ZILBRYSQ (zilucoplan)

ZILBRYSQ (zilucoplan)

Office-Administration – subcutaneous (SC) injection

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of generalized myasthenia gravis (gMG):

• Diagnosis of generalized myasthenia gravis (gMG); AND
• Patient is anti-acetylcholine receptor (AChR) antibody positive; AND
• One of the following:
  • 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

Reauthorization Criteria:

For diagnosis of generalized myasthenia gravis (gMG):

• 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

Coverage Duration:

• Initial: 12 months
• Reauthorization: 12 months

Dosing:

For diagnosis of generalized myasthenia gravis (gMG):

• The recommended dosage of Zilbrysq is given once daily as a subcutaneous injection and is dependent on actual body weight:
  • Less than 56 kg: 16.6 mg
  • 56 kg to less than 77 kg: 23 mg
  • 77 kg and above: 32.4 mg

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Zilbrysq is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject Zilbrysq after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of Zilbrysq according to the "Instructions for Use"

Policy Updates:

• 09/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 08/20/2024)

References:

1. Zilbrysq Prescribing Information. UCB, Inc. Smyrna, GA. October 2023.
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.