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Nemluvio — Blue Cross Blue Shield of Illinois

moderate-to-severe atopic dermatitis (AD)

Initial criteria

  • ALL of the following:
  • 1. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. Diagnosis of prurigo nodularis (PN) and BOTH of the following:
  • • Presence of ≥ 20 firm, nodular lesions AND
  • • Pruritus lasting ≥ 6 weeks AND
  • • History and/or signs of repeated scratching, picking, or rubbing AND
  • 2. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • • Patient diagnosed with stage four advanced metastatic cancer and requested agent used to treat the cancer OR
  • • Patient diagnosed with stage four advanced metastatic cancer and requested agent used to treat associated condition related to stage four advanced metastatic cancer [chart notes required] AND
  • 2. Use of requested agent is consistent with best practices, supported by peer-reviewed evidence, and FDA approved OR
  • B. ONE of the following:
  • • Tried and had an inadequate response to ≥1 medium-potency topical corticosteroid used to treat PN for ≥2 weeks OR
  • • Intolerance or hypersensitivity to ≥1 medium-potency topical corticosteroid used to treat PN OR
  • • FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in treatment of PN OR
  • C. Medication history indicates use of another biologic immunomodulator agent FDA-labeled or compendia-supported for PN OR
  • B. Diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
  • 1. ONE of the following disease severity criteria:
  • • ≥10% body surface area involvement OR
  • • Involvement of difficult-to-treat areas (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds) OR
  • • EASI score ≥16 OR
  • • IGA score ≥3 AND
  • 2. ONE of the following treatment history criteria:
  • A. BOTH of the following:
  • 1. ONE of the following topical corticosteroid criteria:
  • • Tried and inadequate response to ≥1 medium-potency topical corticosteroid for ≥4 weeks OR
  • • Intolerance or hypersensitivity to ≥1 medium-potency topical corticosteroid OR
  • • FDA labeled contraindication to ALL medium-, high-, and super-potency corticosteroids AND
  • 2. ONE of the following topical calcineurin inhibitor criteria:
  • • Tried and inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) for ≥6 weeks OR
  • • Intolerance or hypersensitivity to ≥1 topical calcineurin inhibitor OR
  • • FDA labeled contraindication to ALL topical calcineurin inhibitors OR
  • B. Medication history indicates use of another biologic immunomodulator agent FDA-labeled or compendia-supported for AD OR
  • C. Patient has another FDA labeled indication for the requested agent AND meets age criteria per FDA labeling OR support for use by age in label or literature OR
  • C. Patient has another indication supported in compendia for requested agent AND route of administration
  • 2. For patients with AD, ALL of the following:
  • A. BOTH of the following:
  • • Currently treated with topical emollients and practicing good skin care AND
  • • Will continue topical emollients and good skin care in combination with requested agent AND
  • B. ONE of the following:
  • 1. BOTH of the following:
  • • Currently treated with low-potency topical corticosteroid OR topical calcineurin inhibitor AND
  • • Will continue topical corticosteroid or topical calcineurin inhibitor therapy in combination with requested agent OR
  • 2. Treated with requested agent ≥16 consecutive weeks AND BOTH of the following:
  • • Atopic dermatitis has sufficiently improved AND
  • • Concurrent topical therapies tapered and discontinued OR
  • 3. Intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors AND
  • C. ONE of the following regarding therapy duration:
  • • Initiating therapy with requested agent OR
  • • Treated <16 consecutive weeks OR
  • • Treated ≥16 consecutive weeks AND:
  • – Requested dose is 30 mg every 8 weeks OR
  • – Requested dose is 30 mg every 4 weeks AND:
  • ‣ Patient has NOT achieved clear or almost clear skin OR
  • ‣ Support for continued therapy at 30 mg every 4 weeks exists AND
  • 3. Prescriber is specialist (allergist, dermatologist, immunologist) or has consulted one AND
  • 4. ONE of the following regarding concomitant use:
  • • Patient will NOT use with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
  • • If used concomitantly, BOTH of the following:
  • – Prescribing information does NOT limit such use AND
  • – Support for combination therapy provided (clinical trials or guidelines) AND
  • 5. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

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