Vyvgart hytrulo — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Patient has a diagnosis of generalized myasthenia gravis (gMG) AND ALL of the following: (1) positive serological test for anti-AChR antibodies; (2) MGFA classification class II–IVb; (3) MG-ADL total score ≥ 5; (4) medications known to exacerbate myasthenia gravis discontinued or discontinuation not clinically appropriate; (5) ONE of: (A) treatment of stage IV metastatic cancer consistent with evidence-based, FDA-approved practices; OR (B) tried and inadequate response to ≥1 conventional myasthenia gravis agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); OR (C) intolerance or hypersensitivity to ≥1 conventional agent; OR (D) FDA labeled contraindication to ALL conventional agents; OR (E) required chronic IVIG; OR (F) required chronic plasmapheresis/plasma exchange; AND (6) NOT used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy.
• OR Patient has a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) AND ALL of the following: (1) disease course progressive or relapsing/remitting ≥ 2 months; (2) progressive or relapsing motor/sensory impairment in >1 limb; (3) electrodiagnostic findings indicating demyelination with ≥1 of: prolonged distal motor latency, reduced motor conduction velocity, prolonged or absent F-wave, partial conduction block, abnormal temporal dispersion, or distal CMAP duration increase across ≥2 nerves; (4) ONE of: (A) inadequate response to ≥3‑month trial of standard therapy (corticosteroids, immunoglobulins, plasma exchange); OR (B) intolerance/hypersensitivity to one standard therapy; OR (C) contraindication to all standard therapies.
• OR Patient has another FDA labeled indication for the requested agent and route of administration and meets age requirements per labeling or supported evidence.
• Prescriber is a specialist in area of patient’s diagnosis or has consulted with one.
• Patient does not have any FDA labeled contraindications to the requested agent.
• Additional approvals: (A) MT fully insured/HIM members <18 years with indication supported in ≥2 peer-reviewed medical journal articles for safety and efficacy within specified age bracket; OR (B) Ohio fully insured/HIM Shop members with either FDA labeled indication, compendia-supported indication, or ≥2 peer-reviewed journal articles supporting safe/effective off-label use.

Reauthorization criteria

• Patient previously approved for efgartigimod through plan PA process.
• Patient has had clinical benefit with treatment.
• Prescriber is specialist in area of diagnosis or has consulted with one.
• Agent not used in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy.
• Patient does not have any FDA labeled contraindications to the requested agent.

Approval duration

12 months