Pharmaceutical Pricing, Reimbursement, and Prescribing News in the Third Quarter of 2007
Decision Resources, Inc, December 2007, Pages: 32
Introduction
The third quarter of 2007 was a quiet period in terms of legislation and other major developments in pricing and reimbursement in the major pharmaceutical markets, but recent trends in cost containment continued. In this report, we focus on Q3 measures that health care payers are using to curb their drug expenditures and to improve patient access to medications. We conclude with an assessment of the outlook and implications for the pharmaceutical industry.
Questions Answered in This Spectrum Report
- 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 define 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?
Scope
- 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 first 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; official 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 financial 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.
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 Deficiencies of the Japanese Generics Market
- Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency)
- American Pharmaceutical Group
- Association of the British Pharmaceutical Industry (ABPI)
- Bundesverband der Betriebskrankenkassen (BKK; Federal Association of Occupational Health Insurance Funds) (Germany)
- Bundesvereinigung Deutscher Apothekerverbände (ABDA; Federal Union of German Pharmacists’ Associations)
- Caisse Nationale de l’Assurance Maladie des Travailleurs Salariés (CNAMTS; National Health Insurance Fund for Salaried Workers) (France)
- Centers for Medicare and Medicaid Services (CMS) (United States)
- Central Social Insurance Medical Council’s Expert Subcommittee on the National Health Insurance Drug Pricing (Japan)
- European Commission
- Federación Empresarial de Farmacéuticos Españoles (FEFE; Business Federation of Spanish Pharmacists)
- Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ)
- Institut für Gesundheits- und Sozialforschung (IGES; Institute for Health and Social Research) (Germany)
- Japan Generic Pharmaceutical Manufacturers Association
- Japan Medical Association (JMA)
- Japan Pharmaceutical Manufacturers Association (JPMA)
- Kassenärztliche Bundesvereinigung (KBV; Federal Union of Health Insurance Fund Physicians) (Germany)
- Ministry of Health, Labor, and Welfare (MHLW) (Japan)
- National Institute for Health and Clinical Excellence (NICE) (United Kingdom)
- Office of Fair Trading (OFT) (United Kingdom)
- ProGenerika
- Spanish Ministry of Health
- Spitzenverbände der Krankenkassen (leading German associations of the health insurance funds)
- United Kingdom’s National Health Service (NHS)
- U.S. Department of Labor
- U.S. Food and Drug Administration (FDA)
- Verband Forschender Arzneimittelhersteller (VFA; German Association of Research-Based
Pharmaceutical Companies)
- GlaxoSmithKline
- Hexal
- Janssen-Cilag
- Medice Arzneimittel Pütter
- Novartis
- Pfizer
- Psychonomics
- Sandoz
- Wal-Mart
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