Introduction of New Geographic Atrophy Treatments in Practice

Eleonora Lad, MD, PhD: What are some of the considerations for introduction of these therapies in clinics, provided they become FDA approved? Leadership buy-in, access to therapy, training of the staff, coverage for these treatments, and a plan to ensure patient compliance and adherence? I’ll start with David.

David R. Lally, MD: Yes, these factors matter greatly to our ability to employ these therapies. It’s not something we like to deal with as retina specialists. We want to use tools that we know have benefits for our patients, but our medical systems doesn’t always allow us to use tools as quickly or have accessibility to them. A lot of factors are going to be involved here: what’s the cost to the system? How are the products stored? How is the product made, what’s the manufacturing of the product like? Are insurances going to cover and payers going to pick up these therapies? They’ll also mandate that we treat a certain way with these therapies. Many factors are completely unknown right now that will affect the accessibility and usability of these products. What do you think, Jay?

Jayanth Sridhar, MD: That’s a great point. Before we started this session, we discussed buzzwords. Nancy, you use the words dementia or Alzheimer. Those are buzzwords for the layperson. Cancer is a buzzword. Unfortunately, we deal with real-world dynamics. People who are making decisions and involved in administration and insurance are laypeople who don’t always understand the terminology. Maybe geographic atrophy [GA] needs to become a buzzword, as macular degeneration has. Just as we talked a lot about compliance for patients, we must apply that same education to our colleagues and leaders, and people must understand what we’re trying to achieve. Storage is going to be an issue. We don’t know what the drugstore is going to be like. We don’t know what the label is going to be like. We need to get buy-in from insurance carriers and from the people who are key players in our institutions. We need to get these patients in, so people who are referring doctors, optometrists, and ophthalmologists don’t keep saying come back in 6 months and don’t know that this an option. We’re going to have to do widespread education to get people on board.

Nancy M. Holekamp, MD, FASRS: I couldn’t agree more. Once we have approval of a treatment for GA, there’s going to be a flood of very advanced disease coming in. We saw that when we had our first approvals for treating wet age-related macular degeneration [AMD]. That’s a good problem to have because we’re the specialists who can sift through to determine who will meet the label requirements and whom you can have a discussion with. At first, there will be a big flood, but we won’t reach everyone. We know that patients with GA are out there. They’re with their primary eye care providers. We must have a large educational campaign for general ophthalmologists and optometrists because we have a treatment. That’s very true.

As for adopting this into our clinic, 1 nice thing is that’s it’s an injection, and we know how to do that. Hopefully we can slot in any new medication into our office paradigm, but we may be overwhelmed. I’ve never had an injection clinic in my practice for wet AMD. I don’t know if you have, Nora or Dave. I might need 1. What are your thoughts?

Jayanth Sridhar, MD: If this as successful as we want it to be, then that’s a good problem to have. We’re going to be overwhelmed. There simply aren’t enough injecting doctors in this country to take care of all the patients who are going to need treatment for geographic atrophy and the other diseases, which we already inject for that and are also increasing at an exponential rate. We’re going to have to do that on a micro basis. Working individually, we’re going to have to streamline our process for getting patients to injections and change the way we construct our clinics. We need to start thinking about this as a field. How do we approach this? We need to be proactive in terms of how we handle who does injections. Are injections done? Are we going to change the paradigms? Instead of a retina doctor doing your injections every month, is it going to be more like other subspecialties in medicine, like oncology or radiation oncology, where it’s a guided treatment plan but with someone else administering the treatment that you’re recommending? How do you foresee this happening?

David R. Lally, MD: I agree. It’s going to be a challenge for our field that we haven’t seen before in terms of the burden of these patients already coming into our busy clinics. It’s important from a patient perspective—at least in the beginning until we see how this plays out over time—that the care is provided by a retina specialist. Why? It’s not because we need to change and make decisions based on what happens with the therapy in terms of the efficacy, at least in the beginning until we get more data. It’s more from a safety perspective. We retina doctors know how to look at an OCT [optical coherence tomography]. We know how to evaluate for CNV [choroidal neovascularization] and exudation. We can catch a little of the fluid that develops over a small PED [pigment epithelial detachment] much better than other eye care providers. We want to catch any safety events as early as possible because initiating therapy as early as possible to treat CNV is very important. In the beginning, until we have more experience, these injections should be performed by retina specialists in a retina care setting, or at least the treatment should be monitored carefully by the retina doctor.

Jayanth Sridhar, MD: To your point about safety events, we’ve seen IOI [intraocular inflammation] and retinal vasculitis. These are things that, thankfully, most eye care providers don’t have to recognize or deal with daily. We know weird things can happen. That’s why you’re right. When you initiate new therapy, that’s going to be important. The other thing that’s probably important: do you think we’re going to see cost analysis data? We started this discussion by talking about the cost of geographic atrophy for society. Unfortunately, someone is making decisions as they should for anything. Is this something that insurance companies and American taxpayers should invest in? We’re going to find it is when we do cost analyses, in terms of the loss of function for patients, caregivers, depression, and mortality. There’s going to be a very clear benefit. We don’t know what the price will be for any of these drugs until we see a label, but it’s going to be important to show that, just like anti-VEGF, this is a therapy that not only save lives and is ethical but also probably saves the system money.

Eleonora Lad, MD, PhD: Excellent point. The burden of care associated with these injections was a hot topic at this year’s American Academy of Ophthalmology Retina Subspecialty Day. It seemed to be a central theme throughout the day. In the United Kingdom, for example, nurses are performing most of these intravitreal injections. To your point, David, I agree that close monitoring of adverse events is important as the treatments are available to patients.

Transcript edited for clarity