ANS Submissions for the List of Procedures and Health Events

HTAnalyze structures and manages complete technical dossiers for submission to ANS, the Brazilian National Supplementary Health Agency, aligned with current methodological guidelines and the formal requirements for updating the List of Procedures and Health Events.

We provide technical and strategic support throughout the full process, including evidence strategy, dossier planning, FormRol completion, economic evaluation, budget impact analysis, submission preparation, process monitoring, and support during public consultation.

Our work is designed to translate clinical evidence, economic value, and healthcare system impact into a clear and defensible value proposition for supplementary health decision-making in Brazil.

The process for updating the ANS List of Procedures and Health Events

The incorporation of technologies into supplementary health occurs through a continuous Health Technology Assessment (HTA) process conducted by ANS, which integrates the analysis of:

• Clinical evidence on efficacy and safety
• Economic evaluation, when applicable
• Budget impact analysis
• Relevance to care delivery in supplementary health
• Regulatory compliance

The formal process includes:

Submission through FormRol

The proposal is submitted electronically through the FormRol system, including the complete technical dossier and mandatory documentation.

Eligibility analysis and technical assessment

ANS verifies documentary compliance and conducts a technical-scientific assessment of the evidence submitted.

Technical deliberation and preliminary recommendation

The technology is technically assessed and submitted for review by COSAÚDE members.

Public consultation

Preliminary recommendations are submitted to public consultation, allowing contributions from society and stakeholders.

Final recommendation and update of the List

After analyzing the contributions received, ANS publishes the final decision and updates the List.

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 in supplementary health 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 dossiers for ANS submission

We produce the clinical, economic, and budget impact dossiers, 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