Brasília – The Ministry of Health, through the Brazilian Network for Health Technology Assessment (Rebrats) and the Department of Management and Incorporation of Health Technologies (DGITS), is updating the Methodological Guidelines for Economic Evaluation in Health, which guide the assessment of technologies proposed for incorporation into the Unified Health System (SUS). The current version, published in 2014, is considered outdated given the growing complexity of health technologies and new analytical methods available.

The new draft introduces several key innovations, including the establishment of a cost-effectiveness threshold, improved modeling of long-term patient costs, and clearer methodologies for evaluating medical devices, covering logistics, maintenance, and consumables. It also proposes differentiated parameters for orphan and ultra-rare disease technologies and seeks to enhance transparency, standardization, and reproducibility in economic evaluations submitted to Conitec.

Despite progress, experts point to persistent gaps — such as the absence of explicit guidance on risk-sharing agreements, judicialization costs, and the integration of real-world evidence and observational data into decision-making frameworks. The text also grants flexibility for assessing advanced therapies and high-cost technologies but lacks full alignment with international reference models.

The updated guidelines are expected to strengthen technical rigor, reduce political influence in incorporation decisions, and provide more predictable criteria for industry and policymakers. The final version will be published after analysis of contributions received during the public consultation period.

Source: Futuro da Saúde

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