Health Net lebrikizumab Prior Auth Coverage

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met: diagnosis, severity, prior topical therapy failure, prescriber specialty, age, weight, and no contraindications

Covered when ALL of the following are met:

Initial Approval: 1) Diagnosis: Atopic dermatitis affecting either A) at least 10% of the member's 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; 4) Weight >= 40 kg; 5) Failure of both of the following unless contraindicated or clinically significant adverse effects: a) two formulary medium to very high potency topical corticosteroids of different molecular identities, each used for >= 2 weeks, AND b) one non-steroidal topical therapy used for >= 4 weeks (e.g., topical calcineurin inhibitor or crisaborole); 6) Not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 7) Dose does not exceed loading and maintenance limits: loading 500 mg (two 250 mg 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.

Continuation Therapy — Covered for continuation when the following are met: member is responding, dosing adherence, and no new contraindications

Covered for continuation when the following are met:

Continued Therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria or is enrolled in continuity of care as applicable; 2) Member is responding positively to therapy as evidenced by clinical improvement (e.g., reduction in itching/scratching); 3) Not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 4) Dose does not exceed 250 mg every 4 weeks.

Approval duration: 12 months.

Requests for use of lebrikizumab (Ebglyss) for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

Coverage decisions and the administration of benefits for lebrikizumab are subject to all terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies. This clinical policy is a guide for medical necessity determinations and does not guarantee payment.

Uses for diagnoses or indications that are governed by other line‑of‑business non‑coverage or non‑formulary guidance are not authorized under this policy when those other policies apply. Refer to the relevant non‑coverage/non‑formulary and off‑label policies for direction—examples include CP.CPA.190 (Commercial), HIM.PA.33 (Health Insurance Marketplace), and CP.PMN.255 (Medicaid) for formulary/non‑coverage guidance, or the non‑formulary policies listed for specific lines of business as applicable.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

inv-07: Body Surface Area (BSA) — severity threshold for coverage (>= 10%).

Severity threshold (BSA)>= 10% body surface area (BSA)

Alternate severity—critical sitesDisease affecting hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

ContextRequired as part of initial approval for atopic dermatitis

inv-08: Age — minimum age for indication (>= 12 years).

Minimum age>= 12 years

ContextAge requirement for initial therapy and consistent with FDA indication

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria for atopic dermatitis, including diagnosis and prior therapy documentation. Failure to submit required documentation may result in denial or delayed processing.

Prior authorization required with documentation that member meets initial approval criteria (diagnosis, BSA or affected site, prescriber specialty, age, weight, prior topical therapy trials, and dosing limits).
Failure to submit documentation supporting that member has met approval criteria may result in denial or delayed processing.

Documentation Required

Documentation Requirement

Documentation requirement — Providers must provide supporting clinical documentation (office notes, prior treatment records, laboratory results, etc.) showing the member meets all approval criteria. Documentation should specifically address prior topical therapy trials, treatment duration, response, contraindications, and any specialist consultation. Incomplete or missing documentation may lead to denial or delayed adjudication.

Initial Therapy Criteria

Initial Therapy — initial therapy coverage requires meeting diagnosis, severity (BSA or critical site involvement), prior topical therapy failure, prescriber specialty, age, weight, and no contraindications

Covered when ALL of the following are met:

Initial Therapy Nodes: 1) Diagnosis of atopic dermatitis with either >=10% BSA or 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; 4) Weight >=40 kg; 5) 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), unless contraindicated or intolerant; 6) Not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 7) Dosing limits: Loading dose 500 mg (two 250 mg injections) at Week 0 and Week 2; initial 250 mg every 2 weeks until Week 16 or response; maintenance 250 mg every 4 weeks.

Continuation Therapy Criteria

Continued Therapy — Continued therapy is approved when the member is responding and other conditions (adherence, absence of adverse effects) are met.

Continued therapy is approved when the member is responding and other conditions are met:

Continued Therapy Nodes: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria (or continuity of care applies); 2) Member is responding positively to therapy as evidenced by clinical improvement (e.g., reduction in itching/scratching); 3) Not prescribed concurrently with another biologic immunomodulator or a JAK inhibitor; 4) Dose does not exceed 250 mg every 4 weeks.

Approval duration: 12 months.

Step Therapy Requirements

Step	Required trials (formulary agents, minimum duration)	Notes / examples
1	Two formulary medium to very high potency topical corticosteroids of different molecular identities, each used ≥2 weeks	Examples of very high and high potency topical corticosteroids listed in appendices include clobetasol propionate, augmented betamethasone 0.05%, diflorasone diacetate, fluocinonide, halobetasol propionate; each agent must be a different molecular identity
2	One non‑steroidal topical therapy used ≥4 weeks (e.g., topical calcineurin inhibitor such as tacrolimus 0.03% ointment or pimecrolimus 1% cream, or crisaborole)	These non‑steroidal options may require authorization per product labeling; trial may be waived if contraindicated or not tolerated

Quantity Limits and Dosing

inv-25: Ebglyss (lebrikizumab) dosing — Maintenance: 250 mg every 4 weeks; Initial loading: 500 mg at Week 0 and Week 2; initial dosing up to 250 mg every 2 weeks until Week 16 noted.

Maintenance dosing250 mg subcutaneous every 4 weeks

Loading regimen500 mg (two 250 mg injections) at Week 0 and Week 2

Initial/induction dosing250 mg every 2 weeks until Week 16 or clinical response

Administration routeSubcutaneous injections (two 250 mg/2 mL injections for loading dose)

Site of Care

Note

Site‑of‑care — no restriction specified

No explicit site‑of‑care restriction is listed in this policy; infusion center or other site‑of‑care requirements are not specified in this portion of the clinical policy.

Site‑of‑care not restricted by this policy text

Definitions

inv-20: Atopic dermatitis severity criteria — Documented involvement of at least 10% BSA or disease affecting critical sites (hands, feet, face, neck, scalp, genitals/groin).

BSA thresholdDocumented involvement of at least 10% BSA

Critical/functional site involvementDisease affecting hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

Use in criteriaOne of these severity criteria must be met for initial approval

inv-21: Health Plan — definition referencing Centene-managed/adopted plans.

DefinitionHealth Plan: a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

Scope

Background

Lebrikizumab (Ebglyss) is a biologic immunomodulator that functions as an interleukin‑13 (IL‑13) antagonist. It is 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 agent may be used with or without topical corticosteroids; dosing includes a loading phase of 500 mg at Week 0 and Week 2 followed by maintenance dosing of 250 mg (initially up to every 2 weeks until Week 16 or response, then every 4 weeks thereafter).

OpenPayer

Lebrikizumab (Ebglyss) — Medical Necessity and Prior Authorization Criteria