CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ebglyss (lebrikizumab) — coverage criteria for moderate-to-severe atopic dermatitis

Covers clinical authorization, dosing, quantity limits, and approval criteria for Ebglyss in members (≥12 years, ≥40 kg) with moderate-to-severe atopic dermatitis when specified criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEbglyss (lebrikizumab) — coverage criteria for moderate-to-severe atopic dermatitis

Policy CodePolicy N/A

Change TypeDurations, quantity limits, dosing clarification

Effective DateN/A

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization with documentation of age (≥12 years), weight (≥40 kg), prescriber specialty, affected body surface area or crucial area involvement, prior topical and biologic trials, and dosing regimen to support requested approval duration.

SourceLink

POLICY UPDATE CHANGES

Policy specifies authorization durations for induction and maintenance dosing regimens including 4-month, 6-month, and 12-month approvals depending on dosing frequency and response.

Quantity limit defined as 1 pen/syringe per 28 days with exceptions for induction loading doses and for continuation of 250 mg every 2 weeks with documented inadequate response.

Maintenance dosing described as 250 mg every 4 weeks and initial loading regimen of 500 mg at Weeks 0 and 2 followed by 250 mg every 2 weeks until Week 16.

≥12minimum age for coverage

≥40 kgminimum weight for coverage

4 monthstypical initial approval

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500 mg x2loading doses

1 pen/28 daysmaintenance quantity limit

Coverage Criteria for Ebglyss (lebrikizumab)

Initial Therapy

Covered when ALL of the following are met:

Initial authorization criteria: 1. Member is at least 12 years of age; 2. Member weighs at least 40 kg; 3. Medication is prescribed by or in consultation with a dermatologist or allergist/immunologist; 4. Affected body surface area is greater than or equal to 10% OR crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected; 5. Inadequate treatment response to at least one medium to super‑high potency topical corticosteroid for ≥2 consecutive weeks, or topical corticosteroid use is not advisable (e.g., contraindication or prior intolerance); 6. Inadequate treatment response to pimecrolimus cream or tacrolimus ointment for ≥6 consecutive weeks, or intolerance/contraindication to topical calcineurin inhibitors; 7. Inadequate response, intolerance, or contraindication to Dupixent after a 4‑month trial; 8. Inadequate response, intolerance, or contraindication to Adbry or Nemluvuo after a 4‑month trial; 9. No concomitant use of Ebglyss with any other biologic or targeted synthetic drug (including JAK inhibitors) indicated for atopic dermatitis.

Authorization of 4 months may be granted when all criteria are met.

Maintenance Therapy (250 mg q4w)

Covered when ALL of the following are met:

250 mg every 4 weeks maintenance: A. Documentation that the member has achieved or maintained a positive clinical response with Ebglyss therapy evidenced by low disease activity (e.g., clear or almost clear skin) or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting); B. Member will not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis.

Authorization of 12 months may be granted for members meeting these conditions.

Increased Frequency (250 mg q2w)

Covered on a case-by-case basis when ALL of the following are met:

250 mg every 2 weeks continuation: A. Documentation of a positive clinical response after at least 16 weeks of therapy evidenced by lower disease activity or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting), and medical rationale provided for continuing every‑2‑week dosing frequency; B. Member will not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis.

Authorization of 6 months may be granted for q2w dosing; quantity limit exceptions apply with documentation of inadequate clinical response to support continued q2w dosing.

All indications for Ebglyss (lebrikizumab) beyond the FDA‑approved use for atopic dermatitis are considered experimental/investigational and not medically necessary. Coverage is limited to the FDA‑labeled indication (treatment of moderate‑to‑severe atopic dermatitis in the specified population) and recognized compendium uses; any request for other diagnoses or indications will be denied as investigational.

Ebglyss is covered only for members who meet the FDA‑labeled population criteria. Specifically, use of Ebglyss in patients younger than 12 years of age or weighing less than 40 kg is not covered. Requests for members outside these age or weight limits will be considered not medically necessary.

Prescriber Requirements and Authorization Procedures

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals for moderate-to-severe atopic dermatitis may be granted for 4 months when ALL required criteria are met. Approvals for maintenance dosing vary by dosing frequency and response: 12 months may be granted for 250 mg every 4 weeks when maintenance-response documentation is provided; 6 months may be granted on a case‑by‑case basis for 250 mg every 2 weeks with documented positive response after ≥16 weeks and rationale for continued q2w dosing; continuation approvals require documentation of maintained clinical response (e.g., clear or almost clear skin or improvement in signs/symptoms). Members must not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis.

Initial authorization: 4 months for new therapy when all initial criteria met
250 mg every 4 weeks (maintenance): authorization up to 12 months with documented sustained response
250 mg every 2 weeks: authorization up to 6 months on case-by-case basis with documented response after ≥16 weeks and clinical rationale
Continuation: approval contingent on documentation of maintained positive clinical response
Concurrent use with other biologics or JAK inhibitors for atopic dermatitis is prohibited

Key Definitions and Dosing Regimens

Moderate-to-severe atopic dermatitis definition

BSA thresholdAffected body surface area ≥10%

Crucial area involvementInvolvement of hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas qualifies regardless of BSA

Age and weight contextApplies to adults and pediatric patients ≥12 years old who weigh at least 40 kg

Dosing regimens and quantity limits

Induction regimen500 mg subcutaneously at Week 0 and 500 mg at Week 2 (given as two 250 mg injections each) followed by 250 mg every 2 weeks until Week 16

Maintenance regimen250 mg subcutaneously every 4 weeks after adequate clinical response

Background

Ebglyss (lebrikizumab‑lbkz) is indicated for the treatment of moderate‑to‑severe atopic dermatitis in adults and pediatric patients aged 12 years and older who weigh at least 40 kg, when the disease is not adequately controlled with topical prescription therapies or when topical therapies are not advisable. The product may be used with or without topical corticosteroids.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEbglyss (lebrikizumab) — coverage criteria for moderate-to-severe atopic dermatitis

Policy CodePolicy N/A

Change TypeDurations, quantity limits, dosing clarification

Effective DateN/A

Next Review DateFeb 25, 2025

SourceLink

On This Page

Denial Risk

Requests May Be Denied If Documentation Is Incomplete

Requests lacking required documentation risk denial. Examples of missing information that may result in denial include: absence of member age or weight documentation; missing specialty of prescriber or documentation of dermatology/allergy-immunology consultation; lack of documentation of affected body surface area or involvement of crucial areas; missing prior therapy trials or reasons they were not advisable; and absence of documentation showing prior inadequate responses to required therapies (topical corticosteroids, topical calcineurin inhibitors, Dupixent, Adbry/Nemluvio when applicable).

Missing member age or weight
No documentation that prescriber is a dermatologist or allergist/immunologist or that consultation occurred
No documentation of affected BSA ≥10% or involvement of crucial body areas
Incomplete documentation of prior therapy trials, durations, responses, intolerances, or contraindications
No documentation of positive/maintained response for continuation or maintenance dosing

Documentation Required

Required Patient and Prescriber Documentation

Documentation submitted with the prior authorization request must include the member's age and weight and the prescribing clinician's specialty. For members 12 years and older, include proof the member is ≥12 years and that weight is ≥40 kg when applicable. The request must indicate whether the prescriber is a dermatologist or allergist/immunologist or include documentation of consultation with one of these specialists.

Member age (must be ≥12 years for indication)
Member weight (must be documented; ≥40 kg for pediatric indication)
Prescriber specialty or documentation of dermatologist/allergist-immunologist consultation

Step Therapy

Step-Therapy and Prior Treatment Requirements

Step therapy requirements must be documented. For moderate-to-severe atopic dermatitis, the request must show inadequate treatment response to at least one medium- to super‑high‑potency topical corticosteroid used for ≥2 consecutive weeks (see Appendix for potency groups) or that topical corticosteroids are not advisable (e.g., contraindication, prior intolerance). In addition, documentation is required for inadequate response or intolerance/contraindication to topical calcineurin inhibitors (pimecrolimus/tacrolimus) after ≥6 weeks, and inadequate response, intolerance, or contraindication to Dupixent and to Adbry or Nemluvio after 4-month trials prior to approval. Include dates, durations, and clinical rationale for each prior therapy trial or why a step was bypassed.

Inadequate response to ≥1 medium- to super‑high‑potency topical corticosteroid for ≥2 consecutive weeks (see Appendix potency listings) or documented reason topical corticosteroids are not advisable
Inadequate response to pimecrolimus cream or tacrolimus ointment for ≥6 consecutive weeks, or intolerance/contraindication to topical calcineurin inhibitors
Inadequate response, intolerance, or contraindication to Dupixent after a 4‑month trial
Inadequate response, intolerance, or contraindication to Adbry or Nemluvio after a 4‑month trial
Provide dates, durations, outcomes, and clinical rationale for all prior therapies or reasons for bypassing steps

Quantity limitStandard quantity limit: 1 pen/prefilled syringe (250 mg/2 mL) per 28 days

Induction quantity exceptionException for induction: up to 4 pens per 28 days for initial loading doses (and 2 pens per 28 days for subsequent 12-week fills as specified)

Exception for continued q2w dosingException may be provided to continue 250 mg every 2 weeks (2 pens per 28 days) with documentation of inadequate clinical response