Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of rozanolixizumab-noli (Rystiggo) may be considered medically necessary when ALL of the following criteria are met:
Myasthenia Gravis (gMG)
Initial Criteria
- The individual must meet Food and Drug Administration (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 or neuromuscular specialist; 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 positive serological lab test for one of the following:
- Anti-AChR antibodies; or
- Anti-MuSK antibodies; and
- The individual has one of the following:
- The individual has a Myasthenia Gravis-specific Activities of Daily Living (MG-ADL) total score greater than or equal to three (3); or
- The individual has a documented baseline Quantitative Myasthenia Gravis (QMG) score greater than or equal to 12; and
- If Acetylcholine Receptor (AChR) antibody positive, then ONE of the following:
- The individual is unable to complete glucocorticoid bridge therapy (e.g., diabetes) while waiting for efficacy of oral immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus); or
- The individual required chronic intravenous immunoglobulin (IVIG) or chronic plasmapheresis/plasma exchange (i.e., at least every three (3) months over 12 months without symptom control), despite a 12-month trial (total duration) of immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus); and
- If Muscle Specific Kinase (MuSK) positive, then the individual required chronic intravenous immunoglobulin (IVIG) or chronic plasmapheresis/plasmaexchange (i.e., at least every three (3) months over 12 months without symptom control), despite a 90-day trial of rituximab.
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with rozanolixizumab-noli (Rystiggo) 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 two (2)-point improvement in the individual's total MG-ADL score; or
- A three (3)-point improvement in QMG total score.
Continuation Authorization: 12 months
The use of rozanolixizumab-noli (Rystiggo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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