ModifiedmhnPolicy CP.PMN.73

Lifitegrast (Xiidra) for Dry Eye Disease

Covers medical necessity, prior authorization, and continuation criteria for lifitegrast (Xiidra) for treatment of signs and symptoms of dry eye disease for members covered under the listed Centene lines of business.

Policy Summary

Payermhn

PolicyLifitegrast (Xiidra) for Dry Eye Disease

Policy CodePolicy CP.PMN.73

Change TypeMaterial revisions and clarifications

Effective Date11.01.16

Next Review Date

Key ActionPrior authorization is required and providers must submit documentation showing the member meets all approval criteria, including age ≥17 and required step therapy failures unless IL HIM bypass applies.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

Added requirement for topical anti-inflammatory agents and reduced the number of wetting agents required from 2 to 1; removed duration of trial.

Clarified redirection to generic Restasis is required unless clinically significant adverse effects are experienced or all are contraindicated.

Added Appendix D for guideline related information.

≥17Minimum age for coverage

12 monthsApproval duration

2 drops/eye/dayMaximum daily dosing

1 box/30 daysSupply frequency

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Coverage Criteria

Initial Approval — Dry Eye Disease

Covered when ALL of the following are met:

Initial DED criteria: 1. Diagnosis of DED; 2. Age ≥ 17 years; 3. Failure of an artificial tears agent unless clinically significant adverse effects are experienced or all are contraindicated; 4. Failure of at least one ophthalmic anti-inflammatory agent at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicated; 5. Failure of generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis®) unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed both of the following: a) 2 drops per day in each eye; b) 1 box per 30 days.

For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395.

Continued Therapy — Dry Eye Disease

Covered when ALL of the following are met:

Continued DED criteria: 1. Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; or b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed both: a) 2 drops per day in each eye; b) 1 box per 30 days.

Approval duration: 12 months.

Coverage governance

Policy is a guide to medical necessity and assists in coverage decisions; does not guarantee payment.

Governance: Coverage decisions and administration of benefits are subject to the terms, conditions, exclusions, and limitations of the coverage documents, applicable state and federal requirements, and Health Plan administrative policies and procedures.

This clinical policy is a guide to medical necessity and does not constitute a contract or guarantee of payment.

Coverage for uses of lifitegrast (Xiidra) that are not FDA‑approved and not specifically addressed in this policy is not authorized unless the request includes sufficient clinical documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless the member's evidence of coverage specifically allows the non‑FDA indication.

Coverage determinations for lifitegrast are subject to the terms, conditions, exclusions, and limitations set forth in the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This clinical policy is intended as a guide to medical necessity to assist in making coverage decisions and administering benefits and does not guarantee payment.

Requests to use lifitegrast for non‑FDA approved indications without submission of sufficient documentation of efficacy and safety, per the referenced off‑label use policies, will be considered not medically necessary and are not authorized.

This clinical policy is not medical advice and does not direct individual patient care. Providers are independent and must exercise their own professional medical judgment when diagnosing and treating patients; members should consult their treating physician for individualized treatment decisions.

Coding and Product Availability

Product availability / NDC-like descriptionmixed

N/A	Ophthalmic solution containing lifitegrast 5% (50 mg/mL): 0.2 mL containers (60 single-use containers/box)

inv-09: Maximum daily dose — 2 drops/eye/day

Maximum daily dose2 drops per eye per day

Dosing regimen (context)Instill 1 drop BID in each eye (~12 hours apart)

Policy thresholdDose must not exceed both: a) 2 drops per day in each eye; b) 1 box per 30 days

inv-10: Maximum supply frequency — 1 box per 30 days

Maximum supply frequency1 box per 30 days

Product packaging0.2 mL containers (60 single-use containers/box)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Xiidra (lifitegrast) will be approved only when all initial approval criteria in this policy are met and appropriate prior authorization has been obtained.

Prior authorization required for Xiidra
Approval contingent on meeting all medical necessity criteria

Note

Medical Necessity Guidance

This policy is intended to guide determinations of medical necessity and to assist in coverage decisions and benefit administration. It is not a substitute for clinical judgment. Coverage is subject to the member's benefit terms, exclusions, limitations, and applicable state and federal laws and Health Plan administrative policies.

Policy guides medical necessity determinations and coverage decisions
Coverage subject to plan contract terms, exclusions, and administrative rules

Background

Lifitegrast (Xiidra) is an ophthalmic solution formulated as a 5% lifitegrast (LFA‑1 antagonist) indicated for the treatment of the signs and symptoms of dry eye disease (DED). It is used in the context of standard DED management, in which initial therapy typically includes artificial tears and, if inadequate, escalation to ophthalmic anti‑inflammatory therapies — such as topical cyclosporine, lifitegrast, or short courses of topical corticosteroids — may be considered.

This policy was developed by experienced clinicians after review of available clinical evidence and guidance and is intended to guide determinations of medical necessity; it does not replace clinician judgment in individual patient care.

Definitions

inv-20: dry eye disease — DED definition/abbreviation

AbbreviationDED = dry eye disease

Clinical contextPer AAO, artificial tears are standard therapy for DED; if inadequate, ophthalmic anti-inflammatory therapies (e.g., cyclosporine, lifitegrast, topical corticosteroids) are considered

IndicationLifitegrast (Xiidra) indicated for treatment of signs and symptoms of dry eye disease

inv-21: Health Plan — definition of Health Plan and relationship to Centene Management Company

DefinitionHealth Plan = a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Role of policy