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

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

Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Pricing and Reimbursement in Brazil - Health Technology Assessment (HTA) Studies to Facilitate Setting of Ceiling Prices for New Drugs”. It provides a comprehensive overview of the healthcare system, and pricing and reimbursement process in Brazil with key data, information and analysis of the pricing and reimbursement steps in the country. The report closely scrutinizes the major changes in pharmaceuticals-related pricing and reimbursement in 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 Agencia Nacional de Vigilancia Sanitaria ANVISA which grants the marketing approval and the Camara de Regulacao 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

- Detailed study of the healthcare scenario in 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

- Build an understanding of the pharmaceuticals-related key pricing and reimbursement mechanisms in 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.

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 7
1.2 List of Figures 8
2 Pricing and Reimbursement in Brazil - Introduction 10
3 Pricing and Reimbursement in Brazil - Overview 11
3.1 Trends in Population and Life Expectancy 11
3.1.1 Population of Brazil 11
3.1.2 Comparison of Population amongst BRIC Nations and the US 12
3.1.3 Life Expectancy 13
3.2 Socio-Economic and Demographic Trends 14
3.2.1 Shift in Demographics 14
3.2.2 Rise in Personal Disposable Income 16
3.2.3 Disease Burden 18
3.3 Healthcare in Brazil 20
3.3.1 Healthcare Expenditure in Brazil 20
3.3.2 Comparative Analysis 25
3.4 Healthcare System in Brazil 32
3.4.1 Health Workforce and Infrastructure in Brazil 32
4 Pricing and Reimbursement in Brazil - Introduction to Pharmaceutical Market of Brazil 38
4.1 Market Size and Market Forecasts 38
4.1.1 Pharmaceutical Market Sub-sectors 39
4.1.2 Pharmaceutical Market Share by Therapy Area 40
4.1.3 Opportunities and Challenges 41
5 Pricing and Reimbursement in Brazil - Healthcare Regulation 43
5.1 Introduction 43
5.2 Current Regulatory Framework 43
5.2.1 Agencia Nacional de Vigilancia Sanitaria (ANVISA) 43
5.2.2 Drug Approval Process 44
5.2.3 Drug Registration Process 45
5.3 Patents and Generics (IPR) 46
5.4 Health Insurance Coverage 47
5.4.1 Public Insurance 47
5.4.2 Private Insurance 47
6 Pricing and Reimbursement in Brazil - Pricing 50
6.1 Pricing Policies 50
6.1.1 Annual Price Adjustments 51
6.2 Price - Setting Authorities 52
6.2.1 Ministry of Health (MOH) 52
6.2.2 Agencia Nacional de Vigilancia Sanitaria (ANVISA) 52
6.2.3 National Agency for Supplementary Health (ANS) 53
7 Pricing and Reimbursement in Brazil - Reimbursement 54
7.1 The Reimbursement Process 54
7.1.1 SUS Sistema Unico de Saude (Unified Health System) 57
7.2 Health Technology Assessment (HTA) in Brazil’s Public Health System 58
7.2.1 Objectives of HTA 59
7.2.2 Department of Science and Technology (Departamento de Ciencia e Technologia - DECIT) 59
7.2.3 National Policy on Health Technology Management 60
8 Appendix 61
8.1 Market Definitions 61
8.2 Abbreviations 61
8.3 Sources 62
8.4 Research Methodology 62
8.4.1 Healthcare System 63
8.4.2 Pharmaceutical Regulations 63
8.4.3 Pricing of Pharmaceutical Drugs 63
8.4.4 Reimbursement of Pharmaceutical Drugs 63
8.4.5 Pricing and Reimbursement in Major Therapy Areas 64
8.5 Contact Us 64
8.6 Disclaimer 64

1.1 List of Tables
Table 1: Pricing and Reimbursement in Brazil, Population (million), 2005-2011 11
Table 2: Pricing and Reimbursement in Brazil, Population Estimates (million), 2011-2016 11
Table 3: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2005-2011 12
Table 4: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2011-2016 12
Table 5: Pricing and Reimbursement in Brazil, Average Life Expectancy (Years), 1960-2010 13
Table 6: Pricing and Reimbursement in Brazil, Population Age Structure (%), 1980-2050 14
Table 7: Pricing and Reimbursement in Brazil, Personal Disposable Income, Brazil ($bn), 2006-2011 16
Table 8: Pricing and Reimbursement in Brazil, Personal Disposable Income Forecasts, Brazil ($bn), 2011-2015 16
Table 9: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2006-2011 17
Table 10: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2011-2015 17
Table 11: Pricing and Reimbursement in Brazil, All Causes of Death in Brazil, 2008 19
Table 12: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure, % of GDP, 1995-2010 21
Table 13: Pricing and Reimbursement in Brazil, Public Healthcare Expenditure as Compared to Total Healthcare Expenditure, % of GDP, 1995-2010 22
Table 14: Pricing and Reimbursement in Brazil, Private and Public Healthcare Expenditure, % of Total Healthcare Expenditure, 1995-2002 23
Table 15: Pricing and Reimbursement in Brazil, Private and Public Health Expenditure, % of Total Health Expenditure, 2002-2010 23
Table 16: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 1995-2002 24
Table 17: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 2002-2010 25
Table 18: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure as % of GDP, BRIC and The US, 2006-2010 26
Table 19: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2010-2050 27
Table 20: Pricing and Reimbursement in Brazil, Public Health Expenditure as % of Total Health Expenditure, BRIC and The US, 2006-2010 28
Table 21: Pricing and Reimbursement in Brazil, Per Capita Total Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 29
Table 22: Pricing and Reimbursement in Brazil, Per Capita Public Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 30
Table 23: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, BRIC and The US, 2006-2010 31
Table 24: Pricing and Reimbursement in Brazil, Number of Physicians, BRIC and The US, 2010 33
Table 25: Pricing and Reimbursement in Brazil, Number of Nursery and Midwifery Personnel, BRIC and The US, 2010 34
Table 26: Pricing and Reimbursement in Brazil, Number of Dentistry Personnel, BRIC and The US, 2010 35
Table 27: Pricing and Reimbursement in Brazil, Number of Pharmaceutical Personnel, BRIC and The US, 2010 36
Table 28: Pricing and Reimbursement in Brazil, Number of Hospital Beds per 10,000 Population, BRIC and The US, 2009 37
Table 29: Pricing and Reimbursement in Brazil, Pharmaceutical Market ($bn), 2004-2011 38
Table 30: Pricing and Reimbursement in Brazil, Pharmaceutical Market Forecasts ($bn), 2011-2018 38
Table 31: Pricing and Reimbursement in Brazil, Documents Required for Product Registration by ANVISA 46
Table 32: Pricing and Reimbursement in Brazil, Private Healthcare Coverage Providers, Number of Plan Members and Revenue ($m), 2010 49
Table 33: Pricing and Reimbursement in Brazil, Price Adjustments for Retail Drugs (%), 2004-2011 51
Table 34: Pricing and Reimbursement in Brazil, Institutional and Decision-making Structure of the SUS 57

1.2 List of Figures
Figure 1: Pricing and Reimbursement in Brazil, Population Estimates (million), 2005-2016 11
Figure 2: Pricing and Reimbursement in Brazil, BRIC Nations and The US, Comparison of Population (million), 2005-2016 12
Figure 3: Pricing and Reimbursement in Brazil, Average Life Expectancy (Years), 1960-2010 13
Figure 4: Pricing and Reimbursement in Brazil, Population Age Structure (%), 1980-2050 14
Figure 5: Pricing and Reimbursement in Brazil, Aging Index, 1980-2050 15
Figure 6: Pricing and Reimbursement in Brazil, Personal Disposable Income, Brazil ($bn), 2006-2015 16
Figure 7: Pricing and Reimbursement in Brazil, Per Capita Personal Disposable Income, Brazil ($), 2006-2015 17
Figure 8: Pricing and Reimbursement in Brazil, Top 10 Causes of Death in Brazil, 2008 18
Figure 9: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure, % of GDP, 1995-2010 20
Figure 10: Pricing and Reimbursement in Brazil, Public Healthcare Expenditure Compared to Total Healthcare Expenditure, % of GDP, 1995-2010 21
Figure 11: Pricing and Reimbursement in Brazil, Private and Public Health Expenditure, % of Total Health Expenditure, 1995-2010 22
Figure 12: Pricing and Reimbursement in Brazil, Out-of-Pocket Healthcare Expenditure as % of Private Healthcare Expenditure, 1995-2010 24
Figure 13: Pricing and Reimbursement in Brazil, Total Healthcare Expenditure as % of GDP, BRIC and The US, 2006-2010 25
Figure 14: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2010-2050 26
Figure 15: Pricing and Reimbursement in Brazil, Public Healthcare Spending as % of GDP, BRIC and The US, 2006-2010 28
Figure 16: Pricing and Reimbursement in Brazil, Per Capita Total Health Expenditure (PPP int. $), BRIC Countries, 2006-2009 29
Figure 17: Pricing and Reimbursement in Brazil, Per Capita Public Health Expenditure (PPP Int. $), BRIC Countries, 2006-2009 30
Figure 18: Pricing and Reimbursement in Brazil, Out-of-Pocket Health Expenditure as % of Private Healthcare Expenditure, BRIC and The US, 2006-2010 31
Figure 19: Pricing and Reimbursement in Brazil, Number of Physicians per 10,000 Population, BRIC and The US, 2010 32
Figure 20: Pricing and Reimbursement in Brazil, Number of Nursery and Midwifery Personnel per 10,000 Population, BRIC and The US, 2010 34
Figure 21: Pricing and Reimbursement in Brazil, Number of Dentistry Personnel per 10,000 Population, BRIC and The US, 2010 35
Figure 22: Pricing and Reimbursement in Brazil, Number of Pharmacist per 10,000 Population, BRIC and The US, 2010 36
Figure 23: Pricing and Reimbursement in Brazil, Number of Hospital Beds per 10,000 Population, BRIC and The US, 2009 37
Figure 24: Pricing and Reimbursement in Brazil, Pharmaceutical Market Forecasts ($bn), 2004-2018 38
Figure 25: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2011 39
Figure 26: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2011 39
Figure 27: Pricing and Reimbursement in Brazil, Pharmaceutical Market by Sub-sectors (%), 2011 40
Figure 28: Pricing and Reimbursement in Brazil, Market Drivers and Opportunities 41
Figure 29: Pricing and Reimbursement in Brazil, Market Challenges 42
Figure 30: Pricing and Reimbursement in Brazil, Three Kinds of Drugs According to ANVISA 44
Figure 31: Pricing and Reimbursement in Brazil, Regulatory Approval Process for Clinical Trials 44
Figure 32: Pricing and Reimbursement in Brazil, Regulatory Approval Process for Clinical Trials 45
Figure 33: Pricing and Reimbursement in Brazil, Healthcare Coverage Provider, By Plan Members (%), 2009 48
Figure 34: Pricing and Reimbursement in Brazil, Price-setting Mechanism for New Molecules 50
Figure 35: Pricing and Reimbursement in Brazil, The Reimbursement Process 54
Figure 36: Pricing and Reimbursement in Brazil, Incorporation of Technologies Prior to Formation of CITEC, 2011 55
Figure 37: Pricing and Reimbursement in Brazil, Incorporation of Technologies After Formation of CITEC, 2011 56
Figure 38: Pricing and Reimbursement in Brazil, HTA within the Brazilian Ministry of Health, 2011 59