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zilucoplan sodium — Blue Cross Blue Shield of Montana

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

  • Diagnosis of generalized Myasthenia Gravis (gMG) with ALL of the following:
  • - Positive serological test for anti-AChR antibodies (medical records required)
  • - MGFA clinical classification class II–IVb
  • - MG-Activities of Daily Living total score ≥ 6
  • - ONE of the following regarding current medications: medications known to exacerbate myasthenia gravis have been discontinued OR discontinuation is not clinically appropriate
  • - ONE of the following treatments has been tried or is contraindicated:
  • A. Tried and had inadequate response to ≥1 conventional agent for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • B. Intolerance or hypersensitivity to ≥1 conventional agent
  • C. FDA-labeled contraindication to ALL conventional agents
  • D. Required chronic IVIG or plasmapheresis/plasma exchange
  • - ONE of the following step criteria (may use either prior treatment or contraindication reasoning):
  • A. Currently treated and stable on requested agent (chart notes required)
  • B. Tried and inadequate response to Ultomiris (ravulizumab-cwvz), Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), or Epysqli (eculizumab-aagh)
  • C. Discontinued listed agents due to lack of efficacy/effectiveness, diminished effect, or adverse event (chart notes required)
  • D. Intolerance or hypersensitivity to the above agents (chart notes required)
  • E. FDA-labeled contraindication to ALL of the above agents (chart notes required)
  • F. Expected ineffectiveness, or would cause barrier to adherence, worsen comorbidity, reduce ability to perform activities, or cause adverse reaction/harm (chart notes required)
  • G. Not in the best interest of the patient based on medical necessity (chart notes required)
  • H. Tried another drug in same pharmacologic class or with same mechanism of action as above that was discontinued due to lack of efficacy or adverse event (chart notes required)
  • Prescriber is a specialist in the area of diagnosis (e.g., neurologist), or has consulted with a specialist
  • Requested agent will NOT be used in combination with Rystiggo, Soliris, Ultomiris, Vyvgart, or Vyvgart Hytrulo
  • Patient has no FDA-labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); 3 months (all other plans)