CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY - Tyrvaya

Defines prior authorization requirements for Tyrvaya (varenicline nasal solution) for treatment of signs and symptoms of dry eye disease for Cigna-administered health benefit plans, including approved indication, patient criteria, duration of approval, and disallowed concomitant uses.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY - Tyrvaya

Policy CodePolicy N/A

Change TypeAdministrative/clarifying edits; list updates

Effective Date

Next Review Date

Key ActionPrior Authorization is required; document patient age (≥18), trial of artificial tears, and that the prescriber is or consulted an ophthalmologist/optometrist.

POLICY UPDATE CHANGES

Conditions Not Covered: Concomitant use with an ophthalmic cyclosporine product, Miebo, or Xiidra was revised (Miebo was previously removed then later changes adjusted).

Examples of dry eye disease (dry eye syndrome and keratoconjunctivitis sicca) moved to a note.

Tryptyr was added to the list of medications that should not be used concomitantly with Tyrvaya.

1Covered Indication (FDA-approved)

3Concomitant-use exclusions (examples listed)

1Approval Duration (years)

Coverage Summary

Coverage stance: Covered with criteria for Tyrvaya (varenicline nasal solution) for the treatment of signs and symptoms of dry eye disease. Approval is granted for 1 year when the specified criteria are met. The policy scope defines prior authorization requirements for Tyrvaya for treatment of dry eye disease for Cigna-administered health benefit plans, including the approved indication, patient criteria, duration of approval, and disallowed concomitant uses. The FDA-approved indication is treatment of the signs and symptoms of dry eye disease, and Tyrvaya is indicated for adults ≥ 18 years of age.

FDA-Approved Indication - Dry Eye Disease (Initial Approval)

Approve for 1 year if the patient meets the ALL of the following (A, B, and C):

Age requirement: Patient is ≥ 18 years of age
Age requirement
Trial of nonprescription therapy required: Patient has tried artificial tears
Trial of nonprescription therapy required
Prescriber specialty requirement: Medication is prescribed by or in consultation with an ophthalmologist or optometrist
Prescriber specialty requirement

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Prior authorization is required for Tyrvaya. Approvals are provided for 1 year when all policy criteria are met.

Approval duration: 1 year when criteria are met.

Documentation Required

Document prior therapies and prescriber

Document that the patient is at least 18 years of age, has tried artificial tears, and that the medication is prescribed by or in consultation with an ophthalmologist or optometrist.

Denial Risk

Not medically necessary for other uses

Tyrvaya is considered not medically necessary for any use other than the FDA‑approved indication; claims for non‑covered indications will be denied.

Denial Risk

Concomitant use exclusion

Requests will be considered not medically necessary if Tyrvaya is used concomitantly with certain ophthalmic therapies.

An ophthalmic cyclosporine product (e.g., Cequa, Restasis, Vevye)
Tryptyr (acolmetron ophthalmic solution)
Xiidra (lifitegrast ophthalmic solution)

Applicable Codes

No specific procedure, billing, or NDC code groups were listed in the policy. Providers should follow their formulary and claim-editing guidance and use the most appropriate codes when submitting claims; billing and coding should follow standard formulary/claim edit processes.

Clinical Evidence & Guidance

Key evidence and guidance cited: FDA Prescribing Information — Tyrvaya nasal solution (Oyster Point, February 2024); AAO Dry Eye Syndrome Preferred Practice Pattern (Ophthalmology 2024). The AAO guideline lists Tyrvaya and other FDA-approved therapies as Step 2 options. The policy also notes that safety and efficacy have not been established in pediatric patients.

Background & Definitions

Background: Tyrvaya (varenicline nasal solution) is indicated for the treatment of the signs and symptoms of dry eye disease. The American Academy of Ophthalmology 2024 Preferred Practice Pattern lists Tyrvaya among FDA-approved therapies as a Step 2 treatment option for dry eye disease. The safety and efficacy of Tyrvaya in pediatric patients have not been established; the FDA-approved indication and policy criteria apply to adults ≥ 18 years of age.

Term	Definition
Dry Eye Disease	Also known as dry eye syndrome or keratoconjunctivitis sicca; examples noted in policy.
Ophthalmic cyclosporine products	Examples include Cequa, Restasis, and Vevye (noted in a policy note).

Concomitant Use & Exclusions

Policy exclusion: Concomitant use of Tyrvaya with an ophthalmic cyclosporine product (examples noted in the policy include Cequa, Restasis, and Vevye), Tryptyr (acolmetron ophthalmic solution), or Xiidra (lifitegrast ophthalmic solution) is considered not medically necessary. The policy history documents list edits over time, including revisions related to the list of medications not to be used concomitantly and the later addition of Tryptyr.

Concomitant Use Exclusions

Not medically necessary when used concomitantly with any of the following:

Concomitant use exclusions

Ophthalmic cyclosporine products: Ophthalmic cyclosporine product (e.g., Cequa, Restasis, Vevye)
There are no data to support the concomitant use
Tryptyr (acolmetron ophthalmic solution)
There are no data to support the concomitant use
Xiidra (lifitegrast ophthalmic solution)
There are no data to support the concomitant use

Revision History

09/20/2023revised

Conditions Not Covered: Concomitant use with an ophthalmic cyclosporine product, Miebo, or Xiidra was revised; examples of dry eye disease moved to a note.

04/10/2024revised

Conditions Not Covered: Miebo was removed from the list because Tyrvaya can be used concomitantly with Miebo.

04/30/2025clarified

Cosmetic or administrative wording adjusted; examples of dry eye disease (e.g., dry eye syndrome and keratoconjunctivitis sicca) were moved to a note with no clinical coverage change indicated.

07/09/2025addedLatest

Selected revision added Tryptyr (acolmetron ophthalmic solution) to the list of medications that should not be used concomitantly with Tyrvaya.