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Ebglyss (lebrikizumab-lbkz)Blue Cross Blue Shield of Kansas

other FDA labeled indication for requested agent and route of administration

Initial criteria

  • ONE of the following: (A) continuation of therapy (patient treated with requested agent within past 90 days or prescriber attests to same and risk if changed) OR (B) new start meeting full criteria
  • Diagnosis of moderate-to-severe atopic dermatitis AND BOTH of the following: (1) disease severity illustrated by ≥10% BSA involvement OR involvement of difficult-to-treat areas (hands, feet, face, neck, scalp, genitals/groin, folds) OR EASI ≥16 OR IGA ≥3; AND (2) inadequate response, intolerance, or contraindication to ≥1 medium-potency topical corticosteroid (≥4 weeks), AND inadequate response, intolerance, or contraindication to ≥1 topical calcineurin inhibitor (≥6 weeks)
  • Patient’s medication history may alternatively show use of another biologic immunomodulator agent FDA labeled or supported in compendia for AD
  • Patient’s age within labeling, or supported for requested indication, or indication supported in compendia
  • If diagnosis is moderate-to-severe AD, patient is currently treated with topical emollients and good skin care AND will continue those in combination with requested agent
  • If requested agent is Adbry for AD: ONE of the following applies – patient <18 years; initiating therapy; treated <16 weeks; or treated ≥16 weeks AND either (1) weight <100 kg with clear/almost clear skin and dose reduced to 300 mg every 4 weeks OR not clear/almost clear skin OR continuation support at 300 mg every 2 weeks, OR (2) weight ≥100 kg
  • If requested agent is Ebglyss for AD: patient weighs ≥40 kg
  • Prescriber is specialist (dermatologist, allergist, immunologist) or consulted with specialist
  • ONE of the following: (A) not used concomitantly with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) combination allowed only if labeling does not limit such combination AND support for combination use is provided
  • Patient does NOT have FDA labeled contraindications to requested agent

Reauthorization criteria

  • Previously approved for requested agent through plan’s prior authorization
  • Patient has had clinical benefit with requested agent
  • If AD: continue standard maintenance therapies (topical emollients, good skin care)
  • If Adbry for AD: meets same age/weight/duration and dosing adjustment logic as initial criteria
  • Prescriber is specialist or has consulted with specialist
  • Concomitant therapy rules same as initial criteria (no immunomodulatory unless supported and not prohibited by label)
  • Patient does NOT have FDA labeled contraindications to requested agent

Approval duration

initial 6 months; renewal 12 months