Pharmaceutical Pricing, Reimbursement, and Prescribing News in the Fourth Quarter of 2007

SUMMARY

Introduction

The fourth quarter of 2007 was fairly quiet in the pricing and reimbursement arena. In the United States, the presidential election, legislation in California, and a new initiative from health plans focused attention on the uninsured and universal coverage. A public consultation on the future of pharmaceuticals highlighted the challenges confronting drug manufacturers in Europe, while the Japanese government seemingly changed course on overhauling its pharmaceutical pricing and reimbursement system.

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• Pending U.S. legislation would allow the Department of Health and Human Services to create a national Medicare formulary. How would HHS use this formulary in its price negotiations with pharmaceutical manufacturers?
• U.S. employers and health plans are recognizing the fi nancial and health benefi ts of promoting greater use of generic drugs and improved adherence to chronic disease therapy. What strategies are they pursuing in their efforts to improve patient adherence with chronic disease therapy and encourage the use of generics?
• Pressure to tackle the growth in the ranks of uninsured U.S. residents is mounting. Which states have enacted their own universal coverage legislation? How will the presidential election affect this issue at the national level?

Scope

• Overview: major events in the fourth quarter of 2007 in the pricing, reimbursement, and prescribing environment in the major pharmaceutical markets under study.
• United States: leading stories in 2007, including SCHIP, decline in drug imports, copayment reductions and waivers for generics and chronic disease therapies, and many others.
• European Union: responses to public consultation on the future of pharmaceuticals in Europe.
• France: pressures on pharmaceutical industry, potential reforms for chronic disease treatments.
• Germany: new reference pricing groups, health economic evaluation, growth in rebate contracts.
• Italy: market trends in 2007.
• Spain: amendments to the reference pricing system.
• United Kingdom: proposed amendments to NICE's methods for technology appraisals, OFT report on direct-to-pharmacy distribution, abolition of prescription charges in Scotland.
• Japan: delay in overhaul of pricing and reimbursement system, efforts to increase use of generics.
• Outlook and implications for the pharmaceutical industry: the outlook for pharma in the United States, Europe, and Japan.

TABLE OF CONTENTS

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
• United States
  • Temporary Measures to Defer Medicare Reimbursement Cuts and Prolong Basic Health Insurance for Children
  • Decline in Drug Imports
  • Pressure for the Introduction of a Medicare Formulary
  • PBMs Commit to Greater Transparency
  • Call for Infl ation-Based Medicaid Rebates
  • Copayment Reductions and Waivers for Generics and Chronic Disease Therapies
  • Momentum for Universal Health Insurance
  • Benefi t Cuts at Age 65 Judged Acceptable
• European Union
  • Responses to Public Consultation on the Future of Pharmaceuticals in Europe
• France
  • French Health Care System at a Crossroads
  • Social Security Budget Increases Pressure on Pharmaceutical Industry
  • Potential Reform of Coverage of Treatments for Chronic Diseases
• Germany
• Market Trends in 2007
  • Pharmaceutical Budget for 2008
  • Introduction of New Reference Pricing Groups
  • Continuing Debate Over Procedures for Health Economic Evaluation
  • Continued Growth in Rebate Contracts
• Italy
  • Market Trends
• Spain
  • Amendments to the Reference Pricing System
• United Kingdom
  • Proposed Amendments to NICE's Methods for Technology Appraisals
  • OFT Report on Direct-to-Pharmacy Distribution
  • Abolition of Prescription Charges in Scotland
• Japan
  • Overhaul of Pricing and Reimbursement System Unlikely in 2008
  • Change to Prescription Form to Stimulate Generics Substitution
• Outlook and Implications for the Pharmaceutical Industry

Tables:

• 1. New Reference Pricing Groups Implemented in Germany Effective January 1, 2008
• 2. 2007 Retail Prices and New Reference Prices of Largest Pack Size of Nebilet
• 3. Proposed Changes to the Hierarchy of National Health Insurance Price Premiums in Japan
• 4. Revision Rates for Japanese Reimbursement Prices, 1994-2006

Figures:

• 1. Uninsured U.S. Residents, 2002-2006
• 2. Ten Most Common Registered Chronic Diseases in France, 2006
• 3. Annual Sales of Drugs Facing Patent Expiration in Italy in 2008