Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) — Highmark

Initial criteria

• age ≥ 18 years
• diagnosis of generalized myasthenia gravis (gMG) (ICD-10: G70)
• anti-acetylcholine receptor (AChR) antibody positive (Ab+)
• meets MGFA Clinical Classification Class II to IV
• Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) total score ≥ 5 at initiation
• therapeutic failure, intolerance, or contraindication to at least two agents from two different classes (acetylcholinesterase inhibitors, systemic steroids, non-steroidal immunosuppressants such as azathioprine, cyclosporine, methotrexate, tacrolimus, mycophenolate)
• not concurrently receiving a complement inhibitor (for example, Soliris, Ultomiris, Zilbrysq, or IVIG) within 4 weeks of starting Vyvgart Hytrulo

Reauthorization criteria

• improvement in signs and symptoms of gMG (speech, swallowing, mobility, and/or respiratory function)
• OR decrease in the number of exacerbations of gMG

Approval duration

initial: 6 months; reauthorization: 12 months