Brazil Updated Conitec’s Methods Guidance for SUS Incorporation Dossiers in 2026

Conitec advises the Ministry of Health on the incorporation of health technologies into Brazil’s Unified Health System. Requests are assessed only if they meet the submission requirements set out in Decree 7,646 of 2011, and Conitec’s reports weigh the costs and benefits of a new technology against those already used in the SUS.

According to Conitec’s submission page, requests must be made through the e-GITS system. Accepted file types are PDF, HTML, XLS and XLSX, with a maximum size of 50 MB. The required content includes a description of the disease, a description of the technology, a comparison of the evidence with technologies already available in the SUS, an economic evaluation from the SUS perspective, a budget impact analysis and references. Conitec states that the company’s dossier is made available on its website at the time of public consultation, together with the technical report and the report for society.

The economic evaluation and budget impact analysis are central components of the dossier because Conitec’s recommendation considers both the value of a technology relative to existing SUS options and its affordability for the public system. The requirement to compare with technologies already available in the SUS means that comparators must reflect current public-sector practice in Brazil rather than international standards of care.

The Ministry of Health publishes methodological guidelines that set expectations for the analyses in a dossier. Conitec’s methodological guidelines page lists the Diretriz de Avaliação Econômica, third edition, and a Ministry catalogue entry dates it to 2026. A preliminary version had been released for public consultation in 2025 through the Brazilian network for HTA (REBRATS). The specific changes in the third edition, such as any revision to the discount rate, could not be confirmed from the sources reviewed.

Other guidelines listed include a guideline on quality of life in economic analyses dated 2025, a 2021 guideline on micro-costing studies, and the guideline on preparing technical-scientific opinions. A preliminary version of a budget impact analysis guideline dated 2026 has also been published for consultation; it covers topics such as market share and scenario analysis over a five-year horizon. The Ministry’s catalogue also includes a document on the use of cost-effectiveness thresholds in health decisions.

For applicants, the publication of new guideline editions means that analyses prepared under earlier versions may need to be updated. Elements such as the measurement of quality of life, the costing approach and the structure of budget impact models are each addressed in dedicated guidance, so a dossier that follows the full set of current guidelines is more likely to meet Conitec’s expectations at the evaluation stage.

A December 2025 explanatory booklet on regulatory changes to Conitec’s procedures states that additional analysis steps for high-cost technologies will take place during Conitec’s assessment, and that the Ministry of Health will define these analyses in a methodological guideline. The same booklet describes managed access agreements as a complementary instrument in the implementation of incorporated technologies.

Trade press has reported that Conitec consulted on budget impact thresholds, under which an impact between about R$ 37.8 million and R$ 75.6 million would be considered high and an impact above R$ 75.6 million very high. These figures were presented as proposals, and their final adoption had not been confirmed at the time of checking.

Applicants should prepare economic evaluations and budget impact analyses under the most recent guideline editions, and check Conitec’s methodological guidelines page before finalising a dossier. Because the dossier is published at the time of public consultation, companies should prepare it with publication in mind.

For high-cost technologies, applicants should anticipate additional analyses and consider whether a managed access agreement could support incorporation. Pubrica’s summary is for information only and is not affiliated with Conitec or the Ministry of Health.