Utilization Management Strategies in Treatment of Wet AMD and DME

EP: 1.Overview of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)

EP: 2.How Do the Patient Populations Differ for Wet AMD vs DME?

EP: 3.Important Considerations Regarding Treatment Selection for Wet AMD and DME Patient Populations

EP: 4.Anti-VEGF and Gene Therapy Impacting Wet AMD and DME Treatment Landscapes

EP: 5.Variability of Frequency Dosing for Anti-VEGF Agents in the Treatment of Wet AMD

EP: 6.Faricimab: Mechanism of Action, Payers’ Perspective, and Real-World Experience

EP: 7.Faricimab Approved Label Dosing Interval

EP: 8.Clinical Considerations for Retreatment in Failed Anti-VEGF Therapy

EP: 9.Novel Treatment Mechanisms for Patients with DME and Wet AMD

EP: 10.Diagnostic Imaging Impacting DME and Wet AMD Treatment Landscape

EP: 11.Treatment Barriers Facing Patients With DME and Wet AMD

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EP: 12.Utilization Management Strategies in Treatment of Wet AMD and DME

EP: 13.Wet AMD Resource Utilization Impacted by Medication Duration of Action

EP: 14.Evolution of Access to Treatment for Wet AMD/DME Therapies

EP: 15.Payer Engagement With the Retina Community

EP: 16.Trajectory of Treatment Landscape for Wet AMD and DME

Jim Kenney, RPh, MBA: Dr Sheth, what’s your experience with utilization management strategies, such as step edits, quantity limits, or prescriber restrictions, as they relate to these 2 disease areas, wet AMD [age-related macular degeneration] and DME [diabetic macular edema]?

Veeral Sheth, MD, MBA, FACS, FASRS: The general frustration has been explained here already. Cesar mentioned some of the difficulties, whether it’s patients having to go to specialty pharmacies or these step edits. Let’s put ego aside. Let’s put aside the fact that, as a physician, I want to have some control over my patient’s treatment and have some say in that. Let’s forget that for a second. Let’s just look at science and data for a second. What happens to these patients when you put them through a cycle of failure? You have to see them fail before you can switch to that new medicine. What does failure mean? Failure means they have active disease. What do we know about active disease in our patients? We know that damage is being done, photoreceptors are being burned out, and vision is being lost in a way that’s irrecoverable oftentimes.

Ethically speaking, it’s a difficult thing to grapple with on a day-to-day basis because I’ve had this conversation with patients. I’ve explained to them, “I can switch you to this new medicine, but I can’t do it until we do another 1 of these treatments. You’ve already had 2, and I have to do 1 more.” They feel that frustration. It’s 1 of the most unpleasant conversations I have day-to-day vs some of these other patients where we can pivot and do what we need to do based on how that patient is doing. Those are the best cases that we have because we can doctor. We can do what we need to do to make sure that patient has the best case and the best result. That’s the frustration, so founding it in science and making sure we understand the dangers with that type of process are really important.

Jim Kenney, RPh, MBA: Dr Coney, you mentioned that within 2 or 3 months you can determine if a product isn’t working, and that’s an opportunity to switch. What’s that interval? Could we encourage payers that are going to require these steps to shorten that interval to say after a month or 2 treatments? In some cases, you’ve got to do 2 or 3 of these. If it’s 3 months each, you’re looking at almost a year of vision loss if they’re not responding. What’s the window to negotiate with payers? We can say, “If you insist on a step, let’s make it a shorter interval.”

Joseph Coney, MD, FASRS, FACS: You hit the nail right on the head. With all the experiences we’ve had over the last decade and a half…we may not know what they’re doing well on, but we know when they’re not doing well. We know that by continuing those injections, if that swelling is getting worse when they come back in that first month, at month 2 they’re going to get worse and at month 3 they’re going to get worse. Why are we waiting for patients to continue to worsen before we switch? We need the flexibility to use different agents.

These agents are different. They’re not all the same. We use as a broad name anti-VEGF, but they all have different mechanisms. Some patients respond better to some drugs than others. The most important thing is that the longer the fluid is in the eye, the more damage is done to photoreceptors. That doesn’t take into account that in the real world, patients don’t come back every month. Something may happen—they may have been hospitalized—so now they’re coming out at 2 months. This is a complicated problem when you treat patients in the rural world. We’re talking about random results from randomized clinical trials and trying to understand that. But in the real world, it’s a lot more complicated. Sometimes they don’t come back. Using longer biologics can change the curve of these patients to have dryness quicker because all the studies show that individuals who have increased fluid, particularly intraretinal fluid, typically have worse visual outcomes.

Caesar Luo, MD, FASRS, FACS: [I’d like to] build on that. You made a great point. If we take a step back and now I’m in the payer’s shoes, I can understand this conversation. I understand this argument from their standpoint. They’ve seen some data that show some effective therapies. Avastin, or bevacizumab, is a very effective therapy in a small subset of patients. That’s true. I call those patients my hyper-responders. For those patients, I’ll know in a month if it works for them. I don’t need 6 months to determine that. We have data supporting that as well. Patients stay in their lanes. Once you start treating them, they don’t diverge into other lanes of suboptimal responders. We know who they’re going to be.

Believe me, I’m happy to continue Avastin on a patient who’s doing great on it. The thing is, you can’t make that a blanket statement, that I can’t do anything else for 3 or 6 months until you show me a failure. That’s extremely rare. Yes, it might happen, but it’s extremely rare that a patient ends up getting better in a year. Honestly, that might not have been because of the drug. That might be because their disease process has changed, so it’s difficult to have that conversation. If we could shorten that window to a single injection, we’d be a much happier society to undergo that as a behavior change.

If they want to argue data, most data support the fact that Avastin isn’t as effective as the other treatment options we have. Protocol T and SCORE2 show similar data. You can’t have your cake and eat it. If you want us to use what you think is an effective agent, you’d better show us that it’s equally as effective as what we have. There are no data supporting that. Jim, that’s a great point. If we could shorten that window so we know who those patients are, I’d be happy to continue them on Avastin if they need it.

Jim Kenney, RPh, MBA: You’re the expert, so we should be able to trust you. One advantage of Avastin is that the out-of-pocket cost for the patient on Avastin is significantly less. If they’re paying a 20% co-insurance, that can be an advantage. Sometimes the patients are driving that. They’re coming to you and saying, “I can’t afford this other agent. Can you help me?” It’s worth trying. But if it’s not working, you certainly don’t want to continue the therapy. There’s definitely some education that needs to be put forth. This program is going to help with that. It’s not a 1 size fits all. VEGF isn’t the answer for everyone. Reasonable steps and trials are OK, but the longer we delay, the more damage we’re going to do and the worse off patients are going to be.

To Dr Coney’s earlier comments about these rapidly progressing patients, that’s a big problem. If it were a very slow progressive disease, like an autoimmune [disease]—if we think about rheumatoid arthritis, generally the progression is a little slower. If you have somebody try a drug for a couple of months to see if it works, it’s not likely you’re getting sufficient damage. Correct me if I’m wrong, but it sounds as if we could see significant damage in some of these patients for 3, 6, 9 months if we’re delaying treatment of more effective therapy.

Transcript edited for clarity.