Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Eculizumab (Soliris) may be considered medically necessary when an individual meets the following criteria:
atypical Hemolytic Uremic Syndrome (aHUS)
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 must be, or in consult with, a hematologist or nephrologist;
and
-
The individual must have a diagnosis of atypical Hemolytic Uremic Syndrome (aHUS) and ALL of the following (as evidenced with submitted documentation):
-
Low platelet count, as defined by laboratory reference range or individual requires dialysis;
and
-
Evidence of hemolysis such as an elevation in serum lactate dehydrogenase (LDH), elevated indirect bilirubin, reduced haptoglobin, or increased reticulocyte, as defined by laboratory reference range or individual requires dialysis;
and
-
Serum creatinine above the upper limits of normal, as defined by laboratory reference range or individual requires dialysis;
and
- The individual does not have bloody diarrhea.
Initial Authorization: 6 months
Reauthorization Criteria
Continuation of therapy with eculizumab (Soliris) 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:
-
Normalization of platelet count, as defined by laboratory reference range;
or
-
Normalization of lactate dehydrogenase (LDH), as defined by laboratory reference range;
or
- Greater than or equal to 25% improvement in serum creatinine from baseline or ability to discontinue dialysis.
Continuation Authorization: 12 months
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 a Myasthenia Gravis-specific Activities of Daily Living (MG-ADL) total score greater than or equal to six (6);
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
-
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 90-day trial or
recommended cycle duration of each of the following:
-
Rituximab;
and
-
Ravulizumab-cwvz (Ultomiris);
and
- Efgartigimod (Vyvgart) or rozanolixizumab-noli (Rystiggo).
Initial Authorization: six (6) months
Reauthorization Criteria
Continuation of therapy with eculizumab (Soliris) 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.
Continuation Authorization: 12 months
Neuromyelitis Optica Spectrum Disorder (NMOSD)
-
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;
and
-
The individual must have a diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD);
and
-
The individual has positive serologic test for anti-AQP4 antibodies;
and
-
The individual has a history of greater than or equal to one (1) relapse that required rescue therapy within the past 12 months;
and
-
The individual has an Expanded Disability Status Score (EDSS) of less than or equal to 6.5;
and
-
The individual must have
ONE
of the core clinical characteristics from 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 must have had a three (3)-month trial with ravulizumab-cwvz (Ultomiris), satralizumab-mwge (Enspryng) and pegcetacoplan (Empaveli).
Initial Authorization: Six (6) months
Reauthorization Criteria
Continuation of therapy with eculizumab (Soliris) may be considered medically necessary when the following is met:
-
The individual must have experienced stabilization, slowing of disease progression, or improvement of the condition 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:
- Reduction in relapse rate
- Reduction in symptoms (such as pain, fatigue, motor function)
Continuation Authorization: 12 months
Paroxysmal Nocturnal Hemoglobinuria (PNH)
-
The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age;
and
-
The requested medication must be prescribed by, or in consult with, a hematologist;
and
-
Diagnosis must be confirmed by flow cytometry demonstrating that the individual's peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) - linked proteins (e.g., CD55, CD59);
and
-
One of the following criteria must be met:
-
The individual has had at least one (1) transfusion in the past six (6) months;
or
-
The individual has granulocyte PNH clone size greater than 10% or hemoglobin less than 10 g/dL and symptoms of PNH (e.g., abdominal pain, anemia, shortness of breath, hemolysis, organ dysfunction, debilitating fatigue);
or
-
LDH level of 1.5 times the upper limit of normal (must include at least two (2) different reagents tested on at least two (2) cell lineages);
and
-
The individual must have failed a three (3)-month trial with ravulizumab-cwvz (Ultomiris) and p
egcetacoplan (
Empaveli) with persistent anemia (Hb less than 10 g/dL).
Initial Authorization: six (6) months
Reauthorization Criteria
Continuation of therapy with eculizumab (Soliris) 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 one of the following:
-
Individual has not required transfusion in the past six (6) months;
or
-
Increase in hemoglobin (Hb) by greater than or equal to two (2) g/dL from baseline;
or
- Normalization in LDH levels less than or equal to 280 U/L.
Continuation Authorization: 12 months
The use of eculizumab (Soliris) 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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