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Zilbrysq (zilucoplan) — Blue Cross Blue Shield of Alabama

generalized Myasthenia Gravis (gMG)

Preferred products

  • Ultomiris (ravulizumab-cwvz)
  • Rystiggo (rozanolixizumab-noli)
  • Vyvgart (efgartigimod)
  • Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
  • Epysqli (eculizumab-aagh)

Initial criteria

  • ONE of the following: The patient has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
  • - The patient has a positive serological test for anti-AChR antibodies (medical records required)
  • - The patient has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II–IVb
  • - The patient has a MG-Activities of Daily Living total score ≥ 6
  • AND ONE of the following:
  • - The patient’s current medications have been assessed and any medications known to exacerbate myasthenia gravis have been discontinued OR discontinuation is not clinically appropriate
  • AND ONE of the following:
  • - The patient has tried and had an inadequate response to ≥ 1 conventional agent used for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • - OR the patient has intolerance or hypersensitivity to ≥ 1 conventional agent
  • - OR the patient has an FDA-labeled contraindication to ALL conventional agents
  • - OR the patient required chronic intravenous immunoglobulin (IVIG)
  • - OR the patient required chronic plasmapheresis/plasma exchange
  • AND if preferred agents exist, ONE of the following:
  • - The patient has tried and had an inadequate response to Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, or Epysqli
  • - OR intolerance or hypersensitivity to any of these agents
  • - OR FDA labeled contraindication to ALL of Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, and Epysqli
  • - OR the patient has another FDA labeled indication for the requested agent and route of administration
  • AND if the patient has an FDA approved indication, ONE of the following:
  • - The patient’s age is within FDA labeling OR there is supportive evidence for use at that age
  • AND the prescriber is a neurologist or has consulted one
  • AND the patient will NOT use Zilbrysq in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Vyvgart, or Vyvgart Hytrulo for the same indication
  • AND the patient has no FDA labeled contraindications to Zilbrysq

Reauthorization criteria

  • ALL of the following:
  • - The patient was previously approved for the requested agent through the plan’s Prior Authorization process
  • - The patient has had clinical benefit with the requested agent
  • - The prescriber is a neurologist or has consulted one
  • - The patient will NOT use the requested agent in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Vyvgart, or Vyvgart Hytrulo for the same indication
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 3 months; renewal 12 months