Expanding CAR T-Cell Access With Broader Criteria and Real-World Data: Clark Alsfeld, MD

At the Institute for Value-Based Medicine® event in New Orleans, Louisiana, on November 4, Clark Alsfeld, MD, a hematology and oncology specialist at Ochsner MD Anderson, spoke about the availability of and access to the growing landscape of chimeric antigen receptor (CAR) T-cell therapies for patients.

During a panel discussion titled “Access to Care in Hematology,” Alsfeld addressed the gap in access to these therapies, which are limited to larger cancer care centers like those at Ochsner MD Anderson. He also emphasized that while access to CAR T-cell therapies may be limited, bispecifics are widely accessible throughout different states and communities.

In this interview with The American Journal of Managed Care®, Alsfeld explains how CAR T-cell therapies have broadened in their eligibility criteria. Patients with cancers like leukemia, lymphoma, and multiple myeloma can now be treated with CAR T-cell therapies well into their 80s and 90s, Alsfeld said.

“When we look at patients, maybe before CAR T-cell therapy, we're evaluating echocardiograms, pulmonary function tests, and all these things that we have done historically in transplant,” Alsfeld said. “But we're finding, much like all the other areas that I've mentioned, even patients who may not have perfect pulmonary function tests are still safely getting through CAR T-cell therapy.”

These expansions are backed by real-world data and evidence supporting the safety and efficacy of CAR T-cell therapy. Alsfled also said these data, more specifically patient-reported outcomes, are important for improving treatment access and outcomes for diverse patient populations.

This transcript has been lightly edited; captions were auto-generated.

Transcript

How have community oncology practices in Louisiana adapted to incorporate advanced hematologic treatments like CAR T and bispecifics into local care delivery?

CAR T-cell therapy is still limited to some degree to larger centers, the treatment centers. That is still, to some degree, a barrier, of course. Through support, financially, from the pharmaceutical companies and philanthropic support, there's also the American Cancer Society and Blood Cancer United; those organizations all come together to provide financial support or other areas of support for patients to get to centers for CAR T-cell therapy.

Bispecifics are different. There are many centers across the state and community practices that are able to give bispecifics, and that is something that then leads to a conversation that I have with every patient, especially with multiple myeloma as we're discussing CAR T-cell therapy vs bispecific and which option suits each individual. We also find that the community oncologists are much more engaged, and whether they like it or not, they are much more involved in care for hematologic malignancies.

Again, leaning on my area of myeloid malignancies, our oncology and community partners work heavily with us, and they're very much involved. We try to stay involved to provide support for them so that they have the comfort that they need and that they're able to feel comfortable managing these patients closer to home. And I really do look at it as a strong partnership that we have with all of our community partners so that in areas where we can, we allow them to get their care closer to home.

What patient eligibility factors currently guide CAR T-cell therapy selection, and do these criteria risk unintentionally limiting access for underserved populations?

It's a great question. I think, to some degree, that that is, potentially, a limiting factor. A lot of the eligibility criteria for patients who would receive CAR T-cell therapy are different than what we initially planned with transplants. You see a lot of the guidelines and eligibility criteria; a lot of them were borrowed from the realm of stem cell transplants. What we found, though, is patients who can tolerate CAR T-cell therapy much better, and so performance status, for example, for transplant, we really try to optimize 0 or 1 and try to find more medically fit patients, whereas with CAR T-cell therapy, there's published data that even ECOG of up to 2 is safe to do CAR T-cell therapy.

Age is another factor. Age used to be a limiting factor, especially when we look at transplants. Now, with CAR T-cell therapy, there is published data up to age 91 in diffuse large B-cell lymphoma, and even beyond that, allowing for more patients' access to CAR T-cell therapy. Some interesting work is now evolving, too. When we look at patients, maybe before CAR T-cell therapy, we're evaluating echocardiograms, pulmonary function tests, and all these things that we have done historically in transplant. But we're finding, much like all the other areas that I've mentioned, even patients who may not have perfect pulmonary function tests are still safely getting through CAR T-cell therapy.

I do think that we are finding what was historically a population that we were trying to identify, which was admittedly limited, to make sure it was safe for that individual, has expanded now, thanks to CAR T-cell therapy, so more patients can get to CAR T-cell therapy.

How has the introduction of newer, less toxic therapies influenced patient adherence and long-term disease management in hematology?

I think we have seen some of the newer therapies—the perfect example that I love to share is that if you look at the world of acute myeloid leukemia, again, focusing on my niche. Historically, we really had very few treatment options, the same couple of treatment options for 50-plus years, and that really limited the population of patients that could receive treatment for their acute myeloid leukemia. 2017 was kind of a pivotal year for us in the world of acute myeloid leukemia. Since that time, we have now seen 12 new drugs that have been approved for the treatment of acute myeloid leukemia, and there are a lot of combinations within that new category of 12 drugs. We're seeing more and more patients that are capable of being treated, I think, from my own personal experience treating people with acute myeloid leukemia well into their 80s and even 90s, a patient population that historically could never receive treatment, and not only are they receiving treatment, but they're also getting to remission and maintaining remission and getting back to a good quality of life with all of that.

I think there are always going to be challenges with adherence and challenges with maintaining care and maintaining treatment for some of these patients, but with the implementation and access to these newer drugs and newer therapies, most of which are outpatient therapies, we are seeing more and more patients do well and have good long-term outcomes.

What data or real-world evidence do you find most compelling when evaluating whether innovations are truly improving equity in access and outcomes?

It's a great question. I think real-world data open our eyes to a lot of things. I think real-world data, of course, are now taking a different population than historically what is looked at in some of the clinical trials, where patient selection may leave out a majority of patients. When we're looking at the real-world data, I look at a lot of different things, and one of the more important things that I'm always looking at is patient-reported outcomes. I think patient-reported outcomes, in my opinion, should always be included in a lot of these trials, but they are sometimes included and sometimes not. I love seeing that data when it's there.

I also think real-world data, though, to me, is very helpful, because I think it more accurately reflects a lot of the time the patient populations that we're actually treating. I think, through that, you can really find where there may be limitations in access to care, or maybe subgroups of patients that maybe this is not the best treatment, and maybe we can find other realms of patients to treat. And then it's always challenging when you get conflicting data between real-world studies and some of the clinical trials. We see that frequently, and I think I lean on a lot of these different aspects of clinical trials to assess value and benefit.