A Guide to Drug Pricing and Reimbursement

Table of Contents

Executive Summary

• Drug Pricing and Reimbursement: Strategic Overview
• Factors affecting Pharmaceutical Expenditur
• Key Issues and Challenges
• Pricing Strategies
• Regional Pricing Differences
• Scope and Methodology
• Reasons for Conducting the Study

Drug Pricing and Reimbursement: Strategic Perspectives

• 2.1. Background
• 2.2. Global healthcare costs and their Impact on GDP
• 2.3. Drug Costs and Affordability
• 2.3.1. Price Variability across countries
• 2.4. Factors contributing to Drug Expenditures
  • a) Volume Growth
  • b) Rising Prices
• 2.5. Pharmaceutical Pricing and Ethics
  • 2.5.1. Differential Pricing
  • 2.5.2. HIV/AIDS Pricing & Ethics

Pricing Strategies

• 3.1. Background
• 3.2. Pricing Strategies: Goals
  • 3.2.1. Market Share
  • 3.2.2. Defending Market share
  • 3.2.3. New Customers
  • 3.2.4. Enhancing Brand Loyalty
  • 3.2.5. Improving Margins
  • 3.2.6. Capacity Utilization
• 3.3. Pricing Decisions: Types
  • 3.3.1. Traditional Pricing
• 3.4. Role of Pricing Function in Price setting
• 3.5. Pricing and Pharmacoeconomics
• 3.6. Price Optimization
• 3.7. Pricing in the Product Development Process
  • 3.7.1. Background
  • 3.7.2. The First Price Estimate
  • 3.7.3. Improving Pricing in the Product Development Process

Current Pricing and Reimbursement Trends in the USA

• 4.1.U.S. Healthcare Expenditures
  • 4.1.1. National Prescription Drug Expenditures
  • 4.1.2 Pharmaceutical Costs
    • 4.1.2.3. Factors for rise in pharmaceutical costs
  • 4.1.3. Future trends in Pharmaceutical Costs
    • 4.1.3.2. Increased Generic Penetration
    • 4.1.3.2. Rising Consumerism
    • 4.1.3.4. Shifting Payor Mix
    • 4.1.3.5. Cost Containment and the Formulary
    • 4.1.3.6. Basis of price determination
• 4.2. Pricing mechanism in USA
• 4.3. Price Movement
  • 4.3.1 Impact of Supply Chain on Price
  • 4.3.2. Supply chain and price differentials
    • Retail Sector
    • Non retail sector
• 4.4. Key Pricing measures
  • 4.4.1. Background
    • a) Average Manufacturer' s Price (AMP)
    • b) Average Sales Price (ASP)
    • c) Average Wholesale Price (AWP)
    • d) Estimated Acquisition Cost (EAC)
    • e) Federal Supply Schedule.
    • f) Federal Upper Limit (FUL)
    • g) Maximum Allowable Cost (MAC)
    • h) Wholesale Acquisition Cost (WAC)
• 4.5. Drug Pricing Litigations
• 4.6. Pricing Dynamics
  • Single-Source Drugs
  • Multiple-Source Drugs
• 4.7. Pricing and customer segments
  • 4.7.1 Background
  • 4.7.2 Pharmacy Benefit Managers
    • Background
    • PBM role
    • Cost containment Strategies
    • Pharmacies
    • PBMs' Negotiated Payments to Pharmacies
    • PBMs' Payments to Pharmacies
  • 4.7.3. Mail-Order Pharmacies
  • 4.7.4. Cash Customers
  • 4.7.5. Government Markets
    • 4.7.5.1. Federal Supply Schedule
    • 4.7.5.2. 340B Drug Discount Program
    • 4.7.5.3. Medicare
      • a) PART A
      • b) PART B
      • Medicare Reimbursements
      • c) Part C (Medicare Advantage)
      • d) PART D
      • Future Challenges
      • 2008 Changes in Medicare Part D Payments
      • Calculation of the Low-Income Benchmark Premium Amounts
      • Annual Updates to Medicare Part D Benefit Parameters
    • 4.7.5.4. Medicaid
  • 4.7.6. Third party payors
    • Managed care business structure
    • Healthcare maintenance organizations (HMO)
    • Point of service (PoS)
    • Preferred provider organizations (PPO)
    • MCOs and Pharmacy Benefit Managers (PBMs) relationships
    • Co-payments and cost-reduction initiatives
    • Managed Care Contracting: Pharmaceutical Manufacturers' Perspective
    • Managed Care Business Goals
    • Managed Care Strategy
• 6. Monitoring Performance
  • 4.7.7. Emerging Issues
    • 4.7.7.1.Drug Price Transparency in United States
    • 4.7.7.2. Wal-Mart and $4 Generics
    • 4.7.7.3. Average Wholesale Price and First Data Bank

Current Pricing and Reimbursement Trends in Europe

• 5.1. Background
  • 5.1.1 EU Pricing Environment
  • 5.1.2. Reimbursement Mechanisms
  • 5.1.3. Pricing and Reimbursement impact on new product launch sequence
  • 5.1.4. Drug Budgets
  • 5.1.5. Pricing and Reimbursement Overview
    • U.K. and Germany
    • France, Italy and Spain
  • 5.1.6. Parallel Trade
• Germany
  • 5.2.1. Background
  • 5.2.2. Statutory Health Insurance Funds
    • 5.2.2.1.Reference Prices
  • 5.2.3. Statutory Health Insurance Market
• FRANCE
  • 5.3.1. Background
  • 5.3.2. Regulatory Affairs in France
  • 5.3.3. Regulations
• UK
  • 5.4.1.Pricing System
  • 5.4.2. Pricing of New Products
  • 5.4.3. Pricing Methods for Generic Products
  • 5.4.4. Reimbursement
• ITALY
  • 5.5.1. Pricing Systems
  • 5.5.2. Reimbursement
• SPAIN
  • 5.6.1. Pricing Systems
  • 5.6.2. Reference Pricing System
• 5.7.Tackling Parallel Trade

Current Pricing and reimbursement Trends in Japan

• 6.1. Background
• 6.2. Japanese Healthcare System
  • Employee' s Health Insurance Plan
  • National Public Health Insurance Plan
• 6.2. Bungyo
• 6.3. Reimbursement system
• 6.3. The R-Zone and regular price decreases