Zilbrysq — Blue Cross Blue Shield of Texas

Preferred products

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

Initial criteria

• Patient has 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: medications known to exacerbate MG discontinued OR discontinuation not clinically appropriate
• - ONE of the following: patient has stage IV advanced, metastatic cancer (or related condition) for which requested agent is used appropriately per FDA/evidence-based literature OR patient has tried and had inadequate response to ≥1 conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR patient has intolerance/hypersensitivity to ≥1 conventional agent OR patient has an FDA labeled contraindication to ALL conventional agents OR patient required chronic IVIG OR patient required chronic plasmapheresis/plasma exchange
• - ONE of the following: patient has stage IV metastatic cancer and use is consistent with evidence OR patient currently on and stable with requested agent OR patient has tried and failed Ultomiris (ravulizumab-cwvz), Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), or Epysqli (eculizumab-aagh) OR discontinued such agents due to lack of efficacy/adverse event OR has intolerance/hypersensitivity OR has FDA labeled contraindication to ALL of those agents OR expected ineffectiveness/adherence barrier/comorbidity risk/adverse reaction OR those agents not in patient’s best interest based on medical necessity OR tried another drug in same class or mechanism and discontinued due to inefficacy/adverse event
• - If requesting for other FDA labeled indication: patient age is within labeling OR supported for off-label use by evidence
• - Prescriber is specialist (e.g., neurologist) or has consulted one
• - Patient will NOT use in combination with Rystiggo, Soliris (eculizumab), Ultomiris, Vyvgart, or Vyvgart Hytrulo
• - Patient has no FDA labeled contraindications to Zilbrysq

Approval duration

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