Inclusion Criteria Shaping GA Treatment Landscape


Key opinion leaders discuss clinical and cost considerations for treating patients diagnosed with geographic atrophy.

Ryan Haumschild, PharmD, MS, MBA: With this new agent being FDA-approved and one coming this summer, I think there’s a lot of excitement, at least, amongst us, because I think we recognize the benefit. But Dr Lally, as you start to see patients now being approached for treatment, what do you think will be the patient populations that might be eligible to receive these therapies? Thinking about the inclusion criteria, those that have progressed in disease, is it those that are early on? How do you start to see the early adopters identifying patients for treatment at least initially for both of these therapies?

David Lally, MD: I think for any FDA-approved therapy for a disease, we have an obligation as a physician to at least discuss the option of that therapy with the patient who has the disease regardless of the stage or the presentation or of the symptoms of the patient. I think it’s something that I will start now that it’s FDA- approved for all of my geographic atrophy [GA] patients telling them that there is an FDA-approved treatment. From there, it goes into a discussion with the patient and it’s going to be a very individualized discussion with each patient because these patients can have varying different presentations and they can have varying different ages of disease. We said that age is the most common risk factor. And a lot of the patients are over the age of 80. If you’re an 85-year-old woman with big foveal, geographic atrophic lesions, and your vision [is] 20/400, you can barely see the “E” on the chart in both eyes, and I’m going to discuss a monthly or every other month therapy that’s indefinite, and that patient’s going to have to be brought to the office every month or every other month by their daughter or their son-in-law, they’re more likely not going to want to have that treatment because of the burden of the disease, of receiving an injection in the eye, of having their loved one have to bring them to my office every month and take time from their brother-in-law who has to take time from work for 2 hours a month or every other month to come so that I can receive that treatment. But then on the flip side, I have patients who are 65, 66 years old who have bilateral non-foveal GA, they’re still driving, they’re still working, they’re still really in the middle of their career and they are terrified of losing their central vision and not being legally able to drive. And those patients are very motivated and want treatment, and they want something to slow down the progression of the atrophy from getting into the center and eliminating their ability to drive. There’s a well-reported natural history study that looked at patients with bilateral non-foveal GA and the median time until they lost the ability to legally drive was a median of 1.6 years. So that’s not much time for these patients who are working. I think a lot of the working-class patients, the younger patients are going to be much more motivated to slow down so they can continue working. I think the other patients who are going to want treatment initially are going to be those patients where the non-foveal GA is starting to encroach on the center of the fovea and they’re starting to notice more rapid and more progressive visual deterioration as the months go on. They’re having more anxiety; they're seeing that they're losing vision. I also think a lot of patients with foveal GA still lose significant visual acuity each year, losing 1 to 2 lines of vision per year on average. And they’re noticing they’re losing vision. So it's really those symptomatic patients, the patients that are symptomatic of noticing a continued loss of vision that are not yet to the level of 20/400 vision, where they barely see the “E” but maybe they’re 20/60, 20/70, 20/80 vision, and they’re going to be the ones who are already looking for therapy. They’re the ones in the office who are every time I see them asking, “Do you have anything? Is there anything available? What do you have?” They’re going to be the ones who are going to want therapy initially. I think the patients with more severe vision loss that are older have trouble getting to our office will be the ones less likely to want to go with therapy. But that’s a large percentage of my patients that are symptomatic, that are still working, that are noticing their vision declining every month. I think it’s going to be a few patients every week that are coming to my office that I think would be interested in this type of therapy.

Ryan Haumschild, PharmD, MS, MBA: I don’t blame them. I’d want to hear about the options. And I love your approach of shared decision-making, inviting the patient into a conversation around their treatment. I think that’s really patient-centered care and I think that’s offering the latest to them because they’ll hear about it. GA, it’ll get out there, and you want to make sure that you’re providing them the best outcomes possible. Dr Lopes, I really appreciated hearing that this is going to be an option we want to share with GA patients, but there might be some challenges from a payer perspective with an influx of new patients for the payers and the ophthalmologists. How do you think payers will handle these different challenges of this influx of new patients and treatments?

Maria Lopes, MD, MS: I think one of the rate-limiting factors is probably going to be seen by an ophthalmologist or retinal specialist. I think that in and of itself is probably going to be the biggest limitation of getting therapy and it’s going to be the diagnosis. I appreciated Dr Lally’s comments about maybe the prioritization of who we treat first. With hepatitis C when it was about a cure, we initially started with who we were going to prioritize in terms of treatment, who was going to see the hepatologist or the gastroenterologist. I think the system will be overwhelmed by the number of patients that may present all of a sudden to ophthalmology and retinal specialists. We don’t have enough of them. So I’m not sure how that’s going to be handled. But as a payer, we look at the budget impact as well. And so here, faced with a new therapy for new treatments that are coming, we’re going to look at the indication. We’re likely going to have a prior authorization likely going to involve leaders like the 2 that we have on the panel here in terms of defining the prior authorization for who’s appropriate, largely based on the label and the clinical trial design inclusion-exclusion criteria. And then there’ll be a cost. Is it going to be monthly? Is it going to be every other month? Perhaps we’re going to see over time that like wet AMD [age-related macular degeneration]there’s going to be the real- world data that will perhaps tell a different story about the frequency of administration that may help on the budget impact side of treatment requires less frequent administration. But it’s an important factor because we’re all looking at budget impact usually a year in advance of products coming to market and also looking at commercial Medicare, Medicaid, what that budget impact [is] going to look like. So again, back to guidance around what to expect from a prevalence standpoint we usually think in terms of per 100,000 lives or per million lives, how many members are we potentially going to treat? Is it going to be bilateral or unilateral, and for how long? All that is going to be helpful in terms of understanding the budget impact as well as the potential clinical benefit.

Transcript edited for clarity.

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