Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Efgartigimod (Vyvgart) may be considered medically necessary when an individual meets the following criteria:
Myasthenia Gravis (gMG)
Initial Criteria
- The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- The prescriber is, or in consult with, a neurologist; and
- The individual must have a diagnosis of generalized Myasthenia Gravis; and
- The provider must submit documentation of ALL of the following:
- The individual has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II, III, or IV; and
- The individual has a Myasthenia Gravis-specific Activities of Daily Living (MG-ADL) total score ≥ 6; and
- The individual has a documented baseline Quantitative Myasthenia Gravis (QMG) score ≥ 12; and
- The individual has a positive serological test for anti-AChR antibodies (lab test must be submitted); and
- The individual has had a 90-day trial to pyridostigmine.
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with efgartigimod (Vyvgart) may be considered medically necessary when the following is met:
- The individual must have experienced meaningful clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including one of the following scores and symptoms:
- Decreased rate of Myasthenia Gravis exacerbations; or
- A 3-point improvement in the individual’s total MG-ADL score; or
- A 5-point improvement in quantitative MG total score.
Continuation Authorization: 12 months
Efgartigimod (Vyvgart) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Scientific evidence does not support its efficacy or safety for any other indications.
Procedure Codes
