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202208-153083

2022

Fidelis Care New York

Medicaid

Vision

Pharmacy/ Prescription Drugs

Medical necessity

Overturned

Case Summary

Diagnosis: Dry Eye Disease (DED).
Treatment: Xiidra.

The insurer denied Xiidra. The denial is overturned.

The patient is a female who presented with severe dry eye disease (DED). She has a history of laser-assisted in situ keratomileusis (LASIK) and cataract surgical procedures. The patient has severe symptoms that accompany her dry eye disease. This patient has not had any success with over the counter treatment for symptoms of DED. Clinical findings included abnormal tear osmolarity and a decreased tear break up time. The patient has previously used punctal plugs and a multitude of dry eye medications that have not limited or improved her symptoms. Xiidra was given in sample form, and the patient responded saying that it was "life changing" in regard to improving the symptoms of dry eye syndrome. The subject under review is the medical necessity for the Xiidra.

The health plan's determination is overturned.

Xiidra 5% ophthalmic solution (OP SOLN) is medically necessary for this patient. It is quite common for patients status post LASIK to have severe dry eye syndrome. Xiidra has been proven to create symptom relief in dry eye disease (DED) in 14 days as opposed to the 3 - 6 months before other medications may even start to work. DED has an inflammatory etiology. Artificial tears do nothing more than "soothe" the symptoms of dry eye temporarily. They do not work to alleviate the inflammatory nature of DED disease as Xiidra does. The time frame of symptom relief is so far superior with Xiidra, it is clearly the proper treatment choice. In addition, the prolonged symptoms of this patient were immediately improved with use of Xiidra. Previous treatment methods were attempted with no success.

Xiidra is a preservative-free solution of lifitegrast 5% ophthalmic solution. It is Food and Drug Administration (FDA) approved to treat dry eye disease (DED). The drug went through four separate multicenter, prospective, placebo-controlled, randomized, double-masked FDA clinical trials. Given the rapid onset of effect (14 days is more rapid than any other drug studied to date for DED), and it has good safety profile. In this case it will allow the patient to return to comfortable contact lens wear, adequate visual acuity and a resolution of DED symptoms.

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