Medical Drug Criteria (MDC)

Policy Num:       P1.001.013
Policy Name:     ENJAYMO^® (sutimlimab-jome)
Policy ID:          [P1.001.013] [Ac/L/ M+/ P+ ] [0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC:NONE

ENJAYMO^® (sutimlimab-jome)

Summary

Sutimlimab-jome (Enjaymo) is a monoclonal antibody that inhibits the classical complement pathway by binding to complement protein component 1 subcomponent s (C1s). This inhibition ultimately prevents hemolysis in patients with cold agglutinin disease (CAD). Sutimlimab-jome (Enjaymo) is FDA-approved for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

Policy Statements

Enjaymo may be considered medically necessary in adult patients for the of hemolysis in adults with cold agglutinin disease (CAD).

Policy Guidelines

Coverage eligibility for Sutimlimab-jome (Enjaymo) will be considered when the following criteria are met:

•    Authorization of 6 months may be granted for treatment of adult patients for the of hemolysis with cold agglutinin disease (CAD). 

DOSAGE/ADMINISTRATION

• Vaccinate against encapsulated bacteria at least two weeks prior to treatment.

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

For patients weighing 39 kg to less than 75 kg: 6,500 mg by intravenous infusion.

For patients weighing 75 kg or more: 7,500 mg by intravenous infusion

REQUIRED MEDICAL INFORMATION

Initial Therapy

1.    Initiation of sutimlimab-jome (Enjaymo) meets the definition of medical necessity when used to treat the following indications when the specific criteria are met: 

a.    Cold Agglutinin Disease (CAD)

i.    Diagnosis is confirmed by ALL of the following – documentation must be submitted: 

1.    Chronic hemolysis 

2.    Polyspecific direct antiglobulin test (DAT) 

3.    Monospecific DAT specific for C3d 

4.    Cold agglutinin titer greater than or equal to 64 at 4 degree Celsius

5.    IgG DAT less than or equal to 1+ 

ii.    Member has anemia with a hemoglobin less than the lower limit of normal

iii.    The member had an inadequate response, intolerance, or is not a candidate for rituximab 

iv.    ONE of the following: 

1.    Member has been vaccinated against encapsulated bacteria (e.g., Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B ) at least 2 weeks prior to therapy initiation 

2.    Member has been vaccinated against encapsulated bacteria less than 2 weeks prior to therapy initiation and will receive prophylactic antibiotics for at least 2 weeks following vaccination 

3.    The member does not have cold agglutinin syndrome secondary to infection, rheumatologic conditions, systemic lupus erythematosus, or hematologic malignancy 

4.    The member will not receive an additional complement inhibitor (eculizumab, ravulizumab, pegcetacoplan) or rituximab

Renewal Approval Criteria 

a)    Continuation of sutimlimab-jome meets the definition of medical necessity for CAD when ALL of the following are met 

a.    Member has a history of beneficial response to sutimlimab-jome therapy–examples of beneficial response include absence of or decreased requirement for red blood cell transfusion compared to baseline, improvement in hemoglobin by 2 g/dL from baseline, hemoglobin greater than or equal to 12 g/dL

b.    Member has been revaccinated against encapsulated bacteria (e.g., Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B) according to current medical guidelines for vaccination while receiving sutimlimab-jome therapy 

c.    The member will not receive an additional complement inhibitor (eculizumab, ravulizumab, pegcetacoplan) or rituximab
 

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage

OTHER CRITERIA

N/A

Population Reference No. 1 Policy Statement

References

1.    Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2023 [cited 2023 Feb 1]. Available from: http://www.clinicalpharmacology.com/. 
2.    DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2023 Feb 1]. 
3.    Enjaymo (sutimlimab-jome) injection [package insert]. Bioverativ USA Inc. Waltham, MA. Revised: 02/2024
4.    Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2023 [cited 2023 Feb 1]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

Codes

Applicable Modifiers

N/A

Policy History