CurrentCignaPolicy N/A

Tyrvaya (varenicline nasal solution) — prior authorization for dry eye disease

This policy governs prior authorization requirements and medical necessity criteria for coverage of Tyrvaya for treatment of signs and symptoms of dry eye disease for Cigna-administered health benefit plans and affects prescribing clinicians and payers.

Policy Summary

PayerCigna

PolicyTyrvaya (varenicline nasal solution) — prior authorization for dry eye disease

Policy CodePolicy N/A

Change TypeOperational updates (criteria and exclusions)

Effective DateN/A

Next Review DateApr 30, 2025

Key ActionObtain prior authorization and document patient age (≥18), prior use of artificial tears, and that Tyrvaya is prescribed by or in consultation with an ophthalmologist or optometrist.

SourceLink

POLICY UPDATE CHANGES

Keratoconjunctivitis sicca was added to the Note of examples of dry eye disease.

Miebo was removed from the list of products not to be used concomitantly with Tyrvaya because Tyrvaya can be used with Miebo.

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

1 yearapproval duration

≥18min patient age

Artificial tears triedrequired prior therapy

Ophthalmologist/Optometristprescriber

Cyclosporine, Tryptyr, Xiidraconcomitant-use exclusions

Coverage Criteria for Tyrvaya

Initial therapy — FDA-approved indication

ALL of the following

Patient is ≥ 18 years of age.
Patient has tried artificial tears.
The medication is prescribed by or in consultation with an ophthalmologist or optometrist.

CONDITIONS NOT COVERED - Tyrvaya (varenicline nasal solution - Oyster Point) is considered not medically necessary for ANY other use(s) including the following (this list may not be all inclusive; criteria will be updated as new published data are available):

1. Concomitant Use With An Ophthalmic Cyclosporine Product, Tryptyr (acolmetron ophthalmic solution), or Xiidra (lifitegrast ophthalmic solution). There are no data to support the concomitant use of Tyrvaya with an ophthalmic cyclosporine product, Tryptyr, or Xiidra.

Note: Ophthalmic cyclosporine products are Cequa, Restasis, and Vevye.

Policy Summary

PayerCigna

PolicyTyrvaya (varenicline nasal solution) — prior authorization for dry eye disease

Policy CodePolicy N/A

Change TypeOperational updates (criteria and exclusions)

Effective DateN/A

Next Review DateApr 30, 2025

Key ActionObtain prior authorization and document patient age (≥18), prior use of artificial tears, and that Tyrvaya is prescribed by or in consultation with an ophthalmologist or optometrist.

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.

Explicit non-concomitant agents: Ophthalmic cyclosporine products (Cequa, Restasis, Vevye), Tryptyr (acolmetron ophthalmic solution), and Xiidra (lifitegrast ophthalmic solution) should not be used concomitantly with Tyrvaya as there are no data to support combined use.

Product Coding and Key Coding Details

Drug productNDC

NDC (not specified)

Tyrvaya (varenicline nasal solution) - specific NDCs referenced in prescribing information (prescribing information cited)

inv-05: Minimum age for coverage (>= 18 years)

Minimum age for coverage>= 18 years

Approval duration when criteria metApprove for 1 year

Source policy elementFDA‑Approved Indication: Patient is ≥ 18 years of age (must meet ALL criteria A–C)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tyrvaya®. Approvals are provided for the duration listed in the policy (1 year for FDA‑approved dry eye disease when criteria are met). Submit a prior authorization request before dispensing to avoid claim denials.

Approval duration: 12 months

Step Therapy

Therapy Step Placement — AAO Dry Eye Preferred Practice Pattern

Tyrvaya is placed as a Step 2 option per the AAO Dry Eye Preferred Practice Pattern (2024). Step 2 includes FDA‑approved prescription therapies for dry eye disease such as topical cyclosporine products, perfluorohexyloctane (Miebo®), lifitegrast (Xiidra®), and varenicline nasal solution (Tyrvaya®). Ensure nonpharmacologic measures and over‑the‑counter/artificial tears have been tried per step therapy expectations.

Documentation Required

Documentation Required for Prior Authorization

Required documentation to support prior authorization: include patient age, evidence that artificial tears were tried, and documentation that the medication was prescribed by or in consultation with an ophthalmologist or optometrist. Include relevant clinical notes, prior treatment history, and indication (dry eye disease/keratoconjunctivitis sicca).

Denial Risk

Triggers for Denial — Unsupported Indications and Concomitant Use

Denial triggers: requests for uses other than FDA‑approved dry eye disease (keratoconjunctivitis sicca) or lacking required documentation (age ≥18, prior use of artificial tears, prescriber specialty/consultation) will be denied. Concurrent use with an ophthalmic cyclosporine product, Tryptyr (acolmetron ophthalmic solution), or Xiidra (lifitegrast ophthalmic solution) is considered not medically necessary and will be denied.

Key Definitions

inv-11: Dry eye disease definition (including keratoconjunctivitis sicca)

DefinitionDry eye disease (also called dry eye syndrome or keratoconjunctivitis sicca)

Clinical descriptionA condition classified by symptoms and signs (mild, moderate, severe) with emphasis on symptoms; managed with a staged approach per AAO guidance.

Relevant FDA‑approved therapy exampleTyrvaya (varenicline nasal solution) is indicated for treatment of signs and symptoms of dry eye disease.

AAO classification noteAAO Preferred Practice Pattern lists FDA‑approved topical agents (including Tyrvaya, cyclosporine products, Miebo, Xiidra) as Step 2 options.

Background

Tyrvaya (varenicline nasal solution) is a cholinergic agonist indicated for treatment of the signs and symptoms of dry eye disease. Dry eye disease (also known as dry eye syndrome or keratoconjunctivitis sicca) is managed using a staged approach; topical FDA‑approved agents such as Tyrvaya are considered Step 2 treatment per the American Academy of Ophthalmology Preferred Practice Pattern. Clinical documentation supporting prior conservative therapy (for example, trials of artificial tears) and appropriate prescriber specialty should accompany requests for coverage.