Zilbrysq (zilucoplan) — United Healthcare

generalized myasthenia gravis (gMG) in adult patients who are antiacetylcholine receptor (AChR) antibody positive

Initial criteria

Submission of medical records (e.g., chart notes, laboratory values, etc.) confirming ALL of the following:
(1) Diagnosis of generalized myasthenia gravis (gMG)
AND (2) Positive serologic test for anti-AChR antibodies
AND (3) Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV at initiation of therapy
AND (4) Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥ 6 at initiation of therapy
AND ONE of the following:
(a) History of failure of at least two immunosuppressive agents over at least 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, etc.)
OR (b) History of failure of at least one immunosuppressive therapy AND required four or more courses of plasmapheresis/plasma exchanges and/or intravenous immune globulin over at least 12 months without symptom control
AND Patient is NOT receiving Zilbrysq in combination with another complement inhibitor [e.g., Soliris (eculizumab), Ultomiris (ravulizumab-cwvz)] or a neonatal Fc receptor blocker [e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)]
AND Prescribed by, or in consultation with, a neurologist

Submission of medical records (e.g., chart notes, laboratory tests) demonstrating ALL of the following:
(1) Improvement and/or maintenance of at least a 2-point improvement (reduction in score) in MG-ADL from pre-treatment baseline
(2) Reduction in signs and symptoms of myasthenia gravis
(3) Maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (IST) prior to starting Zilbrysq; add-on, dose escalation of IST, or additional rescue therapy indicates treatment failure
AND Patient is NOT receiving Zilbrysq in combination with another complement inhibitor [e.g., Soliris (eculizumab), Ultomiris (ravulizumab-cwvz)] or a neonatal Fc receptor blocker [e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)]
AND Prescribed by, or in consultation with, a neurologist

12 months