At the recent American Society of Hematology (ASH) Annual Meeting in New Orleans, Leon Bernal-Mizrachi, MD, an Associate Professor of Medicine in the Department of Hematology and Oncology at the Emory University School of Medicine, sat down with Oncology Data Advisor to discuss his research and presentation regarding association of socioeconomic status with adherence to oral agents and progression-free and overall survival in patients with multiple myeloma.

This podcast episode was recorded live by Oncology Data Advisor and ConveyMED at the 2022 ASH Annual Meeting in New Orleans.

Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, we're here at the ASH Annual Meeting, and I'm here with Dr. Leon Bernal-Mizrachi. Thanks so much for being here today.

Leon Bernal-Mizrachi, MD: My pleasure. Thank you.

Oncology Data Advisor: Would you like to go ahead and tell us a little bit about yourself and about what you do, to start off?

Dr. Bernal-Mizrachi: Sure. I'm an Associate Professor and the Chief of Hematology/Oncology at the Grady Campus of Emory University. I do a lot of clinical, as well as translational, research.

Oncology Data Advisor: Great. So, I know you had the study here about the association of socioeconomic status with adherence and survival with oral agents in multiple myeloma patients. Would you like to tell us a little bit about the background for the study and why you decided to investigate?

Dr. Bernal-Mizrachi: So, the main reason of this study was founded by work that we have polished in the past with our pharmacy team, showing that most of our patients who are in underserved populations tend to have poor adherence to our chemotherapies. We did an intervention and it showed that, with support of our pharmacy, we can increase the adherence from 33% to 86%. So, then that founded my curiosity to figure out what is going to happen across the nation in terms of adherence, to see if the reason why we don't see the significant impact of survival in our patients that we normally see in clinical trials is due, maybe, to a poor adherence to our therapies. That was really the question that we had. The second thing that created this project is because I had the fortune to meet some of the colleagues on the epidemiological research at CVS Health. It's a collaboration between CVS and Emory, and they are fantastic—they're just phenomenal. So, we had a little bit of a storm of ideas, then we came out with a plan and then got it going.

Oncology Data Advisor: Great. So, how'd you go about designing the study?

Dr. Bernal-Mizrachi: So, fortunately, most of the medications that are used in multiple myeloma require the specialty pharmacy, which is run by CVS. They have the capacity to be able to identify what they call the adherence index, which defines which patients were or were not adhering based on the time of acquisition of the medication from the pharmacy. Because of that, they were able also to access public data through insurance companies to define their survival and certain demographic characteristics. So, that gave us the foundation to obtain this information to have the study. Now the study had two populations. One population is the health care cohort, which is derived from an insurance and health care network that is actually partnered with CVS, as well as partially owned by CVS. Then the other one is a Medicare/Medicaid database. That one didn't have much survival data. It was mostly what we called the pharmacy cohort. We couldn't do survival, but we could do the analysis of the effect of adherence with that data.

Oncology Data Advisor: Great. So, what were the results that you found?

Dr. Bernal-Mizrachi: The first thing that we have in terms of number of patients—for the patients with the health care cohort, they're about 646 patients that were able to be selected for the study after excluding certain criteria. And I just want to mention that this study was mainly done for newly diagnosed myeloma patients who are transplant-ineligible. That was one of the criteria that we had. In addition, they had to have insurance or some sort of coverage in terms of insurance, so that we were sure that they were going to pick up the medication during the period of time that we selected. We selected around six years. The health cohort is from 2016 to 2020, and the pharmacy cohort is from 2015 to 2020.

Based on the criteria, we started to select all of that. In terms of the health care cohort, we had about 646 patients; for the pharmacy cohort, about 7,000 patients. So, based on that, we did the first part of the analysis that was the health care cohort. The health care cohort demonstrated that adherence impacted outcomes. This is new because in myeloma, all the medications only improve progression-free survival. Thus far, there are very few manuscripts that have shown improvement in overall survival. In this database, what we found is that in terms of progression-free survival, adherence improved the progression-free survival by 10%. So, it's 56% versus 67%, more or less, in those that are adhering versus not adhering.

But more importantly, it impacted overall survival—overall survival improved by almost 20%, so, in a sense, 70% versus 50%. It's close around those numbers, with a P value that is below 0.001. For the first time, we are showing that it's not actually that a drug improves survival, it's just making sure that the patients take the medication that improves survival. That was the first part, and I think it is the most important result of the findings of this study.

The second part is that we did a socioeconomical score based on zip codes, education, and other factors. We correlated with the Centers for Disease Control (CDC) socioeconomical score, so it is representative and it's accurate. We were able to show that at least in the health care cohort, unfortunately, because of the volume that we had—it was only 686 patients—we didn't reach a significance between the different quartiles of socioeconomical status. It's four quartiles, and we didn't see overall survival difference or progression-free survival difference, but I think that the trend is there. However, I think that the P value didn't get reached because of the number of patients. Then we performed several Cox logistical recreation models. And what we found actually are several factors that were determinant of adherence.

And that was the next question—okay, we know that it impacts outcomes—the next question is, "What makes adherence be affected?" So, in the health care analysis with the 600 patients, one of the major factors that affected adherence was age. Believe it or not, the younger you are, the less adherent you are. The second factor was polypharmacy. So, if a patient is taking more than five medications, they may not be adherent. And the third factor is geographical location and comorbidity index.

In terms of geographical regions, there are certain regions in United States that have lower adherence than other regions, and that includes the mountains. It includes the northeast and mid-Atlantic. Those were regions that were highlighted to have low adherence. In the pharmaceutical cohort, because we had a larger number, we were able to identify other factors. One of the main factors was age. So again, the younger the patient, is the less adherent they are. Socioeconomical status was a major factor. So, lower socioeconomical status was associated with low adherence. Geographical, again, was the same regions. Polypharmacy—so, if you have more than five drugs that you are taking, you will be less adherent. And lastly, copay; if you have t a higher copay, you'll be less adherent because of economic reasons.

We also performed several odds ratios and have validated this in addition to cost proportionally, so it validated the results. And lastly, we also evaluated the number of medications and what kind of medications for myeloma were most associated with low adherence. Interestingly, lenalidomide had a high adherence. People were less adherent to pomalidomide, the same as DNA-damaging agents such as melphalan or cyclophosphamide. And then we also saw panobinostat in a much lower level, because by the time we did this study, panobinostat in excessive uses was very little, so we didn't have the volume to compare those arms. So, that's more or less the summary of the results of the study.

Oncology Data Advisor: That's all so interesting.

Dr. Bernal-Mizrachi: Yes, thank you. The conclusion is, in reality, that health care needs to invest in adherence if they want to have better outcomes. And to invest in adherence, they're going to have to address more than just the age. You have to address polypharmacy, have support for polypharmacy, have economical support for access to medications, as well as identify focus points in the United States where most of this effort needs to be done.

Oncology Data Advisor: Do you have any potential reasons why the younger patients were less adherent?

Dr. Bernal-Mizrachi: We are not as responsible as other people, I guess, but we don't know. No, I don't know.

Oncology Data Advisor: Do you have any other practical steps to begin addressing the adherence issue?

Dr. Bernal-Mizrachi: Yes. So, there are ideas that have been discussed, but nothing solid yet. I think that the role of the pharmacist is crucial. I think that if there is a program that needs to be developed, it has to be involved with significant effort of a pharmacist, our pharmacists as well as social workers. There have been some conversations, including with CVS, but nothing has resulted yet. But the idea is to develop programs that can increase adherence.

Oncology Data Advisor: That's great. Anything else you'd like to share about either your study or about maybe your experience at ASH here?

Dr. Bernal-Mizrachi: Sure, the experience has been awesome. This has been a very fantastic meeting. A lot of new things are happening, so it's very exciting. At least in the field of myeloma, there's a lot of excitement. And the last thing is I want to not only thank you for the invitation, but I also want to give thanks to a lot of the industry that is raising awareness about health care disparities and factors that affect outcomes that are outside of just access to medications.

Oncology Data Advisor: Yes, definitely. Well, thanks much for sharing all this.

Dr. Bernal-Mizrachi: Thank you so much. I appreciate it.

Thank you for listening to this podcast recorded live at the 2022 ASH Annual Meeting by Oncology Data Advisor and ConveyMED. For more expert perspectives on the latest in cancer research and treatment, be sure to subscribe to the podcast at conveymed.io and oncdata.com. Don't forget to follow us on social media for news, exclusive interviews, and more.

About Dr. Bernal-Mizrachi

Leon Bernal-Mizrachi, MD, is an Assistant Professor of Medicine in the Department of Hematology and Oncology at the Emory University School of Medicine, as well as the Section Chief for Hematology and Oncology at the Grady Health System. Dr. Bernal-Mizrachi's research and study interests revolve around cancers of the immune system such as lymphomas or myeloma. He is passionate about creating new technologies to improve patient outcomes and reduce toxicity of the various therapies used in lymphoma and myeloma treatments.

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Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.