CurrentMass General Brigham Health PlanPolicy N/A

Xdemvy (lotilaner) ophthalmic solution coverage

Defines prior authorization requirements for Xdemvy (lotilaner) ophthalmic solution under the pharmacy benefit for Commercial/Exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXdemvy (lotilaner) ophthalmic solution coverage

Policy CodePolicy N/A

Change TypeClinical & operational (material)

Effective DateFeb 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Xdemvy under the pharmacy benefit when clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

Requirements that the member try and fail tea tree oil and that the member is experiencing symptoms or architectural changes were removed.

Effective approval duration clarified to 2 months.

Prior AuthorizationProgram type required

PharmacyBenefit applied

2 moApproval duration

Commercial/ExchangePlan applicability

Coverage Criteria for Xdemvy (lotilaner)

Policy Summary

PayerMass General Brigham Health Plan

PolicyXdemvy (lotilaner) ophthalmic solution coverage

Policy CodePolicy N/A

Change TypeClinical & operational (material)

Effective DateFeb 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Xdemvy under the pharmacy benefit when clinical criteria are met.

SourceLink

On This Page

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Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial criteria: Member has a diagnosis of Demodex blepharitis; Member exhibits ONE of the following signs of Demodex infestation: collarettes; eyelid margin erythema; eyelash anomalies (e.g., eyelash misdirection); The requested medication is prescribed by or in consultation with an ophthalmologist or optometrist.1 of listed signs required

If member is new to the plan (coverage effective date ≤ 90 days), submit medical records documenting the member is currently receiving treatment with the requested drug (excluding samples or manufacturer patient assistance).

There are no explicit exclusions listed in this policy beyond the clinical eligibility requirements. Coverage is governed by the stated clinical criteria (diagnosis of Demodex blepharitis and documentation of one of the specified signs) and the prescribing clinician requirement; the policy does not enumerate additional excluded indications or populations.

Use of Xdemvy is not supported when the member lacks a diagnosis of Demodex blepharitis or does not have documentation of at least one of the required clinical signs (collarettes, eyelid margin erythema, or eyelash anomalies). Prior authorization approvals are contingent on meeting these clinical criteria and the prescribing clinician requirement.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Xdemvy (lotilaner) ophthalmic solution when covered under the pharmacy benefit. Approvals are granted when clinical criteria are met; submit supporting documentation (including diagnosis and findings) with the prior authorization request. If the member is new to the plan (coverage effective date ≤ 90 days), include medical records showing the member is currently receiving the requested drug (does not apply to samples or manufacturer patient assistance programs).

Product: Xdemvy (lotilaner) ophthalmic solution
Benefit: Pharmacy benefit
Contact (Pharmacy Benefit): Phone 800-711-4555; Fax 844-403-1029

Step Therapy

No step therapy requirement is listed for Xdemvy.

Denial Risk

Documentation and Denial Risk

Clinical criteria not met may result in denial. Authorization is typically granted only when all required clinical criteria are documented: diagnosis of Demodex blepharitis; documentation of ONE sign of Demodex infestation (collarettes, eyelid margin erythema, or eyelash anomalies such as misdirection); and prescription by or in consultation with an ophthalmologist or optometrist. Missing prior authorization for a pharmacy benefit product may also result in denial.

Required diagnosis: Demodex blepharitis
Required sign: ONE of collarettes; eyelid margin erythema; eyelash anomalies (e.g., misdirection)
Prescriber: Ophthalmologist or optometrist
New member continuity: If coverage effective date ≤ 90 days, submit medical records showing current treatment with the requested drug
Denial risk: Missing prior authorization for pharmacy benefit products

Background

Xdemvy (lotilaner) ophthalmic solution is indicated for the treatment of Demodex blepharitis. The condition is identified by signs of Demodex infestation; for coverage under this policy the member must exhibit one of the following: collarettes, eyelid margin erythema, or eyelash anomalies (for example, eyelash misdirection). The requested medication must be prescribed by or in consultation with an ophthalmologist or optometrist. For new members (coverage effective date ≤ 90 days), submit medical records documenting the member is currently receiving the requested drug (excluding samples or manufacturer patient assistance).

Definitions

Demodex blepharitis — definition and key clinical signs

DefinitionBlepharitis caused by infestation with Demodex mites; clinically identified by characteristic eyelid findings.

Key sign — CollarettesCylindrical dandruff (collarettes) at the base of the eyelashes, listed as a primary sign of Demodex infestation.

Key sign — Eyelid margin erythemaErythema of the eyelid margin is an accepted clinical sign of Demodex blepharitis.

Key sign — Eyelash anomaliesEyelash anomalies such as eyelash misdirection are recognized signs of infestation.

Prescriber requirementRequested medication must be prescribed by or in consultation with an ophthalmologist or optometrist.

OpenPayer

Xdemvy (lotilaner) ophthalmic solution coverage

Coverage Criteria for Xdemvy (lotilaner)

Coding and Product

Provider Actions and Authorization Requirements

Background

Definitions