Zilbrysq (zilucoplan) — CareFirst (Caremark)

Initial criteria

• Anti-acetylcholine receptor (AChR) antibody positive
• Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
• MG activities of daily living (MG-ADL) total score ≥ 5
• AND one of the following:
• Member has had an inadequate response or intolerable adverse event to at least two immunosuppressive therapies over ≥ 12 months (e.g., azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, tacrolimus)
• OR member has had an inadequate response or intolerable adverse event to at least one immunosuppressive therapy and intravenous immunoglobulin (IVIG) over ≥ 12 months
• OR member has a documented clinical reason to avoid therapy with immunosuppressive agents and IVIG
• Medication will not be used in combination with another complement inhibitor (e.g., Soliris, Ultomiris) or neonatal Fc receptor blocker (e.g., Vyvgart, Vyvgart Hytrulo, Rystiggo)

Reauthorization criteria

• No evidence of unacceptable toxicity or disease progression while on current regimen
• Member demonstrates a positive response to therapy (e.g., improvement in MG-ADL score, MG Manual Muscle Test (MMT), or MG Composite)

Approval duration

Initial: 6 months; Reauthorization: 12 months