Before the First Bispecific Dose, Community Practices Need a Playbook

Before administering a first bispecific dose, community oncology practices must have trained, designated teams; standardized protocols; and clearly defined escalation pathways in place, according to participants of The Bispecifics Network roundtable, cohosted by The American Journal of Managed Care^®, Pharmacy Times^®, and CancerNetwork^®.

The discussion was led by Zahra Mahmoudjafari, PharmD, BCOP, director of pharmacy, advanced therapeutics, University of Kansas Health System; Ralph Boccia, MD, hematologist-oncologist, Center for Cancer and Blood Disorders, an American Oncology Network (AON) practice; and Lekan Ajayi, PharmD, chief operating officer, Highlands Oncology Group, who described the nonnegotiables that allowed their respective programs to launch safely as outpatient operations.

Why Designated Teams and Shared SOPs Are Critical to a Safe Launch

Boccia identified 2 nonnegotiables that predated his practice's first commercial bispecific: a restricted T-cell engaging team and a robust set of standard operating procedures (SOPs). Having built those capabilities through a prior clinical research program in bispecific and chimeric antigen receptor T-cell therapies, including participation in the EPCORE NHL-6 trial's (NCT05451810) steering committee, his team had experience to draw on when commercial agents arrived.

"We would just not allow everyone in the practice to touch these patients," Boccia said, describing a deliberate decision to limit administration and triage to a named group of physicians and advanced practice providers (APPs). Internal referrals went directly to that team for step-up dosing, with patients transitioning back to their primary oncologist only once stabilized; external referrals were managed by the T-cell team in full.

For Boccia, stepping into commercial bispecifics meant navigating a steep learning curve, particularly when it came to managing toxicities. Because his practice’s early research trials focused on lymphoma agents rather than myeloma therapies, he had to independently dig into the safety data surrounding cytokine release syndrome (CRS). Ultimately, after comparing the risk profiles of BCMA-directed therapies against lymphoma agents, Boccia chose to implement prophylactic tocilizumab for patients with myeloma at his clinic, while giving other treating physicians across the network the flexibility to make their own clinical calls

Highlands Oncology decided to dedicate a single APP to manage all bispecific consults and patient education.

"That has definitely been a game-changer for us, just because of the education that is needed," Ajayi said. “This APP will do the consults. Once [the patient is] on a maintenance dose, then the provider team will get the patient back.”

This division of labor has allowed the practice to maintain both quality and throughput without overburdening the broader clinical staff, even as 16 medical oncologists at the practice refer patients into the program.

Mahmoudjafari pointed to the practical resource constraints facing most clinics, which is that most programs rely on shared full-time equivalents across physicians, APPs, pharmacists, infusion nurses, navigators, and financial coordinators—not dedicated bispecific staff. In that environment, clarity becomes critical. Order set accuracy, toxicity grading protocols, Risk Evaluation and Mitigation Strategy compliance, patient education materials, and triage workflows must be standardized and accessible to everyone on the team, not dependent on a single champion who happens to know how the process works.

Build In-House or Refer Out?

For practices evaluating whether to develop an internal bispecific program, Boccia suggested that they talk with peers who have more experience and recognize that the capability gap is smaller than it may appear.

"My hope and prayer is that everyone will be doing bispecifics," he said. “If you're not, you're going to be losing these patients,” because sending patients to an academic center for step-up dosing does not guarantee they will come back. “The return…of their patients is very variable depending on the relationship that you have with your academic center.”

Boccia pointed to AON's publicly available bispecific SOP library, developed through the network's Emerging Therapies Working Group, as a concrete resource for practices that would otherwise need to start from scratch.

A pre-survey of roundtable participants painted a more complex picture of staffing models that varied widely, with rotating coverage, dedicated cell therapy pharmacists, formal CRS and immune effector cell–associated neurotoxicity syndrome order sets, emergency department observation workflows, and pharmacy-placed as-needed tocilizumab orders all represented. That variation, Mahmoudjafari argued, reflects how highly localized program design must be.

“What works depends on geography, your hospital relationships, your after-hours access, payer mix, and then that depth of your staffing,” Mahmoudjafari said.

Panelists consistently emphasized that whatever workflow a practice builds today must also be designed to scale. With bispecific use expected to grow across hematologic malignancies and solid tumors, a process that safely handles 2 patients per week needs to be stress-tested for 10, 20, or more. One participant noted that a lack of standardization across the field remains a hindrance, with practices managing as many as 10 different protocols for different bispecifics rather than one unified approach.

"[Write] everything in pencil," Mahmoudjafari advised, noting that practices must continuously adapt their workflows as they gain real-world experience.