Conitec Submissions for the Brazilian Public Health System
HTAnalyze structures and manages complete technical dossiers for submission to Conitec, aligned with the methodological guidelines of the Brazilian Ministry of Health and the formal requirements for health technology incorporation into the SUS, the Brazilian public health system.
We provide technical and strategic support throughout the full process, from evidence strategy and dossier planning to economic evaluation, budget impact analysis, submission preparation, interaction with the assessment process, and support during public consultation.
Our work combines clinical evidence synthesis, critical appraisal, economic modelling, epidemiological estimates, budget impact analysis, and clear value communication adapted to the Brazilian public decision-making context.
The process for incorporating health technologies into the SUS
The incorporation of medicines, devices, and other health technologies into the SUS follows a structured Health Technology Assessment (HTA) process, which integrates the analysis of:
• Clinical evidence on efficacy and safety
• Economic evaluation from the SUS perspective
• Budget impact analysis
• Clinical and epidemiological relevance
• Feasibility of implementation within the public health system
The formal process includes:
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Submission of the proposal through the official system (e-GITS)
The dossier is submitted electronically and undergoes documentary compliance verification. -
Technical analysis by the Conitec Executive Secretariat
A critical appraisal is conducted of the clinical evidence, economic models, and financial impact. -
Deliberation and preliminary recommendation
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National public consultation
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Final recommendation and decision by the Ministry of Health
The legal timeframe for the process is up to 180 days, which may be extended for an additional 90 days.
How HTAnalyze supports your submission
Our work covers all critical dimensions of the process.
Access strategy
Definition of clinical and economic positioning
Analysis of relevant comparators within the SUS
Assessment of technical and regulatory risks
Clinical evidence
Systematic review and meta-analysis
Comparative critical synthesis
Development of the Rational Clinical Narrative
Economic evaluation
Cost-effectiveness / cost-utility / cost-minimization models
Decision trees for therapeutic interventions and diagnostic tests
Markov models
Partitioned survival models
Other specific models
Results presented as:
• ICER / ICUR
• CEAC
• Deterministic and probabilistic sensitivity analyses
Budget impact analysis, with complete modelling considering:
Brazilian epidemiology or estimated population based on measured demand
Expected market share
Technology diffusion
5-year time horizon
Complete development of the Conitec dossier
We produce the complete Main Document, including:
Technology description Clinical and epidemiological context Structured clinical evidence Economic model Budget impact Technical references Alignment with the official template
Strategic support throughout the process
In addition to submission, we offer:
Preparation for technical questions Support during public consultation Analysis of contributions received Technical refinement after consultation
HTAnalyze differentiators
Direct experience with submissions in Brazil
PhD-level team with experience in HTA
Expertise in health economics and market access
Full alignment with Brazilian methodological requirements
International presence. Distributed structure.
Brazil:
Porto Alegre • Florianópolis • Santo André
United States:
Lewes – Delaware
Europe:
Glasgow – Scotland
