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Zilbrysq (zilucoplan sodium) — Blue Cross Blue Shield of New Mexico

other FDA labeled indication for the requested agent and route of administration

Preferred products

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

Initial criteria

  • Diagnosis of generalized Myasthenia Gravis (gMG) AND 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 medications known to exacerbate myasthenia gravis: medications discontinued OR discontinuation not clinically appropriate
  • • ONE of the following conventional treatment responses:
  • – Tried and had inadequate response to ≥1 conventional agent for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide)
  • – Intolerance or hypersensitivity to ≥1 conventional agent
  • – FDA labeled contraindication to ALL conventional agents
  • – Required chronic IVIG or plasmapheresis/plasma exchange
  • • ONE of the following regarding other gMG targeted agents:
  • – Currently treated and stable on Zilbrysq (chart notes required)
  • – Tried and had inadequate response to Ultomiris (ravulizumab-cwvz), Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), or Epysqli (eculizumab-aagh)
  • – Discontinued any of above agents due to lack of efficacy, diminished effect, or adverse event (chart notes required)
  • – Intolerance or hypersensitivity to any of above agents (chart notes required)
  • – FDA labeled contraindication to ALL of Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, and Epysqli
  • – Above agents expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease functional ability, or cause harm (chart notes required)
  • – Above agents not in the best interest of the patient based on medical necessity (chart notes required)
  • – Tried another drug in same pharmacologic class or mechanism and discontinued due to lack of efficacy or adverse event (chart notes required)
  • • Prescriber is (or has consulted with) a specialist in the diagnosis area (e.g., neurologist)
  • • Requested agent will not be used in combination with Rystiggo, Soliris, Ultomiris, Vyvgart, or Vyvgart Hytrulo for requested indication
  • • No FDA labeled contraindications to requested agent

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX) or 3 months (all other plans); Ohio Fully Insured or HIM Shop plans: 12 months