Ebglyss (lebrikizumab-lbkz) — Blue Cross Blue Shield of Texas

Initial criteria

• All target agents are eligible for continuation of therapy if the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed.
• Otherwise BOTH of the following must be met:
• 1. ONE of the following diagnosis requirements:
• A. The patient has moderate-to-severe atopic dermatitis (AD) AND ALL of the following:
• • ONE of the following disease severity criteria:
• – ≥10% body surface area involvement OR
• – Involvement of areas difficult to treat with prolonged topical corticosteroids (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR
• – Eczema Area and Severity Index (EASI) ≥16 OR
• – Investigator Global Assessment (IGA) score ≥3
• • ONE of the following treatment history criteria:
• – Tried and had inadequate response to ≥1 medium-potency topical corticosteroid after ≥4 weeks OR
• – Intolerance or hypersensitivity to ≥1 medium-potency topical corticosteroid OR
• – FDA-labeled contraindication to all medium-, high-, or super-potency topical corticosteroids AND
• • ONE of the following calcineurin inhibitor criteria:
• – Tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel, Protopic) after ≥6 weeks OR
• – Intolerance or hypersensitivity to ≥1 calcineurin inhibitor OR
• – FDA-labeled contraindication to all topical calcineurin inhibitors
• • The prescriber has documented baseline pruritus and other symptom severity (erythema, edema, xerosis, erosions/excoriations, oozing/crusting, or lichenification).
• B. OR the patient has another FDA-labeled indication for the requested agent and route of administration.
• 2. If the patient has an FDA-labeled indication, ONE of the following must apply:
• – Age is within FDA labeling for the requested indication, OR
• – There is support for off-label use per compendia, OR
• – The patient has another compendia-supported indication for the requested agent and route.
• 3. If diagnosis is moderate-to-severe AD, BOTH must be met:
• – Patient is currently treated with topical emollients and practicing good skin care, AND
• – Patient will continue topical emollients and good skin care in combination with requested agent.
• 4. If requested agent is Adbry for AD:
• ONE of the following:
• – Patient age <18 years OR
• – Initiating therapy OR
• – Treated <16 consecutive weeks OR
• – Treated ≥16 consecutive weeks AND:
• • If weight <100 kg: either achieved clear/almost clear skin and dose will be reduced to 300 mg q4w, OR not achieved clear/almost clear skin, OR support for 300 mg q2w dosing.
• • If weight ≥100 kg: dose may continue per labeled recommendations.
• 5. If requested agent is Ebglyss for AD: Patient weight ≥40 kg.
• 6. Prescriber is a dermatologist, allergist, immunologist, or has consulted with a specialist.
• 7. ONE of the following regarding concomitant therapy:
• – Will NOT be used with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors), OR
• – Will be used in combination AND:
• • Prescribing info does not limit such combination, AND
• • Submitted evidence (clinical trials, phase III studies, guidelines) supports combination use.
• 8. Patient does NOT have any FDA-labeled contraindication to the requested agent.
• Compendia allowed: AHFS, DrugDex level 1, 2a, or 2b, or NCCN 1, 2a, 2b.

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); 6 months (other plans)