Diagnosis: Dry eyes
Treatment: Tyrvaya (varenicline)
The insurer denied Tyrvaya (varenicline).
The determination is overturned.

This is a female patient with dry eyes for whom coverage of Tyrvaya is the subject of review. Coverage was previously denied as it was not identified that the patient had failed or had intolerance or contraindication to the required number of formulary alternatives. The formulary alternative is identified as Xiidra.

Reportedly, the patient previously used Xiidra which caused adverse reactions including redness, long-term blurriness, and severe burning. The patient has also tried Cequa and Restasis which caused the same reactions. Additionally, the patient is reported to have tried and failed various artificial tears and tear gels.

An exam dated documents the patient being prescribed Tyrvaya (varenicline) nasal spray and a 2 week course of prednisolone acetate. The patient was taking ocular lubricants as well as oral azathioprine. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

The provider reports that the patient has tried and demonstrated intolerance to the formulary drug, Xiidra (lifitegrast). In addition, the patient has tried and demonstrated intolerance to topical cyclosporine products (Restasis and Cequa). Therefore, as the patient has also tried and failed ocular lubricants as recommended by the Preferred Practice Patterns of the American Academy of Ophthalmology, the medical necessity or Tyrvaya is indicated per standard of care.

Tyrvaya (varenicline solution) nasal spray is a cholinergic agonist Food and Drug Administration (FDA) approved in 2021 for the treatment of the signs and symptoms of dry eye disease. Wirta et al evaluated the efficacy and safety of OC-01 (varenicline solution) nasal spray for the treatment of patients with dry eye disease. Theirs was a randomized, multicenter, double-masked, vehicle-controlled, phase 3 study. The authors concluded that OC-01 nasal spray was well tolerated and showed a clinically meaningful effect on signs and symptoms of dry eye disease.