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Universidade do Estado do Rio de Janeiro
Faculdade de Ciências Médicas
Departamento de Clínica Médica
Health Technology Assessment
Brazilian environment
Denizar Vianna
Outline
 An Overview of Health Care System
 Structure of HTA in Brazil
 How Brazil uses HTA to inform coverage decisions:
Case Study
An Overview of Health Care System
 Population: 192 million
 Area: 8,514, 215.3 km2, 27 states
 GDP: US$ 2.201 trillion, with a GDP per capita of US$
11,600.
 Public Health Care System Coverage: Universal Access
 Private Coverage: 25% of the population (≈ 48 million)
Source: http://www.ipeadata.gov.br/
An Overview of Health Care System
Parameters
Public
Private
100%
25%
Taxes
Employers and employees
contributions
Individuals out-of-pocket
Provision
64,000 primary care units
5,900 hospitals in the
federal, state, and
municipal level
Dedicated private
hospitals and
outpatient clinics
Purchasing
Diagnostic Related Groups
Salaries for physicians
Fee for service
Coverage
Funding
Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets:
How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010
An Overview of Health Care System
Reimbursement
Public
Private
Drugs
Basic health care
Basic Component of
Pharmaceutical Assistance
Not reimbursed
Out of pocket
Drugs
Endemics, HIV,
Blood products
Component of Strategic
Pharmaceutical Assistance
Not reimbursed
Public programme
Drugs
Specialized
health care
Component of Specialized
Pharmaceutical Assistance
Registered drugs taken in
ambulatory or inhospital
care (ICD-10)
Exclusion of oral drugs
Procedures
Medium and High
Complexity of Ambulatory
and Inpatient Care
List of covered procedures
updated every 2-years
Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets:
How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010
Outline
 An Overview of Health Care System
 Structure of HTA in Brazil
 How Brazil uses HTA to inform coverage decisions:
Case Study
Who is who in the Brazilian Context
PRODUCERS
Supply chain of healthcare
products
REGULATORS
MoH and Department of the
treasury
ANVISA
ANS
INMETRO
INPI
MANAGERS
MoH
HMOs
PAYERS
Unified Health System (public)
Employers and out-of-pocket
(private)
USERS
Patients (patients organizations)
EVALUATORS
MoH
ANVISA
Medical Schools
PROVIDERS
Healthcare providers
Health Technology Assessment in Brazil
REGISTRATION
ANVISA
National Agency of Sanitary Vigilance
–Efficacy and safety of new technologies
–Production quality
–Approved label
Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets:
How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010
Health Technology Assessment in Brazil
REGISTRATION
CMED
Chamber for Regulation of the
Pharmaceutical Market (ANVISA)
–Regulation of reference prices for drugs
PRICING
– International price – 9 reference countries
– Price of other drugs with similar efficacy in the
market
–Yearly price updates
–Coefficient of Price Adaptation (21.87%) for
sales to public bodies
Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets:
How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010
Health Technology Assessment in Brazil
REGISTRATION
CONITEC
National Commission for Incorporation of
Technologies
-Evaluations based on HTA reports
PRICING
-Recommendations for inclusion or exclusion of
technologies
-Dossier submission open to the society
REIMBURSEMENT
-Final decision taken by the SCTIE
Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets:
How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010
http://portal.saude.gov.br/portal/saude/Gestor/area.cfm?id_area=1611
Commission for Incorporation of
Technologies (CITEC) Numbers

260 submissions to CITEC from 2003 to 2010
80
73
70
56
60
50
43
49
40
30
24
20
10
2
4
2003
2004
9
0
Industry
2005
2006
Public Bodies
2007
2008
Medical Societies
2009
Others
2010
CITEC Numbers
0
20
40
60
80
100
120
140
48%
Public Bodies
Others
180
13%
Industry
Medical Societies
160
10%
0%
Submissions
Recommendations
Incorporations
CITEC Numbers
0
5
10
15
20
25
30
35
Rheumatology
9%
26%
Oncology
17%
Endocrine and Metabolic Disorders
14%
Mental Health and Neurology
16%
Cardiovascular System
29%
Genetic Disorders
71%
AIDS and Viral Hepatitis
77%
Hematology
22%
Respiratory Disorders
Infectious Diseases
Submissions
33%
Recommendations
Incorporations
40
Outline
 An Overview of Health Care System
 Structure of HTA in Brazil
 How Brazil uses HTA to inform coverage decisions:
Case Study
Case Study:
Statins for patients with high risk of
cardiovascular disease
Scenario
“In Brazil, the expense of the public sector with statins in
the last 12 months was approximately R$ 92 million, and
of this amount, 96% spending represented only with
atorvastatin.
Regarding
the
quantity
purchased,
atorvastatin also has higher percentage (approximately
52%), followed by simvastatin (46%), which consumed
only 3% of public expenditures with this class of drugs.”
Source: Boletim Brasileiro de Avaliação de Tecnologias em Saúde, Ano IV, nº 9, 2009
Results
Cost-Effectiveness Analysis
OUTCOME AVOIDED
ICER*
ICER**
Death from any cause
Cost saving
R$ 433.065,05
Death from
cardiovascular cause
Cost saving
R$ 948.998,15
Myocardial infarction
Cost saving
R$ 157.854,22
Stroke
Cost saving
R$ 824.860,31
CABG or PTCA
Cost saving
R$ 517.761,59
*simvastatin versus placebo
**atorvastatin versus placebo
Source: Araujo DV et al. Análise de Custo-Efetividade da Sinvastatina versus Atorvastatina na
Prevenção Secundária de Eventos Cardiovasculares no Sistema Único de Saúde Brasileiro.
Value in Health 2011;14:S29-S32.
Case Study:
Drug Access to Rare Diseases
Drug Access to Rare Diseases
The fact that Brazil does not have an official policy
specifically for rare diseases does not mean,
however, that patients do not receive care and
treatment. They eventually secure medication,
mostly through the courts. And the SUS, one way
or another, meets the needs of these people - but
in a piecemeal fashion, without planning, with
great waste of public resources.
Drug Access to Rare Diseases
Through these protocols – the official entryway to
care for rare diseases in the public system – 45
drugs and surgical and clinical treatments were
offered, 70,000 office visits and more than 560
laboratory procedures for treatment and diagnosis
were carried out, with investment of more than
than R$ 4 million per year.
Diseases theoretically covered in the National Policy of
2009 with treatment protocol granted*
Universidade do Estado do Rio de Janeiro
Faculdade de Ciências Médicas
Departamento de Clínica Médica
THANK YOU
Denizar Vianna

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