Operationalizing BTCEs: How Pharmacists Are Driving Access, Safety, and Smarter Formulary Strategy

Bispecific T-cell engagers (BTCEs) continue to reshape the treatment landscape in myeloma and lymphoma, but their complexity demands thoughtful planning, cross-disciplinary coordination, and a clear logistical roadmap. In this conversation, Donald Moore, PharmD, BCPS, BCOP, DPLA, FCCP, FASHP, and Brooke Adams, PharmD, BCOP, share how their institutions approached formulary evaluation, outpatient and observation-unit workflows, financial considerations, and the practical strategies that can empower even small community practices to safely deliver these transformative therapies. Their insights reveal not only the operational challenges but also the growing confidence and creativity of pharmacists leading BTCE adoption across diverse care settings.

Q: BTCEs come with significant logistical complexity. When your institution decided to bring these therapies on formulary, where did you even begin in terms of operationalizing the program?

Donald Moore, PharmD, BCPS, BCOP, DPLA, FCCP, FASHP: Sure. I can take this one first. For us, one of the first drugs we were onboarding—really the first approval in that space—was going to be teclistamab (Tecvayli; Jjohnson & Johnson) in late 2022, and so we took a very intentional approach of how to best balance the monitoring requirements as well as not trying to create financial toxicity. We developed a model of outpatient administration followed by observation statuses that would be one after another. We were able to do that by going to one of our hematology services for that. Monitoring was a lot of back and forth within the hospital, but it was a way for us to start developing that model that would eventually launch into more of an outpatient monitoring protocol.

Brooke Adams, PharmD, BCOP: Honestly, that’s beautifully said, and I think it’s so funny. We work at different institutions, we’re many, many hours away, but a lot of us do the same exact thing when we launch novel therapies such as teclistamab, talquetamab (Talvey; Janssen), elranatamab (Elrexfio; Pfizer), linvoceltamab (Lynozyfic; Regeneron), you name it. Once you do one, it’s kind of like riding a bike. So blinatumomab (Blincyto; Amgen)—we’re going to put over into a different bucket because he has all sorts of operational challenges by being a short-acting one that requires a continuous infusion and bag changes and weeks off therapy. That one is completely different, and I think the operations of that for me were absolutely different, but we did the same thing.

For some of our patients who are really high risk and don’t have caregivers, or when we’re not comfortable with the caregiver because they cannot do the teach-back method—and you never know what’s going to happen at home—they still go into this op status right now just to make sure. But you can still bill for everything outpatient as long as you don’t hit that 72-hour rule.

Q: What does the formulary evaluation and financial consideration process look like at your institution, and how do pharmacists lead or contribute to that decision-making?

Moore: I’d say for formulary evaluation, particularly for a lot of our bispecific antibodies—being that we have first, second, and third in class for them in myeloma as well as in lymphoma—our formulary evaluations are pretty robust. We have to look beyond just the traditional issues of efficacy and safety. It’s hard to stack these things directly up against each other; they’re not compared against each other. You can only make so many cross-trial comparisons.

It comes down to a lot of other things: How is it administered? Is it time-limited? Is it fixed-duration? Is it continuous? What’s going to be the cost and the economics of it? What’s going to be the health care resource utilization within the monitoring?

There is a lot that goes into it, but I think we as pharmacists play a pretty critical role in that. We really help develop what that content is going to look like in a nice, objective, unbiased manner so that we can partner with our physician colleagues on pharmacy and therapeutics (P&T) so we can all come to an agreement on how we’re going to manage these drugs from a formulary perspective.

Adams: And I think there’s always something to say when you’re first in class, right? I think we talked about that yesterday in our 3-hour-long boot camp. We talked about how the first that came to market is probably going to be the first one to get that second-line and maybe eventually that first-line indication. Looking at that robust pipeline of where these therapies are going and their combinations is huge.

I am at a community hospital, so I have to take into consideration everyone else around me in these community settings—and what if they want to choose this on their formulary and that on their formulary? At Orlando Health, we took a stance and said, “We technically can give any single bispecific there is, so if you refer a patient here and you have a preference, we will honor your preference.” We’re not going to change up the bispecific on you unless there’s a legitimate clinical reason that it is going to harm a patient. That doesn’t really happen with the bispecifics. They’re all “sexy drugs,” as I like to say. They all have great efficacy; they’re changing the lives of our patients.

Figuring out what each institution wants to do is difficult for places that are doing the step-up dosing for them. We have more of that open formulary right now, but I think as time comes, we really need to take these drugs under scrutiny and decide which one has that more robust pipeline compared to the others, because when you look at efficacy, they’re about all the same.

Moore: Yeah. And I think it’s really going to come down to what’s going to end up pairing with what. How are we going to have combinations? What’s going to get first line first? It’s one of those situations where it’s not just about what the current approval is. We need to start looking ahead so we can be nimble with onboarding these drugs quickly when they move into earlier lines and settings.

Q: Community-based oncology settings face real structural barriers to offering BTCEs. What strategies have you seen work for extending access beyond large academic medical centers?

Brooke Adams: Absolutely. There’s a physician who lives down the road from me, and he and I seem to always be partnered together lately because we are the bispecific champions in our region. One day he decided, “I don’t want to send my patient down the street anymore to get a therapy they can get in my backyard. I’m a 1-stop shop. I can do it all.” He took ownership of his patient—and you can do that.

He said, “I have been through residency, I have been through fellowship, and everything I went through is constantly evolving and changing. I want to constantly evolve and change and provide the best therapy to my patients.” So he started with 1 drug and 1 patient, and he did that education for his entire clinic. He took ownership. He took that phone call at 2 a.m. He called the emergency room when he needed to. He would even show up in that emergency room with that patient to make sure that his first patient was successful.

He does not do that for every patient anymore, but you make sure that first patient absolutely has success. If he can do it at a very small community center—just himself with an [advanced practice provider] and his nurse, without even a dedicated pharmacist like Don and myself—then we all can do it. We are all in this together.

Of course, I know it’s logistically challenging, but I think we’re making a mountain out of a molehill. If we can simplify it and get everyone to open their eyes that this is no different than when we started rituximab(Rituxan; Genentech, Biogen) back in the day, when that was the scary drug on the market—this is just the new class of drugs, and they’re not going away. The time is now.

Q: Interdisciplinary collaboration is essential but notoriously hard to sustain. How have you build and maintained those relationships across pharmacy, nursing, oncology, and beyond?

Don Moore: From my perspective, some things we have done—since we talk a lot about education—include regional roundtable discussions and office hours. It is very much a “how we do it” type of drug class. It’s keeping yourself open and available to colleagues who may be taking a little while to start doing this.

One of the other things I’ve found really successful is pharmacist-to-pharmacist communication across places—someone like myself at a larger center and someone at more of a community-based practice who is really trying to get going. You’ve got a pharmacist who’s really trying to push it and make it happen, and being there as a lifeline to assist through some of the nuances and challenges of this drug class is huge. We say challenges, but not impossible.

Brooke Adams: It’s never impossible. That was the goal of the boot camp we put together yesterday. We spent 3 hours really talking about how the 4 of us did everything very differently, but we reached the end goal of getting therapy to our patients—just through different avenues. And that’s what we’re here to do.