SPECIAL REPORT: Pharmaceutical Pricing and Reimbursement in Germany, 2008

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
• Organization and Funding of the German Health Care System
• Pharmaceutical Prices in Germany
• Reimbursement of Outpatient Medicines
• Cost-Containment
  • Reference Pricing
    • Extension of Reference Pricing to Patent-Protected Drugs
    • A More Aggressive Reference Price Method
    • Market Impact
  • Incentives to Undercut Reference Prices
  • Price Freeze
  • Mandatory Rebates
  • Voluntary Rebate Contracts, Cost-Sharing Deals, and Risk-Sharing Agreements
  • Prescribing Budgets
  • Daily Cost-of-Therapy Limits
  • Prescribing Guidelines
  • Use of Generic Drugs
    • Market Dynamics
    • Pricing Trends and Generic Erosion
    • Generics Substitution
  • Parallel Imports
  • Patient Copayments
  • Negative List
  • Dereimbursement of Nonprescription Medicines
• Health Technology Assessment
  • Role of the Institute for Quality and Effi ciency in Health Care (IQWiG)
  • Introduction of Health Economic Evaluation
    • Regulatory Framework
    • Opposition from Health Economists and the Pharmaceutical Industry
    • Response of the GBA and IQWiG to Criticism
    • Draft Methodology for Health Economic Evaluation
  • Future Focus on Costly New Therapies
• Reimbursement of Hospital Medicines
  • Pricing and Reimbursement
  • Prospective Payment
  • Pharmacy Decision Making
  • Monitoring Pharmaceutical Use and Spending
  • Interaction Between Hospitals and Primary Care
• Disease Management Programs
• Off-Label Prescribing
• Outlook for the German Pharmaceutical Market
• Appendix: Glossary of German Terms Used in This Report

Sidebar

• The Impact of Reference Pricing on the German Statin Market

Tables

• 1. Statutory Health Insurance Receipts and Expenditures, 1991-2006
• 2. German Health Care Reforms of Particular Signifi cance to the Pharmaceutical Industry, 1988-2007
• 3. Multilateral Comparison of Average Ex-Manufacturer Prices of Branded Medicines in Select Markets as a Percentage of U.K. Average Ex-Manufacturer Prices, 1992-2004
• 4. German Prices of Best-Selling Drugs as a Percentage of U.S. and European Average Prices, 2006
• 5. Prices of Leading Biologics in the Major Markets as a Percentage of U.S. Prices, 2006
• 6. Maximum Wholesalers' Margins on Ex-Manufacturer Prices of Prescription-Only Medicines
• 7. Maximum Pharmacists' Margins on Pharmacy Acquisition Prices of Drugs That Are Not Subject to Prescription-Only Status But Are Prescribed and Reimbursed by the GKV
• 8. Average Composition of Retail Pharmaceutical Prices in Germany, 1990-2007
• 9. Targets of Key Pharmaceutical Cost-Containment Measures in Germany
• 10. New Reference Pricing Groups Implemented in Germany Effective January 1, 2008
• 11. 2007 Retail Prices and New Reference Prices of Largest Pack Size of Nebilet
• 12. Evolution of Savings from Reference Pricing in Germany, 1989-2007
• 13. Reference-Priced Drugs' Place in the German Pharmaceutical Market
• 14. Out-of-Pocket Payments for Reference-Priced Drugs in Germany
• 15. Select Rebate, Cost-Sharing, and Risk-Sharing Agreements on Branded Drugs
• 16. Generics' Share of the Potential Generics Market and the Total GKV Prescription Market, 1981-2006
• 17. Average Percentage Price Difference Between Median Prices of Generic and Branded Versions of Off-Patent Drugs, 1981-2006
• 18. Key Trends in the German Prescription Drug Market. Implications for the Pharmaceutical Industry

Figures

• 1. Average Prices of Leading Biologics, Small-Molecule Drugs, and Pharmaceuticals Overall in the Major Markets as a Percentage of U.S. Prices, 2006
• 2. Evolution of Average Drug Prices in the Statutory Health Insurance Pharmaceutical Market, 1983-2007
• 3. Percentage of Reference-Priced Drugs with Retail Prices Above, in Line with, or Below Their Respective Reference Prices, January 1, 2008
• 4. Reference-Priced Drugs' Share of the German Statutory Health Insurance Pharmaceutical Market, 2004-2007
• 5. Evolution of Retail Prices in the German Pharmaceutical Market, June 2006-December 2007
• 6. Reasons Given to Statutory Health Insurance Patients for a Change of Prescription 2007
• 7. Reactions of Statutory Health Insurance Patients Whose Prescriptions Were Changed, Drugs, 2007
• 8. Structure of the German Pharmaceutical Market, First Half of 2007
• 9. Percentage Decrease in Weighted Average Retail Prices of Eight Best-Selling Off-Patent Drugs in Germany, March 2006 Through April 2007
• 10. Average Brand Market and Unit-Volume Share for Products That Have Lost Patent and Exclusivity Protection
• 11. Average Prices of Brands and Generics as a Percentage of Respective Brands' Price Prior to Generics Entry
• 12. Correlation Between Generic Price Erosion and Competitive Intensity
• A. Consumption of Statins in the Statutory Health Insurance Market, 2001-2006