Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Glaucome
Treatment: CPT 0449T LT - procedure of the eye (Xen)
The health plan should cover the proposed procedure.
The requested health service or procedure is likely to be as beneficial, but not more beneficial, than standard treatment(s) for the patient's condition or disease.

In this case, coverage of the XEN Gel Stent is requested for a patient with primary open angle (pigmentary) glaucoma which has been refractory to medical therapy and surgical therapy including laser iridotomy, cataract surgery, and iStent inject. Such treatment would be among standard of care upon review of the peer reviewed medical literature.

The FDA approved the XEN45 Gel Stent and the XEN Injector "for patients with refractory glaucoma who failed previous surgical treatment or in patients with primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy."

According to the American Academy of Ophthalmology, the implant itself is made out of a soft, collagen-derived, gelatin that is known to be non-inflammatory. The goal of implantation is to create an aqueous humor outflow path from the anterior chamber to the subconjunctival space. The implant is injected through a small corneal incision with the use of an inserter similar to those used for intraocular lenses (IOLs). Similar to other implants, it can be performed in conjunction with cataract surgery. XEN also allows for keeping postoperative options open, allowing physicians to utilize other intraocular pressure (IOP)-reduction techniques should they be required after surgery.

An international multicenter retrospective study compared the efficacy, safety, and risk factors for failure of standalone XEN45 gel stent implantation versus trabeculectomy, both with adjunctive MMC. In this study by De Gregorio et al., 354 eyes with uncontrolled glaucoma and no prior incisional filtering surgery underwent microstent implantation (n 185) or trabeculectomy (n 169). The results demonstrated that there was no difference in efficacy, risk of failure, and safety profile between the two surgical procedures.

Most recently, Lenzhofer et al assessed the long-term clinical outcomes in patients after XEN-GGM implantation. Theirs was a prospective, non-randomized, multi-centered study involving 64 consecutive eyes of 64 patients with open angle glaucoma that received the XEN-GGM (63 m) without Mitomycin C. Mean best-medicated baseline IOP was 22.5  4.2 mmHg and decreased significantly to 13.4  3.1 mmHg four years postoperatively (-40%, n = 34, P < 0.001). Mean number of IOP lowering medication decreased significantly from 2.4  1.3 preoperatively to 1.2  1.3 (-50%, n = 34, P < 0.001) postoperatively. Visual field mean deviation showed no significant change between preoperative and postoperative examinations. Complete surgical failure rate per year was ten percent. The authors concluded that the XEN-GGM resulted in lower IOP and a reduction in medications from baseline over four years of follow-up. There was no detectable decrease in visual fields over the study. The surgical failure rate is comparable to other filtration surgeries.