zilucoplan sodium — Blue Cross Blue Shield of Kansas

Initial criteria

• 1. ONE of the following:
• A. The patient has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
• 1. The patient has a positive serological test for anti-AChR antibodies (medical records required) AND
• 2. The patient has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II-IVb AND
• 3. The patient has a MG-Activities of Daily Living total score ≥ 6 AND
• 4. ONE of the following:
• A. The patient’s current medications have been assessed and any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides) have been discontinued OR
• B. Discontinuation of the offending agent is NOT clinically appropriate AND
• 5. ONE of the following:
• A. The patient has tried and had an inadequate response to ≥ 1 conventional agent used for the treatment of myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR
• B. The patient has an intolerance or hypersensitivity to ≥ 1 conventional agent used for the treatment of myasthenia gravis OR
• C. The patient has an FDA labeled contraindication to ALL conventional agents used for the treatment of myasthenia gravis OR
• D. The patient required chronic intravenous immunoglobulin (IVIG) OR
• E. The patient required chronic plasmapheresis/plasma exchange AND
• 6. ONE of the following:
• A. The patient has tried and had an inadequate response to Ultomiris (ravulizumab-cwvz), Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), or Epysqli (eculizumab-aagh) OR
• B. The patient has an intolerance or hypersensitivity to Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, or Epysqli OR
• C. The patient has an FDA labeled contraindication to ALL of the following: Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, Epysqli OR
• B. The patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the patient has an FDA approved indication, then ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist), or has consulted with a specialist AND
• 4. The patient will NOT be using the requested agent in combination with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Vyvgart (efgartigimod), or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the requested indication AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist), or has consulted with a specialist AND
• 4. The patient will NOT be using the requested agent in combination with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Vyvgart (efgartigimod), or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the requested indication AND
• 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 3 months; renewal 12 months