CurrentCignaPolicy IP0395

Tyrvaya (varenicline nasal solution) for Dry Eye Disease — Prior Authorization Guidance for Individual and Family Plans

Prior authorization guidance for coverage of Tyrvaya for treatment of signs and symptoms of dry eye disease for Cigna-administered Individual and Family Plans; describes clinical criteria, prescriber requirements, and conditions considered not medically necessary.

Policy Summary

PayerCigna

PolicyTyrvaya (varenicline nasal solution) for Dry Eye Disease

Policy CodePolicy IP0395

Change TypeClinical and administrative updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of age (>=18), prior use of artificial tears, trial and inadequate efficacy or intolerance to cyclosporine 0.05% emulsion, and that the prescriber is or consulted an ophthalmologist/optometrist.

SourceLink

POLICY UPDATE CHANGES

Added diagnosis, age, prior use of artificial tears, and specialist prescribing requirement to criteria.

Updated preferred product requirements and removed Miebo from the list of medications not recommended for concomitant use with Tyrvaya.

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

Individual and Family Plans (IFP) were added to the policy and Employer Plans removed.

1 yearapproval duration

>=18minimum age

Prior authadministrative requirement

Cyclosporine/Tryptyr/Xiidranot medically necessary

Coverage Criteria for Tyrvaya

Initial approval — FDA indication

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

FDA-Approved Indication for Dry Eye Disease: A) Patient is >= 18 years of age; AND B) Patient has tried artificial tears; AND C) The medication is prescribed by or in consultation with an ophthalmologist or optometrist; AND D) Preferred product criteria is met for the product(s) as listed below (patient has tried and, according to the prescriber, experienced inadequate efficacy OR significant intolerance with cyclosporine ophthalmic 0.05% emulsion).

Approval duration: 1 year when criteria met.

Tyrvaya (varenicline nasal solution) is covered only for its FDA‑approved indication for treatment of the signs and symptoms of dry eye disease when the documented coverage criteria are met. Tyrvaya for any use other than the FDA‑approved indication is considered not medically necessary.

Concomitant use of Tyrvaya with an ophthalmic cyclosporine product (Cequa, Restasis, Vevye), Tryptyr (acolmetron ophthalmic solution), or Xiidra (lifitegrast ophthalmic solution) is considered not medically necessary. The policy cites a lack of supporting data for combined use and such requests may be denied.

Provider Requirements, Prior Authorization, and Billing

Policy Summary

PayerCigna

PolicyTyrvaya (varenicline nasal solution) for Dry Eye Disease

Policy CodePolicy IP0395

Change TypeClinical and administrative updates

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for Tyrvaya. Approvals are provided for the durations specified (1 year when criteria met). Prior authorization documentation should demonstrate patient age (≥18), prior use of artificial tears, that the medication is prescribed by or in consultation with an ophthalmologist or optometrist, and when applicable, prior trial and inadequate efficacy or intolerance to the preferred product (ophthalmic cyclosporine 0.05% emulsion).

Prior authorization approvals: 1 year when all FDA‑approved indication criteria are met
PA documentation must include: patient age (≥18), prior use of artificial tears, prescriber specialty (ophthalmologist/optometrist), and details of prior inadequate efficacy or intolerance to preferred product

Step Therapy

Preferred product/prior trial requirement

Coverage under Individual and Family Plans requires prior trial and inadequate efficacy or intolerance to the preferred product (cyclosporine ophthalmic 0.05% emulsion). Receipt of a sample does not satisfy the prior trial requirement.

IFP prior trial requirement: documented trial of cyclosporine ophthalmic 0.05% emulsion with inadequate efficacy OR significant intolerance
Samples do not fulfill prior trial requirements

Denial Risk

Coding and billing denial risk

Claims submitted without covered diagnosis or procedure codes or not accompanied by covered codes under the applicable Coverage Policy will be subject to denial. When billing, providers must use the most appropriate codes as of the date of submission.

Denied if billed for conditions or diagnoses not covered by this policy
Use the most appropriate and current ICD-10/CPT/HCPCS codes; missing or non‑covered codes may result in denial

Denial Risk

Concomitant therapy denial risk

Requests for Tyrvaya for concomitant use with an ophthalmic cyclosporine product (Cequa, Restasis, Vevye), Tryptyr, or Xiidra will be considered not medically necessary.

Concomitant therapy with ophthalmic cyclosporine products, Tryptyr, or Xiidra — not medically necessary

Documentation Required

Required documentation for PA

Prior authorization documentation should include evidence that the prescriber is an ophthalmologist or optometrist (or that the prescriber consulted with one), and should document prior therapies and the nature of inadequate efficacy or intolerance.

Documentation: prescriber specialty or consult note, trial of artificial tears, details of trial and failure/intolerance to cyclosporine 0.05% when required

OpenPayer

Tyrvaya (varenicline nasal solution) for Dry Eye Disease — Prior Authorization Guidance for Individual and Family Plans

Coverage Criteria for Tyrvaya

Provider Requirements, Prior Authorization, and Billing

Background on Tyrvaya and Dry Eye Disease

Definitions