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Nemluvio (nemolizumab-ilto) — Blue Cross Blue Shield of Alabama

prurigo nodularis (PN)

Preferred products

  • Elidel (pimecrolimus)
  • Protopic (tacrolimus)

Initial criteria

  • ONE of the following:
  • - The requested agent is eligible for continuation of therapy AND ONE of the following:
  • • The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR BOTH of the following:
  • • ONE of the following indication requirements:
  • – The patient has a diagnosis of prurigo nodularis (PN) and BOTH of the following:
  • • The patient has ALL of the following features associated with PN:
  • – Presence of ≥ 20 firm, nodular lesions
  • – Pruritus that has lasted for at least 6 weeks
  • – History and/or signs of repeated scratching, picking, or rubbing
  • • ONE of the following treatment history criteria:
  • – Has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of PN after at least a 2-week duration of therapy
  • – Has an intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of PN
  • – Has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of PN
  • – The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of PN
  • – OR the patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
  • • ONE of the following disease severity criteria:
  • – The patient has at least 10% body surface area involvement
  • – The patient has involvement of body sites that are difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds)
  • – The patient has an Eczema Area and Severity Index (EASI) score ≥ 16
  • – The patient has an Investigator Global Assessment (IGA) score ≥ 3
  • • ONE of the following treatment history criteria:
  • – BOTH of the following:
  • ◦ ONE of the following for topical corticosteroids:
  • ▪ Has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of AD after at least a 4-week duration of therapy
  • ▪ Has an intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of AD
  • ▪ Has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of AD
  • ◦ ONE of the following for topical calcineurin inhibitors:
  • ▪ Has tried and had an inadequate response to ONE topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in the treatment of AD after at least a 6-week duration of therapy
  • ▪ Has an intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in the treatment of AD
  • ▪ Has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in the treatment of AD
  • – OR the patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AD
  • – OR the patient has another FDA labeled indication for the requested agent and route of administration
  • AND if the patient has an FDA labeled indication, then ONE of the following:
  • • The patient’s age is within FDA labeling for the requested indication for the requested agent