mhn lebrikizumab (Ebglyss) Coverage Update

Coverage Criteria

Initial and Continued Therapy Criteria

Covered when ALL of the following are met for Initial Approval (Atopic Dermatitis):

Initial Approval - Atopic Dermatitis

Diagnosis of atopic dermatitis affecting either (a) at least 10% BSA OR (b) involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areasBSA >=10%
See dosing and definitions in policy.
Prescriber: Prescribed by or in consultation with a dermatologist or allergist
Age >= 12 years>= 12 years
Weight >= 40 kg>= 40 kg
Prior topical therapy failure: Failure of both: (a) two formulary medium to very high potency topical corticosteroids of different molecular identities, each used >= 2 weeks; AND (b) one non-steroidal topical therapy used >= 4 weeks (e.g., topical calcineurin inhibitor or crisaborole/Eucrisa) unless contraindicated or clinically significant adverse effects occurred
Concomitant therapy restriction: Not prescribed concurrently with another biologic immunomodulator (e.g., Dupixent, Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or a JAK inhibitor (e.g., Olumiant, Rinvoq, Cibinqo, Opzelura)
Dosing limits: Dose does not exceed: loading 500 mg (two 250 mg/2 mL injections) at Week 0 and Week 2; initial 250 mg SC every 2 weeks until Week 16 or clinical response; maintenance 250 mg SC every 4 weeks
Maximum maintenance dose: 250 mg every 4 weeks

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety per the plan’s off‑label use requirements. Providers should follow the Off‑Label Use Policy CP.PMN.53 (Medicaid) or applicable evidence‑of‑coverage documentation when requesting coverage for off‑label uses.

When there is a conflict between this clinical policy and a state Medicaid coverage provision, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that apply to this policy.

Use of lebrikizumab‑lbkz for indications that are not FDA‑approved and that lack the required off‑label documentation is not authorized. Requests for such non‑FDA indications must include the documentation specified by the plan’s off‑label policies (see CP.PMN.53) to be considered for coverage.

Initial Therapy

Initial therapy for atopic dermatitis — required criteria and dosing:

Initial Therapy: Member meets diagnosis, prescriber, age, weight, prior topical therapy failure, concomitant therapy restriction, and dosing limits as follows: loading dose 500 mg (two 250 mg/2 mL injections) SC at Week 0 and Week 2; then 250 mg SC every 2 weeks until Week 16 or clinical response, followed by maintenance 250 mg SC every 4 weeks.

Initial therapy duration

Initial authorization duration per policy history:

Initial approval duration was extended from 6 months to 12 months.12 months

Per policy history entry.

Prior Topical Therapies Required	Details / Duration	Coverage Status
Two formulary medium to very high potency topical corticosteroids of different molecular identities	Each corticosteroid used for ≥ 2 weeks; examples of very high potency agents include clobetasol propionate 0.05% and augmented betamethasone 0.05% (see appendix)	Failure required unless contraindicated or clinically significant adverse effects
One non‑steroidal topical therapy (e.g., topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or crisaborole/Eucrisa®)	Used for ≥ 4 weeks; examples and dosing in appendix: tacrolimus/pimecrolimus applied BID; Eucrisa® applied BID	Failure required unless contraindicated or clinically significant adverse effects

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Atopic Dermatitis):

Eligibility for continuation: Member currently receiving medication via Centene benefit and/or previously met initial approval criteria OR member is currently receiving medication and continuity of care regulations apply
Response: Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching or scratching
Concomitant therapy restriction: Ebglyss is not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor
Dosing limits:

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must obtain prior authorization and demonstrate that all initial or continuation criteria in this policy are met before requesting coverage for Lebrikizumab (Ebglyss).

Prior authorization required for initial and continued therapy per this policy.
HCPCS potentially used for billing: J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals). Inclusion of these codes does not guarantee coverage.

Documentation Required

Required Documentation

Providers should submit documentation supporting that the member has met all applicable criteria. This includes, but is not limited to, office chart notes, prior treatment history, diagnostic information, baseline weight/age as applicable, and documentation of positive response for continuation requests.

Examples of acceptable documentation: office notes, dermatology/allergy consultation notes, BSA estimates or description of affected areas, prior topical treatment records (agents, durations), and objective/subjective measures of treatment response.

Coding

Referenced HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

inv-06: Body Surface Area (BSA) — qualifying BSA threshold

Qualifying threshold>= 10% of body surface area (BSA)

Alternative qualifying definitionInvolvement of high‑impact areas: hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

Context of useRequired as part of initial approval criteria for atopic dermatitis

inv-07: Weight — qualifying weight threshold

Qualifying weight>= 40 kg

Associated age requirementUsed in combination with age >= 12 years for initial approval

Role in dosing eligibility

Step Therapy

Required Topical Agents	Representative Examples (from Appendix)	Required Duration
Medium to very high potency topical corticosteroids — two agents of different molecular identities	Examples: clobetasol propionate 0.05% (Temovate®), augmented betamethasone 0.05% (Diprolene® AF); other very high/medium potency agents listed in appendix	Each corticosteroid used ≥ 2 weeks
One non‑steroidal topical therapy	Examples: topical calcineurin inhibitors — tacrolimus (Protopic®) 0.03% ointment, pimecrolimus (Elidel®) 1% cream; crisaborole (Eucrisa®)	Used ≥ 4 weeks

Step Therapy Sequence Specified?	Nature of Document Change	Implication for Providers
No explicit step therapy sequence specified in this document segment	Policy history notes operational changes: extended initial approval duration from 6 months to 12 months and broadened continuation language to include 'including but not limited to' for defining positive response	No new step ordering required; providers should note longer initial authorization period and broader continuation response definitions when submitting documentation

Quantity Limits

inv-25: Lebrikizumab-lbkz (Ebglyss) — maintenance dose information (250 mg)

Maintenance dose250 mg subcutaneously every 4 weeks

Maintenance dose described asMaintenance: 250 mg SC every 4 weeks (maximum dose)

Referenced dosing regimenMaintenance follows initial loading and induction dosing per label

inv-26: Lebrikizumab (Ebglyss) — 250 mg per single-dose container

Single-dose container strength250 mg per single-dose prefilled pen or syringe (250 mg/2 mL)

Presentation detailsAvailable in single-dose prefilled pen and single-dose prefilled syringe with needle shield

Site of Care

Note

Product available as single‑dose pen or syringe; site of care not restricted

Ebglyss is supplied as a 250 mg/2 mL single‑dose prefilled pen or single‑dose prefilled syringe; the policy does not restrict site of care (home, office, or infusion center).

Note

Suitable for office administration per prescriber discretion

The product formulation (single‑dose prefilled pen or syringe) is suitable for administration in office settings per prescriber discretion and label instructions.

Definitions

inv-17: Body Surface Area (BSA) involvement — qualifying disease definition (>= 10% BSA or high-impact areas)

Qualifying disease definition>= 10% BSA OR involvement of high‑impact areas (hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas)

Usage in criteriaPart of the initial approval diagnostic requirement for atopic dermatitis

Applies toPatients considered for lebrikizumab therapy under this policy

inv-18: Ebglyss Prescribing Information — reference to official FDA label for dosing and safety

Official prescribing informationEbglyss Prescribing Information (Eli Lilly) — FDA label referenced for dosing, safety, and product information

Publication date/sourceEbglyss Prescribing Information. Indianapolis, IN: Eli Lilly and Company; May 2025. Available at FDA website

Background

Lebrikizumab‑lbkz (brand name Ebglyss) is an interleukin‑13 (IL‑13) antagonist indicated for the treatment of moderate‑to‑severe atopic dermatitis in patients aged ≥ 12 years and weighing ≥ 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Ebglyss is supplied as 250 mg/2 mL single‑dose prefilled pens or syringes for subcutaneous administration; the prescribing information describes a loading regimen of 500 mg (two 250 mg injections) at Week 0 and Week 2 followed by 250 mg doses for maintenance per label guidance.

References and Revision History

Note

Key references: FDA label and clinical guidelines

Key references for clinical and prescribing information include the Ebglyss Prescribing Information and current atopic dermatitis practice guidelines cited in the policy.

Ebglyss Prescribing Information. Eli Lilly; May 2025.
2023 AAACI/ACAAI Atopic Dermatitis Guidelines
Fishbein AB et al., J Allergy Clin Immunol Pract. 2020

2024-11-12policy_created

Policy created for Lebrikizumab (Ebglyss).

2025-08-20operational_update

OpenPayer

Lebrikizumab-lbkz (Ebglyss) coverage for atopic dermatitis

Coverage Criteria

Initial Therapy

Continuation Therapy

Provider Actions and Requirements

Coding

Step Therapy

Quantity Limits

Site of Care

Definitions

Background

References and Revision History