Avaliação De Tecnologias Em Saúde
MINISTÉRIO DA SAÚDE
Avaliação de Tecnologias em Saúde
Brasília - DF
2006
About Us
The Department of Science and Technology (Departamento de Ciência
e Tecnologia – DECIT) was founded in 2000 and is part of the Ministry of
Health’s Secretariat for Science, Technology and Strategic Inputs (Secretaria
de Ciência, Tecnologia e Insumos Estratégicos – SCTIE).
Since 2006, DECIT represents the Ministry of Health of Brazil as
a member of INAHTA (International Network of Agencies for Health
Technology Assessment).
In matters regarding health technology assessments, DECIT’s role is to
develop activities for the support to and production of studies, professional
training and cooperation with teaching and research institutions as well as
with health managers.
DECIT’s HTA’s team is composed by 15 in-house consultants, whose
professional backgrounds cover different training areas that respond
to the various study and technical analysis demands: there are graduate
professionals in Economics, Pharmacy, Medicine and Nutrition science
amongst others. Most of them have a Masters degree in Public Health and
Health Sciences.
HTA activities are supported by some other 40 external consultants.
Those professionals, who are mostly of PhD level and linked to the main
public national universities, are responsible for peer-reviewing the research
proposals that are of interest for the Unified Health System (SUS).
The SUS managers constitute the principal public-target of DECIT’s
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products, amongst which we highlight the following:
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• Systematic Reviews - 31 published and 10 under evaluation
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• Health Technology Economical Appraisals – 12 under evaluation
• Appraisals on Health Technology Assessment (short reviews) – about
60 per year
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The Brazilian Public Health System
Brazil is the only South American Portuguese-speaking country and
has approximately 180 million inhabitants. It comprises 27 states and more
than 5,000 municipalities. The distinct regional, social and epidemiologic
differences throughout Brazil turn health care assistance a great challenge.
The Federal Constitution of 1988 is a landmark for the assurance of
the right to health as it created the Brazilian Public Health System.
The Brazilian Public Health System’s principle is to grant universal and
equal access to complete health care services, from basic health care to
high complexity medical assistance.
The Brazilian Public Health System is managed by the federal, state
and municipal governments through their set attributions, which are also
azil defined for scientific research and health technology assessment.
Health Technology Assessment in the Public Health System
Health Technology Assessment (HTA) is a comprehensive process
y of Health of Br
tr through which the clinical, social and economic impacts of health technology
are assessed by means of its efficacy, effectiveness, safety, costs, cost-
effectiveness ration, among other aspects.
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The main objective of HTA is to assist health policy makers in the decision-
making process concerning the incorporation of health technologies.
The following are part of health technologies: drugs; equipments;
technical procedures; organization, education, information and support
systems; assistance programs and protocol through which assistance and
medical services are rendered to the society.
Legal Landmark
Based on Law nr. 8080, which rules all health care measures and
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services in the country, including technological development in the health
sector, the National Policy on Science, Technology and Innovation in Health
(Política Nacional de Ciência e Tecnologia e Inovação em Saúde – PNCTIS)
was elaborated in 2004, in partnership with several social segments, and is
an institutional landmark for the implementation of science, technology and
innovation in health.
HTA Objectives
• Foster HTA studies for supporting decision-making within SUS in regards
to the incorporation, allocation and use of health technologies, based
on safety, efficacy, effectiveness, economic and social impacts, ethical
requirements and equity criteria;
• Monitor the use of technologies already incorporated into SUS;
• Build capacities amongst health managers and professionals;
• Disseminate HTA results throughout managers.
HTA within the Ministry of Health
Ministry of Health (MS)
Secretariat of Science, Technology
and Strategic Inputs (SCTIE)
Department of Science
and Technology (DECIT)
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General Coordination of Health
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Technology Assessment (CGATS)
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External
Working Group
Consultants
on HTA (GT ATS)
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Coordination of
Coordination of Support
Coordination of
Studies and Projects
to HTA Networks and
Technical Actions for
Clinical Research
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Management Support
Note: Acronyms in Portuguese
Sphere of Action
• Conducting studies and research promotion in the field of HTA, having as priority
criteria: gravity and prevalence of the health condition, the potential of outcomes
of the studies in changing costs and improve the quality of health care, and the
need for State action, with a focus on new technologies under incorporation
pressure as well as on those that need an assessment of effectiveness;
• Producing technical-scientific appraisals for the Commission on Health
Technology Incorporation (CITEC) and other technical areas of the Ministry
of Health and health secretariats;
• Coordinating the Permanent Working Groups on Health Technology
Assessment (GT ATS) of the Council of Science, Technology and Innovation
of the Ministry of Health (CCTI/MS), created in November 2003, which aims
azil at defining priorities for the implementation of HTA in the health system;
• Structuring a Brazilian Network on Health Technology Assessment
(REBRATS), to established for putting together management, research and
training professionals, with the objective of improving the capacities to produce
assessments that will qualify decisions within the public administration;
• Establishing Clinical Research Unites in training hospital, for the structuring
y of Health of Br of the National Network of Clinical Research, which aims at developing
tr clinical trials of drugs, procedures, equipments and diagnostic kits of priority
for the Ministry of Health;
Minis • Coordinating the process of creating the National Policy of Health Technology
Management, underpinned on Rule nr. 2510/GM of 19 December 2005;
• Actively participating in international networks of health technology
assessment, for the exchange of experiences in the area.
Proposal for the National Policy on Health Technology
Management
The National Policy on Health Technology Management (PNGTS) is
currently being finalized. It will be a key reference for measures pertaining
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to the use of health technologies within the Brazilian Public Health System.
Its most important objective is to maximize the health benefits that can be
obtained through the resources available, by ensuring the population’s
equal access to safe and effective technologies.
Furthermore, the PNGTS also strives to:
• Advise SUS and Supplementary Health managers in the process of
incorporating the technologies into the health system and services.
• Guide the process to assess and incorporate health technologies
within the Unified Health System’s spheres of management and within the
supplementary health system with basis on the analysis of consequences and
costs for the health care system and the population.
• Promote the use of updated technical and scientific information in
the process for managing health technologies.
• Promote awareness on behalf of health professionals and the
general public on the importance of the economic and social consequences
resulting from the appropriate use of technologies in the health care system
and services.
• Strengthen the use of explicit criteria and processes in prioritizing
the incorporation of technologies, while considering aspects pertaining to
effectiveness, need, safety, efficiency and equity.
The PNGTS abides to the following guidelines, which address the
efficiency in the use of scientific knowledge and resources:
• Use of scientific evidence to subsidize management: health technology assessment.
• Improve the process of incorporating technologies.
• Rational use of technology.
• Provide support to strengthen health technology teaching and management.
• Systematize and disseminate information.
• Strengthen governmental structures.
• Foster political-institutional and inter-sectorial articulation.
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Methodological Guidelines for HTA Studies
The Methodological Guidelines for Elaborating HTA Studies strive
to contribute to the qualification and assessment of studies elaborated
for the Ministry of Health, and whose demand is expected to increase as
HTA is instituted as one of the key elements in the process of incorporating
technologies in the country.
The Methodological Guidelines project is being developed according
to the type of study being elaborated or financed by the Ministry of Health,
and which includes:
• Methodological Guidelines for Appraisals put together in a partnership
azil with the Institute of Social Medicine of the State University of Rio de Janeiro
(IMS/UERJ). Published in Portuguese, English and Spanish, they are available
in hard and soft copies (www.saude.gov.br.)
• Methodological Guidelines for elaborating Systematic Reviews developed by
the Cochrane Center of Brazil (Centro Cochrane do Brazil) associated with the
Paulista School of Medicine (Escola Paulista de Medicina – EPM/Unifesp).
• Methodological Guidelines for elaborating Economic Evaluation
y of Health of Br
tr studies, developed by the IMS/UERJ, whose preliminary version is available
at www.saude.gov.br .
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Studies and Publications
Access www.saude.gov.br
Published Systematic Reviews
• Acupuncture for the treatment of lateral epicondylitis.
•Acupuncture for the treatment of lombalgy.
•Acupuncture for the treatment of carpal tunnel syndrome.
•Adalimumab for the treatment of rheumatoid arthritis.
•Drotrecogin alpha for the treatment of severe sepsis.
•Ferrara ring for the treatment for keratoconus.
•Intragastric balloon for the treatment of obesity.
•Mason bands and gastroplasties for the treatment of obesity.
•Roux-en-Y gastric bypass for the treatment of obesity.
•Efalizumab for the treatment of psoriasis.
•Embolization for the treatment of uterine myoma.
•Deep cerebral stimulation with electrodes for the treatment of
Parkinson’s disease.
•Imantinib for the treatment of chronic myeloid leukemia.
•Imantinib for the treatment of gastrointestinal tumors.
•Multi-site pacemaker in cardiac resynchronization therapy.
•Skin substitutes for the treatment of burns.
•Nucleoplasty for the treatment of herniated disks.
•Rapamicine or paclitaxel-covered stents for the treatment of
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arterial insufficiency.
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•Suburethral suspension as a technique for the treatment of urinary
incontinence in women.
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•Mechanic suture in colorectal anastomosis surgery.
•Duodenal switch and Scopinary BPD for the treatment of obesity.
•Surgical techniques for the treatment of epilepsy.
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•Single or two-level intersomatic fusion techniques for 09
the treatment of
cervical degenerative disk disease.
•Photodynamic therapy for the treatment of neovascular age-related
macular degeneration.
•Teriparatide for the treatment of osteoporosis in post-menopausal women.
•Positron emission tomography for diagnosing Hodgkin’s disease.
•Positron emission tomography for diagnosing lung cancer – systematic
review of cost-effectiveness studies.
•Positron emission tomography for diagnosing non-small cell pulmonary
carcinoma.
•Positron emission tomography for diagnosing melanoma.
•Positron emission tomography for diagnosing melanoma, Hodgkin’s
disease, non-small cell pulmonary carcinoma (executive summary).
•Positron emission tomography for oncological diagnosis.
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DECIT has also participated in the Brazilian Bulletin for Health
Technology Assessment (BRATS), under the coordination of the National
Agency of Health Surveillance as well as under BRATS’ systematic reviews nr.
1: Entecavir for the treatment of chronic Hepatites B; nr.2: Alfadrotrecogina
for the treatment of grave sepsis; and nr. 3: Test of amplification of nucleic
y of Health of Br acids (NAT) and other strategies for the detection of HIV-1 and HCV viruses
tr in the screening of donated blood.
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Systematic Reviews Being Carried Out
• Betagalsidade for the treatment of Fabry’s disease.
• Etanercept for the treatment of rheumatoid arthritis.
• Etanercept for the treatment of severe psoriasis.
• Infliximab for the treatment of severe psoriasis.
• Laronidase for the treatment of mucopolysacaridosis type I.
• Memantine for the treatment of Alzheimer’s disease.
• Pegvisomant for the treatment of acromegaly.
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• Piribedil for the treatment of Parkinson’s disease.
• Sildenafil for the treatment of pulmonary hypertension.
• Sildenafil for the treatment of pulmonary hypertension secondary to sclerodermy.
Economic Assessment Studies
• Analysis of the cost-effectiveness of the treatment of recent onset atrial
fibrillation: conventional treatment vs. ambulatory treatment.
• Pharmacoeconomic study in squizophrenic patients treated in the
psychiatric ambulatory hospitals of CAPS Florianopolis.
• Minas Telecardio: Assessment of the effectiveness and cost of a
Telecardiology Piloting System in Minas Gerais.
• Psychosis and Low and High-Cost Drugs: the cost-effectiveness relation
in the Brazilian Public Health System.
• Inter-institutional Collaborative Project for Cost-Effectiveness Studies in Health.
• Cost-effectiveness analysis of multidetector computer-automated
tomography for diagnosing coronary disease in adult patients.
• Technology assessment of pegylated interferon and conventional
interferon for the treatment of chronic hepatitis C infection.
• Studies on the cost-effectiveness analysis of incorporating new
vaccines into the routine of the National Immunizations Program
(Programa Nacional de Imunizações) – varicella, rotavirus, conjugate C
meningococcal, hepatitis A and conjugate pneumococcal.
• Study on the cost-effectiveness analysis for the Brazilian Public Health
System: fluor-18-marked PET glucose metabolism exam.
• Cost-utility analysis of alternatives to problems related to femur fractures
due to osteoporosis.
• Therapeutic interventions in urinary incontinence due to vesicle
hyperactivity in elderly women: cost-effectiveness analysis.
• Cost-effectiveness of tracking cervical-uterine cancer by developing a
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Markov model for the natural history of the disease in Brazil.
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Launched Calls for Proposals
In 2007, the Ministries of Health and Science and Technology supported
research proposals for clinical trials and health technology assessment.
Two calls for proposals were published: one public call through the Studies
Supporting Agency (FINEP/MCT), that gave priority to the assessment of
pharmacotherapies for leishmaniasis, bariatric surgeries and recombinant
insulines with human analog; and a call for proposals through the National
Council of Scientific and Technological Development (CNPq), which have
priority to studies of effectiveness, economic evaluation and of management
of health technologies.
Supported Lines of Research
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•Anticholesteremic agents for dyslipidemias:cost-effectiveness analysis (4 projects)
•Arterial hypertension: therapeutic’s variability analysis (3 projects)
•Asthma: therapeutics’ variability analysis (1 project)
•Biological drugs for rheumatoid arthritis: cost-effectiveness and budget
impact analysis. (2 projects)
•Cerebrovascular accident: therapeutics variability analysis. (2 projects)
y of Health of Br
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•High-complexity cardiac procedures: data monitoring. (4 projects)
•Imiglucerase for Gaucher disease: effectiveness and budget impact
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analysis (1 project)
•Judicial decisions and Brazilian Policy of Pharmaceutical Assistance:
impact analysis (5 projects)
•Judicial decisions: technology profile and intervening factors (1 project)
•Law and inequality access to orphans drugs (1 project)
•Nucleoside/nucleotide analog therapies for chronic hepatitis B: cost-
effectiveness analysis (2 projects)
a) Studies of Efficacy and Effectiveness
•Bariatric surgery assessment in Brazil: prospective and retrospective
studies (3 projects)
12•Leishmaniasis pharmacotherapy assessment: safety and efficacy (4 projects)
b) Economic Evaluation Studies
•Anticholesteremic agents for dyslipidemias: cost-effectiveness
analysis (2 projects)
•Arterial hypertension: therapeutics’ variability analysis (1 project)
•Biological drugs for rheumatoid arthritis: cost-effectiveness and
budget impact analysis (2 projects)
•Imiglucerase for Gaucher disease: effectiveness and budget impact
analysis (1 project)
•Nucleoside/nucleotide analog therapies for chronic hepatitis B: cost-
effectiveness analysis (2 projects)
•Recombinant DNA human analog insulins for type 1 Diabetes
Mellitus: cost-effectiveness analysis (2 projects)
•Supervised treatment directly observed for active tuberculosis: cost-
effectiveness analysis (2 projects)
c) Studies for the Management of Health Technologies
• Asthma: therapeutics’ variability analysis (1 project)
• High-complexity cardiac procedures: data monitoring (3 projects)
• Judicial decisions and Brazilian Policy of Pharmaceutical Assistance:
impact analysis (5 projects)
• Judicial decisions: technology profile and intervening factors (1 project)
• Law and inequality access to orphans drugs (1 project)
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Professional Training / Capacitation
Specialization and Master’s Courses in Management of
Health Technology
Through the Ministry of Health’s initiative, the Department of
Science and Technology (DECIT),the Secretariat for Science, Technology
and Strategic Inputs (SCTIE), and the Department of Specialized Assistance
(Departamento de Assistência Especializada – DAE) of the Secretariat
for Health Care (Secretaria de Atenção à Saúde – SAS), promoted
two specialization courses and five professional masters’ courses in
azil management of health technologies, in partnership with the Ministry of
Science and Technology’s Financing Institution for Studies and Projects
(Financiadora de Estudos e Projetos – FINEP).
Seven training institutions are partners in this initiative:
• The specialization is offered by the Federal University of Bahia (UFBA) and
the Faculty of Medical Sciences of Minas Gerais;
y of Health of Br • The Masters programme is offered at the Federal District, Rio de Janeiro,
tr Rio Grande do Sul and São Paulo., linked to the Federal University of São Paulo
(UNIFESP); Federal University of Rio Grande do Sul (UFRGS); State University
Minis of Rio de Janeiro (UERJ) and Oswaldo Cruz Foundation (FIOCRUZ).
Students of the Specialization and Masters programmes in Health Techno-
logy Management promoted by the Ministry of Health, by region, in Brazil
– 2007/2008.
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Source: Decit/SCTIE/MS
Professional Training in Health Technology Assessment
and in Evidence-Based Medicine
Since 2004, several short-term courses for the professional training
and updating of technicians from the State Secretariats of Health and
the Ministry of Health on relevant HTA themes were fostered by means of
collaboration with institutions such as the McMaster University, Cochrane
Center of Brazil, and the Minas Gerais School of Medical Sciences (Faculdade
de Ciências Médicas de Minas Gerais).
Events Promoted
• I International Seminar on Health Technology Management (2005)
• DECIT +2: Role of the Ministry of Health in Science, Technology and
Information (2006).
• II International Seminar on Health Technology Management (2007)
• Research for Health: Development and Innovation for SUS (2007)
• Workshop “Challenges for Implementation of a Policy of Evaluation and
Management of Health Technologies at Brazil”, as part of the pre-events to
the V Meeting of the Health Technology Assessment International (HTAi), in
Montreal, Canada (2008).
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Partners and Collaborators
National Agency for Supplementary Health
National Health Surveillance Agency
Cochrane Center of Brazil
National Council for Scientific and Technological Development
Financing Institution for Studies and Projects
Oswaldo Cruz Foundation
Federal University of Bahia
Federal University of São Paulo
Federal University of Rio de Janeiro
Federal University of Rio Grande do Sul
azil State University of Rio de Janeiro
University of São Paulo
National Network of Clinical Research
National Council of Health Secretaries
National Council of Municipal Secretariats of Health
y of Health of Br
tr International Cooperation
Minis • International Network of Agencies for Health Technology Assessment – INAHTA
CG ATS/Decit has been a member of the INAHTA since 2006 and partici-
pates in its annual events and presentations.
• Mercosur
Decit participates in the Sub-commission on Assessing and Use of Health
Technologies in Health Services
1st International Seminar on the Management of Health Technologies
(2005) – speakers:
Alrich Ruëter – German Institute for Medical Documentation and Information
– German Agency for Health Technology Assessment (Germany)
Andres Pichon-Rivière – Instituto de Efectividad Clínica y Sanitaria (Argentina)
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Bruce Brady - Canadian Coordinating Office for Health Technology
Assessment (Canada)
Carlos Campillo – Health Services Evaluation (Spain)
Jan Persson – Center for Medical Technology Assessment (Swedish)
2nd International Seminar on the Management of Health Technologies
(2007) - speakers
Antonio Sarria – Agencia de Evaluación de Tecnologias Sanitarias del
Instituto Carlos III (Spain)
Harpreet Kohli – NHS Quality Improvement Scotland (United Kingdom)
Oriol de Soiá-Morales – Agency for Quality, Research and Assessment in
Health (Spain)
Sun Hae Lee Robin – Haute Autorité de Santé (France)
Lecture: “The Experience of the Centre for Reviews and Dissemination
Databases (CRD) in creating the inter-institutional databases and scientific
dissemination” (2007), presented by:
Christopher Henshall –York University (United Kingdom)
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Contact Information:
Coordenação Geral de Avaliação de Tecnologias em Saúde
Departamento de Ciência e Tecnologia - Decit
Secretaria de Ciência, Tecnologia e Insumo Estratégicos - SCTIE
MINISTÉRIO DA SAÚDE
Esplanada dos Ministérios
Ed. Sede, Bloco G, Sala 852
Zip Code: 70058-900/Brasília-DF/Brazil
Telephone: +55 61 3315 3885
+55 61 3315 3471
ats.decit@saude.gov.br
azil
www.saude.gov.br
- search for “health technology assessment” or “avaliação de tecnologias
em saúde”
y of Health of Br
tr
Minis
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www.saude.gov.br
