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Developments in Pricing and Reimbursement in Leading Pharma Markets 2010-2020
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The global economic crisis and rising healthcare costs have caused governments to take cautious approaches towards pricing and reimbursement (P&R) for pharmaceuticals. Increasing drug prices and risin.....
The global economic crisis and rising healthcare costs have caused governments to take cautious approaches towards pricing and reimbursement (P&R) for pharmaceuticals. Increasing drug prices and rising demand for the latest treatments - driven by aging, expanding populations and improving standards of living - have increased the burden on healthcare systems, public and private. Those events have particularly affected countries whose healthcare is mostly funded by the state. Developing nations are also finding it challenging to meet the increasing expectations for healthcare, despite rapid economic growth. Our new report covers pharma pricing and reimbursement in detail, showing the implications of P&R developments on the pharma industry and market in leading countries. Worldwide, governments have instigated mechanisms to limit or lower prices of prescription medicines. Those measures include reference pricing, applying cost-benefit analyses and use of other health technology assessments. Those and other P&R policies will continue to exert downward pressure on pharmaceutical pricing from 2010 onwards. As our new report - Developments in Pricing and Reimbursement in Leading Pharma Markets 2010-2020 - shows, there are many opportunities for pharmaceutical companies to increase revenues and be innovative, finding ways to accommodate P&R regulations. Our new report discusses P&R in the following markets, from 2010 looking ahead: • US • Japan • Germany • France • UK • Italy • Spain. In addition, our report covers the expanding role of generic drugs in those markets. Healthcare providers and payers have become increasingly sensitive to drug prices. Governments are using economic evaluations to assess the benefits of prescription drugs, especially biotechnological products. This latest report from visiongain analyses the main issues affecting P&R decisions within the developed pharmaceutical markets. It discusses the principal changes that have been observed and focuses on the present and future consequences for those markets. Comprehensive analysis of pharma pricing and reimbursement in leading markets Developments in Pricing and Reimbursement in Leading Pharma Markets 2010-2020 examines that sector through a comprehensive review of information sources. We harness both primary and secondary research. This report provides quantitative and qualitative analyses, with discussion of commercial drivers and restraints. There are over 45 tables and figures included, as well as two interviews with experts. The result is a comprehensive market- and industry-centred study, with detailed analyses and informed opinion to benefit your work. Report Highlights Companies Listed A. Menarini Pharma UK S.R.L Abbott Laboratories Ltd Abraxis BioScience Inc Acorus Therapeutics Ltd Actavis UK Ltd Actelion Pharmaceuticals UK Ltd Agenzia Italiana del Farmaco (AIFA, Italian Medicines Agency) Alan Pharmaceuticals Ltd Alcon Laboratories (UK) Ltd Alexion Pharma UK Alk-Abello (UK) Ltd Allergan Ltd Allergy Therapeutics Ltd Alliance Pharmaceuticals Ltd Almirall UK Ltd Alphashow Ltd Amdipharm plc Amerlioration du Service Medical Rendu (ASMR, France) Amgen Ltd Archimedes Pharma UK Ltd Ardern Healthcare Ltd Aspen Global Inc Astellas Pharma Inc AstraZeneca plc Axcan Pharma S.A. B. Braun Medical Ltd Basilea Pharmaceuticals Ltd Bayer plc Beacon Pharmaceuticals Ltd Biogen Idec Ltd BioMarin Europe Ltd Biovitrum AB Boehringer Ingelheim Bristol-Myers Squibb Pharmaceuticals Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, Germany) Bundesministerium für Gesundheit (Federal Ministry of Health and Social Security, Germany) Bundesministerium fur Gesundheit und Soziales (BMGS, Germany) Bureau of Indian Affairs (State Provision, USA) Cambridge Laboratories Ltd Celgene Ltd Centre for Medicare and Medicaid Services (CMS, USA) Cephalon UK Ltd Chanelle Medical U.K. Ltd Chemidex Pharma Ltd Chiesi Ltd Chugai Pharma UK Ltd CliniMed Ltd Comité Economique des Produits de Santé (CEPS, formerly CEM, EU) Consiglio Superiore di Sanita (CSS, National Health Council, Italy) Cotisation Maladie Universelle (CMU, France) CP Pharmaceuticals Ltd Crucell (UK) Ltd Daiichi Sankyo Dee Pharmaceuticals Ltd Derma UK Ltd Dermal Laboratories Ltd Dexcel Pharma Ltd DHP healthcare Ltd Dirección General de Farmacia y Productos Sanitarios (DGFPS, Spain) Discovery Pharmaceuticals Ltd Dr Faulk Pharma UK Ltd E C De Witt & Company Ltd Ecolab Inc Eisai Ltd Eli Lilly & Company Ltd Eumedica Pharmaceuticals A.G European Medicines Evaluation Agency (EMEA) Exclusive Provider Organization (EPO, USA) Exelgyn Laboratories Ltd Ferndale Pharmaceuticals Ltd Ferring Laboratories Ltd Flynn Pharma Ltd Food and Drug Administration (FDA, USA) Forest Laboratories UK Forum Health Products Ltd Fresenius Medical Care (UK) Ltd Galderma (UK) Ltd Galen Ltd GE Healthcare Ltd Geistlich Sons Ltd Generics (UK) Ltd Genzyme Therapeutics German Association of Research-based Pharmaceutical Companies (VFA, Germany) GlaxoSmithKline UK Ltd Glenwood Laboratories Ltd Goldshield Group plc Grunenthal Ltd Health Insurance Options for the Unemployed (COBRA, USA) Health Maintenance Organisations (HMOs, USA) HK Pharma Ltd IBA Molecular UK Ltd Independent Practice Association (IPA, USA) INO Therapeutics Ltd Institute for Quality and Economy in the Health Care Sector (IQWiG, Germany) Institute of Pharmaceutical Management Intrapharm Laboratories Ltd Ipsen Ltd IS Pharma plc IS Pharmaceuticals Ltd Janssen-Cilag Ltd Javelin Pharmaceuticals Ltd Johnson & Johnson MSD (McNeil Healthcare (UK) Ltd Kestrel Ophthalmics Ltd King Pharmaceuticals Ltd Kyowa Hakko UK Ltd Lincoln Medical Ltd Lundbeck Ltd Marlborough Pharmaceuticals Ltd Martindale Pharmaceuticals Ltd MASTA Ltd Meda Pharmaceuticals Ltd Medac International GmbH Medicaid (State Provision, USA) Medicare (State Provision, USA) Merck Serono Merck Sharp & Dohme Ltd Merz Pharma UK Ltd Ministry of Health, Labour and Welfare (MHLW, Japan) Molnlycke Health Care Nacional de la Salud/National Institutes of Health, INSALUD, Spain) National Coalition on Health Care (NCHC, USA) National Health Service (NHS, UK) National Institute for Health Management (INGESA, previously Instituto Nacional de la Salud/National Institutes of Health, INSALUD, Spain) National Institute for Health Management (INGESA, previously Instituto) National Institute of Clinical Effectiveness (NICE, UK) National Pharmacists' Association (NPA, Spain) NHS Prescription Services (previously known as the Prescription Pricing Division or PPD, UK) Nordic Pharma (UK) Ltd Norgine Pharmaceuticals Ltd Novartis Novartis Consumer Health (UK) Ltd Novartis Vaccines & Diagnostics Ltd Novo Nordisk Nycomed UK Ltd Organisation for Economic Co-operation and Development (OECD) Orion Pharma UK Ltd Orphan Europe (UK) Ltd Otsuka Pharmaceuticals (UK) Ltd Ovation Healthcare International Ltd Paines & Byrne Ltd Peckforton Pharmaceuticals Ltd Pfizer Inc Pharma Mar, S.A. Pharmasure Ltd Physician-Hospital Organization (PHO, UK) Pierre Fabre Ltd PLIVA Pharma Ltd Preferred Provider Organization (PPO, USA) Procter & Gamble Profile Pharma Ltd Prontuario Farmaceutico Nazionale (PFN, National Pharmaceutical Formulary, Italy) ProStrakan Group plc Ranbaxy (UK) Ltd Ratiopharm (now part of Teva) Recordati Pharmaceuticals Ltd Resource Medical UK Ltd Roche Rosemont Pharmaceuticals Ltd Sagani Ltd Sanochemia UK Ltd Sanofi Pasteur MSD Sanofi-Aventis Schering Plough Ltd Servier Laboratories Ltd Servizio Sanitario Nazionale (SSN, the Italian National Health Service, NHS) Shire Pharmaceuticals Ltd Sigma-Tau Pharma Ltd Smith & Nephew Healthcare Solvay Healthcare Ltd SpectrumThea Pharmaceuticals Ltd SpePharm UK Ltd SSL International plc STADA Arzneimittel AG State Children's Health Insurance Program (SCHIP) (State Provision, USA) STD Pharmaceutical Products Ltd Stiefel Laboratories (UK) Ltd Stragen UK Ltd Syner-Med (Pharmaceutical Products) Ltd Takeda UK Ltd Teofarma S.r.I. Teva UK Ltd The American Association for Retired Persons (AARP) The Medicines and Healthcare Products Regulatory Agency (MHRA, UK) The Pharmaceutical Price Regulation Scheme (PPRS, UK) The Spanish National Health System (SNS) Thornton & Ross Ltd Tillomed Laboratories Ltd TopoTarget A/S Transdermal Ltd TRICARE, formerly Civilian Health and Medical Program of the Uniformed Services (CHAMPUS, USA) UCB Pharma Ltd UnitedHealth Group Veterans Health Administration (VHA, USA) Vitaline Pharmaceuticals UK Ltd Walgreens Wal-Mart William Ransom & Son plc Wyeth (now part of Pfizer) Yamanouchi Pharmaceutical Co. (now Astellas Pharma) [Fade out the market survey infos] |
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1. Executive Summary 1.1 Overview of Pricing and Reimbursement in 2010 1.2 Aims, Scope and Format of the Report 1.3 Research & Analysis Methods 2. Introduction to Pricing and Reimbursement: The Increasing Control by Governments 2.1 Price is the Key (I) 2.2 Reimbursement: Who Pays? 2.3 Price is the Key (II) 2.4 The Reimbursement System Described 2.5 Different Reimbursement Systems, Different Drug Prices 2.6 The Different Systems of Reimbursement 2.6.1 International Reference Pricing 2.6.2 Therapeutic Class Reference Pricing 2.6.3 Profit Controls 2.6.4 Doctors' Budgets 2.6.5 Direct Price Controls 2.6.6 Price-Volume Limitations 2.6.7 Rebate Requirements 2.6.8 Reimbursement Restrictions 2.6.9 Fourth Hurdle Requirements/Cost-Effectiveness Reviews 2.6.10 Positive/Negative Lists 2.7 The Influence of Parallel Trade on Drug Pricing 2.8 Marketing Approval is Necessary Prior to Reimbursement 2.9 Pricing Approval Comes After Marketing Approval 2.10 The High Costs of Bringing a Drug to Market 2.11 Drug Purchase Decisions by Doctors Are All-Important in Drug Sales 2.12 The Price Inelasticity of a Doctor’s Decision over Drug Prescription 2.13 Governmental Influence on Doctors' Prescribing Choices Lowers Drug Costs 2.14 Healthcare Costs Throughout the Developed World are Increasing 2.15 Drivers of Drug Expenditure 2.16 Restraints on Drug Expenditure 2.17 In Proportion to its GDP the US Spent the Most on Healthcare 2.18 All Governments Want to Cut Drug Expenditure: Drug Price Control is a Powerful Budgetary Measure 2.19 The Market and Company Factors that Influence Drug Pricing 2.20 OTC Drugs are Not Price Controlled 2.21 Generic Drugs Lower Healthcare Costs 2.22 Increasing Use of Generic Drugs Will Create Savings for Healthcare Systems 2.23 Price Controls May Affect Drug Launches 2.24 Cost Containment Methods have had Limited Effects? 2.25 The Future of Global Pricing and Reimbursement 3. Pricing and Reimbursement in the US: The Advent of Price Controls? 3.1 An Overview 3.2 US and European Drug Pricing Models Compared 3.3 The US Healthcare System 3.4 Pharmacy Benefit Managers (PBMs): The Middlemen 3.5 The Development of Present-Day Managed Care in the US 3.6 The Cost of Private Health Insurance Premiums 3.7 Private Health Insurance and State Organised Healthcare 3.8 The US Managed Healthcare System 3.9 What are HMOs? 3.10 PPO Plans 3.11 POS Plans 3.12 Different MCOs Compared 3.13 Employers and the US Healthcare System: The Rise of PPO Health Plans 3.14 Health Insurance Options for the Unemployed: COBRA 3.15 The Uninsured Patient in the US 3.16 Medicaid: Overview 3.17 Medicare: Overview 3.18 Drug Reimbursement, MCOs and Medicare/Medicaid 3.18.1 Medicare/Medicaid 3.18.2 Private Insurers 3.18.3 HMOs 3.19 The US Spends Nearly 14% of its GDP on Healthcare 3.20 Private Insurance Pays for Over 35% of US Healthcare Needs 3.21 In 2008 US Prescription Drug Costs Constituted 10% of Healthcare Spending 3.22 US Healthcare Spending Increased by over 10% in 2008 3.23 US Pricing and Federal Discounts 3.24 US Drug Prices are the Highest in the World 3.25 Prices for the Same Drug Can Vary 3.26 Medicare Prescription Drug Improvement and Modernization Act, 2003 3.27 The Patient Protection and Affordable Care Act of 2010 3.27.1 A Brief Overview 3.27.2 Reforms in the New Insurance Marketplace 3.27.3 Reforms Medicare Advantage (MA) 3.27.4 Reforms Part D Coverage Gap: "Donut Hole" Coverage 3.27.5 Reforms in the Retiree Drug Plans 4. Pricing and Reimbursement in Europe: Change in What Ways? 4.1 Reference Pricing is a Common P&R Mechanism in Europe 4.2 Reference Pricing Causes Drugs to be Priced Below the Market Level 4.3 Price Differentials in the EU 4.4 Generic Prescribing and Substitution Varies Throughout Europe 4.5 Generic Use Varies in Europe 4.6 EU Accession Will Encourage Price Differentials and Generic Usage 4.7 A Single European Price for Pharmaceuticals is Unlikely 4.8 European Hospital Drug Prices 4.9 Parallel Trade is Used as a Cost Containment Method 4.10 The Impact of the Euro on Drug Prices 4.11 Different Forms of EU Healthcare Financing 4.12 Single Payer 4.13 Social Insurance – Sickness Funds 4.14 Private Insurance 4.15 The Payment of European Pharmacists 4.16 The Future of Drug Pricing and the Market for Drugs in Europe 5. Pricing and Reimbursement in Germany 5.1 An Overview 5.2 The German Pharmaceutical Market in 2010 5.3 German Healthcare System Recovering from Financial Shortfall 5.4 The German Response to its Healthcare System Shortfall 5.5 The Effect of Reunification on the German National Health System 5.6 Germany has Fastest Drug Approvals Process in Europe 5.7 German Drug Prices are Higher than the European Average 5.8 The German Reference Price System Now Includes Patented Drugs 5.9 Reference Pricing 5.10 Criteria for Reimbursement and Negative Lists 5.11 The Limits on Co-Pay 5.12 Germany Endorses Generic Substitution 5.13 Budgets Imposed on Doctors in an Attempt to Cut Drug Costs 5.14 Healthcare Reform in 2007 5.15 Compulsory Health Insurance for Everyone Living in Germany 5.16 German Pricing and Reimbursement Systems Have Become More Strict 6. Pricing and Reimbursement in France 6.1 An Overview 6.2 The Price of Drugs in France Matches the European Average 6.3 The French Healthcare System 6.4 Healthcare Coverage 6.5 The French Healthcare System 6.6 Voluntary Health Insurance (VHI) 6.7 Out-of-Pocket Payments 6.8 French Drug Pricing is Tightly Regulated 6.9 An Informal Reference Pricing System Exists in France 6.10 Wholesale and Pharmacy Prices 6.11 The Criteria for Reimbursement 6.12 The Size of Reimbursement 6.13 The Nature of the Drug Price Agreements Between the Pharmaceutical Industry and the CEPS 6.14 Generic Substitution as an Attempt to Reduce Drug Costs 6.15 French Health System Reform – How Successful? 7. Pricing and Reimbursement in Italy 7.1 An Overview 7.2 The Italian Healthcare System 7.3 Drug Reimbursement System 7.4 Authorities for Reimbursement Decision Making 7.5 The AIFE: Setting the Drug Price 7.6 Italian Pharmacies 7.7 Changes in Distribution Margins 7.8 Italian Pharmaceutical Law 7.9 The Introduction of Generics 7.10 The Effect of Drug Pricing Strategies on Italian Drug Spending 7.11 The New System 8. Pricing and Reimbursement in Spain 8.1 An Overview 8.2 The Spanish National Health System (SNS) 8.3 Reimbursement Levels 8.4 The Criteria for Reimbursement and Negative Lists 8.5 Drug Authorisations and Other Bodies 8.6 The Pricing of Drugs in Spain 8.7 Reference Pricing System in Spain 8.8 The Penetration of Generics is Low in Spain 8.9 Spanish Parallel Trade and Dual Pricing 8.10 The Price of Drugs in Spain 8.11 Spain Practises Generic Substitution 8.12 The Distribution of Drugs 8.13 Cost Containment and Prescribers’ Budgets 8.14 New "Health Pact" in Spain, 2010 8.15 Spain Uses Price Freezing as a Cost-Saving Procedure 9. Pricing and Reimbursement in the UK 9.1 An Overview 9.2 Drug Approval Process 9.3 Healthcare Coverage 9.4 Patient Co-Payment 9.5 The Pharmaceutical Price Regulation Scheme 9.6 New PPRS Regulations in 2009 9.7 Pharmaceutical Companies and the Monitoring of Drug Profits 9.8 National Institute of Clinical Effectiveness (NICE) – How Effective in Reducing Drug Costs? 9.9 Pharmacy Payments 9.10 The Criteria for Reimbursement 9.11 The Size of Reimbursement 9.12 Prescribers’ Budgets are Unpopular with Some Doctors But Reduce Drug Expenditure 9.13 Generic Use is Increasing 9.14 Drug Prices Have Been Reduced in the UK Market 9.15 Prescribers’ Budgets – the Most Successful Aspect of UK's Pricing and Reimbursement System? 10. Pricing and Reimbursement in Japan 10.1 An Overview 10.2 The Japanese Healthcare System 10.3 Revisions to the Health Insurance Law Caused an Increase in Co-Pay 10.4 Japanese Drug Pricing 10.5 The Japanese Reference System 10.6 The Re-examination and Re-evaluation Drug Systems are Used to Predict Drug Safety 10.7 Japan Has Reduced Healthcare Spending Including that on Drugs 10.8 Generic Drug Prices Are Relatively High 10.9 Japan Promotes Generic Substitution to Reduce Costs 10.10 The Japanese Wholesale Market in Consolidation 10.11 Bungyo: the Separation of Dispensing and Prescribing is Rapidly Increasing 10.12 Bungyo Separation Has Dramatic Effect on Retail Pharmacies 10.13 New Developments: Contract Manufacturing Will Increase 10.14 New Drug Approval and Licensing System Will Cut Drug Approval Time 10.15 Faster Approval Times Will Facilitate Entry into the Japanese Pharmaceutical Market 10.16 The Japanese Government Directly Controls Drug Prices through Price Cuts 11. Expert Views on Pricing and Reimbursement 11.1 Dr Sanjay Bajpai, MS, MABA, PhD, President, Institute of Pharmaceutical Management, New York, USA 11.1.1 Key Issues in US Pricing & Reimbursement 11.1.2 The Current State of Affairs in the US 11.1.3 Insurance Coverage and the Uninsured 11.1.4 Key Changes in US Healthcare Reforms 11.1.5 US and the European Healthcare Systems 11.1.6 Generic Medicines 11.2 Dr Cyrus A. Chowdhury, Vice President, Global Market Access, Insight Strategy Advisors, New York, USA 11.2.1 On Emerging Markets 11.2.2 On BRIC Nations and CEE 11.2.3 On Latin America, Middle East and Africa 11.2.4 Factors Affecting Market Development 11.2.5 On Disease Prevalence in Developing Countries 11.2.6 Long Term Success in Emerging Markets 11.2.7 Cost Burden of New Therapeutic Products 12. Conclusions 12.1 Drug Pricing Controls Will Become More Stringent 12.2 Developments in the US Pharma Market Sector 12.3 Concluding Thoughts [Fade out table of contents] |
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Table 2.1 Comparative Drug Prices in Selected Developed Countries, 2010 Table 2.2 Percentage Excess in Drug Prices in the US Compared to Selected Countries, 2003 Table 2.3 Drug Purchase Decision Making, 2010 Table 2.4 Healthcare Spending by Country, 2007 Table 2.5 Total Health Spending and Drug Expenditure per Patient, 2007 Table 2.6 The Top Five Countries by Out-of-Pocket (OOP) Expenditure on Health, 2007 Table 2.7 The Top Five Countries by Total Expenditure on Health, 2007 Table 2.8 The Top Five Countries by Total Expenditure on Drugs as Percentage of Total Expenditure on Health, 2007 Table 2.9 Top Five Countries by Total Health Spending per Capita, 2007 Table 2.10 Factors that Influence Drug Prices, 2010 Table 2.11 Current Practices in the Development of Increased Generic Use, 2010 Table 3.1 Annual Growth in Private Health Insurance Premiums, 1989-2004 Table 3.2 A Comparison in Average Plan Costs Between Several Californian HMOs, 2004 Table 3.3 Monthly Insurance Premiums: Single and Family Enrolled in Group Health Plans, 2004 Table 3.4 US Spending on Healthcare in Comparison with Other Countries, 2007 Table 3.5 Sources of US Healthcare Payments, 2007 Table 3.6 US Healthcare Spending by Category, 2008 Table 3.7 Annual Growth Rates by US Healthcare Spending Categories, 2008 Table 3.8 US Healthcare Spending, 2000-2005 Table 3.9 The Relative Contributions of Price, Usage and Drug Type to Increases in Pharmaceutical Prices, 1997-2002 Table 3.10 A Comparison of Prescription Drug Prices For a 30-day supply: US and Europe, 2010 Table 3.11 Timeline of Key Elements for the PPACA, 2010-2012 Table 3.12 Timeline of Key Elements for the PPACA, 2013-2020 Table 4.1 Price Control or Drug Supply Control Mechanisms as Part of P&R Systems, 2010 Table 4.2 Pricing and Reimbursement Systems of Selected European Countries, 2005 Table 4.3 The Two Broad P&R Systems in Europe, 2010 Table 4.4 EU Countries and Reference Pricing, 2005 Table 4.5 Generic Use in Europe, 2004 Table 4.6 The Advantages and Disadvantages of a Single European Price for All Drugs, 2010 Table 5.1 Aspects of German Healthcare Spending, 2007 Table 5.2 Examples of Drug Reforms in Germany, 2004-2010 Table 6.1 Aspects of French Healthcare Spending, 2009 Table 7.1 Healthcare Statistics for the Italian Market, 2007 Table 7.2 Reimbursement Classes of Drugs in the Italian Market, 2010 Table 8.1 Aspects of Spanish Healthcare Spending, 2007 Table 8.2 Reimbursement Categories in the SNS, 2010 Table 9.1 Aspects of UK Healthcare Spending, 2007 Table 9.2 Pharmaceutical Companies Participating in the PPRS, 2009 Table 9.3 Prescription Charges in the UK, 2010 Table 9.4 People Entitled to Free Prescriptions in UK, 2010 Table 9.5 How a 'QALY' is Calculated by NICE, 2010 Table 9.6 UK Department of Health Classes of Generic Drugs, 2010 Table 10.1 Aspects of Japanese Healthcare Spending, 2007 Table 10.2 Classification and Rate of Japanese Drug Pricing Premiums, 2010 Figure 2.1 Leading Generic Drug Markets: Market Shares, 2008 Figure 3.1 US Healthcare System, 2010 [Fade out list of tables / figures] |
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