Implementation of Clinical Pathways for CAR-T Cell Therapy in a Brazilian Private Healthcare Organization

Abstract

Introduction: the treatment with CAR-T cells in Brazil is challenging because it requires a highly qualified multidisciplinary team trained in new clinical pathways to take care of these patients. Objective: to describe the implementation of the clinical pathways for CAR-T cell therapy, ensuring safety and quality. Method: this is an experience report study, performed in four private general hospitals of the Americas from São Paulo, Rio de Janeiro and Ceará states, during the year of 2022. The process of implementing the CAR-T Cell clinical pathway included: creation of a medical committee with the main medical references and specialist nurses from each center, for the elaboration of the main clinical protocols and operational procedures, in addition to the discussion of eligibility cases for therapy with CAR-T Cells. Identification of the multidisciplinary reference team in all phases of treatment, training the team involved in the clinical care of the patient, and finally, establishment of patient clinical pathway before, during and after the CAR-T cell therapy. The implementation process lasted seven months between the qualification of centers by the Therapy provider, internal qualification each center and the first cell infusion with CAR-T Cell performed. Results: In all hospitals, professionals from the multidisciplinary team (pharmacy, nursing, physicians - hematologists, pediatric hematology-oncologists involved in hematopoietic stem cell transplantation, neurologists, pediatric and adult intensive care physicians) were trained. The Multidisciplinary Care Protocol was elaborated including indications, early and late complications. The Standard Operating Procedures addressed the pre and post infusion care, daily screening, criteria to transfer the patients to the intensive care unit, recognition and management of cytokine release syndrome and neurological toxicities. The main challenges of this process were to create the routines for evaluation and systematic monitoring and to identify and involve the multidisciplinary professionals directly involved in patient care. Conclusions: the implementation of the program brought improvements to the clinical pathway, positively impacting professional satisfaction, the quality and safety of the patients. The CAR-T cell therapy was performed in a safe and integrated environment, uneventful and successful.