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Transcription

Amy: Hello, and welcome to another episode of Avalere Health Essential Voice and the first episode in our Disease Education series. In this series, we will be covering topics on a wide range of therapeutic areas.

My name is Amy Schroeder, and I’m a Senior Consultant and oncology pharmacist in our Market Access practice. I’m joined today by my colleague Karl Kilgore, who is a Senior Research Scientist in the Health Economics and Advanced Analytics practice.

In today’s episode, we will dive into some recent research we have conducted on patients who received Chimeric antigen receptor (CAR) T-cell therapy in the real-world setting to treat their large B-cell lymphoma, or LBCL.

Since the 2017 US market entrance of CAR T for LBCL, what have we seen in real-world evidence about CAR T therapy for treatment of LBCL?

Karl: We’ve been studying the use of CAR T in elderly patients with relapsed or refractory LBCL using our 100% Medicare fee-for-service claims data. These studies represent the first real-world data available for CAR T. We looked at the characteristics of CAR T patients, their healthcare utilization and outcomes, and the cost of their care, and compared them to results from other cell therapy options.

Amy: What specific studies have we done?

Karl: The first study we conducted showed that CAR T can be successfully used in older patients, even patients with multiple comorbidities—congestive heart failure, renal disease, pulmonary disease—that in many cases would have excluded them from participating in clinical trials for CAR T. We showed that CAR T can be used successfully in these patients in terms of healthcare utilization, such as hospitalizations and emergency department visits, and their associated costs decreased significantly after CAR T. Their overall survival outcomes were very positive.

Amy: You mentioned that we have compared CAR T to other therapeutic options. Can you talk a little more about that?

Karl: Sure. For LBCL patients who failed first-line treatment, there are three options that offer the possibility of good long-term results: autologous stem cell transplant, allogeneic stem cell transplant, and CAR T. In our most recent study, which was presented at Transplantation and Cellular Therapy Conference 2021, we took that original sample of CAR T patients I talked about previously and compared them to matched cohorts of patients who received either autologous stem cell transplant or allogeneic transplants.

We then compared the group’s healthcare utilization and costs for the 6 months prior to the index procedure and the 6 months after. We found that, in general, both transplant groups had higher rates of inpatient hospitalizations and longer hospital stays compared to CAR T in the 6 months prior to the procedure.

Now, the autologous stem cell transplant and the CAR T groups declined after the procedure to roughly equal levels on the hospitalization measures that I just mentioned. But the prevalence of hospitalizations in the allogeneic stem cell transplant group remained higher than CAR T in the 6 months post procedure, and the average length of stay for that group actually increased pre to post transplant.

Amy: Very interesting. So, you mentioned costs. Can you talk a little more about that?

Karl: Sure. Total healthcare costs in the 6 months prior to the procedure were higher for both of the transplant groups than for CAR T. All groups showed a large decrease in costs in the 6 months after, as you would expect. Autologous SCT showed the biggest decrease in costs pre to post. Total healthcare costs decreased by about two-thirds. Then CAR T came in next. Cost decreased by about half. Allogeneic stem cell transplants, which had the highest cost pre procedure. also had the highest post procedure and decreased by only 15%.

Amy: Okay, so the healthcare resource utilization and cost data that you just mentioned are exclusive of each procedure, though, right? Isn’t CAR T more expensive than a stem cell transplant?

Karl: That’s right. Let’s look at utilization first. We did look at the procedures themselves. Both transplant groups had a longer length of stay in the hospital than CAR T for the procedure itself. And for those stem cell transplants who had an ICU transfer during their stay, the transplant patients spent a longer period of time in the ICU—3 to 6 days depending on the transplant type—than CAR T. CAR T patients were slightly more likely to have an ICU transfer, but the stem cell transplant patients stayed longer in the ICU.

Amy: Okay, so based on everything that you’ve just mentioned, what can we conclude from all of these studies?

Karl: We concluded that while the procedure costs are known to be greater for CAR T than for stem cell transplant, we did observe cost offsets in the time periods before and after the index procedure itself. We calculated the cost offsets in autologous stem cell transplant to be about $14,000 per procedure. For the allogeneic procedure, cost offsets were even greater—over $70,000 compared to CAR T.

Amy: So, in addition to the cost offsets, maybe this is a good time to talk about the results that we saw in another study that we don’t have time to get into in depth today.

Although autologous stem cell transplant is the standard goal of treatment for patients with relapsed refractory LBCL, most patients actually never qualify for a transplant because of age, comorbidities, poor response to the treatment that actually helps get them prepared for that stem cell transplant. Isn’t that right?

Karl: That’s exactly right. In that other study, we looked at elderly LBCL patients for whom autologous stem cell transplant was the goal of treatment and we found only 5.1% of these elderly LBCL patients ultimately received one. For the LBCL patient who does not qualify for autologous stem cell transplant, further treatment options are very limited, and the prognosis is poor.

Amy: So then it appears to highlight a really large unmet medical need in these patients. Is there anything that we should know about this research?

Karl: We should keep in mind these studies are retrospective observational designs. They’re not controlled cost effectiveness studies, or comparative effectiveness studies. So we should exercise caution and collect more data on these research topics. We matched patients on demographic and clinical characteristics only looking back 6 months. We were unable to match patients on their entire treatment history. How many prior lines of treatment did the patients receive? Over what period of time? These are important factors in the determination of what the next treatment should be and what the ultimate outcomes are. That’s an area for the research we want to do.

We should also keep in mind that for our CAR T patients, this is very early experience with CAR T. It is literally the first year of CAR T to appear in the Medicare claims data that are available. If we were to look at more recent data, we might find that with the increased use of the procedure and greater familiarity on the part of the providers, more recent studies might yield different results.

Amy: Wow, that really sounds like there’s a lot of opportunity to do some more research. That leads to my next question, which is, what are our plans at Avalere for future CAR T research?

Karl: Well, first of all, we’ve got another year of data, and the use of CAR T itself is increasing. So, it’s not only the time, but also the volume of the procedure. It’s becoming more commonplace. This means we can look at utilization and costs now and try to identify any trends as providers gain experience in managing patients with potentially less use of intensive care units and a better understanding of how best to prevent and treat the adverse events. We might see a reduction in utilization and costs in more recent data. We can also incorporate the longer view of the patient’s history that I mentioned earlier to better account for time since disease onset and the prior treatments that patients may have received. We’ve got some evidence that CAR T currently is used third line, fourth line, fifth or sixth line. By having that longer look-back period, we might garner more insight into the optimal point in the treatment course of these patients to apply CAR T.

This research studied the Medicare fee-for-service patient only. We have much higher volume of data now in the commercial population, Medicare Advantage, even managed Medicaid, so we are looking to extend our research to the other payer types.

Finally, the majority of the CAR T patients in our studies received CAR T in the inpatient setting. There’s a great interest in the costs and outcomes associated with CAR T when it is performed in the outpatient setting and we believe we have enough data now to begin to systematically look at CAR T in outpatient.

Amy: Okay, so thank you so much, Karl. This has been great hearing about all the studies that we’re doing at Avalere and also what the future holds. The insights that we’ve learned from these studies are invaluable to our listeners, especially treatment planners and decisionmakers addressing the challenges in treating relapsed refractory LBCL. I would like to thank you on behalf of Karl, myself and the Avalere team for tuning in to Avalere Health Essential voice. Please stay tuned for more episodes in our Disease Education series. If you would like to learn more about us, please visit our website at avalere.com/podcasts.