Barriers to CAR T Therapy for R/R NHL

EP: 1.Overview of CAR T-cell Therapy in R/R NHL

EP: 2.Transplant-Eligibility and CAR T Considerations in R/R NHL

EP: 3.ZUMA-1 Trial Using CAR T in R/R NHL

EP: 4.Optimizing CAR T in R/R NHL

EP: 5.Emerging Therapies and Future of CAR T-Cell Therapy

EP: 6.Patient Selection of CAR T-Cell Therapy in R/R NHL

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EP: 7.Barriers to CAR T Therapy for R/R NHL

EP: 8.Value of Outpatient CAR T Administration in R/R NHL

EP: 9.Requirements for CAR T in a Community Setting

EP: 10.Outpatient CAR T in R/R NHL: Policies and Procedures

EP: 11.Role of CAR T Administration in the Community

EP: 12.Educating Providers for Outpatient CAR T Administration

EP: 13.Importance of Monitoring Patient AEs With Outpatient CAR T

EP: 14.Management of Outpatient CAR T Adverse Events

EP: 15.Evolving Treatment Paradigm of R/R NHL and Outpatient CAR T

EP: 16.Future of Outpatient CAR T Administration

Examining barriers to receiving CAR T treatment for R/R NHL including telehealth, travel, and cost as well as the impact on patient care.

Transcript

Bruce Feinberg, DO: Let’s focus on understanding the steps in CAR [chimeric antigen receptor] T referral. We have a patient population that is relapsed or refractory, and they’re unstable. They tend to have rapidly progressive disease. And the treating physician is in a bind.

They need to get the patient referred for a therapy like CAR T, but at the same time they also have to treat them to prevent them from being overwhelmed by disease before that happens. In some way, they must wiggle in that referral. They’ve got to go through the scheduling process. And the institution must receive that patient and do an evaluation and whatever testing is needed to determine eligibility. If eligibility is determined, an apheresis must be done in order to collect the leukocytes. But how many cycles of chemotherapy are needed to get that patient stabilized enough to be able to go through the apheresis and the time it takes for the CAR T cells to be generated in the laboratory? These are a lot of steps and a lot of barriers.

Mike, do you think doctors are struggling with the coordination that Ed referred to, the complexity of both coordinating and protecting the patient to get this done? As a result, how many patients fall through the cracks? How many patients get, the decision is made that we can’t make this happen? I’m curious about those barriers because we’re talking about community setting, and what community setting translates to me is you’re going to be treating that patient in the same environment where all the other treatment has been done. And you remove that coordination. To what extent, with the currently available agents in that setting, is that a significant impediment to the utilization of CAR T?

Michael Diaz, MD: The process itself is an impediment, you’re correct, especially in the world of COVID-19 [coronavirus disease 2019], which we are all living in right now. It can make things more difficult for all. On the other hand, it’s made things easier because we are able to do telehealth, which can at least help initiate discussions, so that you can lay groundwork.

Bruce Feinberg, DO: Ian, would you do an initial patient evaluation for CAR T via telehealth?

Ian W. Flinn, MD, PhD: In general, no. I might have a conversation. We’d say you need to come in, but we might have a conversation saying we could get you in right away. You have to see the patient.

Bruce Feinberg, DO: My point was to make that I don’t know if there’s any transplanter, given the nature of the toxicities and risks inherent to the treatment, where you’re right, in theory telemedicine should be a helpful solution, but I don’t know if it works in this case.

Ian W. Flinn, MD, PhD: It’s also a performance status issue. You need to examine the patient and determine what approach to take. We have had brief conversations saying that we need to see them. But I find the phone call easier with the doctor saying, “I’ll see him this week and get him going.” CAR T cells are like a ticking time bomb. These patients are incredibly sick. It’s a rapidly moving disease. We haven’t talked about it yet, but we heard about all the logistical barriers of getting to the center to do the CAR T cell.

What we haven’t talked about is what a nightmare it is when you’re at the center to get them approved. Because of the financial costs associated with them, there’s everybody, you’d never met so many people who want to weigh in and tell you whether you can or cannot give CAR T cells. The institution will have issues because they don’t want to be stuck with the bill. The third-party payers are not quick making decisions around this, so they want all the eligibility done ahead of time before you’ve even got them approved. It’s challenging at the center’s level as well, to get these therapies approved in a timely manner. I hate to say it, but in our center, when was the last time someone told you that it’s quicker to put someone on a clinical trial than it is to treat them with a commercial product? You never hear that. Clinical trials are usually more difficult. In the case of CAR T cells, it’s a lot faster to get them on a clinical trial than it is to give them commercial because of some of these barriers.

Bruce Feinberg, DO: But it’s interesting. I go back to Michael because when the transplanter complains that much about the process, how does that affect the referral process when you hear those kinds of obstacles? To what extent, because your practice at this point isn’t doing transplant, is that impacting referral? Do you get enough of that messaging that you hear through the grapevine? You hear stories of, you read articles that you just don’t use the therapy that’s available to the extent you could because it’s difficult to get it done.

Michael Diaz, MD:That’s a good question. Things can be difficult depending on which environment you’re in. Some institutions, before they will allow a patient to see a transplanter, must see a nontransplanter in that discipline to get referred to see the transplanter. Once again, the institutions alone can set up their own barriers and obstacles that are there for their own reasons. I’m not sure it’s necessary to help facilitate patient care. With all that being said, we are not seeing any hesitancy. If a patient is a candidate for CAR T, they’re getting the treatments. It takes awhile, as long as they maintain their eligibility during that process. It may not be a quick process, and as we’ve even seen with some of these clinical trials, while a patient is waiting to have their T cells conditioned, they may not be a candidate for that treatment by the time the T cells come back. It’s a very complicated process. A lot of things can happen during that time that is required. Depending on what happens, whether the patient progresses very quickly or they have complications, which can happen at any time, all that time delay can impact patient care.

Bruce Feinberg, DO: Michael, there are a lot of situations that I’m thinking about personally. Are you on a first-name basis with the transplanter you use most?

Michael Diaz, MD: No. They keep on moving around so much.

Bruce Feinberg, DO: Because if you’re not on a first-name basis, you probably don’t have their cell phone number.

Michael Diaz, MD: Right.

Bruce Feinberg, DO: Ed, in a practice of your size, which has a deep relationship with the tertiary care center, I’m guessing you have that kind of relationship.

Edward J. Licitra, MD, PhD: Every doctor in our practice has multiple relationships, fortunately, and probably cell phones. Three or 4 transplanters at multiple institutions.

Bruce Feinberg, DO: It is because it depends where the patient lives and their insurance and what’s best access. You have to go through a system with some kind of general intake, and you’re just like anybody else in line…

Edward J. Licitra, MD, PhD: No, it can’t happen.

Bruce Feinberg, DO: Vs having their cell phone, who knows you by name—it’s Ed, it’s Bruce, can you help me. It’s a totally different experience.

Edward J. Licitra, MD, PhD: More important, we have the nurses’ numbers. We go right to the nurse, the doctor’s nurse, and we get right in.

Bruce Feinberg, DO: Now we’re talking.