Implementation of a Model Program at an Independent Community Oncology Practice for the Outpatient Administration of B-Cell Maturation Antigen-Directed Bispecific Antibody Step-Up Doses.

内容摘要

Regulatory approval of B-cell maturation antigen (BCMA)-CD3 bispecific antibodies (BsAbs) has revolutionized the treatment of patients with heavily pretreated relapsed or refractory multiple myeloma. Label-recommended premedications and step-up dose (SUD) regimens are used to mitigate the incidence and severity of serious adverse events such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. Hospitalization of patients during the SUD regimen is also recommended by the manufacturers to facilitate the rapid therapeutic management of adverse events that may arise. Administering these therapies in an inpatient hospital setting increases the costs of delivering care, creates patient inconvenience, and most importantly, reduces overall access to this class of medication. Thus, the practice of administering BCMA-directed BsAb SUD regimens in an outpatient (OP) setting is being slowly adopted at some community practice sites; however, the development of robust OP administration models for these therapies requires more data on the feasibility and safety of doing so. Herein, we describe the OP BsAb program developed at our independent community oncology practice, New England Cancer Specialists (NECS). The program was designed with the intent to reduce health care resource utilization, improve patient experience, and expand treatment access for patients living in remote or underserved areas while preserving a coordinated care model. We outline the operational infrastructure and workflow implemented at NECS to administer BCMA-directed BsAb therapy in an OP setting to patients drawn from a vast rural geography. Finally, based on our clinical experiences, we discuss the potential to expand OP administration programs to BsAb therapies for other malignancies.