Eyeworld

EW GLAUCOMA 36 April 2018 Glaucoma editor's corner of the world by Stefanie Petrou Binder, MD, EyeWorld Contributing Writer FDA approval of MIGS does not guarantee reimbursement. With this in mind, Dr. Brown discusses how much of the struggle for integrating MIGS into standard glaucoma treatment still lies ahead G laucoma treatment has always had an unmet need. Unlike cataract sur- gery, it has proven much more difficult to solve. Traditionally, patients with mild to moderate glaucoma receive medical therapy to lower intraocular pres- sure, with surgical options reserved for extreme cases that no longer respond to drops. Glaucoma treat- ment today, however, is experienc- ing a paradigm change. The mindset has shifted to targeting MIGS as an eye drop replacement early on, rather than saving it for later, as a trabeculectomy replacement in far- gone, refractory patients. EyeWorld interviewed Reay Brown, MD, Atlanta Ophthalmology Associates, Atlanta, and EyeWorld Glaucoma co-editor, about the exciting options that MIGS provides and his outlook on a more hopeful, more solvable future. Changing how we think "MIGS is changing the glaucoma treatment paradigm to more surgery and earlier surgery," Dr. Brown said. "I expect that intervening earlier, in patients with mild to moder- ate disease, will reduce the need for medical therapy and limit the impact of poor compliance. Plac- ing MIGS earlier in the course of disease will limit advanced glauco- ma damage and help avoid future blindness. Much like phaco, which eye surgeons resisted for years before it gained acceptance in the ophthal- mological community, we've been working on MIGS for well over a decade now, and the acceptance of it will take time, too. This is with- out a doubt the MIGS era, and the notion of focusing on the outflow pathways to reduce pressures makes sense and needs to gain more recog- nition. MIGS gives us hope for the future that one day we will solve glaucoma. "The process of getting ad- equate coverage for MIGS from insurers is slow going, but we will get there despite the frustrations of the moment," Dr. Brown said. "Over the past 5 years the FDA has approved three MIGS devices, each with a different mechanism to reduce IOP, the iStent [Glaukos, San Clemente, California], the CyPass [Alcon, Fort Worth, Texas], and the Xen Gel Stent [Allergan, Dublin, Ireland], with even more tools and devices in the pipeline. What has been happening since getting FDA approval, however, is that if I want to implant a CyPass or iStent in a patient, even if I do it in exactly the FDA-approved situation, which is a patient with mild to moderate glaucoma having cataract surgery, I often don't get coverage or don't get adequate coverage. Reimburse- ments are better with the iStent because it has been in use for longer and has had more than a decade of clinical research. Insurance cover- age is complicated. When a device gets FDA approval it goes through a period where it has a T-code, which marks it as 'investigational.' Insurers will then turn down coverage on the basis of the device being 'investiga- tional,' which it is not. The clinical trials that were carried out for these devices, particularly for the CyPass, which included hundreds of pa- tients, more than proved their safety and efficacy." The multicenter COMPASS trial included 505 primary open angle glaucoma patients with cataract, who were randomized to receive MIGS: Now that it's here, who's going to pay? I n this "Glaucoma editor's corner of the world," Reay Brown, MD, discusses the important topic of where money meets MIGS. Although we are in the middle of the MIGS revolution, getting MIGS approved and paid for by insurance companies is often an insurmountable challenge. This topic hits home for me. While I do not consider myself a philanthropist, I per- sonally gave away more free MIGS procedures in the past year than I care to acknowledge. Dr. Brown points out that we had to change our mindset to adopt MIGS, and we might need to again change our mindset to acknowledge that these important and valuable surger- ies deserve fair reimbursement. While the phrases "experimental" or "investigational" often get thrown around by insurance companies, the prospective longitudinal multicenter clinical investigations that resulted in FDA approval for the iStent and CyPass are some of the largest, longest, and best designed randomized clinical trials in the field of surgical glaucoma. Another point that Dr. Brown eloquently makes is that the MIGS alternative medical ther- apy is certainly not free, and it is costly to patients in ways beyond finances that affect quality of life. I am reminded of the recent Medicare proposed cuts to selective laser trabeculoplasty (SLT). I couldn't understand why Medicare would decrease payments to this laser, know- ing that there would be a resulting and much more dramatic increase in medication costs. At least I did not understand this until I realized that the division of Medicare that pays for outpatient medical procedures is a different division with a different budget than the one that pays for pharmaceutical costs. Additionally, while we love surgeries that have a low impact on the patient's quality of life, there is nothing simple or easy about glaucoma surgical decision- making, the procedures themselves, or the care we must provide for months afterward. The final and perfectly accurate point made by Dr. Brown is that vision is on the line with glaucoma, and on average patients continue to lose significant vision from this disease every day. Anyone who stands in the way of treatment by thwarting efforts at reimbursement is contributing to blindness. On a positive note? Reimbursement does generally get better with time, and after reading Dr. Brown's insights, I am confident that brighter (and better reimbursed) days lie ahead for MIGS. Nathan Radcliffe, MD, Glaucoma co-editor Reay Brown, MD

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