Ebglyss (lebrikizumab-lbkz) — Blue Cross Blue Shield of New Mexico

Initial criteria

• 1. ONE of the following: (A) The requested agent is eligible for continuation of therapy AND prescriber states the patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed OR (B) The following are met:
• • Diagnosis of moderate-to-severe atopic dermatitis (AD) AND ONE of: ≥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 EASI score ≥16 OR IGA score ≥3
• • ONE of the following: (A) Tried and had inadequate response to ≥1 medium-potency topical corticosteroid after at least 4 weeks OR intolerance/hypersensitivity to such topical corticosteroid OR has FDA-labeled contraindication to all medium-, high-, and super-potency topical corticosteroids
• • ONE of the following: (A) Tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) after ≥6 weeks OR intolerance/hypersensitivity to such topical calcineurin inhibitor OR has FDA-labeled contraindication to all topical calcineurin inhibitors
• • Medication history indicates use of another biologic immunomodulator agent FDA labeled or compendia supported for AD
• • Prescriber has documented baseline pruritus and other symptom severity (erythema, edema, xerosis, erosions/excoriations, oozing and crusting, lichenification)
• 2. If patient has FDA labeled indication: ONE of (A) Age within FDA labeling OR (B) Support for use in patient’s age OR (C) Other compendia-supported indication for requested agent
• 3. If diagnosis is moderate-to-severe AD: BOTH (A) Patient is currently treated with topical emollients and good skin care AND (B) Will continue use of topical emollients and good skin care in combination with requested agent
• 4. If requested agent is Adbry for AD: ONE of (A) Patient age <18 years OR (B) Initiating therapy OR (C) Treated <16 consecutive weeks OR (D) Treated ≥16 weeks AND ONE of: (1) weight <100 kg and clear/almost clear skin with dose reduction to 300 mg every 4 weeks OR (2) weight <100 kg and not achieved clear/almost clear skin OR (3) support for therapy using 300 mg every 2 weeks OR (4) weight ≥100 kg)
• 5. If requested agent is Ebglyss for AD: patient weighs ≥40 kg
• 6. Prescriber is a specialist in dermatology, allergy, or immunology or has consulted with such specialist
• 7. ONE of the following regarding concomitant immunomodulator use: (A) Will NOT be used in combination with another immunomodulator (TNF inhibitors, JAK inhibitors, IL‑4 inhibitors) OR (B) Will be used in combination AND (1) prescribing information does NOT limit combination use AND (2) submitted support for combination therapy (clinical trials, phase III studies, or guidelines)
• 8. Patient does NOT have FDA labeled contraindications to requested agent
• Compendia allowed: AHFS, DrugDex 1, 2a, or 2b, or NCCN 1, 2a, or 2b recommended use

Approval duration

6 months