Pharmacy Prior Authorization Criteria

Zilbrysq (zilucoplan injection)

Indications for Prior Authorization

Zilbrysq (zilucoplan injection)

• For diagnosis of Generalized myasthenia gravis (gMG)
  Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

Criteria

Zilbrysq

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of generalized myasthenia gravis (gMG)
AND
• Patient is anti-acetylcholine receptor (AChR) antibody positive
AND
• One of the following: [2, 3]
• Trial and failure, contraindication, or intolerance to two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Chronic plasmapheresis or plasma exchange (PE)
• Intravenous immunoglobulin (IVIG)
AND
• Both of the following:
• Trial and failure, contraindication, or intolerance to one of the following:
• Soliris
• Ultomiris
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Rystiggo
• Vyvgart
• Vyvgart Hytrulo
AND
• Prescribed by or in consultation with a neurologist

Zilbrysq

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy
AND
• Both of the following:
• Trial and failure, contraindication, or intolerance to one of the following:
• Soliris
• Ultomiris
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Rystiggo
• Vyvgart
• Vyvgart Hytrulo

P & T Revisions

2025-03-06, 2024-03-12

References

1. Zilbrysq Prescribing Information. UCB, Inc. Smyrna, GA. April 2024.
2. Howard JF Jr, Utsugisawa K, Benatar M, et al. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017 Dec;16(12):976-986.
3. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25.

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Revision History

• 2025-03-06: 2025 UM Annual Review. No criteria changes. Background updates
• 2024-03-12: New Program for Zilbrysq

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