Real-World Treatment Patterns and Costs Among Patients With CLL or SLL

In this video, Kerry Rogers, MD, Ohio State University Comprehensive Cancer Center–James, discusses the results of a real-world study on treatment sequencing and health care costs among patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) treated with venetoclax, finding that costs were high during the initiation phase and lower overall for patients who had previously received ibrutinib (Curr Med Res Opin. 2021; 37[8]:1409-1420. doi:10.1080/03007995.2021.1929894).

Transcript

Hi, I'm Kerry Rogers. I'm an assistant professor in the Division of Hematology at the Ohio State University. I'm going to be talking with you about some results of our exciting study looking at real-world evidence regarding costs of CLL therapy, specifically sequencing of therapy, and use of venetoclax as a targeted agent for CLL.

Everyone's probably familiar with CLL. What's happened in the last decade or so is that the prior standard of chemoimmunotherapy has been largely replaced by oral targeted therapies. This includes both ibrutinib which was developed slightly before the drug we were mainly looking at, which is venetoclax.

Both of them are oral-targeted agents and have drastically changed the outlook for CLL patients, including superior progression-free survival, or in some cases, overall survival compared to chemoimmunotherapy. These are the standard.

One of the drivers for this study was to look at sequencing, and also costs of venetoclax as one of our standard treatments for CLL, and something that's a good option for the majority of our patients. This study was a collaboration with Janssen Oncology, and was a study using claims data, which I thought was exciting and a really interesting way to look at this.

This study used the identified data from Optimum's Clinformatics Data Mart database, which included both commercial and Medicare Advantage data. That's what was included in it, and we used the study period between April of 2016 and June of 2019.

You can think of that range relative to the approvals for venetoclax to get an idea of who we've included in the study. We looked at observed lines of therapy, breaking it into first, second, third, or greater. We considered something someone's first line of therapy if they had not received any therapy in the 12 months prior to the study observation window.

What was looked at then was the cost of care for these patients, including not just the pharmacy costs, but also outpatient and inpatient costs, and costs for things like emergency visits, and divided this into an initiation phase for venetoclax and a post-initiation phase.

For the initiation phase we chose the first 60 days since venetoclax was prescribed. That was to capture this timeframe when patients are undergoing venetoclax dose ramp-up or dose escalation. Venetoclax is a highly successful treatment for CLL, but one of the main difficulties with its use is that it requires a very strict monitoring and prophylaxis system for tumor lysis syndrome.

Tumor lysis syndrome is a major risk with this drug, acute tumor lysis syndrome when you start taking it. It requires a lot of monitoring which can be costly and add to the total cost of care for patients receiving venetoclax.

Then, development of tumor lysis syndrome also is rather costly to treat. Looking at the 60-day window is hoping to capture the ramp-up period versus time after that when people are taking the drug and doing better.

The window was also widened to 60 days to capture people who are prescribed venetoclax but didn't initiate it on the day it was prescribed, which I know in my practice, you prescribe it, and sometimes it takes a while to get them scheduled to actually start it.

That's what the study was. There is information on sequencing and what other therapies patients had received prior to venetoclax for the second, and third, or more line of therapy patients. That was interesting to see.

A large number of patients had received ibrutinib as a prior line of therapy. It was 68% of the patients with prior observed lines of therapy had received ibrutinib, probably due to the earlier approval of ibrutinib compared to venetoclax in our study window, and also the fact that venetoclax is highly effective when used after ibrutinib.

That was unsurprising, but very nice to see. What we found is that there was a higher cost associated with treatment initiation for our first 60-day period compared to the later periods. It did actually cost more to care for patients during this initiation phase.

That's important and also an expected finding. The most cost was with the first-observed line of therapy patients. I'm not sure why that is. It could be because of higher disease burden requiring more monitoring.

This was in the period before obinutuzumab was in widespread use. I'm not sure that's the whole reason, but we did actually find that it did cost more for the first-observed line of therapy compared to subsequent.

The other interesting finding was that for patients receiving their second-observed line of therapy, those who received ibrutinib prior to venetoclax as their prior line of therapy, actually had lower costs in the initiation phase.

That was interesting as well. This study wasn't able to tell us the reason for that finding. It could be due to lower tumor burden for patients switching from ibrutinib who frequently get switched faster to avoid things like disease flare if you're resistant to ibrutinib. That was also a finding we had, so that was interesting to see.

There's a couple of limitations with this type of research. One is the sample size was actually quite small. We didn't have a lot of patients given our time period. Also, it's claims data, so we don't have all the information about these patients and why treatment decisions were made and full patient characteristics that might help add a little more information to what we're seeing in terms of the health care costs.

Then, there's difficulty ascertaining if a first-observed line of therapy is really their first total line of therapy, if some of those patients had actually received something like chemoimmunotherapy in the distant past.

Still, it is what we expected to see, with higher costs during initiation than maintenance phase of venetoclax. Again, this very interesting finding that patients receiving a second line of therapy who had prior ibrutinib treatment had a lower cost during treatment initiation.

Moving forward, I think it would be interesting to look at this with more follow-up after venetoclax, or in a more recent timeframe where people are getting venetoclax for a fixed duration or with anti-CD20 monoclonals to see how that might impact health care utilization costs, especially in a larger cohort of patients.

I was excited to be a part of this study, and I would very much like to acknowledge and thank my collaborators with Janssen Oncology. This was a fun collaboration to have with them, and I think the outcome of this study is very interesting.

Also, I would like to thank the Journal of Clinical Pathways for allowing me to share the results of our study.