VYVGART (efgartigimod alfa-fcab)

VYVGART (efgartigimod alfa-fcab)

Office-Administration – Intravenous

Diagnosis considered for coverage:

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:

• Dose does not exceed 10 mg/kg (max: 1200 mg per infusion for patients weighting > 120 kg) intravenous infusion given over one-hour once weekly for 4 weeks; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with a neurologist; AND
• Documented diagnosis of generalized myasthenia gravis (gMG) that is mild to severe weakness in severity affecting muscles other than ocular muscles; AND
• Documentation of a positive serologic test confirming the presence of acetylcholine receptor antibodies (AchR-Ab+); AND
• Prior to administration, patient must be on a stable dose of at least ONE of the following therapies for the treatment of gMG:
  • Acetylcholinesterase (AChE) inhibitors (e.g., pyridostigmine)
  • Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone)
  • Non-steroidal immunosuppressive therapies (NSISTs) (e.g., azathioprine, cyclosporine, mycophenolate mofetil, methotrexate and tacrolimus)

Reauthorization Criteria:

For diagnosis of Generalized Myasthenia Gravis:

• Dose does not exceed 10 mg/kg (max: 1200 mg per infusion for patients weighting > 120 kg) intravenous infusion given over one hour once weekly for 4 weeks; AND
• Documentation of positive clinical response to therapy

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

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: 

• Dosage and administration
  • Recommended dosing:
    • For patients < 120 kg: 10 mg/kg IV over one hour once weekly for 4 weeks
    • For patients ≥ 120 kg: 1,200 mg per infusion over one hour once weekly for 4 weeks
  • Administer subsequent treatment cycles based on clinical evaluation; the safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatment cycle has not been established
  • Must be diluted with 0.9% Sodium Chloride Injection, USP prior to administration
  • Administer as an intravenous infusion over one hour via a 0.2-micron in-line filter
• Warnings and precautions:
  • Infections: delay administration of Vyvgart to patients with an active infection.  Monitor for signs and symptoms of infection in patients treated with Vyvgart.
• Drug interactions:
  • Monitor for reduced effectiveness of medications that bind to the human neonatal FC receptor.  When concomitant long-term use of such medications is essential for patient care, consider discontinuing Vyvgart and using alternative therapies. 

Policy Updates:

• 5/17/2022 – New policy approved by P&T

References:

1. Vyvgart [prescribing information]. Boston, MA: Argenx US, Inc. December 2021.