Portugal has taken a significant step in mental health care by approving public funding for esketamine, a psychedelic drug used to treat severe depression. This decision, announced by Infarmed, the National Authority for Medicines and Healthcare Products, allows hospitals to prescribe Spravato to adults with treatment-resistant major depressive disorder.
Who is Eligible for Esketamine Treatment?
The approval, formalized on May 7, covers patients who have not responded to at least three different antidepressant treatments. In these cases, Spravato can be used in combination with other oral antidepressants for those experiencing moderate to severe depressive episodes. This approach is intended for individuals who have tried psychotherapy and either have a resistance or contraindication to electroconvulsive therapy (ECT) or have chosen not to pursue it.
Guidelines for Medical Use of Psychedelics
On the same day, a multidisciplinary working group, including medical, pharmaceutical, and psychological experts, along with the National Ethics Council, presented a set of guidelines for the medical use of psychedelics. The group emphasized that these substances should be managed within regulated medical frameworks to ensure safe and controlled access.
Ensuring Safe Use and Regulation
Dr. Albino Oliveira Maia, director of the Neuropsychiatry Unit at the Champalimaud Foundation and a member of this working group, noted the importance of strict medical oversight, stressing that these substances should not be available outside the healthcare system without appropriate regulation.
Next Steps in the Regulation Process
The recommendations were presented at the Champalimaud Foundation, reflecting the collective input of medical professionals, pharmacists, psychologists, and ethics experts. The guidelines aim to establish a structured approach for the clinical use of substances like esketamine, which, despite its known therapeutic benefits, remains subject to careful consideration due to potential off-label misuse.