Coverage is subject to the specific terms of the member’s benefit plan.
The use of sutimlimab-jome (Enjaymo) may be considered medically necessary when ALL of the following criteria are met:
- Sutimlimab-jome (Enjaymo) must be prescribed by, or in consult with, a hematologist or specialist in cold agglutinin disease (CAD); and
- The individual must have all of the following:
- Evidence of chronic hemolysis (e.g., high lactated dehydrogenase [LDH], low haptoglobin, high reticulocyte count); and
- Direct antiglobin (Coombs) test is positive for C3d; and
- Cold agglutinin titer ≥ 64 at 4°C; and
- There is a documented history of at least one blood transfusion in the previous six months; and
- Cold agglutinin syndrome secondary to other factors has been ruled out (e.g., infection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy); and
- The individual has a baseline hemoglobin level ≤ 10 g/dL; and
- The individual has a baseline bilirubin level above normal reference range of the reporting laboratory; and
- The individual has one or more of the following symptoms:
- Symptomatic anemia; or
- Acrocyanosis; or
- Raynaud’s phenomenon; or
- Hemoglobinuria; or
- Disabling circulatory symptoms; or
- Major adverse vascular event; and
- ONE of the following:
- The individual must have been unresponsive to previous rituximab-based therapy; or
- ONE of the following must be documented:
- Member has a medical reason why rituximab-based therapy is not appropriate or is contraindicated; or
- Member has severe anemia or acute exacerbations of hemolysis and needs a bridge therapy awaiting the effects of a rituximab-based therapy.
Initial Authorization: six (6) months
Continuation of therapy with sutimlimab-jome (Enjaymo) may be considered medically necessary when ALL of the following are met:
- The prescriber has provided documentation that the individual has demonstrated a beneficial response to therapy from baseline as shown by one or more of the following:
- Decrease in transfusions from baseline; or
- Increase in hemoglobin (Hgb) by ≥ 2 g/dL from baseline or Hgb level ≥ 12 g/dL; or
- Normalization of bilirubin levels to less than 1.2mg/dL; and
- Therapy continues to be necessary due to ongoing cold agglutinin production and inability to use rituximab.
Continuation Authorization: 12 months
Sutimlimab-jome (Enjaymo) 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.