Shifting Gears from Transplant to CAR T: Creating a Cell Therapy Nurse Coordinator Role

Abstract

Topic Significance & Study Purpose/Background/Rationale With the advent of novel cell therapies such as chimeric antigen receptor (CAR)-T, blood and marrow transplant (BMT) programs find themselves in uncharted territory. While CAR-T shares some aspects with BMT, differences in patient care and program needs warrant the creation of a cellular therapy coordinator (CTC) role. This presentation aims to explore the unique development of the CTC role in an intermediate size transplant program providing commercial CAR-T therapy. Methods, Intervention, & Analysis The CTC role resulted from extensive work by a multidisciplinary cell therapy team. The team created CAR-T focused standard operating procedures, and the CTC then translated these policies into direct patient care. While BMT policies have been long established, little precedent exists for CAR-T therapy. The CTC, in collaboration with the cell therapy team, created program-specific patient education publications, set documentation standards, and developed discharge planning tools. The CTC also created an adverse event reporting system as required by the FDA. In a variation from BMT, the CTC assumed responsibility for patient care coordination from the time of consent through the time of program discharge. This allowed for monitoring at all stages, and allowed the CTC to understand the nuances of each patient's CAR-T experience. Findings & Interpretation The program administered CAR-T cells to 17 patients over six months. Retrospective evaluation demonstrated several factors that differentiate the CTC role. Unlike BMT, manufactured CAR-T cells require oversight from pharmaceutical companies, insurance, and the FDA. The CTC maintains a relationship with the pharmaceutical companies through patient registration, event reporting, and facility audits. Since official billing codes do not exist, the CTC has an increased responsibility in the insurance approval process, working closely with financial coordinators and hospital administrators. The CTC also experiences challenges due to an acutely ill patient population. While most BMT patients are in remission, the relapsed/refractory CAR-T patients often require urgent treatment, adding additional time sensitivity to care coordination. Discussion & Implications As new trials and commercial products become available, cancer centers interested in pursuing cellular therapies should consider early implementation of cell therapy nurse coordinators. By understanding the nuances of cell therapy, a designated CTC ensures patient safety and enhance program development.