Zilbrysq — Blue Cross Blue Shield of Oklahoma

Preferred products

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

Initial criteria

• 1. Patient has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
•   • Positive serological test for anti-AChR antibodies (medical records required)
•   • Myasthenia Gravis Foundation of America (MGFA) clinical classification class II–IVb
•   • MG-Activities of Daily Living total score ≥ 6
•   • Current medications have been assessed and any medications known to exacerbate myasthenia gravis have been discontinued OR discontinuation of the offending agent is not clinically appropriate
•   • ONE of the following applies:
•     – Patient has stage 4 advanced metastatic cancer and use of requested agent is consistent with best practices and FDA-approved use OR
•     – Patient has tried and had inadequate response to ≥1 conventional agent for myasthenia gravis (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR
•     – Patient has intolerance or hypersensitivity to one of these conventional agents OR
•     – Patient has FDA labeled contraindication to all conventional agents OR
•     – Patient required chronic IVIG OR plasmapheresis/plasma exchange
•   • ONE of the following for step therapy:
•     – Patient currently treated with and stable on requested agent OR
•     – Tried and inadequate response to one of the following: Ultomiris (ravulizumab-cwvz), Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), Epysqli (eculizumab-aagh) OR
•     – Discontinued one of the above due to lack of efficacy, diminished effect, or adverse event OR
•     – Intolerance or hypersensitivity to one of the above OR
•     – FDA labeled contraindication to ALL of the following: Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, Epysqli OR
•     – Any of the above agents expected to be ineffective, cause significant barrier to adherence, worsen comorbid condition, or cause harm (documentation required) OR
•     – Not in best interest of patient based on medical necessity (documentation required) OR
•     – Patient tried another drug in same pharmacologic class or mechanism which was discontinued for lack of efficacy or adverse event
•   • Prescriber is a specialist in neurology or has consulted a neurologist
•   • Requested agent will not be used with Rystiggo, Soliris, Ultomiris, Vyvgart, or Vyvgart Hytrulo
•   • No FDA labeled contraindications to requested agent

Approval duration

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