CAR T for R/R DLBCL: Improving Access and Utilization

Ian W. Flinn, MD, PhD: John, as a community oncologist, what are the barriers you experience related to getting patients treated with CAR [chimeric antigen receptor] T cells? We know from the centers that provide them, some of the challenges they have, but can you comment on your experience and the obstacles to actually getting someone treated—very practical real-world issues?

John M. Burke, MD: Yeah, there are a lot of them, and this is really important. As was mentioned before, a lot of patients who could be benefiting from this therapy in real life probably don’t get access to it and don’t receive it, which is too bad because it really does potentially offer better outcomes. 

What are those barriers? One of them is that the disease can move too quickly. It takes a while for me, as community doctor, to see the CT scan or PET [positron emission tomography] scan that shows a recurrence, meet with the patient, discuss the possibility of CAR T-cell therapy among others, and put in a referral. The referral has to get sent by a staff member to the receiving tertiary care center. A patient has to wait for an appointment to get in to see the specialist. The patient may have to travel. I live in a big city, but many patients live 2, 3, 4 hours away from big cities. That’s another barrier. The pandemic is not making travel any easier. That’s another barrier that has occurred.

The other thing I’ve seen is insurance authorization barriers. I saw this especially early on, when CAR T first became available. “Yeah, we have this product available, but it’s going to take a few weeks to get the insurance authorization before we can even more forward and do apheresis.” That’s going to take time and will delay treatment, and many people may not have the luxury of waiting.

The high cost of the treatment is also a barrier. The high costs and physician and hospital concerns about getting reimbursed vs losing their shirts is a barrier. The need for inpatient treatment is a barrier. Some patients, especially older ones who may not be candidates for stem cell transplant, may not want to spend a couple of weeks in the hospital. That has been a barrier for some of my patients. I also think patients’ concerns about potential toxicities and safety can pose a barrier. Some folks really don’t want to go through therapy based on some of those risks.

There are a lot of barriers, and I’m probably forgetting many. A lot of things get in the way of patients seeking out and successfully receiving these treatments. The take-home point for practitioners in the community is to really make your referrals early. Your patient doesn’t have to be ready for apheresis. If you’re waiting that long to make your referral for CAR T, you’re waiting too long. You’ve got to recognize that there are going to be barriers that will delay the apheresis by many weeks. You want to get your patient in the hands of a specialist well before that, so they have time to get all those ducks in a row before the treatment begins.

Ian W. Flinn, MD, PhD: That’s really great advice. Amit, John just spoke on behalf of the referring end. Perhaps you can talk on behalf of the receiving end? What obstacles do you see? If you could reduce some of these obstacles, what would you suggest?

Amitkumar Mehta, MD: I totally agree with John. Earlier referral is key. If the patient is referred late, we are struggling to get all the ducks in a row. One of the bigger challenges on the receiving side, even after insurance approval, which doesn’t happen right away, is that most of the time I do peer-to-peer talks and provide all the evidence and articles and whatnot. That gives us an approval.

One thing I’ve learned during the last year is that approval is not sufficient. The cost of the therapy is so high, and somehow that contract is not under the existing contract with the institution. This means we have to go into a separate agreement with the insurance company, what we call a case-based agreement. The higher-ups in the institution get involved with the insurance company. So that is an additional step to be sure that the therapy is covered and the cost of the therapy will be paid to the institution. Without that, the institution will not move forward with using that almost $0.5 million treatment in that setting.

Once that is done, which also takes an additional week to 10 days, that’s when the scheduling starts. I’ll tell you that the leukapheresis and collection of cells, even though it seems very easy, still requires a sync between the institution and the company, or the commercial side of that. We have to have a slot on their side as well as ours. That’s an additional delay.

I totally agree with John. COVID-19 [coronavirus disease 2019] has changed many things. Even if the patient needs a line, they need to have a COVID test and need to be negative within 3 days. The team doing this may be very busy because of the pandemic. You may not get an appointment right away. These are all barriers. Apart from that, remember that these patients are progressing very fast. So you’re also struggling to control their disease.

There are so many challenges, especially in the era of COVID-19. If I have 1 successful CAR T treatment, I’ll sleep better.

Transcript Edited for Clarity