CurrentUnitedHealthcarePolicy N/A

Ebglyss (lebrikizumab-lbkz) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity criteria for Ebglyss (lebrikizumab-lbkz) for patients ≥12 years and ≥40 kg with moderate to severe atopic dermatitis; applies to prescribers and pharmacy/medical benefit reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyEbglyss (lebrikizumab-lbkz) prior authorization

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document trials (drug and date) showing failure, contraindication, or intolerance to two specified topical therapy classes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12 yrs & ≥40 kgage/weight population

fail 2 classesrequired prior topical therapy trials

12 monthsauthorization duration

3/2025, 3/2026P&T reviewed

Coverage Criteria for Ebglyss (lebrikizumab-lbkz)

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Concurrent use of Ebglyss with certain systemic or topical immunomodulatory therapies is not permitted. Specifically, patients must not be receiving Ebglyss in combination with a biologic immunomodulator (for example, tralokinumab/Adbry or dupilumab/Dupixent) or a Janus kinase (JAK) inhibitor (for example, abrocitinib/Cibinqo, topical ruxolitinib/Opzelura, upadacitinib/Rinvoq, or tofacitinib/Xeljanz).

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization (initial and reauthorization) is required and will be approved only when all listed clinical criteria are met, including diagnosis, prior topical therapy trials, and absence of concurrent biologic or JAK inhibitor therapy.

Initial and reauthorization requests must meet ALL clinical criteria listed in the policy.
Requests lacking required documentation or a supported diagnosis are at risk for denial.

Step Therapy

Required Prior Topical Therapy Trials and Documentation

A history of failure, contraindication, or intolerance to two specified topical therapy classes is required before approval. Document the specific drugs tried, dates of trials, or the clinical reason for contraindication/intolerance.

Required trials (any two of the following classes):
• Medium, high, or very-high potency topical corticosteroid (e.g., mometasone furoate, fluocinolone acetonide, fluocinonide).
• Topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus).
• Crisaborole (Eucrisa).
Documentation must include drug name(s) and date(s) of trial or documented contraindication/intolerance.

Documentation Required

Documentation Requirement and Denial Risk

Documentation must clearly record the diagnosis and the prior topical therapy trials (drug names and dates) or documented contraindications/intolerances. Failure to provide this documentation or to show a qualifying diagnosis may result in denial of the request.

Document: diagnosis of moderate to severe chronic atopic dermatitis.
Document: specific topical agents tried, start/end dates, and reason for failure or intolerance, or documentation of contraindication.
Reauthorization must include documentation of positive clinical response to therapy.

Step Therapy / Trial Documentation

Required trial (drug and date)
Medium, high, or very‑high potency topical corticosteroid (e.g., Elocon [mometasone furoate], Synalar [fluocinolone acetonide], Lidex [fluocinonide]) — document drug name and date of trial
Topical calcineurin inhibitor (e.g., Elidel [pimecrolimus], Protopic [tacrolimus]) — document drug name and date of trial
Eucrisa (crisaborole) — document drug name and date of trial

Site of Care and Supply Limitations

Note

Infusion center / site-of-care: supply limits and plan/state mandates may affect coverage

Coverage may be affected by supply limits, state mandates, federal requirements, or the member's benefit plan; site-of-care rules and program-specific limits (e.g., infusion center policies) can also impact authorization and coverage.

Authorization is issued for 12 months but state mandates and the member's benefit plan may modify coverage
Other policies and utilization management programs may apply and could limit supply or site-of-care options

Definitions

Definition — moderate to severe chronic atopic dermatitis

Population definedPatients aged ≥12 years and weighing ≥40 kg with moderate to severe atopic dermatitis

Clinical statusChronic atopic dermatitis of moderate to severe intensity (disease not adequately controlled with topical prescription therapies or when topical therapies are not advisable)

Prior therapy contextUsed when disease is not adequately controlled with topical prescription therapies or when topical therapies are not advisable

Concomitant use guidanceShould not be used concurrently with a biologic immunomodulator (e.g., tralokinumab, dupilumab) or a Janus kinase inhibitor (e.g., abrocitinib, topical ruxolitinib, upadacitinib, tofacitinib)

Therapeutic classInterleukin-13 (IL-13) antagonist