Pharmaceutical Pricing and Reimbursement

Summary

GBI Research, the leading business intelligence provider, has released its latest research, "Pharmaceutical Pricing and Reimbursement - Reference Pricing and Economic Evaluations Will Dominate Future Pricing and Reimbursement Strategies". It provides key data, information and analysis of the major issues affecting the pricing and reimbursement decisions across the globe. It discusses the major changes that have been observed in the pharmaceutical and healthcare industry at the global level. The report also covers issues specific to particular geographies. The geographies covered include the US and countries within Western Europe, Asia-Pacific, Central and Eastern Europe, and Scandinavia. It covers pricing and reimbursement mechanisms in different countries as well as the impact of issues on the key stakeholders. The report puts a special emphasis on orphan drugs since the pricing and reimbursement patterns for orphan drugs are different from the traditional mechanisms.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research's team of industry experts.

Scope

The scope of this report includes:

• Identification and analysis of major issues that are affecting the pricing and reimbursement decisions across five different geographies. These include North America, Western Europe, Asia-Pacific, Central and Eastern Europe and Scandinavia
• Analysis of the issues and potential impact of pricing and reimbursement decisions on the key stakeholders
• Study of the pricing and reimbursement mechanisms in different countries and the identification of trends in the context of a particular geography as a whole
• Qualitative analysis of the forces that are driving and restraining the prices and reimbursements within a particular geography
• Future outlook of the pricing and reimbursement patterns for geographies under consideration

Reasons to buy

The report will enhance your decision making and will enable you to:

• Build understanding of the major issues in the pricing and reimbursement landscape
• Identify the impact of each issue on your business and develop solutions for adverse impacts
• Negotiate better with the government agencies to maximize the reimbursement on the drugs by understanding the pricing and reimbursement mechanism
• Develop effective business strategies for pricing a drug which is to be launched in any of the markets considered in this report
• Identify and exploit the factors that could help to maximize returns on the drugs for a particular geography in future

Contents

• 1 Table of Contents
  • 1.1 List of Tables
  • 1.2 List of Figures
• 2 Introduction
  • 2.1 GBI Research Report Guidance
• 3 Pharmaceutical Pricing & Reimbursement Issues at Global Level - Innovative Mechanisms To Decrease the Healthcare Costs
  • 3.1 Introduction
  • 3.2 Issues at Global level
    • 3.2.1 Value Based Pricing and Risk-Sharing Models
    • 3.2.2 Increased Focus on Evidence-based Medicine and Health Technology Assessment (HTA)
    • 3.2.3 Role of Pharmacoeconomics in Pricing and Reimbursement
  • 3.3 Conclusion
• 4 Pricing and Reimbursement Issues in US - Government's Cost Rationalization Efforts Will Make Future Tough for Big Pharma
  • 4.1 New Nationwide Database to Set Healthcare Reimbursement Rates
  • 4.2 Medicaid Pricing for Dual Eligibles of Medicare Part - D
  • 4.3 New ICD-10 (International Classification of Diseases - 10) Coding System
  • 4.4 Generic Price War at Retail Sector
  • 4.5 MIPPA (Medicare Improvement for Patients and Providers Act), the AMP Rule Litigation
  • 4.6 First DataBank/Medi-Span Settlement and the Impact on AWP
  • 4.7 Conclusion
• 5 Pricing and Reimbursement Issues in Western Europe - Cost-Effectiveness is the Key to Success
  • 5.1 Parallel Trade
  • 5.2 EU Single Pricing - Still an Issue
  • 5.3 International Price Referencing
  • 5.4 Status quo of P&R in Western Europe
    • 5.4.1 UK
    • 5.4.2 France
    • 5.4.3 Germany
    • 5.4.4 Italy
    • 5.4.5 Spain
  • 5.5 Conclusion
• 6 Pricing and Reimbursement Issues in Central & Eastern Europe (CEE) and Scandinavia - Reference Pricing and Centralization Proves Detrimental for High Price Drugs
  • 6.1 Central & Eastern Europe - Cost-Effectiveness is of Paramount Importance
    • 6.1.1 Czech Republic
    • 6.1.2 Poland
    • 6.1.3 Austria
    • 6.1.4 Romania
    • 6.1.5 Hungary
  • 6.2 Scandinavia - Moving Towards Centralized Healthcare Regime
    • 6.2.1 Denmark
    • 6.2.2 Norway
    • 6.2.3 Sweden
    • 6.2.4 Future Landscape
  • 6.3 Conclusion
• 7 Pricing and Reimbursement Issues in Asia-Pacific - Negative Pricing Pressures Leaves Less Hope for Expensive Medicines
  • 7.1 DPC (Diagnosis Procedure Combination) Reimbursement System in Japan - Immense Savings for the Government
  • 7.2 Reforms in Chinese Pharmaceutical Market: Tougher Landscape for Generic and Off-Patent Brands
    • 7.2.1 Active Ingredient Based Reimbursement: Restricted Market for Original Branded Products
    • 7.2.2 New Regulatory Reforms: Stricter Rules for Innovation Seal
    • 7.2.3 Price Cuts and Hospital Tendering Process: Erosion of Generic Margins
    • 7.2.4 Future Scenario: Innovation is the Key for Western Pharmaceutical Companies
  • 7.3 Transparency Issues with PBS in Australia
    • 7.3.1 AUSFTA (Australia-United States Free Trade Agreement) - Boon for Branded Pharma
    • 7.3.2 Access Issues for HCM (High Cost Medicines) and Controversial Selection Criteria
    • 7.3.3 Consumer Participation in the PBS Drug Listing - A Move towards Greater Transparency and Cost-Efficiency
  • 7.4 Conclusion
• 8 Pricing and Reimbursement Issues for Orphan Drugs - Excessive Prices of Orphan Drugs Increasing Financial Pressures on Government
  • 8.1 Exploiting Orphan Drug Act; Maximizing Revenues
    • 8.1.1 Ovation's Indocin and Questcor's H.P. Acthar Gel
  • 8.2 Pricing of an Orphan Drug
  • 8.3 Price Control Measures
    • 8.3.1 Global Approach for Orphan Drug Development
    • 8.3.2 Introducing Sales Ceiling and Flexible Market Exclusivity
    • 8.3.3 Price Revisions
  • 8.4 Conclusion
• 9 Key Takeaway
• 10 Appendix
  • 10.1 Market Definitions
  • 10.2 Key Support Data
  • 10.3 Abbreviations
  • 10.4 Research Methodology
    • 10.4.1 Coverage
    • 10.4.2 Secondary Research
    • 10.4.3 Primary Research
    • 10.4.4 Expert Panel Validation
  • 10.5 Contact Us
  • 10.6 Disclaimer
  • 10.7 Sources
• 1.1 List of Tables
  • Table 1: Examples of Pharmacoeconomic Evaluations in Ireland
  • Table 2: Drug Manufacturers Receiving Largest Windfalls, ($m), 2006-2007
  • Table 3: Pricing and Reimbursement Mechanisms in Western European countries
  • Table 4: Pricing and Reimbursement Mechanisms in Czech Republic, Romania, Austria, Poland and Hungary
  • Table 5: Different Pricing Mechanisms used in Czech Republic, Poland, Austria, Romania and Hungary
  • Table 6: Box Model for Reimbursement in Austria
  • Table 7: Comparative Analysis of Per Capita Healthcare Expenditures in the Scandinavian Countries, 2006
  • Table 8: Pricing and Reimbursement Mechanisms in the Scandinavian Countries
  • Table 9: Norway - Step Price System, 2008
  • Table 10: Trend in the Revision Rates of Reimbursement Prices in Japan, 1992-2008
  • Table 11: Sales in Pharmaceutical Industry, China, $bn, 1998-2008
  • Table 12: Increase in the Per Capita Expenditure for Medical Services in the Urban and Rural Households, China, $m, 1990-2006
  • Table 13: Ratio of Retail v/s Wholesale Price in Eight European Countries and China, 2005
  • Table 14: Definition and Incentives for Orphan Drugs in US, EU, Japan and Australia
  • Table 15: Average Annual Premiums for Family and Single Coverage. US, ($), 1999-2009
  • Table 16: Australia Drug Price Components and Payment Structure
  • Table 17: GDP (Nominal) Comparison Between Western Europe and Central & Eastern Europe, ($bn), 2008
• 1.2 List of Figures
  • Figure 1: Comparison of Per Capita Expenditure on Health at Average Exchange Rate ($) v/s Life Expectancy, 2006
  • Figure 2: Comparison of CAGR of R&D Expenditure v/s Turnover Over the Last Five Years for the Top 5 Companies, 2003-2008
  • Figure 3: Value Based Pricing - Concept and Process
  • Figure 4: Impact Analysis: Value Based Pricing
  • Figure 5: Drivers and Restraints for EBM (Evidence Based Medicine)
  • Figure 6: Impact Analysis: Evidence Based Medicine
  • Figure 7: ISPOR 33 Guidelines for Pharmacoeconomics Assessment
  • Figure 8: Impact Analysis: Pharmacoeconomics
  • Figure 9: Average Annual Percentage Change in Manufacturer Prices for Most Widely Used Prescription Drugs in US
  • Figure 10: Case: An Example Of Data Tampering To Provide Artificially Low Reference Prices For Reimbursements Of Out-Of-Network Medical Expenses
  • Figure 11: Impact Analysis: New Database for Reimbursement Rates of Out-of-Network Medical Expenses
  • Figure 12: Comparison of Medicare Part D and Medicaid Discounts
  • Figure 13: Impact Analysis: Medicaid Pricing for Dual Eligibles in MPD (Medicare Part D)
  • Figure 14: ICD-10 Coding System; Features and Benefits
  • Figure 15: Impact Analysis: ICD-10 Coding System
  • Figure 16: Impact Analysis: Generic Price War
  • Figure 17: Impact Analysis: MIPPA (Medicare Improvement for Patients and Providers Act)
  • Figure 18: Impact Analysis: First DataBank/Medi-Span Settlement
  • Figure 19: Parallel Import Market Break-down, Europe, 2007, Total Size = $7.5bn
  • Figure 20: Impact Analysis: Parallel Trade
  • Figure 21: Price Level Indices for Pharmaceutical Products, EU25 = 100, 2005
  • Figure 22: Impact Analysis: EU Single Pricing
  • Figure 23: Impact Analysis: International Reference Pricing
  • Figure 24: Overshooting Actual Budget Expenditure, Hungary,(%), 1994-2005
  • Figure 25: Impact Analysis: P&R Issues in CEE and Scandinavia
  • Figure 26: Impact Analysis: DPC (Diagnosis Procedure Combination) Reimbursement System
  • Figure 27: Sales in Pharmaceutical Industry, China, $m, 1998-2008
  • Figure 28: Increase in the Per Capita Expenditure for Medical Services in the Urban and Rural Households, China, ($m), 1990-2006
  • Figure 29: Impact Analysis: Reforms in Chinese Pharmaceutical Market
  • Figure 30: Arguments For and Against the AUSFTA
  • Figure 31: Impact Analysis: AUSFTA
  • Figure 32: Number of Orphan Drugs Approved by FDA, 2000-2009
  • Figure 33: Factors Influencing the Pricing of an Orphan Drug
  • Figure 34: Correlation Between the Prevalence and the Annual Cost of Therapy for Orphan Drugs
  • Figure 35: Impact Analysis: Price Control Measures on Orphan Drugs
  • Figure 36: The US Healthcare Expenditure, Historical, $tn, 1980-2008
  • Figure 37: The US Healthcare Expenditure, Projections, ($tn), 2009-2018
  • Figure 38: GBI Research Methodology