TYRVAYA (varenicline)

TYRVAYA (varenicline)

Self-Administration – nasal

Diagnosis considered for coverage:

Indicated for the treatment of signs and symptoms of dry eye disease (DED).

Coverage Criteria:

For diagnosis of dry eye disease (DED):

• Dose does not exceed 2 nasal spray bottles (8.4 mL) per 30 days; AND
• Prescribed by or in consultation with an ophthalmologist or optometrist; AND
• Patient is 18 years of age and older; AND
• Diagnosis of dry eye disease confirmed by ONE of the following diagnostic tests:
  • Schirmer test
  • Ocular surface dye staining (e.g., rose Bengal, fluorescein, lissamine green)
  • Tear function index/fluorescein clearance test
  • Tear break-up time
  • Tear film osmolarity
  • Slit-lamp lid evaluation
  • Lacrimal gland function; AND
• Chart note documentation provided confirming trial and failure, contraindication, or intolerance to at least one OTC ocular lubricant (e.g., artificial tears, lubricating gels/ointments); AND
• Trial and failure, contraindication, or intolerance to both of the following:
  • Restasis
  • Xiidra; AND
• No concomitant use with an ophthalmic cyclosporine product (Restasis®, Cequa™) or Xiidra® (lifitegrast ophthalmic solution)

Reauthorization Criteria:

For diagnosis of dry eye disease (DED):

• Dose does not exceed 2 nasal spray bottles (8.4 mL) per 30 days; AND
• Documentation of positive clinical response to therapy (e.g., increased tear production or improvement in dry eye symptoms)

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Dosing: 

• One spray in each nostril twice daily (~12 hours apart)
• Prime with seven (7) actuations before initial use.  Re-prime with 1 actuation if not used more than five (5) days.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 5/17/2022 – New policy approved by P&T

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.