Zilbrysq (zilucoplan sodium) — Blue Cross Blue Shield of Illinois

Initial criteria

• Diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
• - Positive serologic test for anti-AChR antibodies (medical records required)
• - MGFA classification class II–IVb
• - MG-Activities of Daily Living total score ≥ 6
• - ONE of the following: (a) Medications known to exacerbate myasthenia gravis have been discontinued, OR (b) Discontinuation not clinically appropriate
• - ONE of the following: (a) BOTH of the following—(1) Diagnosis of stage 4 advanced, metastatic cancer being treated with the agent or for an associated condition and (2) Use consistent with evidence-based, FDA-approved best practices; OR (b) Patient has tried and had inadequate response to at least ONE conventional agent for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); OR (c) Intolerance or hypersensitivity to ONE such conventional agent; OR (d) FDA labeled contraindication to ALL such agents; OR (e) Required chronic IVIG; OR (f) Required chronic plasmapheresis/plasma exchange
• - ONE of the following: (a) BOTH of the following—(1) Diagnosis of stage 4 advanced, metastatic cancer being treated with or related to the requested agent and (2) Use supported by evidence-based data and FDA approval; OR (b) Currently treated and stable on the requested agent; OR (c) 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); OR (d) Those agents discontinued due to inefficacy, diminished effect, or adverse event; OR (e) Intolerance or hypersensitivity to those agents; OR (f) FDA labeled contraindication to ALL of those agents; OR (g) Those agents expected to be ineffective or unsafe based on clinical characteristics; OR (h) Those agents not in the best interest of the patient; OR (i) Tried another drug in the same pharmacologic class or mechanism discontinued for lack of efficacy or adverse event
• - The prescriber is a specialist (e.g., neurologist) or has consulted a specialist
• - The agent will NOT be used in combination with Rystiggo, Soliris, Ultomiris, Vyvgart, or Vyvgart Hytrulo
• - The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL/BCBSMT/BCBSTX); 3 months (all others); 12 months for Ohio Fully Insured or HIM Shop plans