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.
Sutimlimab-jome (Enjaymo) may be considered medically necessary when
ALL
of the following criteria are met:
-
Individual is 18 years of age or older;
and
-
Individual has diagnosis of primary CAD as defined by
ONE
of the following:
-
Chronic hemolysis (e.g., high reticulocytes, high LDH, high indirect bilirubin, low haptoglobin);
or
-
Polyspecific direct antiglobulin test (DAT) positive;
or
-
Monospecific DAT strongly positive for C3d;
or
-
IgG direct antiglobulin test less than or equal to 1+;
or
-
Cold agglutinin titer of greater than or equal to 64 at 4 degrees Celsius;
and
-
Individual has hemoglobin level of less than or equal to 10 g/dL;
and
-
Individual has bilirubin level above the normal reference range (1.2mg/dL);
and
-
Individual has presence of at least
ONE
of the following CAD-related signs or symptoms within three (3) months of screening:
-
Symptomatic anemia defined by
ONE
of the following:
-
Fatigue;
or
-
Weakness;
or
-
Shortness of breath;
or
-
Palpitations/ Tachycardia;
or
-
Light headedness;
or
-
Chest pain;
or
-
Acrocyanosis;
or
-
Raynaud's syndrome;
or
-
Hemoglobinuria;
or
-
Disabling circulatory symptoms;
or
-
Major adverse vascular event (including thrombosis);
and
-
Secondary causes of CAD have been ruled out (e.g., infection, rheumatologic diseases, overt hematologic malignancies, other autoimmune disorders etc.);
and
-
Individual has been vaccinated against encapsulated bacteria (e.g., Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae serogroup b, etc.) at least two (2) weeks prior to initiation;
and
-
Individual has not received rituximab within three (3) months of initiation and will not be using rituximab with sutimlimab-jome (Enjaymo);
and
-
Sutimlimab-jome (Enjaymo) is being prescribed by or in consultation with a hematologist;
and
- Initial authorization will be for a period of six (6) months.
Reauthorization Criteria
Continuation of therapy with sutimlimab-jome (Enjaymo) may be considered medically necessary for the treatment of an individual with CAD when
ALL
of the following criteria are met:
-
Individual has an increase in hemoglobin level of 1.5 g/dL or more from baseline;
or
-
Individual has normalization of hemoglobin level to 12 g/dL or higher;
or
-
Individual has normalization of bilirubin levels to less than 1.2 mg/dL;
or
- Individual has decreased number of blood transfusions since initiation of therapy.
The use of sutimlimab-jome (Enjaymo) 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.
Procedure Code
