Pharmacy Prior Authorization Criteria

Enjaymo (sutimlimab-jome)

Indications for Prior Authorization

Enjaymo (sutimlimab-jome)

• For diagnosis of Cold agglutinin disease
  Indicated for the treatment of hemolysis in adults with cold agglutinin disease.

Criteria

Enjaymo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of cold agglutinin disease (CAD) based on ALL of the following: [A, 2, 3]
• Presence of chronic hemolysis (e.g., bilirubin level above the normal reference range, elevated lactated dehydrogenase [LDH], decreased haptoglobin, increased reticulocyte count)
• Positive polyspecific direct antiglobulin test (DAT)
• Monospecific DAT strongly positive for C3d
• Cold agglutinin titer greater than or equal to 64 measured at 4 degree celsius
• Direct antiglobulin test (DAT) result for Immunoglobulin G (IgG) of 1 plus or less
AND
• Patient does not have cold agglutinin syndrome secondary to other factors (e.g., overt hematologic malignancy, primary immunodeficiency, infection, rheumatologic disease, systemic lupus erythematosus or other autoimmune disorders) [A, 1, 3]
AND
• Baseline hemoglobin level less than or equal to 10.0 gram per deciliter (g/dL) [3]
AND
• One of the following: [B,1, 3]
• Prescribed dose will not exceed 6,500 mg on day 0, 7, and every 14 days thereafter for patients weighing between 39 kg to less than 75 kg
• Prescribed dose will not exceed 7,500 mg on day 0, 7, and every 14 days thereafter for patients for patients weighing 75 kg or greater
AND
• Prescribed by or in consultation with a hematologist

Enjaymo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as evidenced by ALL of the following: [1, 3]
• The patient has not required any blood transfusions after the first 5 weeks of therapy with Enjaymo
• Hemoglobin level greater than or equal to 12 gram per deciliter (g/dL) or increased greater than or equal to 2 g/dL from baseline
AND
• One of the following: [B,1, 3]
• Prescribed dose will not exceed 6,500 mg on day 0, 7, and every 14 days thereafter for patients weighing between 39 kg to less than 75 kg
• Prescribed dose will not exceed 7,500 mg on day 0, 7, and every 14 days thereafter for patients for patients weighing 75 kg or greater
AND
• Prescribed by or in consultation with a hematologist

P & T Revisions

2024-03-10, 2023-09-13, 2023-03-09, 2022-10-06, 2022-03-21

References

1. Enjaymo Prescribing Information. Bioverativ USA Inc. Waltham, MA. February 2024.
2. Diagnosing Cold Agglutinin Disease (CAD) available at https://www.understandingcad.com/diagnosing-cold-agglutinin-disease/. Accessed March 8, 2022.
3. A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants with Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study). Available at https://clinicaltrials.gov/ct2/show/NCT03347396. Accessed March 8, 2022.
4. Roth, A., Barcellini, W., et al. Sutimlimab in Cold Agglutinin Disease. N Engl J Med 2021; 384:1323-1334. Available at https://www.nejm.org/doi/10.1056/NEJMoa2027760?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. Accessed March 8, 2022.

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End Notes

1. Patients with a confirmed diagnosis of CAD based on chronic hemolysis, polyspecific direct antiglobulin test (DAT), monospecific DAT specific for C3d, cold agglutinin titer ≥64 at 4°C, and IgG DAT ≤1+ and a recent blood transfusion in the 6 months prior to enrollment were administered 6.5 g or 7.5 g Enjaymo (based on body weight). Patients with cold agglutinin syndrome secondary to infection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy were excluded. [1]
2. The recommended dosage of Enjaymo for patients with CAD is based on body weight. For patients weighing 39 kg to less than 75 kg, the recommended dose is 6,500 mg and for patients weighing 75 kg or more, the recommended dose is 7,500 mg [1]

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Revision History

• 2024-03-10: 2024 Annual Review
• 2023-09-13: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-03-09: 2023 Annual Review.
• 2022-10-06: GPI Reclassification
• 2022-03-21: New PA Criteria

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