CurrentCignaPolicy N/A

Xiidra (lifitegrast) — Coverage Criteria

This policy governs prior authorization and coverage determinations for Xiidra (lifitegrast ophthalmic solution) for treatment of dry eye disease for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyXiidra (lifitegrast) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRevised coverage exclusions

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests with supporting clinical information; approvals granted for 1 year for patients ≥18 years when used for dry eye disease.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered was revised to prohibit concomitant use of Xiidra with Tryptyr and to list ophthalmic cyclosporine products in a Note; Miebo was previously removed then later reinstated as not allowed in a revision history entry.

1 yrinitial approval duration for Xiidra

≥18age requirement

Prior Authauthorization

Not allowedconcomitant use

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FDA-Approved Indication

Covered when ALL of the following are met

FDA-approved indication and age: Patient is ≥ 18 years of age and Xiidra (lifitegrast ophthalmic solution) is being used for dry eye disease (examples include dry eye syndrome, keratoconjunctivitis sicca)age >= 18

Approve for 1 year

Xiidra (lifitegrast ophthalmic solution) is considered not medically necessary for any use other than the FDA‑approved indication for treatment of the signs and symptoms of dry eye disease. The policy explicitly prohibits concomitant use of Xiidra with certain agents because there are no data supporting combined use. Examples of concomitant uses considered not medically necessary include use with an ophthalmic cyclosporine product, Tryptyr (acolmetron ophthalmic solution), or Tyrvaya (varenicline nasal solution).

Note that the policy identifies specific ophthalmic cyclosporine products by name: Cequa, Restasis, and Vevye. Concomitant administration of Xiidra with any of these ophthalmic cyclosporine products is considered not medically necessary. The Conditions Not Covered section and History note document revisions to this list over time, including additions such as Tryptyr and clarifications on which agents are prohibited for concomitant use.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Recommended

Prior authorization recommended for prescription benefit coverage of Xiidra. Approvals when granted are provided for 1 year for patients ≥18 years when used for the FDA‑approved indication.

Xiidra (lifitegrast ophthalmic solution) — prior authorization recommended
Approval duration: 1 year
Patient age: ≥18 years
Indication: FDA‑approved indication only

Note

Therapy Placement and Context

AAO Dry Eye Syndrome Preferred Practice Pattern (2024) classifies dry eye by symptoms and signs and recommends a staged, four‑step approach to management. Xiidra and other FDA‑approved therapies (cyclosporine ophthalmic products, Miebo™, Tyrvaya®) are listed as Step 2 therapeutic options. Use may be selected based on provider judgment and patient preference; no head‑to‑head trial has proven superiority among these agents.

Documentation Required

Required Documentation

Required documentation must be submitted with prior authorization requests and should include clinical information sufficient to demonstrate medical necessity per the benefit plan. At minimum provide: patient age, diagnosis (supporting signs/symptoms), prior therapies tried and response (including use of and intolerance to alternative FDA‑approved topical therapies when applicable), treatment intent, and planned duration. Documentation should reference the FDA‑approved indication when applicable and any relevant clinical notes, prior authorization forms, and supporting test results.

Patient demographics and age (must be ≥18 for approvals)
Diagnosis and relevant clinical findings (symptoms/signs of dry eye disease)
Prior treatments and responses (e.g., artificial tears, topical cyclosporine, other step‑1/2 therapies)
Rationale for Xiidra and statement that use is for FDA‑approved indication
Copies of clinical notes, test results, and any prior authorization forms

Denial Risk

Denial Triggers & Billing Notes

Claims submitted without covered diagnosis or procedure codes consistent with the applicable coverage policy or without required documentation will be denied. Prior authorization is recommended; reimbursement may be contingent on prior authorization and submission of supporting clinical documentation. Providers must bill using the most appropriate codes as of the date of service.

Claims lacking covered diagnosis/procedure codes — denial risk
Missing required documentation — denial risk
Prior authorization recommended; reimbursement may require prior authorization approval

Background

Dry eye disease (also called dry eye syndrome or keratoconjunctivitis sicca) is an ocular surface disorder characterized by signs and symptoms that guide severity classification and management. Treatment follows a staged approach; topical therapies approved by the FDA are among standard options. Xiidra (lifitegrast), a lymphocyte function‑associated antigen‑1 (LFA‑1) antagonist, is indicated for the treatment of the signs and symptoms of dry eye disease and its safety and effectiveness in pediatric patients have not been established.

Per the policy and clinical guidance, Xiidra is positioned as an FDA‑approved therapy for dry eye disease and may be used in appropriate adult patients (age ≥ 18 years). Prior authorization is recommended for Xiidra, and when approved for the FDA‑approved indication it is authorized for 1 year.

Definitions

Dry eye disease — Definition and clinical classification

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

Clinical classificationGenerally classified by symptoms and signs into mild, moderate, or severe with emphasis on symptoms over signs

Management approachFour-step staged approach; specific therapies may be chosen from any step based on provider experience and patient preference

ExamplesIncludes dry eye syndrome and keratoconjunctivitis sicca

Pediatric useNot established — safety and efficacy of Xiidra in pediatric patients have not been established

Xiidra (lifitegrast) — Drug description and indication

DrugXiidra (lifitegrast ophthalmic solution)

MechanismLymphocyte function-associated antigen-1 (LFA-1) antagonist

IndicationTreatment of the signs and symptoms of dry eye disease; approve for 1 year when patient is ≥ 18 years of age

Pediatric safetySafety and efficacy in pediatric patients have not been established

Prior authorizationPrior authorization is recommended for Xiidra (approvals provided for 1 year for patients ≥ 18 years)

Revision History & Material Changes

2025-07-09revisionLatest

Conditions Not Covered: Tryptyr (acolmetron ophthalmic solution) was added to the list of medications that should not be used concomitantly with Xiidra.

2025-04-30revision

Annual Revision: no clinical criteria changes documented for this revision cycle (listed as Annual Revision, 2).

2024-04-10revision

Early Annual Revision 2 (04/10/2024): administrative history entry recorded (no material criteria changes described in this entry).

2023-09-20revision

Annual Revision (09/20/2023): Conditions Not Covered was revised to list concomitant use with an ophthalmic cyclosporine product, Miebo, or Tyrvaya and the list of ophthalmic cyclosporine products was moved to a Note.

OpenPayer

Xiidra (lifitegrast) — Coverage Criteria

Coverage Criteria for Xiidra (lifitegrast)

Covered / Relevant Codes

Provider Actions, Authorization & Documentation

Background

Definitions

Revision History & Material Changes