Nemluvio (nemolizumab-ilto) — Blue Cross Blue Shield of New Mexico

Initial criteria

• Diagnosis of prurigo nodularis (PN) AND ALL of the following features: ≥20 firm nodular lesions AND pruritus lasting ≥6 weeks AND history and/or signs of repeated scratching, picking, or rubbing
• AND ONE of the following for PN: (A) patient has stage IV advanced, metastatic cancer and requested agent used to treat the cancer or an associated condition AND use is consistent with best practices and FDA approved for that use OR (B) patient has tried and had inadequate response to ≥1 medium‑potency topical corticosteroid after ≥2 weeks OR intolerance/hypersensitivity to ≥1 medium‑potency topical corticosteroid OR FDA labeled contraindication to ALL medium-, high-, and super‑potency topical corticosteroids OR patient’s medication history indicates use of another biologic immunomodulator FDA labeled or compendia supported for PN
• OR diagnosis of moderate‑to‑severe atopic dermatitis (AD) AND BOTH of the following: (1) ONE of: ≥10% BSA involvement OR difficult‑to‑treat body sites OR EASI ≥16 OR IGA ≥3 AND (2) ONE of: (A) BOTH of: (1) tried and had inadequate response to ≥1 medium‑potency topical corticosteroid after ≥4 weeks OR intolerance/hypersensitivity/contraindication AND (2) tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) after ≥6 weeks OR intolerance/hypersensitivity/contraindication OR (B) medication history indicates use of another biologic immunomodulator FDA labeled or compendia-supported for AD
• If patient has FDA‑labeled indication: age within label OR supported use for age bracket
• If AD diagnosis: must be on topical emollients and good skin care AND will continue; AND either (1) currently using topical corticosteroid or calcineurin inhibitor and will continue OR (2) treated ≥16 weeks with Nemluvio with improved AD and topical therapies tapered OR (3) intolerance/hypersensitivity/contraindication to ALL topical corticosteroids and calcineurin inhibitors
• ONE of: initiating therapy OR treated <16 weeks OR treated ≥16 weeks AND (A) dose is 30 mg every 8 weeks OR (B) dose 30 mg every 4 weeks AND either not achieved clear/almost clear skin OR evidence supports continued therapy at 4‑week dose
• Prescriber is or has consulted with specialist (allergist, dermatologist, immunologist)
• NOT used with another immunomodulatory agent (e.g., TNF inhibitor, JAK inhibitor, IL‑4 inhibitor) OR combination supported and permitted by labeling and literature
• Patient has no FDA labeled contraindication to Nemluvio
• Compendia allowed: AHFS, DrugDex 1, 2a, 2b, or NCCN 1, 2a, 2b recommendation
• Special provisions: for BCBS MT fully insured/HIM members <18 years—criteria for two peer‑reviewed journal articles supporting safety/effectiveness for indication and age bracket; OR for Ohio fully insured/HIM Shop—criteria for FDA labeled, compendia, or published evidence in two peer‑reviewed journals

Approval duration

6 months (AD, PN); 12 months (all other indications)