Eculizumab and Ravulizumab-cwvz – Initial Treatment
Eculizumab and ravulizumab-cwvz may be considered medically necessary for individuals with generalized myasthenia gravis (gMG) if they meet criteria 1 through 6:
18 years of age or older.
Diagnosis of gMG with a class II to IV disease per the Myasthenia Gravis Foundation of America (MGFA) classification system (see Policy Guidelines).
Anti-acetylcholine receptor (AChR) antibody positive.
Impaired activities of daily living defined as a MG-Activities of Daily Living (MG-ADL) total score of ≥ 6.
Inadequate treatment response, intolerance, or contraindication to an acetylcholinesterase inhibitor (e.g., pyridostigmine, neostigmine) and at least ONE immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) either in combination or as monotherapy.
Not receiving dual therapy with another C5 complement inhibitor for gMG.
Vaccination against Neisseria meningitidis at least 2 weeks prior to initiation of therapy [unless treatment cannot be delayed].
Prescribing physician is enrolled in the appropriate Risk Evaluation and Mitigation Strategies (REMS) program.
Initial authorization period is for 6 months.
Eculizumab and Ravulizumab-cwvz – Continuation of Treatment
Incremental reauthorization for eculizumab and ravulizumab-cwvz may be considered medically necessary for individuals with gMG if they meet criteria 1 through 2:
Continues to meet the initial treatment criteria cited above.
Decrease of 2 points in MG-ADL total score from pre-treatment baseline value.
Reauthorization period is for 12 months.
Eculizumab and ravulizumab-cwvz are considered investigational for generalized myasthenia gravis when the above criteria are not met.
Efgartigimod alfa-fcab (intravenous) and efgartigimod alfa and hyaluronidase-gvfc (subcutaneous) – Initial Treatment
Efgartigimod alfa-fcab and efgartigimod alfa and hyaluronidase-gvfc may be considered medically necessary for individuals with gMG if they meet criteria 1 through 6:
18 years of age or older.
Diagnosis of gMG with class II to IV disease per the MGFA classification system (see Policy Guidelines).
Anti-AChR antibody positive.
Impaired activities of daily living defined as a MG-ADL total score of ≥ 5.
Inadequate treatment response, intolerance, or contraindication to an acetylcholinesterase inhibitor (e.g., pyridostigmine, neostigmine) and at least ONE immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) either in combination or as monotherapy.
IgG levels ≥ 6 g/L.
Initial authorization period is for 6 months.
Efgartigimod alfa-fcab (intravenous) and efgartigimod alfa and hyaluronidase-gvfc (subcutaneous) – Continuation of Treatment
Incremental reauthorization for efgartigimod alfa-fcab and efgartigimod alfa and hyaluronidase-gvfc (subcutaneous) may be considered medically necessary for individuals with gMG if they meet criteria 1 through 2:
Continues to meet the initial treatment criteria cited above.
Decrease of 2 points in MG-ADL total score from pre-treatment baseline value.
Reauthorization period is for 12 months.
Efgartigimod alfa-fcab is considered investigational when the above criteria are not met.
Rozanolixizumab-noli – Initial Treatment
Rozanolixizumab-noli may be considered medically necessary for individuals with gMG if they meet criteria 1 through 6:
18 years of a or older.
Diagnosis of gMG with class II to IVa disease per the MGFA classification system (see Policy Guidelines).
Anti-AChR antibody positive or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Impaired activities of daily living defined as a MG-DLS total score of ≥ 3 and at least 3 points from non-ocular symptom(s).
Inadequate treatment response, intolerance, or contraindication to an acetylcholinesterase inhibitor (e.g., pyridostigmine, neostigmine) and at least ONE immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) either in combination or as monotherapy.
IgG levels ≥ 5.5 g/L.
Initial authorization period is for 6 months.
Rozanolixizumab-noli – Continuation of Treatment
Incremental reauthorization of rozanolixizumab-noli may be considered medically necessary for individuals with gMG if they meet criteria 1 through 2:
Individual continues to meet the initial treatment criteria cited above.
Decrease of 2 points in MG-ADL total score from pre-treatment baseline value.
Reauthorization period is for 12 months.
Rozanolixizumab-noli is considered investigational when the above criteria are not met.
