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DrugTyrvaya™ (varenicline nasal spray) [Oyster Point Pharma]

October 2022

Therapeutic area - Ophthalmics, Anti-Inflammatory/Immunomodulator

Initial approval criteria

  • Patient is at least18 years old AND
  • Patient has diagnosis of dry eye disease (DED) AND
  • Prescribed by or in consultation with an ophthalmologist or optometrist AND
  • Prescriber attestation that causative factors cannot be mitigated AND
  • Patient has had adequate trial (at least 3 months) and failure of over-the-counter (OTC) artificial tears as documented in pharmacy fill history or chart notes indicating fill/refill history if patient is new to Medical Assistance and pharmacy claims data is not readily available AND
  • Patient has had a 3-month trial and failure of (or contraindication) to Restasis, cyclosporine 0.09% ophthalmic solution or cyclosporine 0.05% ophthalmic emulsion AND
  • Prescriber has documented at least one of the following signs of DED:
    • Corneal fluorescein staining (CFS) score of ≥ 2 points in any field on a 0 to 4 point scale OR
    • Schirmer tear test (STT) of 1 to 10 mm in 5 minutes

Renewal criteria

  • Patient continues to meet the above criteria AND
  • Patient has not had treatment-limiting adverse effects from the drug (e.g., excessive sneezing, cough, throat irritation, instillation-site irritation) AND
  • Patient has improvement in signs of DED, as measured by at least one of the following:
    • Decrease in corneal fluorescein staining score OR
    • Increase in number of mm per 5 minutes using Schirmer tear test

Quantity limits

  • 1 carton (2 bottles) per 30 days


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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