Disparities in AMD apparent in clinical trial enrollment, treatment costs

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First of all, thank you so much for the opportunity to talk about this topic. My name is Dr. Alvin Liu. I'm a Retina Specialist at Johns Hopkins University. And I'm also the Founding Director of the Precision Ophthalmology Center of Excellence. I will start with age-related macular degeneration, AMD. It is the leading cause of central vision loss in persons over the age of 50 in the U.S. And currently, in the United States, roughly 20 million Americans live with this condition. When it comes to the baseline prevalence of this condition, the vast majority of Americans with this condition are caucasian patients with a baseline prevalence of about 15 million people. When it comes to African American patients, currently, in the U.S., about a million patients with AMD identified as African American. When it comes to the disparity in the management or diagnosis of this condition, one thing comes to my mind, which is the enrollment of minority patients in clinical trials. In medicine, overall, and definitely in the field of retina, a lot of times treatment guidelines are guided by what we call phase three pivotal randomized clinical trials. And oftentimes, we try to enroll as many patients as appropriate. Ideally, the mix of patients should represent the makeup of the U.S. population. However, due to the relatively low prevalence of AMD in minority patients, if you look across these landmark phase three clinical trials for AMD, typically, the amount, or number, of minority patients is quite low. What this means is that maybe some of the results of these clinical trials may not be completely applicable to non-caucasian patients.

In general, AMD can be divided into two different types, the dry form of AMD and the wet form of AMD. The wet form of AMD is also called neovascular AMD. It is characterized by the abnormal growth of blood vessels either within or underneath the retina. These abnormal blood vessels end up leaking fluid or bleeding. And as a result, people lose vision from it. The vast majority of patients with AMD lose vision because of the wet form of the condition. Right now, the standard of care for the treatment of wet AMD is repeated intravitreal injection of medications into the eye. And once you think of this as a chronic condition, at least 90% percent of patients will need some form of treatments for wet AMD indefinitely. Oftentimes, these medications are quite expensive. For some of the brand name medications, it can cost up to $3,000 per dose. And as I mentioned, a lot of times these medications have to be given on a repeated basis indefinitely. So, you can imagine if someone with insurance copay of 20%, that could represent a significant financial burden on someone from a lower income situation. So, this is one form of disparity that I can think about. Fortunately, a lot of these pharmaceutical companies do have patient assistance programs to help with the copay. But I have definitely experienced situations where the patient told me he or she could not afford the more expensive medications due to copay. And as a result, we have to revert to a medication called bevacizumab (Avastin; Genentech), which you use off-label. Now, this medication, bevacizumab, works very well. However, typically, it lasts not as long as some of the brand name ones, which in turn increases the treatment burden in terms of the number of treatments needed over a specific time period.

This is a very relevant topic as we know in medicine, overall, and also in retinal care. 80% of someone's health outcome actually happens outside of the healthcare delivery setting. What this means is that someone's social determinants of health is extremely important in terms of affecting someone's health outcome, including in the context of retinal conditions. We won’t be able to fix what we don't measure. So, the first step in addressing disparities is to measure these social determinants of health. In recent years, this is a very important hot topic of research. So, I'm glad to see that as a scientific community as a whole, a lot more attention has been paid to social determinants of health. In this regard, there has been an exciting and important development recently coming from the CMS and the government. Noting the importance of social determinants of health, there's now a new regulation, or rule, saying that social determinants of health will have to be recorded at scale in a standardized format across the country. The goal of this initiative is such that once we have data collection at scale in a standardized manner, we can then start systematically analyzing how social deter of health will affect health outcomes.