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

Initial criteria

• age ≥ 18 years
• diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) (ICD-10: G61.81)
• progressive symptoms for at least 2 months
• progressive or relapsing motor sensory dysfunction of more than one limb or peripheral nerve nature, developing over at least 2 months
• hypo- or areflexia (usually involving all four limbs)
• nerve conduction studies strongly supportive of demyelination meeting one of: motor distal latency prolongation in ≥ 2 nerves, reduction of motor conduction velocity in ≥ 2 nerves, prolongation of F-wave latency in ≥ 2 nerves, absence of F-waves in ≥ 2 nerves, motor conduction block in ≥ 1 nerve, abnormal temporal dispersion in ≥ 2 nerves, distal CMAP duration prolongation in ≥ 1 nerve
• therapeutic failure, intolerance, or contraindication to one of: systemic corticosteroids or immune globulin (IVIG or subcutaneous immunoglobulin)

Reauthorization criteria

• improvement in functional ability or strength from baseline

Approval duration

initial and reauthorization: 12 months