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
- Positive direct antiglobulin (Coombs) test for C3d; or
- Cold agglutinin titer of greater than or equal to 64 at 4 degrees Celsius; and
- Individual has history of at least one (1) documented blood transfusion within six (6) months of initiation; 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 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
- 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 2 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; and
- Individual has decreased number of blood transfusions since initiation of therapy.
The use of sutimlimab-jome (Enjaymo) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
