Demystifying the Delivery and Adverse Event Management of Bispecific Antibodies in the Community Setting
Authors: Kajdic Hodzic Rifeta , Mehta Amitkumar N. , Koff Jean L. , Budde Elizabeth , Devarakonda Srinivas , Moore Donald C , Brody Joshua , Wuthrich Bradley , Mancini Robert , Martin Cassie , Mangir Christina , Harvey Allison , Plotkin Elana , Kisiel Molly , Lile Ashley , Colwell Nicole A 
Published: December 2024

Introduction
After 2 decades of research, bispecific antibodies (BsAbs) are an emerging treatment option for several hematologic malignancies. BsAbs are administered in multiple care settings (ie, community, academic, inpatient, and outpatient). While clinical trials have shown that FDA-approved BsAbs are safe and effective, there remains a need for additional research to inform real-world implementation in community cancer centers, where most cancer care is provided (Ellis et al, J Rural Health 2022). Patients need to be monitored for adverse events such as cytokine release syndrome (CRS), which must be promptly recognized and managed appropriately.
Methods
Semi-structured focus groups were facilitated to ascertain types of organizational resources needed for BsAbs implementation in the community setting. Topics addressed included effective delivery of high-quality care and patient safety considerations, with a particular focus on adverse event management. Multidisciplinary professionals (n=30) participated in 2 focus groups held in June 2024.
Roles represented were administrators (n=13), pharmacists (n=8), nurses (n=2), advanced practice nurses (n=2), medical oncologists (n=2), financial advocacy managers (n=2), and other health care professionals (n=2). Community cancer programs (n=12), large academic/NCI-designated cancer centers (n=11), integrated health systems (n=4), and physician practices (n=3) were represented, inclusive of diverse geographic settings across the US. Participants had varying levels of experience with BsAbs (ie, already administering BsAbs, delivering maintenance doses only, currently exploring potential options). Predominant themes from the focus groups were identified by 2 co-investigators using Rigorous and Accelerated Data Reduction (RADaR), a robust technique utilized in qualitative research.
Results
Themes that emerged from the qualitative analysis included: lack of familiarity with BsAbs, importance of education and training, models of care, financial affordability and sustainability, and need for capacity building.
Lack of familiarity with BsAbs
In the community setting, BsAbs are often conflated with chimeric antigen receptor (CAR) T-cell therapy. Misconceptions persist regarding the frequency of adverse events during the maintenance phase of treatment. These factors contribute to a lack of confidence among providers and organizations hesitant to administer BsAbs. However, participants currently delivering BsAbs believe they are ready for administration in the community, with multiple models of care available (eg, offering both ramp-up and maintenance or working with another program to provide maintenance closer to patients' homes). To identify the best model, community centers should assess internal capacity and regional capabilities (eg, hospital partnerships, home health).
Importance of education and training
Focus group participants emphasized the importance of provider and patient/caregiver education to ensure safety (eg, internally housing recordings of provider education for easy reference, holding trainings with local emergency departments, and using EMR smart phrases to document delivery of patient education). Participants indicated the need for cross-organizational coordination (eg, sharing direct contact information and providing transition of care notes) to facilitate appropriate management adverse events.
Models of care
To ensure financial affordability and sustainability, participants acknowledged the importance of predetermining prior authorization structure and impact on BsAb delivery (ie, inpatient or outpatient). A community center should begin by selecting 1 or 2 BsAbs that best fit their institutional capacity. All participants emphasized the need for capacity-building resources (eg, staff needed to manage adverse events, selection criteria for patients/caregivers, and sample clinical workflows).
Conclusions
The findings of this qualitative pilot study suggest that common fears and misconceptions may be ameliorated through education. Various models of care can support BsAbs delivery in the community setting. Additional qualitative and quantitative health services research is warranted to provide practical guidance for BsAb delivery at community cancer centers, with a focus on patient safety and improved patient access.