Medical Access and Reimbursement in Brazil

Psilocybin and psilocin remain controlled under ANVISA's special-control lists. No psilocybin medicine was identified as generally authorised or reimbursed in Brazil. ReBEC records show early psilocybin research, including BTP23 safety studies and a tobacco pilot, but those are research signals rather than patient-access pathways. # # # # #

MDMA remains controlled under ANVISA's current special-control framework. No registered MDMA-assisted therapy product, SUS reimbursement route or mandatory private-plan coverage route was identified in this refresh. Any legitimate medical work would need ethics and regulatory approval as research. # # # #

Intranasal esketamine has a real authorised route in Brazil. ANVISA registered Spravato for specified major depressive disorder indications, including treatment-resistant depression with an oral antidepressant and short-term reduction of depressive symptoms in adults with major depressive disorder and acute suicidal ideation or behaviour. Administration is a supervised medical route, not take-home access. #

Injectable esketamine is different. CFM-linked guidance treats injectable esketamine for mental disorders as off label and stresses careful indication, consent, specialist oversight, monitoring and a hospital or day-hospital style setting. ANVISA also has an esketamine generic registration as an anaesthetic, which should not be confused with psychiatric market authorisation. # # #

Reimbursement remains unresolved. This refresh did not identify a high-confidence nationwide CONITEC incorporation decision for Spravato in SUS or a clean mandatory-coverage signal in ANS materials. Coverage should therefore be described as uncertain and variable by plan, setting and legal route until checked locally. # # #

Ketamine is controlled in ANVISA's List B1 framework and remains a legitimate medical anaesthetic. Psychiatric use is mainly off label or research-based. CFM-linked guidance on ketamine-class treatment emphasises professional responsibility, consent, supervised administration and capacity to manage cardiovascular and psychiatric adverse events. # #

Brazilian research and service signals include sublingual, subcutaneous and naturalistic ketamine records, including a Porto Alegre naturalistic study. These records support limited specialist use and research activity, not a standard national reimbursement pathway for antidepressant ketamine. # # # #

DMT remains controlled under ANVISA's special-control lists. Brazil has credible DMT research through UFRN-linked healthy-volunteer and depression studies, but no authorised DMT medicine or routine reimbursement route was identified. The ayahuasca exception is for ritual and religious use of the brew, not general possession or prescribing of DMT. # # # # #

5-MeO-DMT is listed in ANVISA's controlled framework and no authorised medical product or reimbursement route was identified. Any legitimate clinical work would need research and controlled-substance permissions. # # #

No authorised ibogaine medicine or routine reimbursement route was identified in Brazil. ReBEC does show a Phase II/III ibogaine record for cocaine and crack dependence, which is a material research signal. It should not be described as patient access unless the specific protocol, authorisations and recruitment route are verified. # # #

CONAD recognises ritual and religious ayahuasca use and sets deontological principles for that context. The same framework rejects commercialisation, tourism-style exploitation and unsupported therapeutic claims. Ayahuasca is therefore not a reimbursed medical product, even though it is a major Brazilian research topic. # # #

Mescaline remains controlled under ANVISA's special-control lists. No authorised mescaline medicine, routine SUS reimbursement route or mandatory private-plan coverage route was identified in this refresh. # # #

Representative 2C-series compounds are covered by Brazil's controlled-substance framework. No authorised medical product or reimbursement route was identified. Clinical research would require formal ethics and ANVISA-linked permissions. # # #