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

Published by: Decision Resources

Published: Dec. 11, 2007 - 32 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Overview

United States

Changes to Medicare Part D in 2008

FDA Amendments Act

Payers Ready to Promote Use of Biogenerics

Wal-Mart Expands Low-Priced Generics Range

Generics Mitigate Drug Infl ation

European Union

First Biosimilar Epoetin Alfa Products Approved

France

Emergency Pharmaceutical Cost-Containment Measures

Pressure for Further Cost Containment in the 2008 Budget

Germany

Market Trends

Generics Manufacturers Under Pressure Despite Strong Demand For Their Products

Continued Growth in Rebate Contracts

Growing Demand for Copayment-Exempt Medicines

Abolition of Bonus-Malus Rule

Italy

Increased Focus on Innovation in Reimbursement Decision Making

Spain

Impact of the 2006 Medicines Law on Older Drugs

Guidance on Innovations of Therapeutic Interest

Restrictions on Generics Substitution

United Kingdom

Government Plans to Replace the Pharmaceutical Price Regulation Scheme

Judicial Review of Initiatives to Promote Drug Switching

Japan

Proposals for Reform of the Pricing and Reimbursement System

Steady Growth in Demand For Generics Despite Physician Reservations

Outlook and Implications for the Pharmaceutical Industry

Tables and Figures

Tables

1. Medicare Part D: Key Parameters of the Standard Drug Benefi t Design, 2006-2008

2. Impact of Key Factors on Changes in German Statutory Health Insurance Funds’ Pharmaceutical Expenditures, 2005-2008 (projected)

3. Projected Changes in German Statutory Health Insurance Spending on Pharmaceuticals, 2007-2008

4. Select Drugs Excluded from Generics Substitution in Spain

5. Proposed New Japanese Pharmaceutical Premium System Suggested by the Federation of Pharmaceutical Manufacturers Associations of Japan

Figures

1. Standard Medicare Part D Drug Benefi t Design, 2008

2. Annual Deductible Policies of Standalone Medicare Prescription Drug Plans, 2006-2008

3. Annual Deductible Policies of Medicare Advantage Plans, 2006-2008

4. Coverage Gap Policies of Standalone Medicare Prescription Drug Plans, 2006-2008

5. Detailed Coverage Gap Policies of Standalone Medicare Prescription Drug Plans, 2008

6. Coverage Gap Policies of Medicare Advantage Plans, 2006-2008

7. Detailed Coverage Gap Policies of Medicare Advantage Plans, 2008

8. Managed Care Organizations’ Coverage of Omnitrope

9. HMO Pharmacy Directors’ Views on Main Drivers of Biogeneric Usage in the United States

10. HMO Pharmacy Directors’ Views on Likely Strategies for Promoting Biogeneric Usage

11. Projected Savings From Emergency Pharmaceutical Cost-Containment Measures in France

12. Percentage Decrease in Weighted Average Retail Prices of Eight Best-Selling Off-Patent Drugs in Germany, March 2006 Through April 2007

13. Structure of the German Pharmaceutical Market, First Half of 2007

14. Japanese Physicians’ Views on Defi ciencies of the Japanese Generics Market

Abstract

• Although biosimilars are licensed at the EU level, manufacturers of branded biologics will need to adapt to • national reimbursement and prescribing policies on biosimilars. What policies are European countries taking with regard to biologics and biosimilars? What impact will reference pricing have on biologics manufacturers?
• The Italian Medicines Agency will pay increased attention to pharmaceutical innovation as a key criterion • in reimbursement decision making. What requirements will the Italian government place upon manufacturers regarding their products’ degree of innovation? How will Italy defi ne its various levels of pharmaceutical innovation? What methods will it use to assess this innovation?
• The pharmaceutical industry will soon have to adapt to a new pricing and reimbursement system in the United • Kingdom. What pricing and reimbursement reforms are under consideration in the United Kingdom? What will the short- and long-term impacts be on industry players working in this country?

• Overview: • major events in Q3 2007 in the pricing, reimbursement, and prescribing environment in the major pharmaceutical markets under study.
• United States: • 2008 changes to Medicare Part D; FDA Amendments Act and its reforms to the FDA; payers’ enthusiasm toward the emergence of biogenerics; the impact of Wal-Mart on low-priced generics.
• European Union: • the fi rst approval of biosimilar epoetin alfa products.
• France: • emergency pharmaceutical cost-containment measures to address booming costs; use of the 2008 social security budget as a tool to curb spending.
• Germany: • overview of general spending trends; pressures on generics manufacturers; continued growth in negotiated rebate contracts between manufacturers and health insurance funds; growing demand for copayment-exempt medicines; abolition of the Bonus-Malus rule.
• Italy: • increased focus on innovation in reimbursement decision making.
• Spain: • continued concerns of the pharma industry over the impact of Spain’s 2006 Medicines Law on mature agents; offi cial establishment of what constitutes an innovation; restrictions on generics substitution.
• United Kingdom: • plans to replace the circa-1957 Pharmaceutical Price Regulation Scheme; outcome of judicial review of fi nancial incentives in place to encourage brand-to-generic drug switching.
• Japan: • proposals for reform of the pricing and reimbursement system; growing public demand for generics in the face of physician reservations.

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