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H4-13, Market Access, Pricing, and Reimbursement News in the Third Quarter of 2009

Published by: Decision Resources

Published: Oct. 28, 2009 - 40 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Overview

United States

Healthcare Reform

An Increasingly Heated Debate

Slow Progress of Healthcare Reform Legislation

Government Deals with the Pharmaceutical Industry and Hospitals

Health Insurance Trends

U.S. Census Bureau Survey

Centers for Disease Control and Prevention Survey

Kaiser Family Foundation/Health Research & Educational Trust Employer Survey

Kaiser Commission on Medicaid and the Uninsured Survey

Drug Benefi t Trends

Comparative Effectiveness Research

Regulatory Pathway for Biosimilars

European Union

Publication of the Final Report of the Pharmaceutical Sectoral Inquiry

France

New Cost-Containment Measures Proposed for 2010

Continued Steady Growth in the Generics Market

Germany

Market Trends

Pressure for Reform from Health Insurance Funds

Expansion of the Second Opinion Process

New Government’s Deliberations on Healthcare Policy

Italy

Creation of a New Working Group on Access to Medicines

Italian Medicines Agency’s New Focus on Pharmaceutical Strategy and Economic Policy

Spain

Double Legal Setback for the Pharmaceutical Industry

United Kingdom

Economic Slowdown Exerts Pressure on Prescribing Budgets

Supply Shortages Resulting from Parallel Exports

Likely Delay to the Introduction of Generics Substitution

Review of NICE’s Infl uence on Pharmaceutical Innovation

Japan

Prospective Trial Introduction of a Price Maintenance System

New Government Likely to Stimulate the Generics Market

Barrier to Reimbursement of Drugs Not Yet Approved in Japan

Outlook and Implications for the Pharmaceutical Industry

Tables

1. Key Proposals for U.S. Healthcare Reform

Figures

1. Health Insurance Coverage of the Total U.S. Population, 1999-2008

2. Health Insurance Coverage of the Nonelderly U.S. Population, 1999-2008

3. Health Insurance Coverage of the Senior U.S. Population, 1999-2008

4. Percentage of U.S. Employers Sponsoring Employee Health Benefi ts, 1999-2009

5. U.S. Employers That Sponsor Employee Health Benefi ts: Likelihood of Implementing Various Cost-Containment Measures in the Next Year

6. Percentage of U.S. Covered Workers in Formulary Designs of Various Structures, 2000-2009

7. Average Copayments in the United States by Formulary Tier, 2000-2009

8. Average Coinsurance Rates in the United States by Formulary Tier, 2000-2009

9. U.S. Employers’ Use of Common Utilization Management Tools, 2007-2009

10. U.S. Managed Care Executives’ Priorities for Comparative Effectiveness Research

11. Generics’ Share of the Japanese Pharmaceutical Market, Fiscal Years 2006-2008

Abstract

Introduction:

The third quarter of 2009 saw a heated debate in the United States over healthcare reform, the publication of a report on a European investigation of the pharmaceutical industry, the election of new governments in Japan and Germany, and new initiatives by governments in other countries to control their national pharmaceutical spending. Faced with declining revenues and increasing expenditures, healthcare payers in all markets are exerting increasing pressure on the pharmaceutical industry to cut costs and deliver genuine innovation.

Questions Answered in This Report:
  • In the United States, the Democrats are committed to passing healthcare reform legislation by the end of the year. What difficulties have lawmakers encountered in drafting legislation? What are the recent trends in health insurance coverage in the United States? What deal has the U.S. government struck with the pharmaceutical industry?
  • The French government is looking to cut $2 billion from the national healthcare budget in 2010. How much does the government hope to save by cutting prices, reducing the reimbursement rate of certain drugs, and stimulating greater use of generics? What impact are new voluntary physician contracts likely to have on the French pharmaceutical market?
  • Spending on prescription drugs by the German statutory health insurance system grew by 5.3% in 2008. How did spending and pricing trends compare for generic and branded drugs? What changes would some health insurance funds like the government to make to controls on pharmaceutical coverage? What new restriction has the government introduced on coverage for certain cancers?
  • The economic downturn is beginning to have an impact on the U.K. healthcare system. What is the effect on pharmaceutical budgets? How have recent price cuts and exchange rate movements altered parallel trade patterns and contributed to shortages of certain drugs?
  • The Japanese pricing and reimbursement environment faces the prospect of significant changes in the coming years. How is the new government likely to respond to industry proposals for a price maintenance system? How will generics feature in future government healthcare policy? What are the implications of a recently confirmed restriction on access to drugs not yet approved in Japan?
Scope:
  • Issues affecting the pharmaceutical industry in the United States: healthcare reform; health insurance trends; drug benefit trends; managed care executives' views on comparative effectiveness research; regulatory pathway for biosimilars.
  • Issues affecting the pharmaceutical industry in Europe: market trends; generic drug use; proposed prescribing and reimbursement restrictions; shifting patterns of parallel trade; impact of the economic downturn on the pharmaceutical market; access to medicines.
  • Issues affecting the pharmaceutical industry in Japan: prospects for the introduction of a price maintenance system; government policy on generics; reimbursement of drugs not yet approved in Japan.
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