Abstract
Introduction: Epilepsy is a neurological condition characterized by recurrent seizures. According to the Ministry of Health, approximately 30% of patients are estimated to be refractory to treatment with conventional medicines, experiencing impacts on quality of life. According to the Ministry of Health, approximately 30% of patients present resistance to conventional drug treatments, which significantly compromises their quality of life. Cannabidiol (CBD), derived from Cannabis sativa, has shown efficacy in refractory epileptic syndromes, according to scientific evidence. Since 2020, the supply of cannabidiolbased products in Alagoas has occurred exclusively through legal action, which motivated the development of a state Clinical Protocol and Therapeutic Guidelines (PCDT), published in the Official Gazette of the State on July 1, 2025, representing a technical and regulatory milestone for SUS in Alagoas. Objective: To present data related to CBD judicialization in Alagoas between 2024 and 2025, as well as to describe the process of developing the state PCDT for the treatment of refractory epilepsies with cannabidiol. Methods: This is a retrospective descriptive study based on the analysis of legal proceedings requesting medicines and on the development of the protocol. Data regarding judicialization were obtained from the Alagoas State Department of Health, covering the years 2024 and 2025. In parallel, the technical and methodological criteria used in the construction of the protocol were analyzed, involving a review of scientific evidence, meetings with specialists, academic institutions, and health managers, coordinated by the Health Technology Assessment Committee (CATS). Results: The survey demonstrated the financial and clinical impact of the absence of a protocol, with patients receiving products through judicial seizure, without pharmacotherapeutic monitoring. In 2024, 41 legal proceedings related to CBD use were registered, of which 10 (24.4%) had a diagnosis of epilepsy, with ICD codes G40.2 (n=5), G40 (n=4), and G40.6 (n=1). In 2025, until the date of protocol development, 16 proceedings were registered, with 4 (25%) related to epilepsy: G40.8, G40.4, G40.3, and G40. Currently, within the Specialized Component of Pharmaceutical Services (CEAF), 101 patients with ICD codes G40.4 (LennoxGastaut Syndrome) and G40.5 (Dravet Syndrome) are using other drug therapies according to the Ministry of Health’s epilepsy PCDT, and in these cases, the introduction of cannabidiol becomes a new therapeutic option. The new state PCDT exclusively covers Dravet syndrome, LennoxGastaut syndrome, and Tuberous Sclerosis Complex, supported by clinical studies. The standardization of CBD concentrations of 20 mg/mL, 50 mg/mL, and 200 mg/mL with THC limits ≤0.2% ensures safety and legal compliance according to ANVISA RDC No. 327/2019. Conclusions: The creation of the PCDT with CBD for refractory epilepsies in Alagoas represents an advance in care, expanding safe and evidencebased access, reducing judicialization, optimizing public resources, and strengthening SUS with a focus on equity and the responsible use of new technologies.
