Ethical challenges with multiple myeloma BCMA CAR-T slot allocation: a multi-institution experience. Transplantation and cellular therapy Kourelis, T., Bansal, R., Berdeja, J., Siegel, D., Patel, K., Mailankody, S., Htut, M., Shah, N., Wong, S. W., Sidana, S., Cowan, A. J., Alsina, M., Cohen, A., Holstein, S. A., Bergsagel, L., Ailawadhi, S., Raje, N., Dhakal, B., Rossi, A., Lin, Y. 2023

Abstract

CAR T cell therapies are FDA approved for patients with triple refractory multiple myeloma (MM). Real-world access to CAR T remains challenging due to supply chain limitations impacting manufacturing. The goal of this study was to evaluate the extent of this issue and how major centers are handling the challenges of CART manufacturing slot allocation. MM CAR T physician leaders at each CART treatment center across the US were surveyed. We received response from 17/20 centers. A median of one slot is allocated per month per center and the median number of patients per center on the waitlist since ide-cel approval was 20 (range 5-100). As a result, patients remained on the waitlist for a median of 6 months prior to leukapheresis (range 2-8). For patient selection, all centers reported using a committee of experienced CART physicians to ensure consistency. To ensure transparency, 15 centers make selection criteria, selection timeline and priority score readily available for CAR-T providers. Centers also reported using ethical values for selection: a) equal treatment: time spent on waiting list (n=12); b) priority to the worst-off: limited therapeutic options (n=14), MM burden (n=11), high comorbidity index (n=5); c) maximize benefit: most likely to complete apheresis (n=13) or infusion (n=13) or achieve response (n=8) and d) social value: younger pts (n=3). Maximizing benefit was considered the most important criterion by 10 centers. Our study is the first attempt to evaluate existing issues with MM CAR T access and the variability and challenges in patient selection. Integrating ethical resource allocation strategies, similar to the ones described here, into formal institutional policies would help streamline CAR-T access and protect the needs of both current and future patients and physicians.

View details for DOI 10.1016/j.jtct.2023.01.012

View details for PubMedID 36681151