nemolizumab-ilto — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. Diagnosis of prurigo nodularis (PN) AND BOTH of the following:
• 1. Presence of ≥ 20 firm, nodular lesions AND
• 2. Pruritus lasting ≥ 6 weeks AND
• 3. History or signs of repeated scratching, picking, or rubbing AND
• ONE of the following:
• – Has tried and had inadequate response to ≥ 1 medium-potency topical corticosteroid for ≥ 2 weeks OR
• – Has intolerance/hypersensitivity to ≥ 1 medium-potency topical corticosteroid OR
• – Has FDA labeled contraindication to all medium-, high-, and super-potency topical corticosteroids OR
• – Medication history indicates use of another biologic immunomodulator agent FDA labeled/supported in compendia for PN
• OR
• B. Diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
• 1. ONE of the following: ≥10% body surface area involvement OR difficult-to-treat areas OR EASI ≥16 OR IGA ≥3
• 2. ONE of the following:
• – Tried and had inadequate response to ≥1 medium-potency topical corticosteroid for ≥ 4 weeks OR
• – Intolerance/hypersensitivity to ≥1 medium-potency topical corticosteroid OR
• – FDA labeled contraindication to all medium–, high–, and super–potency corticosteroids AND
• Has tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) for ≥6 weeks OR
• Intolerance/hypersensitivity to ≥1 topical calcineurin inhibitor OR
• FDA labeled contraindication to all topical calcineurin inhibitors
• OR medication history indicates use of another biologic immunomodulator agent FDA labeled/supported in compendia for AD
• C. If other FDA labeled indication for requested agent and route of administration is present, patient’s age must be within FDA label or supported by evidence for age range
• AND additional requirements for AD if applicable:
• – Patient currently treated with topical emollients and practices good skin care AND will continue same in combination with requested agent
• – Concurrent or prior topical corticosteroid or topical calcineurin inhibitor therapy, unless contraindicated
• – Specialist prescriber or consultation (e.g., allergist, dermatologist, immunologist)
• – Requested agent not used in combination with another immunomodulatory agent unless prescribing information and literature support combination use
• – No FDA labeled contraindications to requested agent

Reauthorization criteria

• Continuation of therapy is supported when:
• – Patient has been treated with requested agent ≥16 consecutive weeks AND demonstrates sufficient improvement in disease activity AND concurrent topical therapies tapered/discontinued
• – Requested dose within limits (30 mg every 8 weeks OR 30 mg every 4 weeks if not clear/almost clear or supported by clinical need)
• – Prescriber continues to meet specialist criteria
• – No new contraindications

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); otherwise 6 months for AD/PN and 12 months for other indications