Pricing and Reimbursement in Brazil - Health Technology Assessment (HTA) Studies to Facilitate Setting of Ceiling Prices for New Drugs

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Pricing and Reimbursement in Brazil - Health Technology Assessment (HTA) Studies to Facilitate Setting of Ceiling Prices for New Drugs

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Pricing and Reimbursement in Brazil - Health Technology Assessment (HTA) Studies to Facilitate Setting of Ceiling Prices for New Drugs

Summary Brazil Brazil Brazil

Due to the rapid growth in its economy, Brazil is increasingly becoming an affluent country, one which consistently spends a high proportion of its Gross domestic product (GDP) on healthcare (close to 9%, compared to the 10-12% of the US and 4-5% for other emerging nations). Through a comprehensive public health insurance programme, it aims to offer high quality healthcare provisions to the general population. While the pharmaceutical industry has grown due to the favorable regulations implemented by the government over the past two decades, the further growth of the market in Brazil will mainly arise through a direct correlation with GDP growth. This is in contrast to the growth due to an increase in the volume of the healthcare infrastructure witnessed in other emerging economies such as China and India.

The pricing of drugs in Brazil is mainly controlled by the government through various agencies such as the Agência Nacional de Vigilância Sanitária ANVISA which grants the marketing approval and the Câmara de Regulação do Mercado de Medicamentos CMED which is responsible for determining the price of new drugs and any subsequent annual price changes. While 70% of the population is covered under the public health insurance system implemented by the government, this amounts to only about 30% of the total government expenditure on drugs. About 58% of the total healthcare expenditure is accounted for by the private healthcare system. Special programs have been launched by the government to include the essential drug list, chronic diseases and diseases that require specialized treatments. Healthcare reimbursement has been well appreciated in Brazil, and many international health organizations, such as the World Health Organization (WHO) and the International Red Cross have lauded the efforts of the Brazilian government to reach out to the masses and make available quality healthcare at costs affordable to them.

Scope Brazil

- Analysis of the pricing and reimbursement mechanisms in Brazil.

- Details about government bodies which regulate different processes of pricing and reimbursement in Brazil.

- Details about the shares of major companies in the reimbursement program of Brazil.

- Insight into the various reimbursement programs available in Brazil.

Reasons to buy Brazil

- Optimize your investment through identification and understanding of the changes in the pharmaceutical regulatory mechanism in Brazil.

- Knowledge about the regulatory bodies who undertake different processes of price registration.

- Develop effective business strategies related to new drug launches through the analytical insight gained from key trends in pricing and reimbursement scene in Brazil.

- Negotiate better with the government agencies to maximize reimbursement on the drugs by understanding the mechanism.

Table of Contents

1 Table of Contents1 Table of Contents 61.1 List of Tables 81.2 List of Figures 92 Pricing and Reimbursement in Brazil - Introduction 103 Pricing and Reimbursement in Brazil - Overview 113.1 Trends in Population and Life Expectancy 113.1.1 Population of Brazil 113.1.2 Comparison of Population amongst BRIC Nations and the US 123.1.3 Life Expectancy 133.2 Socio-Economic and Demographic Trends 143.2.1 Shift in Demographics 143.2.2 Rise in Personal Disposable Income 163.2.3 Disease Burden 183.3 Healthcare in Brazil 203.3.1 Healthcare Expenditure in Brazil 203.3.2 Comparative Analysis 253.4 Healthcare System in Brazil 313.4.1 Health Workforce and Infrastructure in Brazil 314 Pricing and Reimbursement in Brazil - Introduction to Pharmaceutical Market of Brazil 374.1 Market Size and Market Forecasts 374.1.1 Pharmaceutical Market Sub-sectors 384.1.2 Pharmaceutical Market Share by Therapy Area 394.1.3 Opportunities and Challenges 405 Pricing and Reimbursement in Brazil - Healthcare Regulation 425.1 Introduction 425.2 Current Regulatory Framework 425.2.1 Agência Nacional de Vigilância Sanitária (ANVISA) 425.2.2 Drug Approval Process 445.2.3 Drug Registration Process 455.3 Patents and Generics (IPR) 465.4 Health Insurance Coverage 475.4.1 Public Insurance 475.4.2 Private Insurance 476 Pricing and Reimbursement in Brazil - Pricing 506.1 Pricing Policies 506.1.1 Annual Price Adjustments 516.2 Price - Setting Authorities 516.2.1 Ministry of Health (MOH) 516.2.2 Agência Nacional de Vigilância Sanitária (ANVISA) 526.2.3 National Agency for Supplementary Health (ANS) 527 Pricing and Reimbursement in Brazil - Reimbursement 537.1 The Reimbursement Process 537.1.1 SUS Sistema Único de Saúde (Unified Health System) 567.2 Health Technology Assessment (HTA) in Brazil's Public Health System 577.2.1 Objectives of HTA 587.2.2 Department of Science and Technology (Departamento de Ciencia e Technologia - DECIT) 597.2.3 National Policy on Health Technology Management 598 Appendix 608.1 Market Definitions 608.2 Abbreviations 608.3 Sources 618.4 Research Methodology 618.4.1 Healthcare System 628.4.2 Pharmaceutical Regulations 628.4.3 Pricing of Pharmaceutical Drugs 628.4.4 Reimbursement of Pharmaceutical Drugs 628.4.5 Pricing and Reimbursement in Major Therapy Areas 638.5 Contact Us 638.6 Disclaimer 63

List of Tables

1.1 List of TablesTable 1: Pricing and Reimbursement in Brazil, Population (million), 2005-2010 11Table 2: Pricing and Reimbursement in Brazil, Population Estimates (million), 2010-2016 11Table 3: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2005-2010 12Table 4: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2010-2016 12Table 5: Pricing and Reimbursement in Brazil, Average Life Expectancy (Years), 1960-2010 13Table 6: Pricing and Reimbursement in Brazil, Population Age Structure (%), 1980-2050 14Table 7: Pricing and Reimbursement in Brazil, Personal Disposable Income, Brazil ($bn), 2006-2010 16Table 8: Pricing and Reimbursement in Brazil, Personal Disposable Income, Brazil ($bn), 2010-2015 16Table 9: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2006-2010 17Table 10: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2010-2015 17Table 11: Pricing and Reimbursement in Brazil, All Causes of Death in Brazil, 2008 18Table 12: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure, % of GDP, 1995-2010 20Table 13: Pricing and Reimbursement in Brazil, Public Healthcare Expenditure as Compared to Total Healthcare Expenditure, % of GDP, 1995-2010 21Table 14: Pricing and Reimbursement in Brazil, Private and Public Healthcare Expenditure, % of Total Healthcare Expenditure, 1995-2002 22Table 15: Pricing and Reimbursement in Brazil, Private and Public Health Expenditure, % of Total Health Expenditure, 2002-2010 22Table 16: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 1995-2002 23Table 17: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 2002-2009 24Table 18: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure as % of GDP, BRIC and The US, 2006-2009 25Table 19: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2010-2050 26Table 20: Pricing and Reimbursement in Brazil, Public Health Expenditure as % of Total Health Expenditure, BRIC and The US, 2006-2009 27Table 21: Pricing and Reimbursement in Brazil, Per Capita Total Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 28Table 22: Pricing and Reimbursement in Brazil, Per Capita Public Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 29Table 23: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, BRIC and The US, 2006-2009 30Table 24: Pricing and Reimbursement in Brazil, Number of Physicians, BRIC and The US, 2010 32Table 25: Pricing and Reimbursement in Brazil, Number of Nursery and Midwifery Personnel, BRIC and The US, 2010 33Table 26: Pricing and Reimbursement in Brazil, Number of Dentistry Personnel, BRIC and The US, 2010 34Table 27: Pricing and Reimbursement in Brazil, Number of Pharmaceutical Personnel, BRIC and The US, 2010 35Table 28: Pricing and Reimbursement in Brazil, Number of Hospital Beds per 10,000 Population, BRIC and The US, 2009 36Table 29: Pricing and Reimbursement in Brazil, Pharmaceutical Market ($bn), 2004-2010 37Table 30: Pricing and Reimbursement in Brazil, Pharmaceutical Market Forecasts ($bn), 2010-2018 37Table 31: Pricing and Reimbursement in Brazil, Documents Required for Product Registration by ANVISA 46Table 32: Pricing and Reimbursement in Brazil, Private Healthcare Coverage Providers, Number of Plan Members and Revenue ($m), 2010 49Table 33: Pricing and Reimbursement in Brazil, Price Adjustments for Retail Drugs (%), 2004-2011 51Table 34: Pricing and Reimbursement in Brazil, Institutional and Decision-making Structure of the SUS 56

List of Figures

1.2 List of FiguresFigure 1: Pricing and Reimbursement in Brazil, Population Estimates (million), 2005-2016 11Figure 2: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2005-2016 12Figure 3: Pricing and Reimbursement in Brazil, Average Life Expectancy (Years), 1960-2010 13Figure 4: Pricing and Reimbursement in Brazil, Population Age Structure (%), 1980-2050 14Figure 5: Pricing and Reimbursement in Brazil, Aging Index, 1980-2050 15Figure 6: Pricing and Reimbursement in Brazil, Personal Disposable Income, Brazil ($bn), 2006-2015 16Figure 7: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2006-2015 17Figure 8: Pricing and Reimbursement in Brazil, Top 10 Causes of Death in Brazil, 2008 18Figure 9: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure, % of GDP, 1995-2010 20Figure 10: Pricing and Reimbursement in Brazil, Public Healthcare Expenditure Compared to Total Healthcare Expenditure, % of GDP, 1995-2010 21Figure 11: Pricing and Reimbursement in Brazil, Private and Public Health Expenditure, % of Total Health Expenditure, 1995-2010 22Figure 12: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 1995-2009 23Figure 13: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure as % of GDP, BRIC and The US, 2006-2009 25Figure 14: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2010-2050 26Figure 15: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2006-2009 27Figure 16: Pricing and Reimbursement in Brazil, Per Capita Total Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 28Figure 17: Pricing and Reimbursement in Brazil, Per Capita Public Health Expenditure (PPP Int. $), BRIC Countries, 2006-2009 29Figure 18: Pricing and Reimbursement in Brazil, Out-of-Pocket Health Expenditure as % of Private Healthcare Expenditure, BRIC and The US, 2006-2009 30Figure 19: Pricing and Reimbursement in Brazil, Number of Physicians per 10,000 Population, BRIC and The US, 2010 31Figure 20: Pricing and Reimbursement in Brazil, Number of Nursery and Midwifery Personnel per 10,000 Population, BRIC and The US, 2010 33Figure 21: Pricing and Reimbursement in Brazil, Number of Dentistry Personnel per 10,000 Population, BRIC and The US, 2010 34Figure 22: Pricing and Reimbursement in Brazil, Number of Pharmacist per 10,000 Population, BRIC and The US, 2010 35Figure 23: Pricing and Reimbursement in Brazil, Number of Hospital Beds per 10,000 Population, BRIC and The US, 2009 36Figure 24: Pricing and Reimbursement in Brazil, Pharmaceutical Market Forecasts ($bn), 2004-2018 37Figure 25: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2010 38Figure 26: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2010 38Figure 27: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2010 39Figure 28: Pricing and Reimbursement in Brazil, Market Drivers and Opportunities 40Figure 29: Pricing and Reimbursement in Brazil, Market Challenges 41Figure 30: Pricing and Reimbursement in Brazil, Three Kinds of Drugs According to ANVISA 43Figure 31: Pricing and Reimbursement in Brazil, Regulatory Approval Process for Clinical Trials 44Figure 32: Pricing and Reimbursement in Brazil, Regulatory Approval Process for Clinical Trials 45Figure 33: Pricing and Reimbursement in Brazil, Healthcare Coverage Provider, By Plan Members (%), 2009 48Figure 34: Pricing and Reimbursement in Brazil, Price-setting Mechanism for New Molecules 50Figure 35: Pricing and Reimbursement in Brazil, The Reimbursement Process 53Figure 36: Pricing and Reimbursement in Brazil, Incorporation of Technologies Prior to Formation of CITEC, 2011 54Figure 37: Pricing and Reimbursement in Brazil, Incorporation of Technologies After Formation of CITEC, 2011 55Figure 38: Pricing and Reimbursement in Brazil, HTA within the Brazilian Ministry of Health, 2011 58