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.
Eculizumab (Soliris) Initial Criteria
Eculizumab (Soliris) may be considered medically necessary when an individual meets the following criteria:
Myasthenia Gravis (gMG)
- The individual has a diagnosis of generalized Myasthenia Gravis; and
- The individual is 18 years of age or older; and
- 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 6; 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 two (2) immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) for at least a 1-year total trial (either combination or monotherapy); or
- The individual has an intolerance or hypersensitivity to at least two (2) immunosuppressive therapies; or
- The individual has tried and had an inadequate response to treatment to at least one (1) immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) for at least a 1-year total trial AND ONE of the following:
- 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 an intolerance or hypersensitivity to at least one (1) immunosuppressant AND plasmapheresis/plasma exchange; or
- The individual has an FDA labeled contraindication to ALL immunosuppressive therapies and plasmapheresis/plasma exchange; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to efgartigimod alfa-fcab (Vyvgart) or ravulizumab-cwvz (Ultomiris); or
- The individual has an intolerance or hypersensitivity to efgartigimod alfa-fcab (Vyvgart) or ravulizumab-cwvz (Ultomiris); or
- The individual has an FDA labeled contraindication to BOTH efgartigimod alfa-fcab (Vyvgart) and ravulizumab-cwvz (Ultomiris); and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to eculizumab (Soliris).
Paroxysmal Nocturnal Hemoglobinuria (PNH)
- The individual is 18 years of age or older and has a diagnosis of PNH as confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating that the individual’s peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) – linked proteins (lab tests required); and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to BOTH pegcetacoplan (Empaveli) AND ravulizumab-cwvz (Ultomiris); or
- The individual has an intolerance or hypersensitivity to BOTH pegcetacoplan (Empaveli) AND ravulizumab-cwvz (Ultomiris); or
- The individual has an FDA labeled contraindication to BOTH pegcetacoplan (Empaveli) AND ravulizumab-cwvz (Ultomiris); and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to eculizumab (Soliris); and
- The individual will NOT be using eculizumab (Soliris) in combination with ravulizumab-cwvz (Ultomiris) or pegcetacoplan (Empaveli).
atypical Hemolytic Uremic Syndrome (aHUS)
- The individual has a diagnosis of aHUS; and
- The individual is two (2) months of age or older; and
- The diagnosis was confirmed by ONE of the following: (medical records required)
- Genetic mutation (e.g., CFH, CD46, CFI, C3, CFB, THBD, CFHR1, CFHR3, CFHR5); or
- Antibodies to complement factors; or
- A differential diagnosis of complement-mediated HUS has been demonstrated [i.e. screening for Shiga toxin-producing E. coli (STEC) for STEC-HUS, pneumococcal culture of blood/sputum/cerebrospinal or pleural fluid for pneumococcal-associated HUS, ADAMTS13 <10% activity for thrombotic thrombocytopenic purpura (TTP), screening for defective cobalamin metabolism]; and
- The individual is negative for Shiga toxin-producing coli (STEC); and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to ravulizumab-cwvz (Ultomiris); or
- The individual has an intolerance or hypersensitivity to ravulizumab-cwvz (Ultomiris); or
- The individual has an FDA labeled contraindication to ravulizumab-cwvz (Ultomiris); and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to eculizumab (Soliris); and
- The individual will NOT be using eculizumab (Soliris) in combination with ravulizumab-cwvz (Ultomiris).
Neuromyelitis Optica Spectrum Disorder (NMOSD)
- The individual has a diagnosis of (NMOSD); and
- The individual is 18 years of age or older; and
- The individual is anti-aquaporin-4 (AQP4) antibody positive; and
- The diagnosis was confirmed by at least ONE of the following:
- Optic neuritis; or
- Acute myelitis; or
- Area postrema syndrome: episode of otherwise unexplained hiccups or nausea and vomiting; or
- Acute brainstem syndrome; or
- Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; or
- Symptomatic cerebral syndrome with NMOSD-typical brain lesions; and
- The individual has had at least one (1) discrete clinical attack of CNS symptoms; and
- Alternative diagnoses (e.g., multiple sclerosis, ischemic optic neuropathy) have been ruled out; and
- ONE of the following:
- Information has been provided that indicates the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with eculizumab (Soliris) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
- The individual has tried and had an inadequate response to satralizumab-mwge (Enspryng) OR inebilizumab-cdon (Uplizna); or
- The individual has an intolerance or hypersensitivity to satralizumab-mwge (Enspryng) OR inebilizumab-cdon (Uplizna); or
- The individual has an FDA labeled contraindication to satralizumab-mwge (Enspryng) OR inebilizumab-cdon (Uplizna); or
- The individual has severe disease, and the prescriber has determined that BOTH satralizumab-mwge (Enspryng) AND inebilizumab-cdon (Uplizna) would not be clinically appropriate for the individual; and
- The prescriber is a specialist in the area of the individual’s diagnosis or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual does NOT have any FDA labeled contraindications to eculizumab (Soliris); and
- The individual will NOT be using eculizumab (Soliris) in combination with rituximab, satralizumab-mwge (Enspryng) or inebilizumab-cdon (Uplizna).
Length of Approval: Generalized Myasthenia Gravis: 3 months
All other diagnoses: 6 months
Eculizumab (Soliris) not meeting the criteria listed in this policy is considered experimental/investigational, and therefore, not covered because the safety and/or effectiveness of this use cannot be established by review of the available published peer-reviewed literature.
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