Prior Authorization Criteria — Ebglyss (lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis
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Prior authorization criteria for coverage of Ebglyss (lebrikizumab-lbkz) for patients with moderate-to-severe atopic dermatitis, specifying prescriber qualifications, diagnostic documentation, prior topical therapy trials, age/weight eligibility, and approval durations.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ebglyss (lebrikizumab-lbkz)
Initial Approval Criteria
Covered when ALL of the following are met
Trial of medium-to-high potency topical steroid is required unless affected area involves sensitive areas (face, skin folds, genitals); if sensitive area, trials of two other agents from the list are still required prior to approval.
Criteria for Reauthorization
Reauthorization requirements
The policy includes a limited exception for sensitive areas when documenting prior topical therapy trials. Generally, coverage requires failure of a minimum 30-day trial of a medium-to-high potency topical corticosteroid as one of two required topical agents. However, if the affected area involves sensitive sites (face, skin folds, or genitals), the medium-to-high potency topical steroid trial is not required. Even when the steroid trial is waived for sensitive areas, the patient must still have documented failure of two other agents from the specified list (Elidel, Eucrisa, Tacrolimus or a medium-to-high potency topical corticosteroid where appropriate) within the prior 12 months.
Failure to document the required prior topical therapy trials, or to show the sensitive-area involvement when a steroid trial was not performed, may lead to denial of prior authorization.
Age, Weight, and Clinical Thresholds
Prior Authorization, Documentation, and Denial Triggers
Prior authorization required; prescriber qualification and core prerequisites
Prior authorization (PA) is required for Ebglyss (lebrikizumab-lbkz). The request must be submitted by an M.D./D.O. or a specialty-trained prescriber with a clinical specialty certification/degree in allergy, immunology, or dermatology, and the request must document moderate-to-severe atopic dermatitis with affected BSA ≥10% and age/weight consistent with the FDA label (≥12 years and ≥40 kg).
Step therapy — failure of two listed topical agents (each ≥30 days)
Member must have failed two topical agents from the policy-specified list, with each agent tried for a minimum of 30 days within the last 12 months. A trial of a medium-to-high potency topical corticosteroid is required unless the affected area involves sensitive areas (face, skin folds, genitals); even when a steroid trial is exempted, two other listed agents must still be tried.
- Acceptable agents: medium-to-high potency topical corticosteroid*, Elidel, Eucrisa, Tacrolimus
- Minimum trial duration: 30 days per agent within the past 12 months
- Sensitive-area exception: steroid trial not required if affected area is face, folds, or genitals, but two other agents from the list are still required
Documentation required for approval and reauthorization
Include documentation of the clinical diagnosis of moderate-to-severe atopic dermatitis with the affected body surface area (BSA), specific areas of involvement, and severity of symptoms; include prescriber specialty/certification and documentation of prior topical trials (each ≥30 days) within the last 12 months. For reauthorization, provide current affected BSA and documentation of satisfactory clinical response.
- Diagnosis: moderate-to-severe atopic dermatitis
- Affected BSA (report numeric percentage) and areas involved
- Severity of symptoms and clinical course
- Prescriber credential (M.D./D.O. or specialty-trained with allergy, immunology, or dermatology certification/degree)
- Prior topical therapy trials: agent names, start/stop dates or durations (each ≥30 days) within past 12 months
- For reauthorization: current BSA and evidence of satisfactory response
Denial triggers — common documentation and eligibility failures
Common reasons for denial include missing prescriber specialty/certification, absent or incomplete diagnosis details (BSA, areas involved, severity), patient not meeting FDA age/weight criteria, affected BSA <10%, or lack of documented failure of two required topical agents with 30-day trials in the last 12 months.
- Prescriber is not an M.D./D.O. or lacks required specialty certification
- No documented affected BSA, areas of involvement, or symptom severity
- Patient outside FDA label age/weight (e.g., <12 years or <40 kg)
- Affected BSA documented as <10%
- Insufficient evidence of two prior topical trials of ≥30 days each within the past 12 months
Key Definitions
Background on Ebglyss (lebrikizumab-lbkz)
Ebglyss (lebrikizumab-lbkz) is an interleukin‑13 antagonist indicated for treatment of patients with moderate-to-severe atopic dermatitis who meet FDA labeling. Per the FDA label referenced in this policy, the agent is indicated for patients who are 12 years of age and older and weigh at least 40 kg (age/weight eligibility must be documented in the PA request).
Clinically, this therapy is intended for patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when topical therapies are not advisable. The policy requires documentation of the diagnosis including affected body surface area (BSA), involved areas, and symptom severity; coverage requires an affected BSA of >= 10%. Initial approval is limited to 3 months with reauthorization contingent on documented clinical response.
Revision History
Policy became effective for prior authorization criteria for Ebglyss (lebrikizumab-lbkz).
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