ModifiedCentenePolicy CP PMN.73

Lifitegrast (Xiidra)

Defines medical necessity criteria, prior authorization expectations, and coverage limits for lifitegrast (Xiidra) to treat signs and symptoms of dry eye disease for Centene-affiliated plans.

Policy Summary

PayerCentene

PolicyLifitegrast (Xiidra)

Policy CodePolicy CP PMN.73

Change TypeCriteria additions and wording revisions

Effective DateNov 1, 2016

Next Review Date

Key ActionSubmit office chart notes or other clinical documentation showing the member meets all approval criteria when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Added requirement for topical anti-inflammatory agents prior to approval and reduced the number of required wetting agents from two to one.

Clarified that redirection to generic cyclosporine (Restasis generic) is required unless contraindicated or adverse effects are experienced.

Revised terminology from 'non-prescription wetting agent' to 'artificial tears'.

BIDdosing frequency

2 drops/daymaximum dose

12 monthsapproval duration

5%product concentration

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Commercialline of business

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of dry eye disease (DED).

Initial Approval Criteria: 2) Member is age 17 years or older.

Initial Approval Criteria: 3) Failure of at least one artificial tears agent (see Appendix B for examples), unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval Criteria: 4) Failure of at least one ophthalmic anti-inflammatory agent (examples in Appendix B) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval Criteria: 5) Failure of generic ophthalmic cyclosporine emulsion 0.05% (generic Restasis) unless contraindicated or clinically significant adverse effects are experienced.

Initial Approval Criteria

Dose limits: a) Instill no more than 2 drops per eye per day.
Dose limits: b) Product supply limit: 1 box per 30 days.

Initial Approval Criteria: Approval duration = 12 months.

Continuation Therapy

Continued therapy is covered when ONE of the following is met:

Continued Therapy Options: a) Member is currently receiving the medication via the Centene benefit or has previously met the initial approval criteria, and is responding positively to therapy.

Continued Therapy Options: b) Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

Continued Therapy Conditions: If the request is for a dose increase, the new dose must not exceed maximum dosing limits (no more than 2 drops per eye per day) and supply limits (1 box per 30 days).

Continued Therapy: Approval duration = 12 months.

Coverage for indications not included in this policy is limited. Specifically, non‑FDA approved indications are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or per the member’s evidence of coverage documents.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage rules and any state‑level exclusions or requirements that supersede this policy.

Requests to use lifitegrast for non‑FDA approved indications without adequate off‑label justification are not authorized. Approval requires submission of sufficient clinical documentation supporting efficacy and safety per the applicable off‑label use policies or the member’s evidence of coverage.

Product Availability, Dosing, and Coding

Dosing frequencyInstill one drop twice daily (BID) in each eye (~12 hours apart).

Maximum daily dose2 drops/day (total; one drop per eye twice daily).

Product descriptionOphthalmic solution containing lifitegrast 5% (50 mg/mL): 0.2 mL single-use containers; 60 single-use containers per box.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be required for certain therapies referenced in this policy, including ophthalmic anti-inflammatory agents and cyclosporine emulsion (e.g., generic Restasis). Authorization requirements may vary by line of business and should be verified through the plan's prior authorization processes.

Prior authorization may be required for ophthalmic anti-inflammatory agents
Prior authorization may be required for cyclosporine emulsion (Restasis/generic)

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, laboratory results, prior medication trials, and other clinical information demonstrating that the member meets all approval criteria.

Office chart notes

Clinical Background

Lifitegrast (Xiidra) is a lymphocyte function‑associated antigen‑1 (LFA‑1) antagonist indicated to treat the signs and symptoms of dry eye disease (DED). Management of DED typically begins with artificial tears; if symptoms persist, guideline‑recommended next steps include topical anti‑inflammatory therapies such as topical cyclosporine, lifitegrast, or short‑term topical corticosteroids. Lifitegrast is supplied as a 5% ophthalmic solution and is dosed as one drop in each eye twice daily (BID) per product labeling.

Key Definitions

Definition — Dry eye disease (DED)

DefinitionDry eye disease (DED): a chronic ocular surface disorder characterized by insufficient tear production or increased tear evaporation leading to ocular discomfort and visual disturbance.

Clinical contextManagement typically begins with artificial tears; if inadequate, next steps per AAO include topical anti-inflammatory therapies such as cyclosporine, lifitegrast, or topical corticosteroids.

Indication for lifitegrastLifitegrast (Xiidra) is indicated to treat the signs and symptoms of dry eye disease (DED).

Definition — Health Plan

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 its affiliates.

Purpose

Policy Summary

PayerCentene

PolicyLifitegrast (Xiidra)

Policy CodePolicy CP PMN.73

Change TypeCriteria additions and wording revisions

Effective DateNov 1, 2016

Next Review Date

Key ActionSubmit office chart notes or other clinical documentation showing the member meets all approval criteria when requesting authorization.

SourceLink

On This Page

Medication trial history and documentation of failures or contraindications

Other pertinent clinical information

Denial Risk

Documentation and Indication Noncompliance

Requests that lack the required documentation or that request coverage for non‑FDA approved (off‑label) indications without sufficient supporting clinical evidence may be denied. Providers should include justification and references when requesting coverage for non‑FDA uses per the applicable off‑label use policies.

Incomplete documentation may result in denial
Non‑FDA indications require sufficient evidence and justification per CP CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid)

Documentation Required

Documentation and Medical Necessity

Coverage decisions are based on medical necessity and the information provided by the treating provider. Providers are expected to exercise professional medical judgment; however, determinations remain subject to the terms, conditions, exclusions, and limitations of the member's benefit plan.

Providers must exercise professional medical judgment
Coverage is subject to plan contract terms, exclusions, and limitations

Step Therapy

Step Therapy Requirements

Step therapy requirements apply. Prior to approval for therapies such as lifitegrast (Xiidra) or prescription ophthalmic anti‑inflammatory agents, the member must have trialed and failed an adequate course of OTC artificial tears and at least one ophthalmic anti‑inflammatory agent (unless contraindicated or adverse effects occur).

Failure of an artificial tears agent is required unless contraindicated
Failure of at least one ophthalmic anti‑inflammatory agent at maximally indicated doses is required unless contraindicated or adverse effects occur

Step Therapy

Step Therapy Prerequisite — OTC Artificial Tears

As a prerequisite to step‑up therapies, members must have tried non‑prescription wetting agents/artificial tears. The policy language was revised to clarify that failure of non‑prescription wetting agents (OTC artificial tears) is required prior to considering prescription therapies, unless there is documented contraindication or intolerance.

Trial and failure of OTC artificial tears (examples listed in Appendix B) required prior to prescription therapy
Documented contraindication or clinically significant adverse effects to OTC agents may waive this prerequisite

Note

State Medicaid Precedence

For Medicaid members, state Medicaid coverage provisions supersede this clinical policy when conflicts exist. Providers should consult the applicable state Medicaid manual for any differing coverage requirements.

State Medicaid coverage provisions take precedence over this policy when in conflict
Refer to the state Medicaid manual for state‑specific coverage rules

This clinical policy serves as a guide to medical necessity to assist in coverage decisions and benefit administration; it is not a contract or guarantee of payment.

ApplicabilityCoverage decisions are subject to plan terms, state/federal requirements, and Health Plan-level administrative policies and procedures.