Operationalization and Use of Bispecific T-Cell-Engaging Antibodies in Community Practices: Multidisciplinary Perspectives on Developing Logistics and Workflow for Cytokine Release Syndrome Management.

Abstract

Objectives: Operationalizing workflows to manage cytokine release syndrome (CRS) in community practices presents challenges for multidisciplinary teams. Real-world experience was gathered from OneOncology community health-care professionals to establish best-prac-tice workflows for CRS management.

Methods: Qualitative data were gathered via focus groups from hematology-oncology MDs, PharmDs, and nurse providers (N = 13) with experience treating patients with bispecific T-cell-engaging antibodies (BsAbs). Theme matrix techniques facilitated analysis.

Results: Three themes were identified: (1) creating a coordinated workflow plan, (2) building network partnerships, and (3) understanding patient support. Workflow decisions were driven by community practices managing patients treated with BsAbs or partnering with sites for initial dosing and maintenance. Catalysts for developing CRS workflows included: FDA approval of BsAbs; BsAbs clinical trial experience; BsAbs on formulary; having patients receiving BsAbs; and practice champion(s) for protocol development. Key steps included defining communication during and after practice hours, designating training leads, and creating practice-specific plans for interdisciplinary team coordination. Inpatient admission processes developed with hospital staff and hospital staff training were fundamental for successful patient management. Communication processes among practice, pharmacy, and hospital staff throughout BsAbs treatment were established, along with methods to ensure the availability of CRS treatment if needed. Continuous patient/caregiver education on BsAbs treatment, monitoring for adverse events (particularly CRS), and how/when to access care were described.

Conclusions: BsAb use in community settings requires multidisciplinary coordination between practices and hospitals. Actions included identifying practice champions, establishing clear workflows for transitioning patients between inpatient and outpatient settings, and ensuring continuous training of staff, patients, and caregivers.