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Market Access, Pricing, and Reimbursement News in the First Quarter of 2009

Published by: Decision Resources

Published: Apr. 30, 2009 - 32 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Overview

United States

Market Trends

Impact of the Recession on the Pharmaceutical Market

Measures to Promote Easier Access to Health Insurance

A Growing Uninsured Population

Health Reform: A Key Priority for the Obama Administration

Support from Congress

Opposition to a Government-Run Program and Health Insurance Industry Reaction

Comparative Effectiveness Research

Creating a Federal Coordinating Council for Comparative Effectiveness Research

Repercussions for the Pharmaceutical Industry

Regulatory Framework for Biosimilars

New Attempt to Authorize Prescription Drug Importation

France

Expanded Role for the National Health Authority

Germany

Government Appeal for Industry Price Freeze

Health Economic Evaluation

New Drugs Subject to Second Opinion Process

Continued Strong Growth of the Generics Market

Biosimilars Subject to Reference Pricing

Italy

Market Trends

Spain

Market Trends

Amendments to the Reference Pricing System

United Kingdom

General Price Cut

Faster Access to Innovative Medicines

Improved Coverage of End-of-Life Treatments

Japan

Market Trends

Industry Proposal for Pricing Reform

Proposed Amendments to Repricing in Response to Market Expansion

New Guidelines on the Licensing of Biosimilars

Outlook and Implications for the Pharmaceutical Industry

Figures

1. Projected Growth of the U.S. Prescription Drug Market in Select Years, 2006-2018

2. Sales of Prescription Drugs in the United States, 2003-2008

3. Prescriptions Dispensed in the United States, 2003-2008

4. Percentage of Nonelderly U.S. Residents Unable to Afford to Fill All Their Prescriptions in Select Years, 2000-2007

5. Uninsured U.S. Residents’ Time Without Health Insurance, 2007-2008

6. Prescriptions Dispensed in Italy, 2003-2008

7. Net Pharmaceutical Spending by the Italian National Health Service, 2003-2008

Abstract

Introduction

The fourth quarter of 2009 was characterized by a wide range of new pricing and reimbursement initiatives in the United States but more focused measures in most of the world’s other leading pharmaceutical markets. In the short term, payers are exerting pressure on manufacturers to reduce their prices. In the long term, payers will increasingly rely on health technology assessment (HTA) to inform their coverage decisions.

Get the Answers You Need to Shape Your Strategy
  • The new U.S. administration has identifi ed health reform as one of its highest political priorities. How does the government plan to promote easier access to health insurance? What role will comparative effectiveness research play in the U.S. pharmaceutical market in future? What measures are under way to create a regulatory framework for biosimilars?
  • The French National Health Authority (HAS) recently published an ambitious plan of action for 2009-2011. How is the HAS responding to government calls for increased focus on health economic evaluation? What plans does the authority have for postmarketing research? How does the HAS intend to develop international collaborations?
  • The German government is intensifying its efforts to curb pharmaceutical spending. What action might the government take if the pharmaceutical industry fails to exercise voluntary pricing restraint? What progress has been made toward implementing government initiatives to promote health economic evaluation and to require a second opinion regarding the use of certain drugs?
  • The United Kingdom has been very active in introducing reforms in recent months. What plans does the government have for U.K. pricing from 2009 through 2013? What new measures will promote faster access to innovative medicines? How does the government plan to improve coverage of end-of-life treatments?
Scope
  • Issues affecting the pharmaceutical industry in the United States: market trends in 2008 and
    • projections to 2018; impact of the recession on the pharmaceutical market; measures to promote easier access to health insurance; adoption of comparative effectiveness research; legislation to create a regulatory framework for biosimilars; new attempt to authorize prescription drug importation.
  • Issues affecting the pharmaceutical industry in Europe: expanded role for France’s HAS; government
    • appeal for price restraint in Germany; market trends in Italy and Spain; measures to promote faster access to innovative medicines in the United Kingdom.
  • Issues affecting the pharmaceutical industry in Japan: market trends; industry proposal for pricing reform; proposed amendments to the process of repricing drugs in response to market expansion; publication of new guidelines on the licensing of biosimilars.


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