Vyvgart Hytrulo (efgartigimod alfa–hyaluronidase-qvfc) — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. Diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
• 1. Positive serological test for anti–AChR antibodies (medical records required)
• 2. MGFA clinical classification class II–IVb
• 3. MG-Activities of Daily Living total score ≥ 5
• 4. ONE of the following:
• A. Medications known to exacerbate myasthenia gravis have been discontinued OR
• B. Discontinuation of the offending agent is NOT clinically appropriate
• 5. ONE of the following:
• A. Use for stage IV advanced metastatic cancer or related condition consistent with best practices and FDA approval 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 (same list) OR
• D. FDA labeled contraindication to ALL conventional agents (same list) OR
• E. Required chronic intravenous immunoglobulin (IVIG) OR
• F. Required chronic plasmapheresis/plasma exchange
• 6. Patient will NOT use requested agent in combination with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Zilbrysq (zilucoplan), or Imaavy (nipocalimab-aahu)
• B. 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 of >1 limb
• 3. Electrodiagnostic findings of demyelination with ≥1 criteria (e.g., prolonged distal motor latency, reduced conduction velocity, prolonged/absent F-wave, conduction block, temporal dispersion, or distal CMAP duration increase in specified nerves)
• 4. ONE of the following:
• A. Tried and had inadequate response to ≥3-month trial of ≥1 standard of care (corticosteroids, immunoglobulins, plasma exchange) OR
• B. Intolerance or hypersensitivity to ≥1 standard of care therapy OR
• C. FDA labeled contraindication to ALL standard of care therapies
• C. Another FDA labeled indication for the requested agent and route of administration
• AND age within FDA label or supported for indication
• Prescriber is a specialist in the area of diagnosis (e.g., neurologist) or has consulted with one
• Patient has no FDA labeled contraindications to the requested agent
• BCBSIL/MT/TX: approval duration 12 months; other plans: 6 months
• Additional plan-specific criteria:
• 1. BCBS MT Fully Insured/HIM members <18 years, no contraindications, indication supported by ≥2 peer-reviewed major journal articles and age support in same—approved
• OR
• 2. Ohio fully insured/HIM Shop members with no contraindications and indication supported by FDA label, compendia, or ≥2 peer-reviewed articles deemed generally safe and effective

Reauthorization criteria

• 1. Previously approved for requested agent through plan’s prior authorization process
• 2. Demonstrated clinical benefit with requested agent
• 3. Prescriber is a specialist in area of diagnosis or consulted with one
• 4. Will NOT use in combination with Rystiggo, Soliris, Bkemv, Epysqli, Ultomiris, Zilbrysq, or Imaavy
• 5. No FDA labeled contraindications to requested agent

Approval duration

12 months