CurrentQualChoicePolicy CP.PCH.58

Lebrikizumab-lbkz (Ebglyss) — Coverage Criteria for Atopic Dermatitis

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Criteria and authorization rules for coverage of lebrikizumab-lbkz (Ebglyss) for treating moderate-to-severe atopic dermatitis in patients meeting age, weight, prior-therapy, and dosing requirements under QualChoice plans.

Policy Summary

PayerQualChoice

PolicyLebrikizumab-lbkz (Ebglyss) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CP.PCH.58

Change TypeNo material change

Effective DateAug 20, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, BSA or affected sites, specialist involvement, age/weight, prior topical/systemic therapy trials, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum covered patient age

≥40 kgminimum covered patient weight

12 moapproval duration

250 mgmaintenance dose

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CurrentQualChoicePolicy CP.PCH.58

Lebrikizumab-lbkz (Ebglyss) — Coverage Criteria for Atopic Dermatitis

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Policy Summary

PayerQualChoice

PolicyLebrikizumab-lbkz (Ebglyss) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CP.PCH.58

Change TypeNo material change

Effective DateAug 20, 2025

Next Review Date

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum covered patient age

≥40 kgminimum covered patient weight

12 moapproval duration

250 mgmaintenance dose

J3590, C9399HCPCS codes referenced

Coverage Criteria

inv-01: Initial Therapy — Atopic Dermatitis

Covered when ALL of the following are met:

Initial AD criteria: 1. Diagnosis of atopic dermatitis affecting either (a) ≥ 10% body surface area (BSA) OR (b) involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas;

2. Prescribed by or in consultation with a dermatologist or allergist;

3. Age ≥ 12 years;>= 12 years

4. Weight ≥ 40 kg;>= 40 kg

Prior topical/systemic therapy failure

Option a
- i. Two formulary medium-to-very-high potency topical corticosteroids of different molecular identities, each used for ≥ 2 weeks;
- ii. One non‑steroidal topical therapy used for ≥ 4 weeks (topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or Eucrisa®);
Option b (Illinois HIM only): For Illinois HIM requests only: one topical therapy;
Follow IL HB 5395 modification for Illinois HIM requests as noted in policy

6. Failure of Dupixent® or Rinvoq® used for > consecutive 4 months, unless clinically significant adverse effects are experienced or both are contraindicated;

7. Ebglyss (lebrikizumab-lbkz) is 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®);

8. Dose does not exceed policy dosing limits: loading 500 mg (two 250 mg/2 mL injections) at Week 0 and Week 2; initial 250 mg every 2 weeks until Week 16 or clinical response; maintenance 250 mg every 4 weeks.

inv-02: Continued Therapy — Atopic Dermatitis

Covered when ALL of the following are met:

Continued therapy criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

2. Member is responding positively to therapy as evidenced by clinical improvement (for example, reduction in itching or scratching);

3. Ebglyss is 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);

4. Dose does not exceed 250 mg every 4 weeks (maintenance dosing).250 mg every 4 weeks

Requests for indications that are not FDA‑approved for lebrikizumab‑lbkz (Ebglyss) are not authorized under this policy unless the provider submits sufficient clinical documentation demonstrating efficacy and safety per the applicable off‑label use policies (see CP.CPA.09 for commercial members and HIM.PA.154 for health insurance marketplace members).

For Medicaid members, any applicable state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the relevant state Medicaid manual for specific coverage rules that supersede the policy.

Ebglyss must not be prescribed concurrently with another biologic immunomodulator (examples: Dupixent, Adbry, Cinqair, Fasenra, Nucala, Tezspire, Xolair) or with a JAK inhibitor (examples: Olumiant, Rinvoq, Cibinqo, Opzelura). This restriction applies to both initial and continued therapy criteria.

Coding and Product Presentation

Product strengths / NDC-like descriptionNDC

250 mg/2 mL	Injection: 250 mg/2 mL in a single-dose prefilled pen
250 mg/2 mL	Injection: 250 mg/2 mL in a single-dose prefilled syringe with needle shield

HCPCS Codes (referenced)HCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Body weight

Minimum weight≥ 40 kg

ContextRequired for initial approval of lebrikizumab (Ebglyss) for atopic dermatitis

Source sectionInitial Approval Criteria — weight requirement

Age

Minimum age≥ 12 years

ContextRequired for initial approval of lebrikizumab (Ebglyss) for atopic dermatitis

Source section

Provider Actions and Authorization

Prior Authorization

Prior authorization required with complete clinical documentation

Prior authorization is required. Submit documentation showing the diagnosis of atopic dermatitis, affected body surface area (or involved sites), prescribing specialist (dermatologist or allergist) or consultation, member age (≥12 years) and weight (≥40 kg), and evidence of prior topical/systemic therapy trials including trials required by step therapy (see step therapy block) and failure of Dupixent® or Rinvoq® unless contraindicated. Dosing must be within policy limits (loading and maintenance dosing described in policy).

Diagnosis: atopic dermatitis with ≥10% BSA or involvement of specified sites
Specialist: prescribed by or in consultation with a dermatologist or allergist
Age/weight: ≥12 years and ≥40 kg
Prior therapies: topical regimens as specified and failure of Dupixent® or Rinvoq® (>4 consecutive months) unless contraindicated
Dosing: must not exceed loading/initial/maintenance dose limits in policy

Definitions and Clinical Thresholds

Atopic dermatitis severity/location criteria

DefinitionAtopic dermatitis affecting ≥10% body surface area (BSA)

Or involving specific locationsHands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

UsageOne of these findings is required for initial approval under the policy

Contraindication

ContraindicationPrior serious hypersensitivity to lebrikizumab-lbkz or any excipients of Ebglyss

AppendixListed under Appendix C: Contraindications/Boxed Warnings

Implication

Background

Lebrikizumab‑lbkz (Ebglyss) is an interleukin‑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. The product is provided as a 250 mg/2 mL injection in prefilled pen and prefilled syringe presentations; induction dosing includes 500 mg (two 250 mg/2 mL injections) at Week 0 and Week 2, followed by 250 mg maintenance dosing per the policy dosing schedule.

Policy Summary

PayerQualChoice

PolicyLebrikizumab-lbkz (Ebglyss) — Coverage Criteria for Atopic Dermatitis

Policy CodePolicy CP.PCH.58

Change TypeNo material change

Effective DateAug 20, 2025

Next Review Date

SourceLink

On This Page

Initial Approval Criteria — age requirement

Billing Rule

HCPCS codes referenced (informational)

The policy references HCPCS codes for informational purposes only: J3590 (unclassified biologics) and C9399 (unclassified drugs or biologicals). Inclusion of these codes in the policy does not guarantee coverage; verify coding prior to claim submission.

J3590 — Unclassified biologics
C9399 — Unclassified drugs or biologicals

Step Therapy

Step therapy: required topical and biologic/JAK failures

Step therapy must be documented prior to initial approval: failure of topical regimens defined as either (a) two formulary medium-to-very-high potency topical corticosteroids of different molecular identities, each used ≥2 weeks, plus one non‑steroidal topical therapy used ≥4 weeks; or (b) for Illinois HIM requests only, one topical therapy. Additionally, failure of Dupixent® or Rinvoq® used for >4 consecutive months is required unless contraindicated.

Topical regimen: two different medium-to-very-high potency topical corticosteroids (≥2 weeks each) AND one non‑steroidal topical (≥4 weeks)
Illinois HIM modification: one topical therapy acceptable per IL HB 5395 for Illinois HIM requests
Biologic/JAK step: failure of Dupixent® or Rinvoq® >4 months unless contraindicated

Note

Policy redirects to preferred agents (Dupixent® or Rinvoq®)

For atopic dermatitis initial approvals the policy was adapted to redirect to preferred agents Dupixent® or Rinvoq®; operational workflows should follow this redirection when applicable (i.e., document trials of those agents per step therapy requirement).

Policy adaptation adds redirection to preferred agents Dupixent® or Rinvoq® for initial approval criteria

Documentation Required

Required supporting documentation to demonstrate criteria are met

Providers must submit supporting documentation such as office chart notes, lab results, or other clinical information that demonstrates the member meets all approval criteria, including prior therapy trials and clinical response for continuation requests.

Office chart notes documenting diagnosis, BSA or affected sites, specialist involvement
Documentation of prior topical/systemic therapy trials and durations
For continuation: evidence of clinical response (e.g., reduction in itching or scratching)

Note

Dosing and product presentation (induction and maintenance)

Prescribing and dosing must follow policy dosing limits: induction with 500 mg (two 250 mg/2 mL injections) subcutaneously at Week 0 and Week 2, then 250 mg subcutaneously every 2 weeks until Week 16 or clinical response, with maintenance 250 mg subcutaneously every 4 weeks. Product is supplied as 250 mg/2 mL in prefilled pen or prefilled syringe.

Induction: 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
Presentation: 250 mg/2 mL prefilled pen and prefilled syringe

Denial Risk

Missing documentation may cause denial or delay

Failure to submit required supporting documentation (chart notes, labs, or other clinical information) to demonstrate that approval criteria are met may result in delay or denial of the request.

Ensure all prior therapy trials, specialist consultation, age/weight, BSA or affected site documentation, and dosing justification are included with the request

Denial Risk

Non‑FDA indications require off‑label documentation

Requests for non–FDA‑approved indications that do not include sufficient documentation per the off‑label use policies (CP.CPA.09 or HIM.PA.154 as applicable) are not authorized and may be denied.

Refer to off‑label use policy CP.CPA.09 (commercial) or HIM.PA.154 (health insurance marketplace) for required documentation

Billing Rule

Coding listed in policy does not guarantee coverage

Inclusion of HCPCS or other codes in this clinical policy is for informational purposes only; it does not guarantee coverage. Providers should reference the most up‑to‑date professional coding guidance prior to claim submission.

Codes referenced in policy do not ensure reimbursement or coverage; verify coding and billing rules before submitting claims

History of serious hypersensitivity should preclude use per policy

Induction dosing

Induction regimen500 mg (two 250 mg/2 mL injections) subcutaneously at Week 0 and Week 2

Follow-up dosing until responseThen 250 mg SC every 2 weeks until Week 16 or later when adequate clinical response is achieved

Presentation noteInduction uses two 250 mg/2 mL injections (total 500 mg)

Maintenance dosing

Maintenance dose250 mg subcutaneously every 4 weeks

ConditionUsed once adequate clinical response is achieved after induction

Policy referenceListed as maintenance dosing in Appendix C: Dosage and Administration