The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.
EFGARTIGIMOD ALFA-FCAB (VYVGART ™)
Efgartigimod alfa-fcab (Vyvgart) is considered medically necessary and, therefore, covered for the treatment of adult individuals with generalized myasthenia gravis (gMG) when all of the following criteria are met:
- The individual is anti-acetylcholine receptor (AChR) antibody-positive.
- The Individual meets Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV.
- The individual has a Myasthenia Gravis--Specific Activities of Daily Living scale (MG-ADL) total score of five or greater.
- The individual is on a stable dose of MG therapy either in combination or alone of any of the following medication:
- acetylcholinesterase (AChE) inhibitors
- non-steroidal immunosuppressive therapies (NSISTs)
- IgG levels of at least 6 g/L
All other uses for efgartigimod alfa-fcab (Vyvgart), are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
An Individual's medical record must reflect the medical necessity for the care provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
When coverage of efgartigimod alfa-fcab (Vyvgart) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.