Bringing Bispecific Therapy Into the Outpatient Community Oncology Setting

Bispecific therapies are expanding treatment possibilities for patients with relapsed or refractory hematologic malignancies, including individuals who may not be eligible for chimeric antigen receptor (CAR) T-cell therapy. As these therapies move beyond the inpatient setting, community oncology practices must determine which patients can be treated safely as outpatients and establish protocols for monitoring, education, toxicity management, and emergency response.

During a panel focused on FDA-approved bispecific therapies for lymphoma and leukemia, clinicians reviewed real-world patient cases and discussed the advantages and challenges of outpatient administration. In an interview with Pharmacy Times, Cherise Steib, PharmD, HDDP, discussed patient selection, caregiver requirements, cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and the American Oncology Network’s approach to building an outpatient bispecific therapy program. She also highlighted the essential role pharmacists play in preparing clinical teams and supporting patients throughout treatment.

Pharmacy Times: How are bispecific therapies changing the treatment landscape for patients with lymphoma and leukemia, and which patients may benefit most from these agents?

Cherise Steib, PharmD, HDDP: Bispecific therapies provide highly targeted immunotherapy options for patients who may previously have had limited treatment choices. They can also be a good option for patients who may not be eligible for CAR T-cell therapy because of their overall health, accessibility challenges, or other factors.

Bispecific therapy provides another treatment option, particularly for patients whose disease may be progressing rapidly.

Pharmacy Times: Based on the patient cases discussed during the panel, what clinical or practical factors most strongly influence whether bispecific therapy should be administered in the inpatient or outpatient setting?

Steib: Several factors are important when determining whether a patient is an appropriate candidate for outpatient bispecific therapy. One of the most important considerations is whether the patient has a caregiver who can remain available 24 hours a day, particularly during the step-up dosing period, when the risk of CRS and ICANS is greatest.

We also want to ensure that the patient lives within approximately 1 hour of a hospital facility in case an emergency occurs. The patient and caregiver must be fully educated about the potential adverse effects and other considerations associated with bispecific therapy. We also need to confirm that the patient has access to any necessary oral supportive care medications.

Pharmacy Times: What are the greatest benefits of outpatient bispecific therapy for patients and health systems, and what risks or limitations must be considered before launching a program?

Steib: One of the greatest benefits of outpatient bispecific therapy is convenience. Patients can receive treatment in an outpatient clinic and then return home for the monitoring period rather than spending the night in a hospital.

Many patients prefer being able to go home instead of remaining in the hospital. Outpatient administration can therefore provide greater comfort and convenience for patients.

It can also benefit health systems by freeing hospital beds for patients who are experiencing urgent or emergent medical situations.

Pharmacy Times: How does the American Oncology Network’s outpatient bispecific therapy program address operational challenges such as step-up dosing, patient monitoring, emergency preparedness, and coordination between community clinics and hospitals?

Steib: At American Oncology Network, we developed an extensive outpatient bispecific therapy program that includes pharmacists, nurses, providers, and other clinical staff members who have direct contact with patients.

Our policy allows us to closely monitor patients and educate them about the potential risks associated with treatment. The program also enables patients to self-monitor at home, and each patient receives detailed education about what to do in the event of an emergency.

We have on-call providers available to assist patients if an emergency occurs. Our policy also includes a guide that hospital teams can use to help manage CRS or ICANS if a patient presents to an outside hospital or emergency department.

Pharmacy Times: How should care teams educate patients and caregivers to recognize and respond to potential complications, particularly CRS and ICANS, after treatment in the outpatient setting?

Steib: Education is extremely important when bispecific therapy is administered in the outpatient setting. Before patients begin treatment, they participate in a training session led by nurses or other clinical staff members.

During that training, patients and their caregivers demonstrate that they can measure important vital signs that may help them recognize signs of CRS or ICANS. We also provide educational guides and tutorials to support patients and caregivers throughout the treatment process.

Pharmacy Times: What role do pharmacists play in successfully operationalizing outpatient bispecific therapy, including treatment verification, supportive care planning, toxicity management, staff education, and transitions of care?

Steib: Pharmacists play a very important role in successfully preparing patients and clinics for outpatient bispecific therapy. We are an integral part of the multidisciplinary care team.

Before a clinic begins offering outpatient therapy, pharmacists provide education to the clinical staff members who may be involved in the patient’s care. We also assist with building treatment regimens and developing education for both patients and staff.

Pharmacists provide clinical support to providers when questions arise. We also assist with dosage adjustments that may be necessary because of toxicities. Overall, pharmacists work hand in hand with the clinics to help ensure that patients can be treated safely and successfully.