efgartigimod alfa-hyaluronidase-qvfc — Blue Cross Blue Shield of New Mexico

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. Myasthenia Gravis Foundation of America (MGFA) clinical classification class II–IVb
• 3. MG-Activities of Daily Living total score ≥ 5
• 4. ONE of the following:
• A. Current medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, PD-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides) discontinued OR
• B. Discontinuation of the offending agent is NOT clinically appropriate
• 5. ONE of the following:
• A. Metastatic cancer criteria (stage IV cancer related use consistent with best practices and FDA-approved) 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 listed above OR
• D. FDA labeled contraindication to ALL conventional agents listed above OR
• E. Required chronic intravenous immunoglobulin (IVIG) OR
• F. Required chronic plasmapheresis/plasma exchange
• 6. Will NOT use with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Zilbrysq (zilucoplan), or Imaavy (nipocalimab-aahu)
• B. OR diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) AND ALL of the following:
• 1. Disease course is progressive or relapsing/remitting for ≥2 months
• 2. Progressive or relapsing motor sensory impairment of more than one limb
• 3. Electrodiagnostic findings indicating demyelination (at least one of: prolonged distal motor latency, reduced conduction velocity, prolonged or absent F-wave, partial conduction block, abnormal temporal dispersion, or distal CMAP duration increase per criteria)
• 4. ONE of the following:
• A. Tried and had inadequate response to at least 3-month trial of ≥1 standard of care therapy (corticosteroids, immunoglobulins, plasma exchange) OR
• B. Intolerance or hypersensitivity to ≥1 standard of care therapy listed above OR
• C. FDA labeled contraindication to ALL standard of care therapies listed above
• C. OR patient has another FDA labeled indication for the requested agent and route of administration
• AND
• 2. If FDA labeled indication: ONE of the following:
• A. Patient's age is within FDA labeling for that indication OR
• B. There is support for using agent for the patient's age for that indication
• 3. Prescriber is a specialist in the disease area (e.g., neurologist) or has consulted with one
• 4. Patient has no FDA labeled contraindications to the requested agent
• Special regional provisions:
• • BCBS MT Fully Insured or MT HIM member <18 years: must have indication supported by TWO major peer-reviewed journal articles, with age-appropriate safety and efficacy evidence. No FDA-labeled contraindications.
• • Ohio Fully Insured/HIM Shop member: no FDA contraindications AND either FDA-labeled indication, or indication supported in compendia (DrugDex level 1,2A,2B or AHFS-DI supportive), or TWO major peer-reviewed journal articles supporting use.

Reauthorization criteria

• 1. Patient previously approved for the requested agent through plan’s PA process
• 2. Patient has had clinical benefit with requested agent
• 3. Prescriber is a specialist in the disease area (e.g., neurologist) or has consulted with one
• 4. Will NOT use with Rystiggo (rozanolixizumab-noli), Soliris (eculizumab), Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Ultomiris (ravulizumab-cwvz), Zilbrysq (zilucoplan), or Imaavy (nipocalimab-aahu)
• 5. No FDA labeled contraindications to the requested agent

Approval duration

12 months (some plans 6 months for initial)