Abstract

Introduction Administration of chimeric antigen receptor therapy (CAR-T) requires the coordination of a multi-disciplinary team including physicians, nurses, pharmacists, apheresis and financial leaders. With the commercial approval of tisagenlecleucel and axicabtagene ciloleucel, centers were challenged with securing financial authorization, completing leukapheresis and lymphodepleting chemotherapy in a timely manner prior to cellular infusion in an acute patient population. Objectives/Methods To establish these processes our team participated in weekly meetings and created an email group to track from time of referral to admission for therapy. All patient communication was filtered through this group. Result/Conclusion At our center, our median time from patient referral and assessment to submission for financial clearance was 1 day (range 1-4) [Table 1]. To secure insurance clearance our financial team completed prior authorization and single case agreements for each patient. This took a median time of 12 days (range 1-36) but has shown a general decrease over time. After financial clearance our institution requires executive approval prior to submission of the purchase order before patients can undergo leukapheresis. Our executive leadership team approved and a purchase order was submitted in a median of 1 day (range 0-4). The leukapheresis procedure was scheduled and completed in a median of 5 days (range 2-12). Our team waits for confirmation that the product has cleared quality and product is ready for shipment before beginning lymphodepleting treatment in the outpatient setting but generally do not wait for the cellular product to arrive. Time from leukapheresis procedure to admission for CAR-T cells was a median of 22 days (range 20-57). This was dependent on the patient's disease status at the time of leukapheresis and varied if a patient required bridging chemotherapy. Our median timeline from initial patient referral to admission for cell infusion is approximately 37 days (range 31-80). Our median length of stay is 11.5 days (range 7-59). This is the first report of quality outcomes related to the time from initial patient referral to admission for CAR T infusion. Opportunities still exist to decrease this pre-treatment timeline in this heavily treated acute patient population.

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