Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
The use of efgartigimod (Vyvgart) may be considered medically necessary when ALL of the following criteria are met:
- ONE of the following:
- The individual has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
- The individual has a positive serological test for anti-AChR antibodies (lab test must be submitted); and
- The individual has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II-IV; and
- The individual has a MG-Activities of Daily Living total score of greater than or equal to 5; and
- ONE of the following:
- The prescriber has assessed the individual’s current medications and discontinued any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides); or
- The prescriber has provided clinical rationale indicating that discontinuation of the offending agent is not clinically appropriate; and
- ONE of the following:
- The individual has tried and had an inadequate response to pyridostigmine; or
- The individual has an intolerance or hypersensitivity to pyridostigmine; or
- The individual has an FDA labeled contraindication to pyridostigmine; and
- ONE of the following:
- The individual has tried and had an inadequate response to at least 2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) for at least a 1-year total trial (either combination or monotherapy); or
- The individual has an intolerance or hypersensitivity to at least 2 immunosuppressive therapies; or
- The individual has tried and had an inadequate response to treatment to at least 1 immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) for at least a 1-year total trial AND ONE of the following:
- The individual required chronic intravenous immunoglobulin (IVIG) (i.e., at least every 3 months over 12 months without symptom control); or
- The individual required chronic plasmapheresis/plasma exchange (i.e., at least every 3 months over 12 months without symptom control); or
- The individual has an intolerance or hypersensitivity to at least 1 immunosuppressant AND plasmapheresis/plasma exchange; or
- The individual has an FDA labeled contraindication to ALL immunosuppressive therapies and plasmapheresis/plasma exchange; or
- The individual has another FDA approved indication for efgartigimod (Vyvgart); and
- ONE of the following:
- The individual’s age is within FDA labeling for the requested indication for efgartigimod (Vyvgart); or
- The prescriber has provided information in support of using efgartigimod (Vyvgart) for the individual’s age for the requested indication; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using efgartigimod (Vyvgart) in combination with Soliris (eculizumab) for the requested indication; and
- The individual does NOT have any FDA labeled contraindications to efgartigimod (Vyvgart).
Initial Length of Approval: 3 months
The use of efgartigimod (Vyvgart) for any other indication is considered experimental/investigational and therefore non-covered due to the lack of scientific evidence to support efficacy and safety.
Procedure Codes
