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DrugVyvgart® (efgartigimod alfa-fcab) [argenx US]

October 2022

Therapeutic area - Immunomodulators, Miscellaneous

Initial approval criteria

  • Patient is at least 18 years of age AND
  • Patient has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease AND
  • Patient has a positive serologic test for anti-acetylcholine receptor (AChR) antibodies AND
  • Patient has a baseline immunoglobulin G (IgG) level of ≥ 6 g/L (600 mg/dL) AND
  • Patient does NOT have an active infection, including clinically important localized infections AND
  • Patient had an inadequate response after a minimum 1-year trial 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
  • Efgartigimod will NOT be used in combination with other immunomodulatory biologic therapies (e.g., rituximab [Rituxan®, biosimilars], eculizumab [Soliris®]) AND
  • Live-attenuated or live vaccines will NOT be administered during efgartigimod treatment AND
  • Patient will avoid or use with caution medications known to worsen or exacerbate symptoms of MG (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine) AND
  • For patients with thymomas OR non-thymomatous patients who are ≤ 50 years of age, patient has had a thymectomy AND
  • Physician has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., including, but not limited to, the Quantitative Myasthenia Gravis [QMG] score) AND
  • Patient has a baseline MG-Activities of Daily Living (MG-ADL) total score of ≥ 5
  • Initial approval is for 3 months

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient must have disease improvement as indicated by a reduction in MG-ADL total score of ≥ 2-points from baseline that is sustained for ≥ 4-weeks* AND
    • *May substitute an improvement of ≥ 3-points from baseline in the Quantitative Myasthenia Gravis (QMG) total score sustained for ≥ 4-weeks, if available
  • Patient experiences improvement in muscle strength testing with fatigue maneuvers as evidenced on neurologic examination when compared to baseline AND
  • Patient requires continuous treatment, after an initial beneficial response, due to new or worsening disease activity (Note: a minimum of 50 days must have elapsed from the start of the previous treatment cycle)
  • Patient does not experience unacceptable toxicity from the drug.  Examples of unacceptable toxicity include infection, severe hypersensitivity reactions, etc.
  • Renewal approval is for 6 months

Quantity limits

  • 3 vials (1,200 mg) per week for 4 doses per 50 days

Billing for Vyvgart

Vyvgart must be billed as a medical claim.


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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