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    Zilbrysq®

    Drug - Zilbrysq® (zilucopan) [UCB Inc.]

    January 2025

    Therapeutic Area - Immunomodulators, Miscellaneous

    Initial approval criteria:

    • Patient is at least 18 years of age; AND
    • Patient has a diagnosis of generalized myasthenia gravis (gMG) with a Myasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV; AND
    • Patient has a positive serologic test for anti-acetylcholine receptor (AChR) antibodies; AND
    • Prescriber has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., the Quantitative Myasthenia Gravis [QMG] score); AND
    • Patient has a baseline MG-Activities of Daily Living (MG-ADL) total score of ≥ 6; AND
      • Patient had an inadequate response after a minimum 1-year trial of concurrent use with ≥ 2 immunosuppressive therapies (e.g., corticosteroids plus an immunosuppressant such as azathioprine, cyclosporine, mycophenolate); OR
      • Patient required chronic treatment with plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy; AND
    • Prescriber is enrolled in the Zilbrysq Risk Evaluation and Mitigation Strategy (REMS) program; AND
    • Zilbrysq is prescribed by or in consultation with a neurologist; AND
    • Patient has completed or is up to date on meningococcal vaccination (for serogroups A, C, W, and Y [MenACWY], and serogroup B [MenB]) ≥ 2 weeks prior to administering the first dose (unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection) in compliance with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor; AND
    • Patient does NOT have an unresolved Neisseria meningitidis infection; AND
    • Patient has completed or is up to date on vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines; AND
    • Prescriber has obtained baseline amylase and lipase levels; AND
    • Zilbrysq will NOT be used in combination with other immunomodulatory biologic therapies (e.g., efgartigimod, eculizumab, pegcetacoplan, satralizumab, inebilizumab-cdon, ravulizumab-cwvz, rozanolixizumab-noli); AND
    • Patient will avoid or use caution with medications known to worsen or exacerbate symptoms of MG (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine); AND
    • Initial approval is for 3 months

    Renewal criteria

    • Patient must continue to meet the above criteria; AND
    • Patient has had an improvement (e.g., reduction) of ≥ 1-point from baseline in the MG-ADL total score (may substitute an improvement of ≥ 1-point from baseline in the QMG total score, if available); AND
    • Improvement in muscle strength testing with fatigue maneuvers as evidenced on neurologic examination when compared to baseline; AND
    • Patient has NOT experienced any treatment-restricting adverse effects (e.g., unresolved meningococcal infection; other infections, especially with encapsulated bacteria; pancreatitis or suspected pancreatitis); AND
    • Patient should be revaccinated in accordance with ACIP recommendations depending on the duration therapy.
    • Renewal approval is for 12 months

    Quantity limit

    • 28 single-dose prefilled syringes/28 days for any of the 3 product strengths (16.6 mg/0.416 mL, 23 mg/0.574 mL, 32.4 mg/0.81 mL)
    • Max dose 32.4 mg once daily for patients with an actual body weight ≥ 77 kg

    Questions?

    Provider Call Center (844) 575-7887

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