ANS Submissions
(List of Procedures and Health Events)
HTAnalyze structures and manages comprehensive submission dossiers for the Brazilian National Regulatory Agency for Private Health Insurance and Plans (ANS), in full compliance with current methodological guidelines and the formal requirements of the Health Procedures and Events List update process.
We provide technical and strategic support throughout every stage of the submission journey, from evidence strategy planning and FormRol completion to dossier submission, assessment monitoring, and support during the public consultation process.
The process of updating the ANS (Brazilian National Agency for Supplementary Health) list to incorporate technologies in supplementary health care occurs through a continuous Health Technology Assessment process, conducted by the ANS, which analyzes in an integrated manner:
• Clinical evidence of efficacy and safety
• Economic evaluation, when applicable
• Budget impact analysis
• Healthcare relevance in supplementary health care
• Regulatory compliance
1.
Submission via FormRol
The proposal is submitted electronically through the FormRol system, including the complete technical dossier and required documentation.
2.
Eligibility analysis and technical evaluation
ANS verifies the documentary compliance and conducts a technical-scientific evaluation of the evidence presented.
3.
Technical deliberation and preliminary recommendation
The technology is analyzed from a technical standpoint and submitted to evaluation by the members of COSAUDE.
4.
Public consultation
The preliminary recommendations are submitted for public consultation, allowing contributions from society and stakeholders.
5.
Final recommendation and update to the list.
After analyzing the contributions, the ANS publishes the final decision and updates the list.
How HTAnalyze supports your submission
Access strategy
Clinical and economic positioning;
Relevant comparators in the SUS;
Technical and regulatory risks.
Before any submission, we map the competitive landscape: what technologies are already incorporated into the SUS (Brazilian Public Health System), how your product differentiates itself clinically and economically, and what regulatory obstacles may arise throughout the process.
This analysis guides the entire dossier's construction, avoiding rework and strengthening the technical defense points from the outset.
Economic Evaluation
Cost-effectiveness, utility, and minimization models;
Budget impact analysis.
We build tailored economic models for the clinical landscape of technology, decision trees for targeted interventions, Markov models for chronic conditions, and partitioned survival models for oncology.
The results are accompanied by deterministic and probabilistic sensitivity analyses, while the budgetary impact projects market share and technological diffusion over 5 years, based on real Brazilian epidemiology.
Clinical evidence
Systematic review and meta-analysis;
Comparative critical synthesis;
Rational Clinical Narrative.
We gathered and critically evaluated all available scientific literature on the technology and its comparators, identifying gaps, biases, and the robustness of the evidence.
The result is a structured clinical narrative, clear enough for lay members of the committee, yet rigorous enough to withstand technical questioning.
Dossier Development & Strategic Support
Complete preparation of the Conitec dossier;
Strategic support after submission.
We drafted the Main Document in its entirety, strictly following the template required by Conitec, from the technical description of the technology to the bibliographic references.
After submission, we continue to work alongside you: preparing responses to committee questions, analyzing contributions from the public consultation, and adjusting the dossier as needed until the final decision.
HTANALYZE DIFFERENTIALS
Direct experience with submissions in Brazil.
Expertise in health economics and market access.
Team with PhDs and experience in ATS.
Full alignment with Brazilian methodological requirements.
Our expertise covers every critical dimension of the submission process.
Market Access Strategy
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Definition of the clinical and economic positioning
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Analysis of relevant comparators within the Brazilian Public Health System (SUS)
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Assessment of technical and regulatory risks
Clinical Evidence
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Systematic reviews and meta-analyses
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Comparative critical evidence synthesis
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Development of the Rational Clinical Narrative
Economic Evaluation
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Cost-effectiveness, cost-utility, and cost-minimization models
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Decision-tree models for therapeutic interventions and diagnostic tests
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Markov models
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Partitioned survival models
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Other tailored modeling approaches
Results presented as:
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ICER / ICUR
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CEAC (Cost-Effectiveness Acceptability Curve)
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Deterministic and probabilistic sensitivity analyses
Budget Impact Analysis
Comprehensive modeling considering:
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Brazilian epidemiology or demand-based target population estimates
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Expected market share
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Technology diffusion and uptake
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Five-year time horizon
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Full alignment with Brazilian methodological guidelines and HTA requirements
International presence. Distributed structure.
Brazil:
Porto Alegre • Florianópolis • Santo André
United States:
Lewes – Delaware
Europe:
Glasgow – Scotland
