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Pharmaceutical Pricing, Reimbursement, and Market Access News in the Second Quarter of 2011
Decision Resources, Inc, September 2011
In the second quarter of 2011, several governments in major pharmaceutical markets announced plans for important regulatory changes or new cost-containment measures, while other governments continued their preparations for the implementation of pending reforms. Increasing economic pressures are forcing politicians in all countries to make tough decisions with regard to pharmaceutical spending.
Questions answered in this report:
- The U.S. pharmaceutical market grew by just 2.3% in 2010. How did demand for branded drugs compare with the consumption of generics? What measures are pharmacy benefit management companies (PBMs) adopting to control pharmaceutical expenditures? What pressures are the U.S. government and state administrations facing?
- The French government recently unveiled plans to overhaul its regulatory system. What prompted this action and what are the key reforms? What measures have been proposed to control pharmaceutical spending in 2012?
- Germany has begun the implementation of a radical new price-setting procedure. What impact has the new system had to date? How has the pharmaceutical industry reacted to the new pricing procedures?
- Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) recently completed a comparison of the prices of off-patent drugs in Italy with the prices of equivalent products in France, Germany, Spain, and the United Kingdom. For how many drugs has the agency cut reference prices? What is the average reduction in reference prices? What is the projected impact on the pharmaceutical market?
- Effective November 1, 2011, the Spanish government will implement major new cost-containment measures. What are the key reforms? How much are these measures projected to save?
- The U.K. government has published its responses to a consultation on the new value-based pricing system scheduled to take effect in January 2014. Which drugs are likely to be included in the new system? How will the government incentivize manufacturers to develop innovative drugs? What role is the National Institute for Health and Clinical Excellence (NICE) expected to play in the new system?
Issues affecting the pharmaceutical industry in the United States: slowdown in the pharmaceutical market; pharmacy benefit management trends; obstacles to healthcare reform; increasing pressure on state Medicaid programs.
Issues affecting the pharmaceutical industry in Europe: plans for an overhaul of the French regulatory system; French proposals for healthcare savings in 2012; reimbursement reductions in France; initial impact of new pricing procedures in Germany; substantial cuts to thousands of reference prices in Italy; pharmaceutical market trends in Italy; Spanish government’s pledge to tackle healthcare budget deficit; new cost-containment measures in Spain; U.K. government’s response to consultation on value-based pricing; amendments to U.K. healthcare reform legislation.
Issues affecting the pharmaceutical industry in Japan: industry recommendations for April 2012 biennial price revision.
Legislation: American Recovery and Reinvestment Act of 2009 (ARRA); Department of Defense and Full-Year Continuing Appropriations Act, 2011 (H.R.1473); Budget Control Act of 2011; Gesetz zur Änderung Krankenversicherungsrechtlicher und Anderer Vorschriften (Act for the Amendment of Health Insurance and Other Regulations); Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG; Pharmaceutical Market Restructuring Act); Health and Social Care Bill 2011; Health Care and Education Reconciliation Act of 2010 (HCERA); Loi de Financement de la Sécurité Sociale 2011 (LFSS; Social Security Finance Act 2011); Loi Hôpital, Patients, Santé et Territoires (Hospital, Patients, Health, and Territories Act); Patient Protection and Affordable Care Act (PPACA); Projet de Loi de Financement de la Sécurité Sociale 2012 (PLFSS; Social Security Finance Bill 2012); Real Decreto Ley 9/2011 (Royal Decree Law 9/2011).
Outlook and implications for the pharmaceutical industry: prospects for further cost-containment measures in the United States; more-rigorous pricing procedures in Europe; increasing price sensitivity in Europe; growth of European generics markets; potential introduction of health economic evaluation in Japan.
Pharmaceutical Market Trends
Pharmacy Benefit Management Trends
Recent Spending Trends
Drug Pricing Trends
Increasing Use of Generics
Obstacles to Healthcare Reform
Reversal of Two Healthcare Reform Measures in 2011 Budget Deal
Legal Challenges to the Healthcare Reform Legislation
Medicaid Under Increasing Pressure
Plans for an Overhaul of the French Regulatory System
Proposed Healthcare Savings in 2012
Creation of a New Class of Coordinating Pharmacists
Reimbursement Reduction for Hundreds of Products
Challenges Presented by the Pharmaceutical Restructuring Act
New Procedures for Price Setting
Industry Reactions to the Reforms
Impact of Increased Mandatory Rebates
Substantial Cuts to Thousands of Reference Prices
Government Pledge to Tackle Healthcare Budget Deficit
New Cost-Containment Measures
Government Response to the Public Consultation on Value-Based Pricing
Amendments to Healthcare Reform Legislation
Prescription Charges Increased in England But Abolished in Scotland
Industry Proposals for Pricing Reform in 2012
Outlook and Implications for the Pharmaceutical Industry
About the Author
- Actelion UK
- Biogen Idec
- Boehringer Ingelheim
- Bristol-Myers Squibb
- CVS Caremark
- Express Scripts
- Forest Laboratories
- GE Healthcare
- IMS Health
- Eli Lilly
- Medco Health
- Merck & Co.
- Novo Nordisk
- UCB Pharma
- Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS; French Agency for the Safety of Health Care Products)
- Agence Nationale de Sécurité du Médicament (ANSM ; National Agency for the Safety of Medicines)
- Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency)
- Association of the British Pharmaceutical Industry (ABPI)
- Associazione Nazionale Industrie Farmaci Generici (Assogenerici; National Association of the Generic Pharmaceutical Industry)
- British Medical Association
- Bundesverband der Deutschen Industrie (Federal Association of German Industry)
- Caisse Nationale d’Assurance Maladie (CNAM; National Health Insurance Fund)
- Chuikyo (Central Social Insurance Medical Council)
- Congressional Budget Office
- Consejo Interterritorial del Sistema Nacional de Salud (CISNS; Interregional Council of the National Health System)
- Expert Subcommittee on NHI Drug Pricing Affairs
- Federal Trade Commission
- Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ)
- Gemeinsamer Bundesausschuß der Ärzte, Zahnärzte, Krankenhäuser und Krankenkassen (GBA; Federal Joint Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds)
- Haute Autorité de Santé (HAS; National Health Authority)
- Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG; Institute for Quality and Efficiency in the Health Care System)
- Japan Pharmaceutical Manufacturers Association
- Japanese Pharmaceutical Group
- Kaiser Commission on Medicaid and the Uninsured (KCMU)
- Kaiser Family Foundation
- Les Entreprises du Médicament (Leem; Pharmaceutical Companies)
- National Association of State Budget Officers (NASBO)
- National Conference of State Legislatures (NCSL)
- National Institute for Health and Clinical Excellence (NICE)
- Osservatorio Nazionale sull’Impiego dei Medicinali (OsMed; National Observatory on the Use of Medicines)
- Pharmaceutical Care Management Association (PCMA)
- Spitzenverband Bund der Krankenkassen (National Association of the Federation of Health Insurance Funds)
- U.S. Census Bureau
- American Recovery and Reinvestment Act of 2009 (ARRA)
- Budget Control Act of 2011
- Department of Defense and Full-Year Continuing Appropriations Act, 2011 (H.R.1473)
- Gesetz zur Änderung Krankenversicherungsrechtlicher und Anderer Vorschriften (Act for the Amendment of Health Insurance and Other Regulations)
- Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG; Pharmaceutical Market Restructuring Act)
- Health and Social Care Bill 2011
- Health Care and Education Reconciliation Act of 2010 (HCERA)
- Loi de Financement de la Sécurité Sociale 2011 (LFSS; Social Security Finance Act 2011)
- Loi Hôpital, Patients, Santé et Territoires (Hospital, Patients, Health, and Territories Act)
- Patient Protection and Affordable Care Act (PPACA)
- Projet de Loi de Financement de la Sécurité Sociale 2012 (PLFSS; Social Security Finance Bill 2012)
- Real Decreto Ley 9/2011 (Royal Decree Law 9/2011)