses to the threat by all relevant players
Overview of lifecycle management, identifying key factors for successful product placement over time
Examination of Latin American experience in terms of pricing strategies and lessons that can be learned globally
Who should buy this report?
Companies wishing to examine the most current pricing and regulatory environments in major global markets, including different cost-containment strategies used by governments and purse-holders.
Companies interested in understanding the impact and implications of parallel trade, with a view to minimising disadvantages to their products.
Companies interested in understanding the wider opportunities and challenges in the American, Japanese and European markets.
Pharmaceutical and biotech companies wishing to identify both the threats to products in these markets as well as the variety of profit maximisation strategies outlined in this report.
- 1 Executive Summary, Report Objectives and Scope
- 1.1 Executive Summary
- 1.2 Report Objectives and Scope
- 2 Introduction
- 2.1 Pharmaceutical and Biotechnology Industries: Brothers in Need
- Case Study: Biotech-Biotech Take-Over Deal - Amgen and Immunex
- 2.1.1 Pipeline Problems
- 2.1.2 Big Pharma's Image under Attack
- 2.1.3 The Secret Price of Drugs
- 2.2 Biotechnology as an Equal Partner
- 2.2.1 Risk Management Strategies for Biotech Firms
- 2.2.2 Biotech in Europe
- Case Study: The European Biotechnology Patents Directive
- 2.2.3 The One That Can: Amgen, the Most Successful Biotech Company
- 3 Key Issues Affecting Global Pharmaceutical and Biotechnology Industries
- 3.1 Pharmaceuticals: Strength in Numbers
- 3.2 Pharmaceuticals: The Medical Needs/Financial Means Gap
- 3.3 Pharmaceuticals: The Public Voice
- 3.4 Pharmaceuticals: Big Names in Pharma Business
- 3.5 Biotechnology: What's Hot and What's Not
- 3.6 Key Markets: The US, Japan, Europe
- 3.6.1 The Awesome Threesome: The US
- 3.6.2 The Awesome Threesome: Japan
- 3.6.3 The Awesome Threesome: The EU
- 4 Market Entrance Strategies - General Overview
- Minority equity investment
- Consortium
- Outsourcing
- Partnerships and R&D partnering
- Niche market launches
- New blockbuster therapy
- Me-too drugs
- Not launching or delaying launches
- Marketing and promotion
- Full reimbursement versus lower prices or restrictions on prescribing
- Launching without reimbursement
- Sequence of launch
- Licensing
- Orphan drug status
- Acquisition
- Mergers
- Price corridors
- Generic market entry
- Patent extension, data exclusivity and market protection
- Prescription to OTC switching
- Case Study: Biotechnology Commercialisation Agreement - Innovex and CVT
- Case Study: Launching Without Reimbursement - Aricept
- Case Study: AstraZeneca and Atherogenics Licensing Deal
- Case Study: Aspreva and Rare Disease Research
- Acquisition Case Study: Novartis and Lek
- Case Study: the US - Pfizer and Pharmacia Merger
- Case Study: Europe: Aventis and Sanofi-Synthelabo Merger
- Case Study: Japan: Daiichi and Sankyo Merger
- Case Study: Supplementary Protection Certificates and Data Exclusivity in Europe
- 5 An Introduction to Pricing and Reimbursement
- 5.1 The Basics of Pricing
- 5.2 Elements of Pricing
- 5.3 Strategic Pricing
- 5.4 Pharmacogenomics and Pricing Ramifications
- Case Study: Pharmacogenomics in the UK's NHS
- 6 Pricing/Reimbursement in the US
- 6.1 US Healthcare System - Overview
- 6.2 Medicare
- 6.3 Medicaid
- 6.4 Federal Healthcare Budget
- 6.5 Recent Developments
- 6.6 Pricing in the US
- 6.6.1 Price-Fixing
- 6.6.2 State-Specific Pricing Policies
- 6.6.2.1 Price Controls in Maine
- 6.6.2.2 Florida's Medicaid Drug Rebates
- 6.7 Pricing in the US: Market Entrance Strategies
- 6.8 Reimbursement in the US: Present Climate and Conditions
- 6.9 Reimbursement in the US: Market Entrance Strategies
- 7 Pricing/Reimbursement in Japan - Overview
- 7.1 Pricing in Japan
- 7.2 Pricing in Japan: Market Entrance Strategies
- 7.3 Reimbursement in Japan: Present Climate and Conditions
- 7.4 Reimbursement in Japan: Market Entrance Strategies
- 8 Pricing in the EU: Present Climate and Conditions - Overview
- 8.1 Price Controls
- 8.1.1 Supply Side
- 8.1.2 Demand Side
- 8.2 EU Enlargement
- 8.3 Pricing in Europe: Market Entrance Strategies
- 8.4 Reimbursement in the EU: Present Climate and Conditions - Overview
- 8.5 Reimbursement Strategies
- 8.6 Reimbursement in Europe: Market Entrance Strategies
- 8.7 Pricing/Reimbursement in Select EU Countries
- 8.7.1 Pricing in the UK
- 8.7.2 Reimbursement in the UK
- 8.7.3 Pricing in France
- 8.7.4 Reimbursement in France
- 8.7.5 Pricing in Germany
- 8.7.6 Reimbursement in Germany
- 8.8 Pricing and Reimbursement in Other EU Countries
- 8.8.1 Pricing and Reimbursement - Spain
- 8.8.2 Pricing and Reimbursement - Italy
- 8.8.3 Pricing and Reimbursement - Greece
- 8.8.4 Pricing and Reimbursement - Portugal
- 8.8.5 Pricing and Reimbursement - Poland
- 8.8.6 Pricing and Reimbursement - Hungary
- 8.8.7 Pricing and Reimbursement - The Czech Republic
- 9 Parallel Trade
- 9.1 Definition
- 9.2 Reasons for Parallel Trade
- 9.2.1 The Cost-Cutting Rationale
- 9.2.2 Principles of Free Trade
- 9.2.3 Disparate Regulatory and Intellectual Property Environments
- 9.3 Who Benefits from Parallel Trade?
- 10 Parallel Trade in the US: Canadian Re-importation
- 10.1 Re-importation into the US - The Desire to Save
- 10.2 Re-Importation into the US - Patent Rights
- 10.3 Re-Importation into the US - Legislative Support
- 10.4 Reasons for Parallel Trade from Canada
- 10.5 Company Opposition
- 10.6 State Actions
- 10.7 Patients' Involvement
- 10.8 FDA Response
- 10.9 Potential Savings
- 11 Parallel Trade in Europe
- 11.1 Single Market and Parallel Trade
- 11.2 EU PT Market Figures
- 11.3 EU Enlargement
- 11.4 Parallel Trade and EU Enlargement
- 11.5 Parallel Trade and the Euro
- 11.6 How to Stop Parallel Trade
- 11.7 Legal Examples of Parallel Trade Disputes
- 11.7.1 Pharmaceutical Repackaging: Aventis' Insuman
- 11.7.2 Repackaging: Boehringer Ingelheim & Others v. Swingward and Dowelhurts
- 11.7.3 Trademarks: Pharmacia & Upjohn SA v. Paranova A/S
- 11.7.4 Market Authorisation Withdrawal: Ferring v. Eurim-Pharm and Paranova
- 11.7.5 Common Origin: Germany v. Kohlpharma
- 11.7.6 Stock Management: Bayer and Adalat
- 11.8 A Single European Price?
- Case Study: Single European Price for Merck's Crixivan
- 12 Regional Lessons for Pharmaceutical Pricing
- 12.1 Regional Pricing: Latin American Examples
- 13 Conclusion: The Lessons Learnt
- 13.1 Pricing - Global Lessons
- 13.2 Reimbursement - Essential Market Access Factor
- 13.3 R&D - Continued Need for Innovation
- 13.4 Globalisation of the Pharmaceutical Market
- 13.5 Future Considerations
- 13.5.1 Development of New Markets
- Case Study: Bird Flu
- 13.5.2 Discoveries in Technology and Genetics
- 13.5.3 Bioterrorism, New Diagnostics
- 13.5.4 Lifecycle Management
- 13.6 Closing Remarks
- Glossary
- Tables
- Table 2.1 Total and On-Patent Drug Revenues for Selected Organisation for Economic Co-Operation and
- Development (OECD) Countries
- Table 2.2 Total and Off-Patent Drug Revenues for Selected OECD Countries
- Table 2.3 Key Off-Patent Drugs
- Table 2.4 World's Largest Biotech Companies by Sales, 2005
- Table 2.5 World's Largest Healthcare Companies by Sales of Biotech Products, 2003
- Table 2.6 Amgen's Financial Statement Figures
- Table 3.1 Big Pharma by Sales
- Table 3.2 Top Products, October 2005
- Table 3.3 Retail Medicine Sales by Main Markets, 12 Months to November 2005
- Table 3.4 Promotional Expenditure in Select EU Countries, 2003
- Table 4.1 FDA Orphan Drugs - Products Designated as Orphan Drugs, September 2005 to December 2005
- Table 6.1 OECD Health: Spending and Resources (2003 Figures)
- Table 6.2 US Online Advertising Spending by Major Industry Category as a % of Total Online Ad Spending
- Table 6.3 Marketing and R&D Costs by Major Pharmaceutical Companies, 2003
- Table 8.1 Pharmaceutical Sales and Growth by Value
- Table 8.2 European Reference Pricing Situation
- Table 8.3 Overview of Supply-Side Pricing and Reimbursement in the Old EU
- Table 8.4 Overview of Demand-Side Pricing and Reimbursement in the Old EU
- Table 8.5 Estimated Pharmaceutical Market Value by Country, 2005
- Table 9.1 Parallel Trade Benefits and Threats
- Table 11.1 Savings Achieved by PT in Select EU Countries
- Table 11.2 Share of Parallel Imports as % of Total Pharmaceutical Market, 1998, 2000, 2002
- Table 11.3 Share of Parallel Imports as % of Total Pharmaceutical Market, 1997, 1999
- Table 11.4 National Policies Regarding Parallel Import Drugs in Europe, 2004
- Table 11.5 Pros and Cons of Single and Decentralised Pricing Strategies 2002
- Table 12.1 Antiretroviral Therapy Coverage in the Developing Countries, December 2002
- Graphs
- Graph 2.1 Average R&D Expenses of Major Pharmaceutical Companies in Japan and the US
- Graph 3.1 Geographical Breakdown of Retail Medicine Sales by Main Markets
- Graph 3.2 Pharmaceutical Sales in the New EU
- Graph 4.1 European Price Corridor Strategy
- Graph 8.1 Main EU Markets, 2004
- Graph 11.1 Average Pharmaceutical Price per Tablet, 19 Leading Molecules
- Graph 11.2 Shortcomings of a One-Price Policy
- Graph 12.1 Cumulative Number of Reported HIV/AIDS Cases in the WHO European Region
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