CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xdemvy (lotilaner ophthalmic solution) — coverage criteria for Demodex blepharitis

Covers authorization criteria and quantity limits for Xdemvy (lotilaner ophthalmic solution) for treatment of Demodex blepharitis in adult members, and who may prescribe. Affects providers seeking prior authorization for this medication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXdemvy (lotilaner ophthalmic solution) — coverage criteria for Demodex blepharitis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization documenting age ≥18, >10 collarettes on upper lid lashes, at least two symptoms, prescriber specialty, and trial of one listed prior therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age

3 monthsauth duration

10 mL/42dquantity limit

>10 lashesdiagnostic sign

trial ≥1prior therapy

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Coverage Criteria for Xdemvy (lotilaner ophthalmic solution)

Initial approval — Authorization of one fill for 3 months may be granted if ALL of the following are met:

Authorization of one fill for 3 months may be granted if ALL of the following are met:

Main approval criteria: All of the following must be satisfied

Age: Member is 18 years of age or older>=18 years

Prescriber specialty: Xdemvy is prescribed by or in consultation with an optometrist or ophthalmologist

Diagnostic sign: Presence of collarettes on more than 10 lashes on the upper lid>10 lashes (upper lid)

Symptoms: Patient demonstrates at least two of the following symptoms of Demodex infestation: at least mild erythema of the upper eyelid margin; itching or burning; crusting or matter on lashes; foreign body sensation; blurry vision; discomfort or irritation>=2 symptoms

Prior therapy: Member remains symptomatic for Demodex blepharitis after an adequate trial of ONE of the following: topical tea tree oil; eyelid hygiene regimen (e.g., warm compress, cleansing, artificial tears, lid scrubbing wipes, debridement)trial of >=1 listed therapy

No explicit exclusions are listed in this policy document.

None specified.

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior authorization and quantity limit

Prior authorization may be granted for one fill covering 3 months when all approval criteria are met. A quantity limit of one 10 mL bottle per 42 days applies.

Authorization duration: one fill for 3 months
Quantity limit: one 10 mL bottle per 42 days

Step Therapy

Step therapy requirement

Member must remain symptomatic after an adequate trial of at least one listed conservative therapy before approval will be granted.

Acceptable trials include topical tea tree oil or an eyelid hygiene regimen (warm compress, cleansing, artificial tears, lid scrubbing wipes, debridement).

Documentation Required

Required documentation

Documentation submitted for prior authorization must confirm member age, diagnostic signs, prior therapies/trials, and prescriber specialty.

Member is 18 years of age or older.
Presence of collarettes on more than 10 lashes on the upper lid.
Record of an adequate trial of at least one listed prior therapy.
Confirmation that Xdemvy is prescribed by or in consultation with an optometrist or ophthalmologist.

Denial Risk

Denial triggers

Failure to provide any required documentation may result in denial of the request.

Missing documentation of member age (≥18).
Missing documentation of diagnosis with required sign (collarettes on >10 upper lashes) or required symptoms.
Missing evidence of an adequate trial of a listed prior therapy.
Absent confirmation that Xdemvy was prescribed by or in consultation with an optometrist or ophthalmologist.

Key Definitions

Collarettes — definition and diagnostic threshold

DefinitionCollarettes: cylindrical dandruff-like debris at the base of eyelashes associated with Demodex blepharitis.

Diagnostic thresholdPresence of collarettes on more than 10 lashes on the upper lid is required for diagnosis and coverage consideration.

Measurement locationCount is taken on the upper eyelid lashes (upper lid).

Role in criteriaRequired sign documented in the medical record to meet the policy’s approval criteria for Xdemvy (lotilaner ophthalmic solution).

Associated documentationMedical record must note the documented number of affected upper lid lashes (>10) as part of required supporting documentation for prior authorization.

Background and Clinical Context

Demodex blepharitis is an eyelid infestation characterized clinically by the presence of collarettes (cylindrical dandruff-like debris at the base of lashes), eyelid margin erythema, and symptoms such as itching, burning, foreign-body sensation, crusting on lashes, blurry vision, or general ocular discomfort/irritation. This policy addresses use of Xdemvy (lotilaner ophthalmic solution) as a topical treatment option and defines coverage criteria that require documentation of collarettes on more than 10 lashes on the upper lid, at least two qualifying symptoms, and persistent symptoms after an adequate trial of conservative measures (for example topical tea tree oil or an eyelid hygiene regimen including warm compresses, cleansing, artificial tears, lid scrubbing wipes, or debridement).