Outpatient Bispecific Step-Up Dosing Expands Despite Operational Barriers

In an interview with Pharmacy Times, Manale Maksour, PharmD, BCOP, BCPS, associate director of Pharmacy Services at American Oncology Network, discussed why outpatient step-up dosing for bispecific T-cell engager therapies is becoming more common and the operational barriers oncology practices must address before implementing these programs.

According to Maksour, one of the main drivers of outpatient administration is the increasing difficulty of securing hospital beds for patients who may otherwise require several days of inpatient monitoring. Delivering step-up dosing in the outpatient setting can also be more convenient for patients, who may feel more comfortable recovering and monitoring symptoms in their home environment. Growing clinical experience with bispecific therapies has also helped care teams become more confident in managing treatment outside the hospital.

However, Maksour emphasized that outpatient step-up dosing is not appropriate for every patient. Careful patient selection is essential. Candidates should have adequate cognitive function, be able to tolerate treatment, and have limited or manageable comorbidities. Patients must also understand that they will be responsible for monitoring their condition at home and promptly contacting the care team if they experience concerning symptoms or feel unwell.

Caregiver involvement is another critical component. Maksour explained that patients need a caregiver who can remain with them around the clock during the first several days following treatment. Caregivers must understand the therapy, know which adverse events to watch for, and have clear instructions regarding when and whom to call.

Operationalizing an outpatient bispecific program also requires extensive multidisciplinary coordination. Pharmacists, physicians, nurses, emergency departments, and hospital teams must understand how bispecific therapies work and how to recognize and manage cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome. Even when treatment is administered entirely in the clinic, a hospital must remain prepared to evaluate or admit the patient if complications occur. Maksour also identified payer barriers, particularly involving prophylactic tocilizumab, as an additional challenge for outpatient programs.