CurrentCentenePolicy CP PMN.291

Lotilaner (Xdemvy) for Demodex blepharitis

Clinical coverage policy governing medical necessity criteria, dosing, and authorization rules for lotilaner (Xdemvy) for treatment of Demodex blepharitis for Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyLotilaner (Xdemvy) for Demodex blepharitis

Policy CodePolicy CP PMN.291

Change TypeNo material changes

Effective Date12.01.23

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of Demodex blepharitis, age ≥18 years, and request not exceeding 1 bottle per 6 weeks.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 drop BIDrecommended dosing regimen per eye

0.25% 10 mLproduct concentration and package size available

6 weeksinitial approval length

Not permittedre-authorization

Commercial, HIM, Medicaidlines of business

Coverage Criteria

Policy Summary

PayerCentene

PolicyLotilaner (Xdemvy) for Demodex blepharitis

Policy CodePolicy CP PMN.291

Change TypeNo material changes

Effective Date12.01.23

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis of Demodex blepharitis, age ≥18 years, and request not exceeding 1 bottle per 6 weeks.

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.

Initial Approval

Covered when ALL of the following are met

Initial Approval - Demodex Blepharitis: Diagnosis of Demodex blepharitis.

Age requirement: Member is age >= 18 years.age >= 18

Supply limitation: Requested quantity does not exceed 1 bottle per 6 weeks.max 1 bottle/6 weeks

Approval duration: 6 weeks

Dosing consistent with label: Dosing consistent with FDA-approved prescribing information: 1 drop twice daily in each eye approximately 12 hours apart (maximum 2 drops/day in each eye).max 2 drops/day per eye

Continued Therapy

Covered for continuation only when criteria met

Continued Therapy: Re-authorization is not permitted. Members must meet the initial approval criteria for any authorization.none

Approval duration: Not applicable

Non‑FDA approved indications are not covered under this policy unless the provider submits sufficient documentation of 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).

Use of lotilaner (Xdemvy) for indications that are not FDA‑approved and that do not have sufficient supporting documentation per the referenced off‑label use policies is considered not authorized and will not be covered.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation of the initial approval criteria (diagnosis of Demodex blepharitis, member age ≥18 years, and request not to exceed 1 bottle per 6 weeks). Approval duration for initial requests: 6 weeks. Re-authorization is not permitted; continuation requests will be denied if initial approval criteria are not met.

Initial approval requires: diagnosis of Demodex blepharitis; member age ≥18 years; request ≤1 bottle per 6 weeks.
Approval duration (initial): 6 weeks.
Re-authorization: not permitted — members must meet initial approval criteria for any new request.

Step Therapy

Formulary / Step Alternatives

Follow applicable formulary, non-formulary, and off-label policies when considering alternatives or uses outside the FDA-approved indication. For drugs on the formulary/PDL or non-formulary, refer to the relevant line-of-business policy listed below. Off-label uses require sufficient supporting evidence per the off-label use policies.

Formulary / PDL (commercial, marketplace, Medicaid): see CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP PMN.255 (Medicaid).
Non-formulary (commercial, marketplace, Medicaid): see CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP PMN.16 (Medicaid).
Off-label use: see CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

Documentation Required

Required Documentation

Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets ALL approval criteria.

Include documentation of diagnosis and clinical findings consistent with Demodex blepharitis.
Include member age and prior treatment history as applicable.

Denial Risk

Denial Triggers

Requests lacking required documentation demonstrating the member meets all approval criteria may be denied. Requests for non–FDA‑approved indications without sufficient off‑label evidence per the referenced off-label policies may be denied.

Denial triggers include: missing office chart notes or clinical data to confirm diagnosis; member <18 years; request exceeding 1 bottle per 6 weeks.
Non‑FDA approved indications: may be denied if off‑label evidence is insufficient per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

OpenPayer

Lotilaner (Xdemvy) for Demodex blepharitis

Coverage Criteria

Coding

Provider Actions & Requirements

Background

Definitions