CAR T-Cell Therapy and Bispecifics in the Community: Opportunities and Obstacles
At CPC+CBEx 2025, Lavi Kwiatkowsky discussed how payer frameworks, accreditation requirements, and operational challenges are shaping access to CAR T-cell and bispecific therapies in community oncology—and how technology could bridge the gap to expand patient access and streamline care.
CAR T-cell therapy and bispecific antibodies require significant resources and coordination. How do you see payers and policy frameworks either enabling or hindering community oncology practices’ ability to offer these therapies, and what changes would have the greatest impact?
Lavi Kwiatkowsky: For payer support for CAR T-cell therapy and bispecifics in the community, I think I would split my answer into two. CAR T-cell therapy is a case where it's a little bit more on the hindering side. What I've heard from practices is that the requirement for fact accreditation significantly hinders because it's primarily more about bone marrow transplant than it is specifically for CAR T-cell therapy.
The direction the industry is moving in at large is that we're learning more and more about CAR T-cell therapy, how to administer it in a safer way, and how to do it and expand access. As we know, only 20% of patients who are eligible actually receive CAR T-cell therapy, unfortunately.
Not surprisingly, in line with the trends that we're seeing, the US Food and Drug Administration (FDA) has removed Risk Evaluation and Mitigation Strategy (REMS) from CAR T-cell therapy recently for some of the drugs. We're seeing a trend of “this is good for patients”: we want to see increased access, we want to see them receive it, but we haven't seen that trend develop as much with the payers as of yet. That is the feedback that I'm getting from the practices that we work with, none of which are doing CAR T-cell therapy outside the hospital at the moment. Certainly, there is interest in the community.
In terms of bispecifics, generally speaking, there is wall-to-wall support. That's a case of endorsing and not of hindering. As you look at the challenges for community practices to adopt bispecifics—and let's set CAR T-cell therapy aside because that's not currently fully accessible—first of all, let's get ready. Let's train everyone so that everyone knows what to do—doctors nurses, staff, etc. Then there's having the protocols, procedures, and the drugs, like tocilizumab, to manage toxicities on hand. There's the hospital partnership, and then there are staffing and operational challenges.
For example, guidelines say that the practice, a nurse or someone clinical, should be calling the patient every 3 or 4 hours to check in with them. As you can imagine, that level of staffing after hours and on weekends as the population of patients receiving bispecifics grows and grows is not sustainable. So, there are certainly a lot of challenges associated with that, and we see the adoption advancing more slowly than we would've wanted to see as a result.
Your session emphasized practical solutions. What strategies work most effectively to close care gaps that community oncology teams can realistically implement in the near term?
Kwiatkowsky: As you look at these challenges for the adoption of bispecifics in the community setting, certainly some of them could be addressed with a lot of sheer will, dedication, and a physician champion in procedures and investment. But also, it would be extremely hard to scale a program beyond that one physician champion or two and their direct staff—to every nurse knowing what to do, every physician being ready, expanding access across our sites, hub and spokes, and so on.
I'm talking from my own book because I do lead a technology company, but I do it because that's what I believe and I believe that there's a huge opportunity for technology to support patients across the challenges we've articulated. It's really hard to train nurses to memorize things that they will see one patient a month for in the beginning, if that. However, if there's a software like Canopy that they're already using every single day to do their day-to-day job—to triage patients, to see what to do—and everything was there, all the protocols and the standard guideline-based therapy, basically at their fingertips, they don't need to memorize it. That significantly lowers the bar for training and education.
For monitoring and staffing, instead of calling them every 3 hours, what if the software walks the patient through a check-in process every few hours? If the patient, for any reason, does not submit that, then the nurse will be informed that a report is missing or [they should] check in and they would check on the patient to see that they're fine.
If they do submit that, which is [what happens] the majority of the time, then we could algorithmically say, "Okay, these patients are doing well. Let's take our nurses' valuable time and invest it in those who really need their help." Basically, let’s not just practice at the top of the license, but let's use our resources where we can have the best come out of it and also to measure how we're doing and to show that patients are getting these therapies in the community. They are doing well, they are feeling better, and they are appropriately managed. Across the board, technology could play a significant role.
What have been your biggest takeaways from CPC+CBEx 2025?
Kwiatkowsky: [There are] three themes that I'm seeing here in the meeting today. The first is bispecifics, CAR T-cell therapy, and novel therapies, not just in the panel that I participated and moderated, but also the conversations that I'm seeing. A lot of the conversations in the halls and on stage revolve around novel therapies and our need to adopt them faster and allow patients to have access and benefit.
The second theme that I'm seeing is around technology's role and the use of artificial intelligence (AI). Surprisingly, there's a lot more excitement and questions of "how do we" then there are concerns and "how do we, but." I'm seeing a lot more of the excitement than I am the concerns and inhibitions.
Lastly, what makes this meeting unique is the fact that it's cross stakeholder. We see everyone. We see academics, we see community oncology, we see payers, we see manufacturers, we see vendors, and industry. I think that facilitates a really interesting conversation when all the partners are in the room. That's wonderful.
