Jeffrey Matous, MD: I want to challenge our panel with the following. We have a patient. You work in a very large community-based practice. That’s far and away where the great majority of patients with cancer go and where doctors are in our country. Some of us work at places that are referral centers, and we have our way of doing things. But there’s no denying that teclistamab and bispecifics are going to be commonly and regularly given preferentially over CAR [chimeric antigen receptor] T-cell therapy in the community setting. It’s going to happen. What are some potential barriers to inpatient vs outpatient administration? What are the logistics? Let’s say I’m in a community of 80,000 and giving teclistamab to somebody. Who’s involved? Who needs to be trained? Do I need standard operating procedures?

Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA: Yes.

Jeffrey Matous, MD: How do we do this? Let’s not start in the ivory tower. Let’s start in the real world right now.

Kirollos Hanna, PharmD, BCPS, BCOP, FACCC: That was 1 of the biggest things for us. There’s a REMS [Risk Evaluation and Mitigation Strategy] program around teclistamab. You can expect that many of the bispecifics or trispecifics will have similar recommendations or maybe be under a REMS program with all the CARs and everything else. At Minnesota Oncology we have 12 clinics, soon to be 14. Do we roll this out across the entire institution? What’s the actual number of patients on teclistamab that we’re going to be seeing? We’re a very large community practice, but we elected to confine it to a single site in the center of our geographical region. If I have someone coming from the North, South, East, or West, this is a centralized metropolitan area where we can provide care. A couple of our concerns were, who’s involved and whom do we train? If I train all staff at all 12 of my clinics, they’ll likely see 1 or 2 patients on teclistamab in a year. The likelihood is low that they’re going to remember REMS requirements because this is not an Epic Systems–based institution. Even if we do all these, we try to have checks, balances, and communications within the EMR [electronic medical record]. A lot of individuals are going to be outdated. How do you deal with CRS [cytokine release syndrome] or ICANS [immune effector cell-associated neurotoxicity syndrome]? What do you look for? What do I need to do in terms of going to that REMS program, authorizing a dose, and getting that authorization number? It poses challenges based on anticipated volume.

Many of our patients are accustomed to some commute outside their norm because we initiate within the inpatient setting. We go to the University of Minnesota, and we refer them to the Mayo Clinic. Mayo Clinic is a 90-minute drive from the Twin Cities. But we elected that clinic, we trained the infusion nurses, we trained the care coordinators and collaborative nurses who work directly with providers. We trained the providers who will be prescribing teclistamab because they have to be certified. We enrolled our site, and we have a dedicated representative for the entire organization who oversees all this. We implemented with EMR-standardized phrases, so the nurses—right before administration—are verifying that the provider is certified, getting the authorization code, and making sure all of that is documented. It was a significant group effort, but confining it to a site aligned with our practice model.

It was also what we were seeing at the University of Minnesota. They confined teclistamab to a certain site. Mayo Clinic is a single hospital connected with tunnels. I wouldn’t say it’s confined. It’s done in the outpatient setting. That was the best model that fit. With opportunity, we’re emailing one another about increasing to 1 more site.

Beth Faiman, PhD, MSN, APN-BC: Three sites.

Kirollos Hanna, PharmD, BCPS, BCOP, FACCC: We’re having those conversations clearly.

Jeffrey Matous, MD: Let me ask our academic colleagues, are you doing any commercial CAR T outpatient?

Beth Faiman, PhD, MSN, APN-BC: No.

Jeffrey Matous, MD: Everything is still in house?

Beth Faiman, PhD, MSN, APN-BC: When ide-cel [idecabtagene vicleucel] was approved, we had 2 patients in the outpatient area when the pandemic calmed down, and they did quite well. We had our inpatient BMT [bone marrow transplant] team do virtual visits with them. We made sure that they were within 20 minutes of the clinic and realistic. But there’s that fear about the CRS. It’s not something we feel comfortable with, but we’re going to move forward. We’ve expanded because of our outpatient infusion area just expanded to Sunday hours. Now that we’re expanding our hours to every day, we might be like a Mayo Clinic 1 day if we’re lucky, with that outpatient-inpatient feel.

Jeffrey Matous, MD: Sure. How about in Kansas? Any outpatient bispecifics or CAR T-cell therapy?

Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA: For bispecifics, not outside ramp-up. Once they get to maintenance, they’re outpatient of course. For patients on CAR T, we have an ambulatory space that’s open 7 days a week. However, we aren’t directly next to our inpatient units, so the larger concern is the median time to CRS and the older population that has multiple myeloma. That’s a concern from not only a safety perspective but also a reimbursement perspective. The main driver was that the median CRS is 1 to 3 days. Knowing how aggressive we like to be with cytokine release syndrome, we didn’t want to be in a situation where we wouldn’t have a bed available. That availability has always been a concern. Even though we’re set up and very safe to do so on the outpatient side, we continue to admit these patients for that reason.

Transcript edited for clarity.