nemolizumab-ilto — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of prurigo nodularis (PN) with ALL of the following: ≥20 firm nodular lesions AND pruritus lasting ≥6 weeks AND signs/history of repeated scratching, picking, or rubbing
• AND EITHER (a) stage 4 advanced metastatic cancer use per FDA and literature support OR (b) inadequate response/intolerance/FDA contraindication to ≥1 medium-potency topical corticosteroid for ≥2 weeks OR (c) medication history shows use of biologic immunomodulator for PN
• OR Diagnosis of moderate-to-severe atopic dermatitis (AD) with ONE of: ≥10% BSA involvement OR difficult-to-treat body sites OR EASI ≥16 OR IGA ≥3
• AND inadequate response/intolerance/FDA contraindication to ≥1 medium-potency topical corticosteroid for ≥4 weeks AND inadequate response/intolerance/FDA contraindication to ≥1 topical calcineurin inhibitor for ≥6 weeks
• OR medication history shows use of biologic immunomodulator for AD
• Patient’s age is within FDA labeling or supported for the requested indication
• Patient will continue topical emollients/good skin care with Nemluvio
• AND will continue or has appropriately tapered topical corticosteroid or calcineurin inhibitor therapy unless intolerant/contraindicated
• Prescriber is a dermatologist/allergist/immunologist or has consulted with one
• Requested agent not used with another immunomodulatory agent unless combination supported by labeling and evidence
• Patient has no FDA-labeled contraindications
• Special criteria for BCBS MT fully insured or MT HIM members under age 18 years: indication supported by ≥2 peer-reviewed articles showing safety and efficacy for indication and age bracket
• Special criteria for Ohio fully insured or HIM Shop (SG) members: no contraindications AND indication supported by FDA labeling, compendia, or ≥2 peer-reviewed articles showing safety and efficacy

Reauthorization criteria

• If treated ≥16 consecutive weeks, atopic dermatitis has sufficiently improved AND concurrent topical therapies have been tapered/discontinued unless intolerant/contraindicated
• Requested dose may continue at 30 mg every 8 weeks or every 4 weeks if clear/almost clear skin not yet achieved or supported by evidence

Approval duration

12 months (BCBSIL/MT/TX), or 6 months for AD/PN for other plans; 12 months for other indications