Eyeworld

37 EW GLAUCOMA April 2018 The issues of labeling and insurance coverage are delicate and require diplomacy, tenacity, and patience. The facts, however, con- tinue to stand for themselves, that excellent studies have been carried through and that reimbursement is essential if continuous progress is to be made. It changes who is going to use MIGS and how often. "The problem with glaucoma therapy is that it is almost never over treat- ment," Dr. Brown said. "It is usually too little, too late. So anything that you do that makes it more difficult to do glaucoma treatment is going to cause people to lose vision." Medical therapy is expensive, has side effects (ocular surface disease, burning, foreign body sensation, and more), and there is a disturbing lack of compliance. Traditional filtration surgery is often associated with sight-threatening complications, while the hallmark of MIGS is safety. MIGS also allows a more individualized approach to treatment. According to Dr. Brown, there is no doubt that the MIGS era has begun. MIGS is evolving, and progress is ongoing. Physicians are beginning to understand which patients will benefit the most from the different devices available and are begin- ning to consider MIGS as a valid alternative to medical treatment in mild to moderate patients. This is a new strategy altogether that may take time to sink in. According to Dr. Brown, "MIGS has brought new excitement to glaucoma treatment and has increased hopefulness in the face of a potentially blinding disease. We may be in the position to solve glaucoma, and we desper- ately need these new technologies to be able to treat glaucoma patients more safely." EW Reference 1. Vold S, et al. Two-year COMPASS trial results: supraciliary microstenting with phacoemulsification in patients with open-an- gle glaucoma and cataracts. Ophthalmology. 2016;123:2103–12. Editors' note: Dr. Brown has no finan- cial interests related to his comments. Contact information Brown: reaymary@comcast.net out of their comfort zones to make the commitment to MIGS. More than just a money matter The issues, however, extend beyond the payment concerns. Most MIGS devices have been approved only for patients having cataract surgery, which is often a drawback, as many of the patients with the most seri- ous glaucoma, who would benefit most from MIGS, are pseudophakic patients. He explained, "I recently made a plea to the FDA to make a statement on the label of the CyPass saying that it would be expected to be effective in pseudophakic patients. Only with a positive state- ment on the label do we have hope for coverage. The irony is that the CyPass, in every case, is put into the eye after the surgeon has made the patient pseudophakic, after cataract surgery has already been performed. But according to the current label, you can't put them into an eye that was made pseudophakic previous- ly. To me, that is inconsistent, and it makes no sense to think that it would not be effective in pseu- dophakic patients." the device, anesthesia, the surgi- cal facility, etc. off-label, or out of pocket. Appropriate reimbursement also encourages eye doctors to jump in and start using MIGS. "The issue is when people don't get paid for something, they stop doing it, and the companies stop making it, and the whole thing falls apart," Dr. Brown said. "The reimbursement for an iStent or CyPass, when it is covered at all, might be as low as $300, which is grossly unfair for a glaucoma procedure. We are talking about the treatment of a blinding and incurable disease, with substan- tial chair time, follow-up, postop management issues, and so much more that goes into the care of these highly complicated patients. That is going to have a chilling effect on the use of these devices, and I think that's a terrible thing." According to Dr. Brown, insur- ance coverage just needs to be fair, not excessive, for eye doctors to take on MIGS, which ultimately is an in- vestment of their time and resourc- es. Without coverage, MIGS progress could be set back. The lower the reimbursement is, the fewer eye doctors will want to cross the line either phacoemulsification plus the CyPass microstent (n=374) or phaco only (n=131). The CyPass patients achieved a reduction in IOP that was greater than that achieved in patients who had phaco alone, with the IOP-lowering effects steady throughout the follow-up period of 2 years. Seventy-seven percent of mi- crostent patients achieved >20% un- medicated IOP lowering compared to baseline at 24 months, compared to 60% of controls (P=.001), and the mean IOP reduction was 7.4 mm Hg in the microstent group and 5.4 mm Hg in controls (P<.001). 1 "This was by far the largest study ever done for a MIGS device—and the outcomes were excellent," Dr. Brown said. "'Investigational' is holding us back from being able to give this to our patients. Despite the coverage issues, however, the COMPASS outcomes and the approval of CyPass should increase awareness among surgeons, as the iStent also has, that MIGS devices are safe and effective." Despite all the positive evi- dence, reimbursement remains an obstacle. Insurance coverage makes MIGS feasible for patients who could not afford the high costs of The CyPass implanted after cataract surgery; two rings are visible and the tip of the orifice is at the top of the trabecular meshwork Source: Reay Brown, MD

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