CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ebglyss

Policy governs coverage and authorization criteria for Ebglyss (lebrikizumab-lbkz) in members (Medicaid scope) for FDA‑approved indication: treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients ≥12 years and ≥40 kg. It defines initial and continuation/maintenance authorization durations, dosing/quantity limits, required prescriber specialty and prior treatment failures, and concomitant therapy exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEbglyss

Policy CodePolicy N/A

Change TypeClarified (reviewed header dates; no material changes)

Effective DateMay 1, 2025

Next Review Date

Key ActionRequire documentation of age (>=12), weight (>=40 kg), prescriber specialty, affected BSA or crucial areas, prior inadequate responses to specified topical and systemic therapies, and confirmation that Ebglyss will not be used concomitantly with other biologics or JAK inhibitors.

SourceLink

POLICY UPDATE CHANGES

Reviewed: 2/25; Effective Date: 5/1/2025; Scope: Medicaid.

1FDA-approved indication described

3Authorization durations (4, 12, 6 mo, induction exception)

8Required prior treatment criteria

Coverage Summary

Age>= 12 years

Weight>= 40 kg

Body surface area / areas>= 10% BSA OR crucial areas affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous)

Topical steroid requirementInadequate response to ≥1 medium to super‑high potency topical corticosteroid for >= 2 consecutive weeks (or topical steroid not advisable)

Topical calcineurin requirementInadequate response to pimecrolimus cream or tacrolimus ointment for >= 6 consecutive weeks (or intolerance/contraindication)

Dupixent (dupilumab) requirementInadequate response, intolerance, or contraindication after a 4‑month trial

Adbry or NemliviO requirementInadequate response, intolerance, or contraindication after a 4‑month trial

Ebglyss Q2W continuation criterionPositive clinical response after >= 16 weeks of therapy required to consider continuing every 2 weeks

Initial Therapy Criteria (Authorization — 4 months)

Covered Indications - Moderate-to-severe atopic dermatitis (Initial authorization 4 months)

Authorization of 4 months may be granted when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older>= 12 years
Documentation that the member weighs at least 40 kg>= 40 kg
Medication prescribed by or in consultation with a dermatologist or allergist/immunologist
ONE of
- Affected body surface is greater than or equal to 10% body surface area>= 10% BSA
- Crucial body areas are affected (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
Documentation that the member has had an inadequate treatment response to at least one medium to superhigh potency topical corticosteroid for >= 2 consecutive weeks or use of a topical corticosteroid is not advisable (e.g., due to contraindications, prior intolerances)>= 2 consecutive weeks
See appendix for potency groups
Documentation that the member has had an inadequate treatment response to pimecrolimus cream or tacrolimus ointment for >= 6 consecutive weeks, experienced an intolerance, or is contraindicated to topical calcineurin inhibitors>= 6 consecutive weeks
Documentation that the member has had an inadequate treatment response with a 4-month trial, intolerance, or contraindication to Dupixent (dupilumab)4 months
Documentation that the member has had an inadequate treatment response with a 4-month trial, intolerance, or contraindication to Adbry (tralokinumab) or NemliviO (nemolizumab)4 months
Source spells NemliviO/Nemluvio variants
Member will not use Ebglyss concomitantly with any other biologic drug or targeted synthetic drug, including JAK inhibitors, indicated for atopic dermatitis
Concomitant biologic/JAK inhibitor use excluded

Continuation and Maintenance Criteria

Requests for 250 mg every 4 weeks (Continuation/Maintenance authorization 12 months)

Authorization of 12 months may be granted when BOTH of the following are met:

ALL of the following

Documentation that member has achieved or maintained a positive clinical response with Ebglyss therapy evidenced by low disease activity (i.e., clear or almost clear skin), or improvement in signs and symptoms of atopic dermatitis (e.g., redness, itching, oozing/crusting)
Positive clinical response defined in policy
Member will not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis
Concomitant biologic/JAK inhibitor use excluded

Requests for 250 mg every 2 weeks (Case-by-case authorization 6 months)

Authorization of 6 months may be granted on a case-by-case basis when BOTH of the following are met:

ALL of the following

Documentation that member has achieved a positive clinical response with Ebglyss therapy after at least 16 weeks of starting 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 frequencyafter at least 16 weeks
Medical rationale required for Q2W continuation
Member will not use Ebglyss concomitantly with other biologics or JAK inhibitors indicated for atopic dermatitis
Concomitant biologic/JAK inhibitor use excluded

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation of criteria

Prior authorization requires documentation that the member meets age and weight thresholds, that the medication is prescribed by or in consultation with an appropriate specialist, documentation of affected body surface area or involvement of crucial areas, prior treatment responses, and confirmation that Ebglyss will not be used concomitantly with other biologic or targeted synthetic drugs (including JAK inhibitors).

Age ≥ 12 years
Weight ≥ 40 kg
Prescriber specialty: dermatologist or allergist/immunologist
Affected BSA ≥ 10% OR involvement of crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
Documentation of prior inadequate responses to required topical and systemic therapies (see documentation callout)
Confirmation that Ebglyss will not be used concomitantly with other biologic drugs or targeted synthetic drugs, including JAK inhibitors

Documentation Required

Document prior treatment failures/intolerances

Require documentation of inadequate treatment response, intolerance, or contraindication to specified prior therapies with the durations listed.

At least one medium to superhigh potency topical corticosteroid — ≥ 2 consecutive weeks
Pimecrolimus cream or tacrolimus ointment — ≥ 6 consecutive weeks
Dupixent (dupilumab) — 4 months
Adbry (tralokinumab) or NemliviO/Nemluvio (nemolizumab) — 4 months

Billing Rule

Quantity limit and induction exceptions

Quantity limit: standard limit is 1 pen/prefilled syringe (250 mg/2 mL) per 28 days. An induction exception allows two initial loading doses (totaling 4 pens/prefilled syringes) per 28 days and then 2 pens/prefilled syringes per 28 days for 12 weeks (three fills). An exception may also permit continuing 250 mg every 2 weeks (2 pens per 28 days) with documentation of inadequate clinical response.

Induction dosing: 500 mg (two 250 mg injections) at Week 0 and Week 2 — reflected as two initial loading doses totaling 4 pens per 28 days
Post-induction: 250 mg every 2 weeks for 12 weeks (2 pens per 28 days) — covered as 3 fills under induction exception
Standard refill limit after induction/maintenance: 1 pen/prefilled syringe (250 mg/2 mL) per 28 days (maintenance dosing 250 mg every 4 weeks)

Denial Risk

Concomitant biologic/JAK inhibitor exclusion

Claims or authorizations may be denied if Ebglyss is used concomitantly with any other biologic drug or targeted synthetic drug, including JAK inhibitors, indicated for atopic dermatitis.

Affected drug classes: other biologic drugs and targeted synthetic drugs (including JAK inhibitors) indicated for atopic dermatitis

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEbglyss

Policy CodePolicy N/A

Change TypeClarified (reviewed header dates; no material changes)

Effective DateMay 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Ebglyss

Coverage Summary

Initial Therapy Criteria (Authorization — 4 months)

Continuation and Maintenance Criteria

Exclusions / Not Covered

Provider Actions & Prior Authorization Requirements

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History