Pharmacy Prior Authorization Criteria

Tyrvaya (varenicline solution)

Indications for Prior Authorization

Tyrvaya (varenicline solution) nasal spray

• For diagnosis of Dry Eye Disease
  Indicated for the treatment of the signs and symptoms of dry eye disease.

Criteria

Tyrvaya

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of dry eye disease
AND
• Trial and failure, contraindication, or intolerance to at least one OTC ocular lubricant (e.g., artificial tears, lubricating gels/ointments) [B, 2-4]
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Restasis (cyclosporine 0.05%)
• Xiidra (lifitegrast)
AND
• Prescribed by or in consultation with one of the following:
• Ophthalmologist
• Optometrist

Tyrvaya

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy. (e.g., increased tear production or improvement in dry eye symptoms)

P & T Revisions

2024-09-04, 2024-05-29, 2023-10-26, 2023-09-10, 2022-06-01, 2021-11-17

References

1. Tyrvaya Prescribing Information. Oyster Point Pharma, Inc. Princeton, NJ. October 2021.
2. American Academy of Ophthalmology. Dry Eye Syndrome Preferred Practice Pattern. October 2018. Available at https://www.aaojournal.org/article/S0161-6420(18)32650-2/fulltext#tbl3. Accessed November 4, 2021.
3. Wood, S., Mian, S. Diagnostic Tools for Dry Eye Disease. Available at https://www.touchophthalmology.com/wp-content/uploads/sites/16/2017/01/Diagnostic-Tools-for-Dry-Eye-Disease_1.pdf. Accessed Nov 9. 2021.
4. Zeev, M., Miller, D, et al. Diagnosis of dry eye disease and emerging technologies. Clin Ophthalmol 2014;8:581-590. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964175/#b16-opth-8-581. Accessed November 9, 2021.

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End Notes

1. Traditional diagnostic tests include the Schirmer test, ocular surface dye staining, tear function index/fluorescein clearance test, tear break up time, tear film osmolarity, slit lamp evaluation of lid [2-4]
2. As disease severity increases, aqueous enhancement of the eye using topical agents is appropriate (e.g., emulsions, gels, ointments). Anti-inflammatory therapies (e.g., topical cyclosporine, corticosteroids), systemic omega-3 fatty acid supplements, punctal plugs, and eyeglass side shields/moisture chambers may also be considered in addition to aqueous enhancement therapies in patients who need additional symptom management [2-4]

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Revision History

• 2024-09-04: update guideline
• 2024-05-29: update guideline
• 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-09-10: 2023 Annual Review.
• 2022-06-01: Removed requirement for paid claims/submission of medical records.
• 2021-11-17: 2022 New PA UM Criteria

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