nemolizumab-ilto — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Patient has a diagnosis of prurigo nodularis (PN) AND ALL of the following: presence of ≥20 firm nodular lesions; pruritus lasting ≥6 weeks; history/signs of repeated scratching, picking, or rubbing
• AND ONE of the following for PN: (a) patient has tried and had inadequate response to ≥1 medium-potency topical corticosteroid with ≥2 weeks of therapy OR (b) intolerance/hypersensitivity to ≥1 such corticosteroid OR (c) has FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids OR (d) medication history indicates use of another biologic immunomodulator agent FDA labeled or compendia-supported for PN
• OR patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following: (a) ONE of the following—(1) ≥10% body surface area involvement OR (2) involvement of difficult-to-treat sites (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR (3) EASI ≥16 OR (4) IGA ≥3; AND (b) ONE of the following—(1) BOTH of: (i) has tried and had inadequate response to ≥1 medium-potency topical corticosteroid for ≥4 weeks, or intolerance/hypersensitivity/contraindication to all medium-high-super-potency corticosteroids, AND (ii) has tried and had inadequate response to ≥1 topical calcineurin inhibitor for ≥6 weeks, or intolerance/hypersensitivity/contraindication to all topical calcineurin inhibitors OR (2) medication history indicates use of another biologic immunomodulator agent FDA labeled or compendia-supported for AD
• Patient age is within or supported for FDA labeling for requested indication
• For AD: patient currently treated with topical emollients and practicing good skin care, and will continue these with requested agent
• For AD: either (a) continues topical corticosteroid or calcineurin inhibitor with agent, OR (b) has completed ≥16 weeks of treatment with requested agent with sufficient improvement and taper/discontinuation of other topicals, OR (c) has intolerance, hypersensitivity, or contraindication to all topical corticosteroids and calcineurin inhibitors
• Requested dose consistent with criteria: initial treatment, or maintenance 30 mg every 8 weeks, or 30 mg every 4 weeks if not clear/almost clear
• Prescriber is or has consulted a specialist (allergist, dermatologist, immunologist)
• Patient not using another immunomodulatory agent (TNF, JAK, IL-4 inhibitors), unless prescribing info and supportive data allow combination, with supporting clinical evidence
• Patient lacks FDA labeled contraindications to requested agent

Approval duration

6 months (AD, PN) or 12 months (other indications)