Step Therapy for Patients With DME

EP: 1.Overview of Anti-VEGF Treatments for AMD and DME

EP: 2.Barriers to Optimal Treatment Outcomes

EP: 3.Patient and Cross-Care Education Strategies for AMD and DME

EP: 4.Real-World Long-Term Safety Data of Anti-VEGF Agents

EP: 5.Treat and Extend Strategy for Anti-VEGF Injections

EP: 6.Markers of Disease Progression in nAMD Patients

EP: 7.Significance of SRF vs IRF in nAMD

EP: 8.Current Treatment Options for nAMD

EP: 9.Managing Suboptimal Responders to Anti-VEGF Treatment

EP: 10.Applying CATT Study Results in Real World

EP: 11.Long-Term Treatment Experience with Aflibercept

EP: 12.Treat and Extend Strategy for Aflibercept

EP: 13.Prospective Therapies and Treatment Strategies for nAMD

EP: 14.Unique Challenges of DME Treatment

EP: 15.Key Findings of Protocol T Study

EP: 16.Key Findings of DRCR Protocol AC Study

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EP: 17.Step Therapy for Patients With DME

EP: 18.Efficacy of Faricimab in Clinical Trails

EP: 19.High Dose Aflibercept as Emerging Therapy for Retinal Diseases

EP: 20.Other Emerging Retinal Disease Therapies

EP: 21.Emerging Gene Therapies for Retinal Diseases

EP: 22.Final Thoughts on Retinal Disease Treatments and Outcomes

Transcript

Ehsan Rahimy, MD: Ali, with insurers mandating step therapy now, it’s come up a couple of times here already, let’s discuss it, with bevacizumab first. What are these implications in your practice? Is it something you’re starting to deal with in your geography?

Ali Khan, MD, FACS, FASRS: I think it’s everywhere to some degree. Unfortunately, there is usually a staff of people whose job it is to figure out which patients need to be on this drug for a certain number of times before you can switch, because ultimately you need to treat the patient. Any out of insurance cost for patients is usually exorbitantly high for these medications, so you have to work within their insurance coverage to make it affordable for them. So I think, unfortunately, at the present time, you are beholden to the specific requirements of each individual payer and hope that the efforts of the ASRS [American Society of Retina Specialists], the American Academy of Ophthalmology, and others, continue to fight for the ability to have a choice. Now that we have more options, maybe that argument becomes easier.

But I think how you can implement step therapy without compromising vision is to be very mindful of where you are after the step therapy mandate is over. There are some people who, after 3 injections, immediately switch, even if the patient’s doing fine. Jon, to your prior point, that’s why I think the switch criteria were so stringent in Protocol AC, so it could be iron tight that people had a very clear reason to switch. And the fact that 70% of patients in that trial ultimately switched to aflibercept shows that with step therapy, most of these people are going to be on a different drug. In Protocol AC, half of those switches happened in the first 4 months. I think that’s matching what typical step therapy mandates are for bevacizumab. And I think we need to continue to work together to see if there’s a way around it. To Jon’s prior point, if some of these people are doing very poorly early, I wouldn’t necessarily want to wait too long, and I think it becomes a slippery slope if those step therapy mandates become not the 3 injections, but perhaps 6 injections. It’s something we need to work on as a broader community to make sure we’re doing the right thing for each patient.

Veeral Sheth, MD, MBA, FASRS, FACS: The slippery slope extends beyond DME [diabetic macular edema] too in this type of case, where payers can say, “Well, we saw it here, we’re going to apply it to all disease indications.” We know that’s not what was studied, and we know there’s a likelihood that doesn’t apply to other diseases, right? I think that’s the other scary part, we deal with these types of things and payers push back all the time. We know that a lot of times [it doesn’t make sense]. That’s the concern we have, when you get these data and then people start to run with it and start to kind of expand the indications for it, it’s a little challenging.

Jonathan Jonisch, MD: Yes, I think all of us strive to practice cost-effective medicine. I think that’s the highest level of medicine you can perform, not only effective medicine but within a cost-saving strategy. What gives me reassurance is when you look at the FDA-approved treatments, when you compare them with other therapies across other indications outside of retina care—oncology, blood pressure, cholesterol—our medications stack up tremendously well, even with monthly injections, on a cost basis and quality of life, which are objective measures. And fortunately, we’re not treating all our patients monthly, so the costs go down with similar efficacy. I do believe even with our branded, more expensive therapy, we’re still practicing cost-effective therapies in terms of the quality-of-life years they get per cost, as well as the number needed to treat. The number needed to treat in these medicines is so low. In medicine, a number needed to treat below 100 is considered reasonable. In retina [care], our number needed to treat is below 10, which is really unprecedented in medicine. So I sleep like a baby knowing I’m giving patients good care that’s cost effective.

Ehsan Rahimy, MD: I think that is a great point. To me, one of the biggest take-home points, you mentioned the extremely stringent criteria, and yet still 70% of patients switched. The thing this type of study doesn’t reflect, as you touched on, is going to be cost savings over time. Our goal is to maximize durability, stretch out office visits and injection appointments. It’s not just injections or the cost of the medicines. It’s the burden of bringing a patient into the office, testing, time taken away from the workplace and the workforce. All these things add up, and this study doesn’t necessarily reflect that, but I think we all feel it. We all know it, if we’re able to buy a patient even an extra month or 2 months in between treatments.

Have you guys been feeling stuck at all where you are? I’ve been hearing from colleagues around the country about how they’re incorporating the biosimilars in between, and this is kind of the slippery slope about step [therapy]. At least in the beginning, it used to be as simple as try it once and if you don’t like the response for any reason, you just write down why and you move on. But I’m hearing in some parts of the country, 3 bevacizumab [injections] first, 3…next, or ranibizumab biosimilar, and then you can move on. Are you guys starting to experience this?

Jonathan Jonisch, MD: Yes, I think we’re seeing it. We’re only going to see it more. I think Medicare Advantage is going to be more than 50% of Medicare before we know it, and so that’s only going to grow. We see most of the steps being rolled out by not only the commercial [insurance companies], but the Medicare Advantage [as well]. I think it’s present in all of our practices and is only going to grow.

Transcript edited for clarity.