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

Initial criteria

• 1. ONE of the following: (A) Continuation of therapy AND prescriber states patient has been treated with requested agent within past 90 days AND is at risk if therapy is changed OR (B) New start meeting all remaining criteria.
• 2. For new starts, ONE of the following: (A) Diagnosis of moderate-to-severe atopic dermatitis AND ALL of the following:
• • ONE of the following disease severity measures: ≥10% body surface area involvement OR involvement of difficult-to-treat sites (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR EASI score ≥16 OR IGA score ≥3.
• • ONE of the following topical corticosteroid requirements: (a) Tried and had inadequate response to at least one medium-potency topical corticosteroid after ≥4 weeks, (b) Intolerance or hypersensitivity to one medium-potency corticosteroid, or (c) FDA-labeled contraindication to all medium-, high-, and super-potency topical corticosteroids.
• • ONE of the following topical calcineurin inhibitor requirements: (a) Tried and had inadequate response to one topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) after ≥6 weeks, (b) Intolerance or hypersensitivity to one topical calcineurin inhibitor, or (c) FDA-labeled contraindication to all topical calcineurin inhibitors.
• • OR the patient’s 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/crusting, lichenification).
• • For other indications: Patient has FDA labeled indication or compendia-supported use for requested route.
• 3. Patient age is within FDA labeling or supported in compendia for indication.
• 4. For AD: BOTH (A) Patient is currently treated with topical emollients and practicing good skin care, AND (B) Will continue topical emollients and good skin care with requested agent.
• 5. If requested agent is Adbry for AD, ONE of the following: (A) Patient age <18 years OR (B) Initiating therapy OR (C) Treated <16 consecutive weeks OR (D) Treated ≥16 consecutive weeks AND: (1) If weight <100 kg, then (a) achieved clear/almost clear skin AND dose will be reduced to 300 mg every 4 weeks OR (b) not achieved clear/almost clear skin OR (c) support for 300 mg every 2 weeks; OR (2) If weight ≥100 kg — criteria not fully shown (assumed dosing determination).
• 6. If requested agent is Ebglyss for AD, patient weighs ≥40 kg.
• 7. Prescriber is or has consulted with relevant specialist (dermatologist, allergist, immunologist).
• 8. ONE of the following regarding concomitant therapy: (A) Will NOT use agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) Will use concurrently AND BOTH: (1) Prescribing information does not limit combination use, AND (2) Support provided via clinical trials/guidelines.
• 9. Patient does NOT have FDA labeled contraindications to the requested agent.

Approval duration

6–12 months