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 at least ONE agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
- The individual has an intolerance or hypersensitivity to ONE agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
- The individual has an FDA labeled contraindication to ALL agents used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide; or
- 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 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 Eculizumab (Soliris) for the requested indication; and
- The individual does NOT have any FDA labeled contraindications to efgartigimod (Vyvgart).
Initial Length of Approval: 6 months
Efgartigmod alfa-fcab (Vyvgart) not meeting the criteria as listed in this policy is considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
