efgartigimod alfa-hyaluronidase-qvfc — Blue Cross Blue Shield of Illinois

Initial criteria

• The patient has a diagnosis of generalized myasthenia gravis (gMG) AND ALL of the following:
• • Positive serological test for anti-AChR antibodies (medical records required)
• • MGFA class II–IVb
• • MG-Activities of Daily Living total score ≥ 5
• • Medications known to exacerbate myasthenia gravis have been discontinued OR discontinuation is not clinically appropriate
• • ONE of the following: (a) The patient has stage 4 advanced/metastatic cancer and use is consistent with best practices; OR (b) Tried and had inadequate response to ≥1 conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); OR (c) Intolerance or hypersensitivity to ≥1 conventional agent; OR (d) Labeled contraindication to ALL conventional agents; OR (e) Required chronic IVIG; OR (f) Required chronic plasmapheresis/plasma exchange
• • The patient will NOT use the requested agent in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy
• OR The patient has a diagnosis of CIDP AND ALL of the following:
• • Disease course is progressive or relapsing-remitting ≥ 2 months
• • Progressive/relapsing motor sensory impairment ≥ 1 limb
• • Electrodiagnostic findings of demyelination with ≥1 listed criterion (e.g., prolonged distal motor latency, reduced conduction velocity, etc.)
• • ONE of the following: (a) Tried and inadequate response to ≥3-month trial of one standard therapy (corticosteroids, immunoglobulins, plasma exchange); OR (b) Intolerance/hypersensitivity to one standard therapy; OR (c) Labeled contraindication to all standard therapies
• OR The patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication: (a) Patient’s age is within FDA labeling OR (b) Supported for patient’s age
• Prescriber is a specialist in the patient’s diagnosis area or has consulted a specialist
• The patient has no FDA labeled contraindications to the requested agent
• Additional approval pathways for BCBS MT insured/HIM members < age 18 OR Ohio residents on fully insured or HIM Shop plans meeting literature or compendia support criteria

Reauthorization criteria

• Patient previously approved for the requested agent via plan’s PA process
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in the patient’s diagnosis area or has consulted with such a specialist
• The patient will NOT use the requested agent with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy
• The patient has no FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL, MT, TX); 6 months (other plans)