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Nemluvio — Blue Cross Blue Shield of Alabama

moderate-to-severe atopic dermatitis

Initial criteria

  • There is support for using the requested agent for the patient's age for the requested indication OR the patient has another indication supported in compendia for the requested agent and route of administration
  • If the patient has moderate-to-severe atopic dermatitis, then ALL of the following:
  • • The patient is currently treated with topical emollients and practicing good skin care AND will continue use of topical emollients and good skin care practices in combination with the requested agent
  • • ONE of the following:
  • – The patient is currently treated with at least a low-potency topical corticosteroid OR topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) AND will continue topical corticosteroid OR topical calcineurin inhibitor therapy in combination with the requested agent
  • – The patient has been treated with the requested agent for at least 16 consecutive weeks AND BOTH of the following: atopic dermatitis has sufficiently improved AND based on disease activity, concurrent topical therapies have been tapered/discontinued
  • – The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors
  • • ONE of the following dose situations: initiating therapy; treated less than 16 consecutive weeks; treated ≥16 weeks AND (requested dose 30 mg every 8 weeks OR 30 mg every 4 weeks if not achieved clear/almost clear skin OR support for continued therapy at 30 mg every 4 weeks)
  • The prescriber is a specialist (e.g., allergist, dermatologist, immunologist) or has consulted with one
  • ONE of the following regarding concomitant immunomodulatory therapy: NOT using with another immunomodulatory agent (e.g., TNF, JAK, IL‑4 inhibitors) OR if used in combination, prescribing information does not limit such use AND there is supporting evidence (clinical trials, phase III, or guidelines)
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s prior authorization process
  • The patient has had clinical benefit with the requested agent
  • If the patient has moderate-to-severe atopic dermatitis, then ALL of the following:
  • • The patient will continue standard maintenance therapies (e.g., topical emollients, good skin care) in combination with the requested agent
  • • ONE of the following: will continue topical corticosteroid OR calcineurin inhibitor therapy; has been treated at least 16 weeks with sufficient improvement and tapered concurrent therapy; or has an intolerance/hypersensitivity/FDA labeled contraindication to ALL topical corticosteroids and topical calcineurin inhibitors
  • • ONE of the following dose situations: initiating therapy; treated less than 16 weeks; treated ≥16 weeks AND (requested 30 mg every 8 weeks OR 30 mg every 4 weeks if not achieved clear/almost clear skin OR support for continued 30 mg every 4 weeks)
  • The prescriber is a specialist or has consulted with one
  • Concomitant immunomodulatory therapy rule as in initial criteria
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months for AD and PN; 12 months for other indications and reauthorization