Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Glaucome
Treatment: CPT 0449T LT - procedure of the eye (Xen)
The health plan should not cover the proposed treatment.  

The treatment is considered investigational/experimental.  See rationale below.

The requested health service or procedure is not likely to be more beneficial than any standard treatment(s) for the patient's condition or disease.  Other standard treatment options are available.

The Xen gel ab-interno stent is a soft, permanent, subconjunctival implant that shunts fluid from the anterior chamber to the subconjunctival space, and recently received FDA approval for the treatment of glaucoma.  It is a novel treatment that is considered to be a part of the MIGS (micro-invasive glaucoma surgery) treatment options.

A review of published literature by Kerr et al. (2017) concluded that a growing body of evidence suggests that primary minimally invasive glaucoma surgery (including but not limited to the XEN Glaucoma Treatment System) may be a viable initial treatment option to non-surgical intervention. However, further investigator-initiated randomized trials of sufficient size and duration are necessary to better evaluate efficacy.
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The American Academy of Ophthalmology (AAO) Preferred Practice Pattern Glaucoma Panel (Prum et al, 2015) addressed novel glaucoma procedures (such as the Xen Gel Stent) and stated that "Several other glaucoma surgeries exist as alternatives to trabeculectomy and aqueous shunt implantation.  The precise role of these procedures in the surgical management of glaucoma remains to be determined."  The American Academy of Ophthalmology Panel further states, "Limited long-term data are currently available for MIGS (micro-invasive glaucoma surgery)."  

A recent review (Agarwal 2018) of the current studies on MIGS, evaluated the results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events.  The authors concluded:  "Larger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost."

There are multiple clinical trials in progress relating to the XEN Glaucoma Treatment System (www.clinicaltrials.gov).  Therefore, the proposed treatment is still currently under investigations.  

In summary, further investigation with randomized clinical trials is needed on the XEN Glaucoma Treatment System, especially with its long-term effectiveness and safety.  The proposed treatment has not been shown to be more beneficial than current standard treatment options.