CurrentBlue Cross Blue Shield - IowaPolicy 05.05.67

Ebglyss (lebrikizumab) — Prior Authorization and Medical Necessity Criteria for Moderate-to-Severe Atopic Dermatitis

Prior authorization and medical necessity criteria for Ebglyss (lebrikizumab- Ibkz) for treatment of moderate-to-severe atopic dermatitis in patients ≥12 years and ≥40 kg; applies to members whose benefits include the therapy.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyEbglyss (lebrikizumab) — Prior Authorization and Medical Necessity Criteria for Moderate-to-Severe Atopic Dermatitis

Policy CodePolicy 05.05.67

Change TypeNo material change

Effective DateJan 30, 2025

Next Review Date

Key ActionObtain prior authorization and submit chart notes showing prerequisite topical therapy trials or documentation why they are not advisable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12min patient age

≥40 kgmin patient weight

4 monthsinit auth (prior biologic)

12 monthsmaintenance auth

4 syringesinit quantity limit

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Coverage Criteria for Ebglyss (lebrikizumab)

Initial Therapy

Covered when ALL of the following are met

Eligibility and baseline: Patient is >=12 years of age and weighs >=40 kg; has moderate-to-severe atopic dermatitis defined as affected body surface area >=10% OR involvement of crucial body areas (hands, feet; face, neck, scalp, genitals/groin, intertriginous areas); member will not exceed the maximum FDA‑approved dose for this indication.

From indications and criteria

Prior topical therapy: Within the past 180 days the member has had an inadequate response to EITHER a medium‑ to super‑high potency topical corticosteroid OR a topical calcineurin inhibitor; OR documentation that these topical therapies are not advisable (e.g., contraindication, intolerance, age‑appropriate potency not suitable).180 days

Step therapy requirement

Concomitant therapy exclusion: Member will not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis.

Coverage exclusion if concomitant use occurs

Continuation Therapy

Covered when ALL of the following are met

Clinical response: Member has achieved or maintained a positive clinical response with Ebglyss therapy for moderate‑to‑severe atopic dermatitis, evidenced by low disease activity (clear or almost clear skin) or improvement in signs and symptoms (e.g., redness, itching, oozing/crusting).

Required for 12‑month authorization

Dose limit: Member will not exceed the maximum FDA‑approved dose for this indication.

Dosing aligned with FDA labeling

Coverage for Ebglyss is limited to members who meet the clinical and administrative criteria set forth in this policy. Members who do not meet the specified criteria are not eligible for coverage. Use of Ebglyss concomitantly with any other biologic or targeted synthetic drug (including JAK inhibitors) for the same indication is excluded from coverage and will result in denial. Members obtaining Ebglyss through samples or a manufacturer's patient assistance program must meet the same initial authorization requirements as other members to ensure equal treatment.

Not medically necessary: Ebglyss is considered not medically necessary for members who do not meet the criteria set forth in this policy.

Coding and Dosing Limits

Procedures and billing codesmixed

No codes listed

Quantity limits / dosing — initiation and maintenance (Ebglyss)

Standard initiation quantity limit4 syringes/pens per first 28 days (initiation)

Induction period quantity2 syringes/pens until Week 16

Maintenance quantity limit1 syringe/pen per 28 days (maintenance)

FDA recommended induction dosing500 mg at Week 0 and Week 2 (two 250 mg injections), then 250 mg every other week until Week 16

FDA recommended maintenance dosing250 mg every 4 weeks

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ebglyss (lebrikizumab) for atopic dermatitis. Typical authorization lengths: initial approvals may be granted for up to 4 months in members ≥12 years who previously received a biologic or targeted synthetic for AD in the past year; otherwise authorization durations follow criteria-based approvals (see clinical criteria). Quantity limits and FDA-recommended dosing apply.

Prior authorization required
Initial authorization commonly 4 months in specified circumstances
Do not exceed FDA‑approved dosing

Documentation Required

Required Documentation to Support Requests

For initial requests, submit the member's chart notes or medical record documentation and claims history showing prerequisite therapies (including drug name, dose, start/stop dates, duration, and response). If prerequisite topical therapies are not advisable, include documentation explaining why (e.g., contraindication, intolerance, age-related potency concerns). Also include documentation of affected area(s) and body surface area where applicable. For continuation requests, provide chart notes demonstrating a positive clinical response (reduction in disease activity or improvement in signs/symptoms).

Background

Ebglyss (lebrikizumab) is indicated for the treatment of adolescents and adults 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis that is inadequately controlled with topical therapies or when topical therapies are not advisable. The policy defines moderate-to-severe disease by affected body surface area (BSA) ≥10% or involvement of crucial body areas (for example hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas). Ebglyss may be used with or without topical corticosteroids; dosing and quantity limits are aligned with FDA labeling and policy-specified limits.

Definitions and Disease Severity

Moderate-to-severe atopic dermatitis — key thresholds and definitions

Disease extent thresholdAffected body surface area (BSA) ≥10%

Critical body areas definitionInvolvement of hands, feet; face, neck, scalp; genitals/groin; or intertriginous areas

Topical therapy prerequisite timeframeInadequate response within the past 180 days to either a medium- to super-high potency topical corticosteroid or a topical calcineurin inhibitor

Age and weight eligibilityPatients ≥12 years of age and weighing ≥40 kg

Most actionable thresholdCoverage requires BSA ≥10% OR involvement of crucial body areas (hands/feet, face/neck/scalp, genitals/groin, intertriginous areas)