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Pricing & Reimbursement

Pharmaceutical Pricing Strategies

Price optimization, reimbursement and regulation in Europe, US and Japan

Publication Date   January 2005
Publisher   Business Insights
Product Type   Report
Pages   240
ISBN Number   not applicable
Product Code   RBI043
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Price £1,495.00

approximately: $2,640 | €1,896

Summary


Maximizing prices and securing reimbursement status for a product is increasing in importance, as pharmaceutical companies seek to ensure that they achieve a high return on investment from current and future drugs in light of a sustained R&D productivity shortfall and a wave of impending blockbuster patent expiries. Pharmaceutical Pricing Strategies: Price optimization, reimbursement and regulation in Europe, US and Japan, is a report which will help you create an effective pricing policy, in the midst of continued regulatory uncertainty, stagnant R&D and the continued cost-containment efforts of healthcare payors. This report will provide detailed analysis of the key issues and market environments making up the pricing landscape, and enable you to conduct pricing and reimbursement evaluations for products throughout the development lifecycle. Gain a detailed understanding a drug's potential price profile and optimize future returns by including these assessments in portfolio evaluations and lifecycle planning, with the help of this report.

Content


  • Executive Summary
    • The Importance Of Price Optimization
    • Pricing And Reimbursement In North America
    • Pricing And Reimbursement In Europe
    • Pricing And Reimbursement In Japan And The Rest Of The World
    • Pricing Strategies For New Drugs
    • Pricing Strategies For Established Drugs
  • Chapter 1 The Importance Of Price Optimization
    • Summary
    • Introduction
    • Maximizing Return On Investment
    • R&d Productivity Shortfall
    • Key Patent Expiries
    • Healthcare Cost Containment
    • Cost-Containment Initiatives
    • Cost Containment In Pharmaceutical Expenditure
    • Key Issues
    • Price Optimization
    • Reimbursement Regulations
    • Reference Pricing
    • Pharmacoeconomic Evaluations
    • Parallel Imports
    • Generic Substitution
    • Hot Topics
    • Us Reimportation
    • Medicare Drug Benefit
    • Eu Enlargement
    • Price Harmonization
    • Pricing And Reimbursement Hurdles
  • Chapter 2 Pricing And Reimbursement In North America
    • Summary
    • Introduction
    • Us Pricing Regulations
    • Medicare
    • Medicaid
    • Private Healthcare
    • Recent Developments In The Us
    • The 2003 Medicare Prescription Drug Act
    • Expanded Access
    • Improved Drug Compliance
    • Higher Utilization
    • Price Comparison Tool
    • Medicare Drug Benefit Formularies
    • Medicaid Budget Crisis
    • Price Controls In Maine?
    • Florida's Medicaid Drug Rebates
    • Pharmacoeconomics In The Us
    • Pharmacoeconomics In Public Healthcare Provision
    • Pharmacoeconomics In Private Healthcare Provision
    • Managed Care Pharmacoeconomic Submissions
    • Future Use Of Pharmacoeconomics In The Us
    • Parallel Imports In The Us
    • Developments In Cross-Border Trade
    • Reimportation Task Force Report
    • State-Level Action
    • Generic Substitution In The Us
    • The Waxman-Hatch Act
    • Pediatric Exclusivity Provisions
    • Anti-Competition Agreements
    • Delaying Tactics And 180-Day Exclusivity
    • Biogenerics
    • Trends In Generic USAge
    • 'March-In' Law
    • 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
    • Driving Down Prices
    • Reimportation
  • Chapter 3 Pricing And Reimbursement In Europe
    • Summary
    • Introduction
    • European Pricing Regulations
    • France
    • Recent Developments
    • Germany
    • Recent Developments
    • Italy
    • Recent Developments
    • Spain
    • Recent Developments
    • The UK
    • Recent Developments
    • Pharmacoeconomics In Europe
    • France
    • Germany
    • Italy
    • Spain
    • UK
    • Parallel Importing In Europe
    • Penetration Of Parallel Imports
    • Price Differentials
    • Initiatives To Encourage Use Of Parallel Imports
    • Ability To Obtain A License To Import Products
    • Regulations And Key Legal Decisions
    • Merck Versus Stephar
    • Bayer (Adalat)
    • Bristol-Myers Squibb Versus Paranova
    • The Silhouette Case
    • The Maglite Case
    • The Davidoff Case
    • Recent Developments
    • Gsk's Supply Restriction In Greece
    • Lack Of Regulatory Framework In France
    • Novo Nordisk's Supply Of Actrapid Novolet In Spain
    • Pfizer's Direct Distribution To Pharmacies In Spain
    • Generic Substitution In Europe
    • The Mutual Recognition Procedure
    • Future Changes In European Generics Legislation
    • Government Initiatives Encouraging Generic Uptake
    • Eu Accession
    • Drug Pricing Policies And Reimbursement Post-Accession
    • Parallel Trade Post-Accession
    • Generics Post-Accession
    • 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
    • Pharmacoeconomics In Japan
    • Parallel Importing In Japan
    • Generic Substitution In Japan
    • 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
    • Chinese Pricing Regulations
  • Chapter 5 Pricing Strategies For New Drugs
    • Summary
    • Introduction
    • Pricing Strategies In Early-Stage Development
    • Therapy Area Analysis
    • Epidemiology Analysis
    • Treatment Delivery Analysis
    • Market Needs Analysis
    • Pricing Analysis
    • Cost Analysis
    • Economic Analysis
    • Decision-Maker Analysis
    • Market Research
    • Initial Assessment Of Drug Candidates
    • Pricing Strategies In Mid Stage Development
    • Evaluating Opportunities
    • Case Study: Aventis Appeal Against Nice
    • Improving Product Value
    • Case Study: Johnson & Johnson's Concerta
    • Pricing Strategies In Late Stage Development
    • Sub-Population Analysis
    • Choosing Outcomes
    • Case Study: Merck's Zocor (Simvastatin)
    • Patient Reported Outcomes
    • Case Study: Pfizer's Viagra
    • Head-To-Head Trials
    • Phase Iii Pharmacoeconomic Studies
    • Phase Iv Studies
    • Pricing Strategies For New Product Approvals
    • Submission Dossiers
    • Identifying Key Decision Makers
    • Failure To Secure Reimbursement
    • Working With Decision Makers
    • Case Study - Eli Lilly's Xigris
    • Applying Pressure Through Lobbying
    • Case Study - Amgen's Aranesp
    • Brokering Deals
    • Case Study - Celebrex In France
    • External Support
    • Eu Launch Order
    • First Choice Countries
    • Second Choice Countries
    • Third Choice Countries
    • Fourth Choice Countries
    • Global Price Optimization
  • Chapter 6 Pricing Strategies For Established Drugs
    • Summary
    • Introduction
    • Strategic Pricing Of Reformulations
    • Benchmarking Relative Pricing
    • Patient Expansion Strategies
    • Patient Switching And Generic Defence Strategies
    • Generic Defence Reformulations
    • Strategic Pricing At Patent Expiry
    • Us Patent Expiry
    • European Patent Expiry
  • Chapter 7 Appendix
    • Glossary
    • Sources
  • List Of Figures
    • Figure 1.1: Declining Trend In Number Of Ndas And Nmes Approved, 1995-2004
    • Figure 1.2: Rise In The Cost Of Drug Development, 1975-2000
    • Figure 1.3: Us Patent Expiries For Top Ten Selling Drugs, 2004
    • Figure 1.4: Trends In Healthcare Spending As A Proportion Of Gdp Between 1998 And 2002
    • Figure 1.5: Pharmaceutical Expenditure As A Share Of Total Healthcare Expenditure In 2002
    • Figure 1.6: Key Drivers And Resistors Of Pharmacoeconomics
    • Figure 2.7: Average Branded Drug Prices In Selected Countries Compared With The Us
    • Figure 2.8: Distribution Of 2003 Medicare Drug Expenditure
    • Figure 2.9: Average Annual Growth Rates Of Total Medicaid Spending, 1995-2002
    • Figure 2.10: Drivers And Resistors Of Parallel Imports Into The Us
    • Figure 3.11: External Reference Pricing In Europe, 2004
    • Figure 3.12: The Nice Appraisal Cycle
    • Figure 5.13: Stop-Go Decision Portfolio Review Phase Iia
    • Figure 5.14: Use Of Economic Evaluation
    • Figure 5.15: Optimal Country-By-Country Sequence Launch For Entry Into The Eu-15 Countries
    • Figure 5.16: Global Pricing And The Interaction Between Countries
    • Figure 6.17: Comparative Analysis By Strategic Type - Relative Average Us Pricing Four Quarters Following Launch For 25 Reformulations
    • Figure 6.18: Relative Average Us Pricing - Patient Switching Versus Generic Defense
    • Figure 6.19: Relative Average Us Pricing 12 Quarters Following Launch In Patient Switching Reformulations
  • List Of Tables
    • Table 1.1: Number Of Ndas And Nmes Approved By The Fda, 1990-2004
    • Table 1.2: R&d Expenditure Within The Us And Abroad By Phrma Members, 1980-2004
    • Table 1.3: Trends In Healthcare Spending As A Proportion Of Gdp Between 1970 And 2002
    • Table 2.4: Future Pricing Scenarios In The Us
    • Table 3.5: Use Of Economic Evaluations In Different European Countries
    • Table 3.6: Generic Substitution In Across European Countries
    • Table 3.7: Future Pricing Scenarios In Europe
    • Table 4.8: Co-Payments For Drugs/Services In Japan
    • Table 4.9: Classification For Price Premium (Japanese Healthcare System)
    • Table 4.10: Future Pricing Scenarios In Japan
    • Table 6.11: Calculating Relative Pricing - Prozac 20mg Versus Prozac Weekly 223