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Sutimlimab (Enjaymo ®)
Commercial Utilization Management Policy
Version Date: April 2024

Restricted Product(s)

  • sutimlimab-jome (Enjaymo ®) intravenous infusion for administration by a healthcare professional

FDA Approved Use

For the treatment of hemolysis in adults with cold agglutinin disease (CAD)

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval

  1. The patient is 18 years of age or older; AND 
  2. The patient has a diagnosis of cold agglutinin disease (CAD) based on ALL of the following tests [medical record documentation required]:
    1. Chronic hemolysis 
    2. Positive polyspecific direct antiglobulin test (DAT) 
    3. Positive monospecific DAT specific for C3d 
    4. Cold algutinin titer ≥64 at 4°C 
    5. IgG DAT ≤1+; AND 
  3. The patient has had at least one red blood cell transfusion in the last 6 months [medical record documentation required]; AND 
  4. Baseline hemoglobin level, markers of hemolysis (e.g., bilirubin, haptoglobin, lactate dehydrogenase [LDH], reticulocyte count), and IgM levels have been documented and submitted [medical record documentation required]; AND 
  5. The patient has tried and had an inadequate response to a rituximab containing regimen for at least 6 months [medical record documentation required]; OR 
    1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to rituximab [medical record documentation required]; OR 
    2. The prescriber has submitted documentation demonstrating that the patient is not a candidate for treatment with rituximab [medical record documentation required]; AND 
  6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist); AND 
  7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

    Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval

  1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
  2. The patient would have met initial criteria for approval at the time they started therapy; AND 
  3. The patient has had a sustained improvement in their hemoglobin level of ≥2 g/dL since baseline [medical record documentation required]; OR 
  4. The patient has had a sustained increase in their hemoglobin level to ≥12 g/dL [medical record documentation required]; AND 
  5. The patient has not required any blood transfusions after the first four weeks of therapy with sutimlimab; AND 
  6. The patient has not received any additional treatment for CAD after the first four weeks of therapy with sutimlimab (e.g., rituximab); AND 
  7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist); AND 
  8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
  9. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

    Duration of Approval: 365 days (1 year) 

FDA Label Reference  
Medication  IndicationDosing  HCPCS  Maximum Units* 

sutimlimab (Enjaymo™)

intravenous (IV) Infusion

Hemolysis in adults with cold agglutinin disease (CAD)

Weight-based dosage weekly for two weeks then every two weeks:

For patients weighing 39 kg to <75 kg: 6,500 mg by intravenous (IV) infusion.

For patients weighing ≥75 kg: 7,500 mg by intravenous (IV) infusion.

J1302

For patients weighing 39 to <75kg

Initial: 9,100
Continuation: 16,900

For patients weighing ≥75 kg

Initial: 10,500
Continuation: 19,500

*Maximum units allowed for duration of approval 

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
    4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
    5. Requirement of a change in the requested restricted product formulation; AND 
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

April 2024: Criteria update: Added revised indication for the treatment of hemolysis in adults with cold agglutinin disease (CAD) per update to FDA label
October 2022: Coding update: Added HCPCS code J1302 to dosing reference table effective 10/1/2022, deleted C9094, J3490, J3590, and J9999 termed 9/30/2022. Updated maximum units per code definition.
July 2022: Coding update: Added HCPCS code C9094 to dosing reference table effective 7/1/2022, deleted C9399 termed 6/30/2022.
February 2022: Original medical policy criteria issued.
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