asal Esketamine: Analysis of the judicialization of medications in the Court of Justice of the State of Rio de Janeiro 2020-2024

Abstract

Introduction: This study examines the judicialization of nasal esketamine for the treatment of treatment-resistant depression in the Court of Justice of the State of Rio de Janeiro, Brazil, from 2021 to 2024. Esketamine, marketed as Spravato, was approved by ANVISA in 2020 and is a nasally administered antidepressant. However, its cost and absence from the essential medicines list (RENAME) make judicial recourse the primary means of access.

Materials and Methods: A cross-sectional and retrospective case study approach was employed, analyzing the jurisprudence of the Court of Justice of the State of Rio de Janeiro (Brazil). Cases initiated between 2021, and June 2024 were selected, searching for the terms "Spravato" or "esketamine" in civil proceedings. Cases outside the period or duplicates were excluded. Variables analyzed included the year of request, the plaintiff's argument, the defendant's profile, and the judgment.

Results: Thirty-one cases were identified, with 28 favorable judgments ordering the provision of the medication, primarily against private health insurers. Judicialization appears to be on the rise, and medical indication prevails over contractual or budgetary conditions.

Conclusions: Nasal esketamine is a promising option for treatment-resistant depression, but its cost and the need for judicialization to access it underscore the urgency for public policies that ensure adequate and safe supply of the medication, avoiding delays and the expense of judicial requests.