The value of CAR T administration for a community setting is explored, and the panel shares their personal experience with expanding CAR T in this setting.
Bruce Feinberg, DO: Would a hospital want to do this? Ian talks about all the issues in trying to get the patient certified and the huge amount of money that’s at risk to the hospital and potential impact of delayed payment, no payment, or challenges to payment because of questions about the appropriateness of the patient. Do you think hospitals are standing in line?
Edward J. Licitra, MD, PhD: They’re not. In New Jersey, we have a community-based CAR [chimeric antigen receptor] T-cell program. We started the program about a year and a half ago, when we engaged with, at the time, Juno [Therapeutics, Inc] and now BMS [Bristol Myers Squibb]. We opened 2 clinical trials that are active. Both are focused on community-based administration of CAR T cells in a community-based office. We’ve enrolled a number of patients on those trials. When we started about a year and a half ago, it was interesting because a lot of the things we just brought up, like FACT [Foundation for the Accreditation of Cellular Therapy] certification, we have a bone marrow transplant center down the street from us. That was a big deal because we originally wanted to use them as our hospital partner. We were not allowed to do so because we were not FACT certified and they were.
The key to the case was that we worked with a community hospital that was more open to working with our community-based group. We created all the policies and procedures so that we could do this safely. We coordinated and created a team at the hospital that we involved; the ICU [intensive care unit] team, neurologists, cardiologists, nephrologists, and the ER [emergency department]. We embedded our SOPs [standard operating procedures] and our order sets within the hospital EMR [electronic medical record]. We flag every patient. If a patient did wind up the ER, they were flagged as a CAR T-cell patient.
We created all the infrastructure of that program in the context of 2 clinical trials, which are the liso-cel trials, for JCAR017. [This was done] with the hope that if we could perform well in a clinical trial setting—to get a CAR T cell off the ground and infuse that CAR T cell next to a patient getting R-CHOP [rituximab, cyclophosphamide, vincristine, prednisone] in our office in East Brunswick, New Jersey—when the commercial products came, we would be sitting in a good position to become a community-based infusion center. Because we were concerned that there are going to be major problems with access to care. If every patient must go to a bone marrow transplant center to get a CAR T cell, I don’t think patients are going to get CAR T cells.
If every patient who needs a CAR T cell has to cut through all the red tape of a hospital that’s unwilling to make a financial decision to move forward with a CAR T cell because of the economics, perhaps community-based practices such as the larger sophisticated ones should be taking a leadership role in CAR T cells. We have a unique position in terms of our connectivity with the patients but also our ability to organize teams in highly efficient ways and then ultimately work on the finances of CAR T cells. Then we can go to payers directly to contract with payers as a community-based practice to administer all this care. This is the path that we’re moving down in New Jersey. This is the opportunity as we move forward in terms of CAR T-cell administration in the community.
Bruce Feinberg, DO: Michael, your practice is large in Florida. Is this path similar? I don’t think you’re as far along as what Ed described. But I’m curious about what you’ve experienced so far and where are you in terms of finding hospital partners?
Michael Diaz, MD: That’s a good question. Our initial plan before COVID-19 [coronavirus disease 2019] was to try to have a program up and running by the end of the year. Obviously, COVID-19 put everything on hold. We’ve been trying to hold our own here. We’re hoping we can have this set up by the middle of next year. We’re going to start with 1 location. We have a good relationship with the local hospital there who is willing to work with us on this endeavor and to develop partnerships, protocols, and infrastructure so this can be done safely. We will be developing this together with the manufacturer as well as experts so it’s the safest for the patient.
When you look at the big picture, the patients can have this treatment closer to their home or within a small travelable distance, rather than having to travel 3 hours to get the treatment. If it can be given just as safely, it’s going to be better for the patient. As you’ve heard, given all the red tape and the bureaucracy that you can experience with larger institutions, this will help serve the patients better and they will have access to this therapy in a timely fashion.
Our second goal, once we get 1 site set up, then we would like to have it strategically placed throughout Florida. Because our geographic footprint in Florida is two-thirds of the state. Once we get it well developed at 1 site, we’ll probably set up maybe 3, possibly 4, sites across the state.
Bruce Feinberg, DO: I want to stay focused on this because I’m going to go between you and Ed for a second. Ed, when you were developing this program to conduct the 2 clinical trials, were you doing the math based on the size of the practice, the potential number of eligible patients, to have a sense of how many patients you can have? Because it seems to me that part of that infrastructure is going to relate to a skill set, and that skill set is going to require a certain level of experience. It seems it works only if you’ve got enough patients going through. You can’t set all that up and invest all that infrastructure and training and have a patient go 3 months before you have the next patient. Was that analysis done to try to look at what is that patient volume you believe could be generated to figure out if this makes sense?
Edward J. Licitra, MD, PhD: I don’t think we were that sophisticated. We were purposefully not that sophisticated because for me, we needed to make a commitment long term to CAR T cells infused in a community-based setting. We were laser focused in terms of getting up and running with these 2 clinical trials. It didn’t matter if I put 1 patient or 10 patients on trial, I just wanted to use the clinical trial as a vehicle to put the policies, procedures, and workflows in place to safely give CAR T cells to patients in a community-based setting.
My focus was to build a relationship with the local hospital so we could take the finances out of the equation. Because once you introduce a commercial CAR T cell, suddenly there are a lot of discussions that we have to have with the local hospital regarding patients who get admitted. But when you do it in the context of a clinical trial and the proper financial indemnifications are in place, all of a sudden we have an incubator if you will, so we had the luxury of building our program out without having to worry about the finances of giving CAR T cell. As I said, it didn’t matter for me.
We did an analysis because we had to do an analysis in terms of how many patients we might be able to put on trial, but that was not my motivator. My motivator was to use this because it forced us in the most precise way to build a program that we knew could ultimately stand the test of time, and that we could put it up against other people who wanted to potentially say your program is not great because if we could do it in the context of a trial, then we were ready to move into the world of commercial CAR T-cell infusions.
Bruce Feinberg, DO: Michael, has the practice done an analysis to look at what is that potential patient throughput if you could do it the way you’re describing it?
Michael Diaz, MD: That’s a difficult question because we have newer therapies that are being studied. Also, when we are looking at this, we’re looking at the newer generations of immunotherapies that will be coming out; the biphenotypic antibodies also have cytokine release syndrome as well. We’re going to start with 1 location, and depending on where things are at the time, yes, at that time, we will do an analysis to determine whether it’s financially feasible or responsible to set this up at other locations. But the math will continue to evolve and change. Your business will continue to evolve and change over time. This is 1 of these things where you have to start at some point and then continually look and reassess your system and figure out what makes best sense for the patients as well as your practice.
Bruce Feinberg, DO: Thanks, Michael.