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市場調査レポート
医薬品市場アクセス、薬価、償還ニュース：2009年第2四半期
Market Access, Pricing, and Reimbursement News in the Second Quarter of 2009
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Abstract
Introduction
The second quarter of 2009 saw steady progress toward healthcare reform in the
United States and action in several of the world' s other major pharmaceutical
markets to curb pharmaceutical expenditures. Cost-containment strategies vary
considerably from one country to another, but governments and other payers
increased their emphasis on strategies such as increased use of generics,
price cuts, and health technology assessment (HTA).
Questions Answered in This Report
- President Barack Obama has declared his intention to pass healthcare
reform legislation in the United States before the end of 2009. What are the
key features of legislation under review by Congress? How much would
healthcare reform cost? What are the implications for the pharmaceutical
industry?
- The European Court of Justice (ECJ) recently issued two judgments that
could have signifi cant repercussions for drug manufacturers. How much freedom
do European governments have to impose price cuts or freezes on prescription
drugs? Can generics manufacturers use drugs licensed many years ago in
recently acceded EU member states as reference products for abridged
applications for generic drugs?
- The German government has earned a reputation for strict control of
healthcare costs. What changes are pending for certain widely prescribed
cardiometabolic drugs? What barriers to market access will new drugs likely
face in the future?
- The Japanese government has recently begun preparations for a new round of
pricing and reimbursement reforms in 2010. What is the government considering
with regard to the regular price revision process? What are the prospects for
long-listed drugs subject to generics competition?
Scope
- Issues affecting the pharmaceutical industry in the United States:
healthcare reform; pharmacy benefi t management trends; comparative
effectiveness research; regulatory pathway for biosimilars; fl exible pricing
arrangements.
- Issues affecting the pharmaceutical industry in Europe: market trends;
generic drug use; health economic evaluation; proposed prescribing and
reimbursement restrictions; shifting patterns of parallel trade; fl exible
pricing arrangements.
- Issues affecting the pharmaceutical industry in Japan: disagreement on
pricing reform; continued resistance to the use of generics; approval of the
fi rst biosimilar.
- Outlook and implications for the pharmaceutical industry: potential impact
of U.S. healthcare reform; increased focus on cost cutting; potential impact
of the recession on healthcare spending; continued growth of generics markets;
challenges for biosimilars; market access barriers for new drugs; prescribing
and reimbursement restrictions; growth of fl exible pricing arrangements.
Mentioned in This Report
- AARP
- Advanced Medical Technology Association
- Agency for Healthcare Research and Quality (AHRQ)
- Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency)
- American Hospital Association
- American Medical Association
- America' s Health Insurance Plans
- Association of the British Pharmaceutical Industry (ABPI)
- AstraZeneca
- Baxter
- Bayer
- Caisse Nationale de l' Assurance Maladie (CNAM; National Health Insurance
Fund)
- Celgene
- Chuikyo (Central Social Insurance Medical Council)
- Cigna
- Comision Interministerial de Precios de los Medicamentos (CIPM;
Interministerial Committee on Pharmaceutical Prices)
- Congressional Budget Office (CBO)
- CVS Caremark
- Department of Health and Human Services (HHS)
- European Court of Justice (ECJ)
- European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Express Scripts
- Farmindustria
- Federal Trade Commission
- Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ)
- Federazione Nazionale Unitaria dei Titolari di Farmacia Italiani
(Federfarma; National Federation of Italian Pharmacy Owners)
- Gemeinsamer Bundesausschus der Arzte, Zahnarzte, Krankenhauser und
Krankenkassen (GBA; Joint Federal Committee of Physicians, Dentists,
Hospitals, and Health Insurance Funds) Generics UK
- GlaxoSmithKline
- Health Alliance Medical Plans
- IMS Health
- Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen (IQWiG;
Institute for Quality and Efficiency in the Health Care System)
- Institute of Medicine (IOM)
- Janssen-Cilag
- Kaiser Commission on Medicaid and the Uninsured
- Lilly
- Lundbeck
- Medco Health
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Menarini
- Merck & Co.
- Merck Serono
- Merck Sharp & Dohme
- Mylan
- National Audit Office
- National Institute for Health and Clinical Excellence (NICE)
- National Institutes of Health (NIH)
- Novartis
- Pharmaceutical Care Management Association (PCMA)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Pharmaceutical Services Negotiating Committee (PSNC)
- Procter & Gamble
- Roche
- Sandoz
- Sanofi-Aventis
- Schering-Plough
- Service Employees International Union
- Shire Pharmaceuticals
- Tribunale Amministrativo Regionale del Lazio (Regional Administrative
Court for Lazio)
- UCB
- Waldheim
- Wissenschaftliches Institut der Allgemeinen Ortskrankenkassen (WIdO;
Scientific Institute of the General Local Insurance Funds)
- Wyeth
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Overview
- United States
- Healthcare Reform
- Funding New Healthcare Initiatives
- Pending Legislation
- Obstacles to Reform
- Pharmacy Benefit Management Trends
- Recent Spending Trends
- Drug Pricing Trends
- Increasing Use of Generics
- Comparative Effectiveness Research
- Regulatory Pathway for Biosimilars
- Flexible Pricing Arrangements
- European Union
- Implications for EU of Court Ruling on Price Cuts and Freezes in Italy
- Court Ruling on Data Protection
- France
- Continued Steady Growth in the Generics Market
- Germany
- Market Trends
- Government Plans for Stricter Limits on Access to Some New Therapies
- Health Economic Evaluation
- New Restrictions on the Reimbursement of Certain Cardiometabolic Drugs
- Generics Substitution
- Italy
- Temporary Cuts in Pharmaceutical Spending
- Spain
- Legal Action Over Reimbursement Decisions
- Amendments to the Reference Pricing System
- Steady Growth of the Generics Market
- United Kingdom
- Flexible Pricing Arrangements
- Shifting Patterns of Parallel Trade
- Substantial Savings from the Use of Generics
- Japan
- Disagreement on Pricing Reform
- Continued Resistance to the Use of Generics
- First Biosimilar Approved in Japan
- Outlook and Implications for the Pharmaceutical Industry
Tables
- 1. Key Proposals for U.S. Healthcare Reform
- 2. Proposed Topics for U.S. Comparative Effectiveness Research of
Particular Relevance to the Pharmaceutical Industry
Figures
- 1. Leading PBMs' Growth Rates for Per Member Per Month Pharmaceutical
Expenditures, 2008
- 2. Leading PBMs' Reported Changes in Drug Prices, 2008
- 3. Leading PBMs' Generics Dispensing Rates, 2006-2008
- 4. Express Scripts' Calculations of Actual and Untapped Generics
Dispensing Rates and Potential Savings in the United States, 2008
- 5. Generics Dispensing Rates for Frequently Used Generics in France, 2008
- 6. Key Market Trends in Germany, 2008
- 7. Growth in German Statutory Health Insurance Expenditures on Drugs in
Select Therapeutic Areas, 2008
- 8. Generics' Share of the Spanish Pharmaceutical Market, 2000-2008
- 9. Impact of Generics on Spending on Select Drug Classes in England, 2008
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