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Drug  - Enjaymo™ (sutimlimab-jome) [Sanofi]

October 2022

Therapeutic area - PNH Agents

Initial approval criteria

  • Patient is at least 18 years of age AND

Universal Criteria

  • Patient must be vaccinated against encapsulated bacteria (e.g., Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, etc.) at least two weeks prior to initiation of therapy in accordance with the most current Advisory Committee on Immunization Practices (ACIP) recommendations and will continue to be revaccinated (Note: If urgent therapy is indicated in an unvaccinated patient, administer vaccine(s) as soon as possible and provide patients with two weeks of antibacterial drug prophylaxis) AND
  • Patient does not have an active chronic systemic infection (e.g., hepatitis B, hepatitis C, or HIV, etc.) AND
  • Will not be used in combination with another complement-inhibitor therapy (e.g., ravulizumab, eculizumab, pegcetacoplan, avacopan, etc.) or B-cell directed therapy (i.e., rituximab) AND
  • Patient does NOT have systemic lupus erythematosus (SLE) or other autoimmune disease with positive anti-nuclear antibody AND
  • Patient will avoid cold exposure where possible AND

Cold-Agglutinin Disease (CAD)

  • Patient has a confirmed diagnosis of CAD based on the following:
    • chronic hemolysis
    • polyspecific direct antiglobulin test (DAT)
    • monospecific DAT specific for C3d
    • cold agglutinin titer ≥64 at 4°C
    • IgG DAT ≤1+
    • recent blood transfusion in the 6 months prior
  • Patient is transfusion dependent on packed red blood cells (PRBCs) due to chronic hemolysis AND
  • Other causes of CAD have been ruled out such as coexisting diseases or conditions (e.g., infection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy, etc.) [Note; patients with a history of or concomitant low-grade lymphoproliferative disease are not subject to exclusion] AND
  • Documented baseline values for both of the following (necessary for renewal): hemoglobin level, packed RBC transfusion requirement, and markers of hemolysis

Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in the initial approval criteria AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections, severe infusion reactions, autoimmune disease (e.g., SLE), etc. AND
  • Patient has experienced a disease response compared to pretreatment baseline:
    • Hemoglobin response defined as an increase from baseline in Hgb level ≥2 g/dL or a Hgb level ≥12 g/dL without transfusion over a four week or longer time period OR
    • Absence of packed RBC transfusion OR
    • Patient had an increase in Hb and/or decrease in transfusion requirement, to a lesser extent than the above, AND also had an improvement in the signs and symptoms (e.g., fatigue, jaundice, shortness of breath) and/or markers of hemolysis (e.g., indirect bilirubin, reticulocyte count, LDH, haptoglobin, etc.)
  • Renewal approval is for 6 months

Quantity limits

  • 39 kg to less than 75 kg: 6,500 mg weekly for the first two weeks, then every two weeks thereafter
  • 75 kg or more: 7,500 mg weekly for the first two weeks, then every two weeks thereafter
  • Patient’s weight (in kg) must be submitted at time of request

Billing for Enjaymo

Enjaymo must be billed as a medical claim.


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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