Eleonora Lad, MD, PhD: What are some of the considerations for introduction of these therapies within clinics, provided they become FDA approved? Leadership buy-in, access to therapy, training associated with the staff, coverage for these treatments, and a plan to ensure patient compliance and adherence? I’ll start with David.
Jesse 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 in order 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 plus payers likely to pick up these treatments? They’ll also mandate that we treat a certain way with these remedies. 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 make use of the words dementia or Alzheimer . Those are buzzwords for the layperson. Cancer is a buzzword. Unfortunately, we offer with real-world dynamics. People who are making decisions and involved in administration and insurance are usually laypeople who don’t always understand the particular 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 in order to achieve. Storage is going to be an issue. We don’t know what the drugstore is going to be like. All of us don’t know what the label is going to be like. We need to get buy-in from insurance carriers plus from the particular 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 will this a good option. We’re going to have to do widespread education in order to get people on board.
Nancy M. Holekamp, MD, FASRS: I couldn’t agree more. Once we possess approval associated with a treatment for GA, there’s going to be the flood of very advanced disease coming in. We all 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 that 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, yet we won’t reach everyone. We know that individuals with GA are out there. They’re with their primary eye care providers. We must have got a large educational campaign for general ophthalmologists plus optometrists due to the fact we have a therapy. That is very true.
As for adopting this into our clinic, 1 nice thing will be that’s it’s an injection, and all of us know how to do that. Hopefully we can slot within any new medication in to 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 even Dave. I might need 1 . What are your thoughts?
Jayanth Sridhar, MD: If this as successful as we would like it to be, then that’s a good problem to have. We are going in order to be confused. There simply aren’t enough injecting doctors in this country to take care of all the individuals who are usually 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 heading to need to do that on a micro basis. Working individually, we’re likely to have to streamline our process with regard to getting sufferers to injections and change the way we all construct our own clinics. We need in order to start thinking about this particular as a field. How do we approach this? We require to be proactive in terms of how all of us handle who else does shots. Are injections done? Are usually we going to change the particular paradigms? Instead of the retina doctor doing your shots every month, is usually it likely to be a lot more like some other subspecialties in medicine, like oncology or radiation oncology, where it is a guided treatment plan yet with someone else administering the treatment that you’re recommending? How do you foresee this particular happening?
David R. Lally, MD: I agree. It’s going to be a challenge regarding our field that we all haven’t seen before within terms associated with the burden of these types of patients currently coming into the busy clinics. It’s important from a patient perspective—at least in the beginning until we see how this plays away over time—that the care is provided by a retina specialist. Why? It’s not really because we need to change plus make choices based on what happens with the therapy in terms of the efficacy, at least in the beginning till we get more data. It’s more from a safety perspective. We retina doctors understand 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 the small PED [pigment epithelial detachment] much better than other vision care companies. We want to catch any safety events while early because possible since initiating treatment as early as possible to treat CNV is very important. In the beginning, until all of us have more experience, these injections should be performed by retina professionals in a retina care setting, or even at minimum the therapy should be monitored carefully by the retina physician.
Jayanth Sridhar, MD: To your point about safety events, we’ve observed IOI [intraocular inflammation] and retinal vasculitis. These are things that, thankfully, most eye treatment providers don’t have to recognize or deal with daily. We understand weird things can happen. That’s why you are right. When you initiate new therapy, that’s likely to be essential. The other thing that’s probably important: do you think we’re going to notice cost analysis data? All of us started this particular discussion simply by talking regarding the cost of geographic atrophy intended for society. Regrettably, someone is definitely making decisions as they ought to for anything. Is this something that insurance companies and American taxpayers need to invest inside? We’re going to find it is when we perform cost analyses, the loss of function for patients, caregivers, depression, and mortality. There’s going to be a very clear benefit. We all don’t understand what the price will be to get any of those drugs until we see a label, but it’s likely to be important to show that, just like anti-VEGF, this a therapy that not only save lives and is ethical but also most likely saves the particular system money.
Eleonora Lad, MD, PhD: Excellent point. The burden of care associated along with these injections was a hot topic in this year’s American Academy of Ophthalmology Retina Subspecialty Day. It seemed in order to be the central theme throughout the day. In the United Kingdom, for example, nurses are usually performing the majority of these types of intravitreal injections. To your point, David, I agree that will close monitoring of adverse events is important as the treatments are available to individuals.
Transcript edited for clarity