Tyrvaya™
Drug - Tyrvaya™ (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
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411