Currentsierra health and lifePolicy 2026D0100G

Enjaymo (sutimlimab-jome) — Coverage Criteria for Cold Agglutinin Disease

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Medical policy governing coverage criteria and administrative requirements for Enjaymo (sutimlimab-jome) for treatment of cold agglutinin disease (CAD) under Sierra Health and Life (UnitedHealthcare) Commercial and Individual Exchange benefit plans.

Policy Summary

Payersierra health and life

PolicyEnjaymo (sutimlimab-jome) — Coverage Criteria for Cold Agglutinin Disease

Policy CodePolicy 2026D0100G

Change TypeRevised — operational wording and template updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that initial or continuation coverage criteria are met, including hematology consultation and required diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

Updated list of examples of complement inhibitors the patient must not be receiving in combination with Enjaymo; replaced 'Soliris (eculizumab)' with 'eculizumab'.

Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans and added Application section.

≤12 months

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Currentsierra health and lifePolicy 2026D0100G

Enjaymo (sutimlimab-jome) — Coverage Criteria for Cold Agglutinin Disease

Customize your policy alerts

Sign up for sierra health and life Policy 2026D0100G alerts

Get alerted when Policy 2026D0100G changes without checking for updates manually.

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Policy Summary

Payersierra health and life

PolicyEnjaymo (sutimlimab-jome) — Coverage Criteria for Cold Agglutinin Disease

Policy CodePolicy 2026D0100G

Change TypeRevised — operational wording and template updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that initial or continuation coverage criteria are met, including hematology consultation and required diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

Updated list of examples of complement inhibitors the patient must not be receiving in combination with Enjaymo; replaced 'Soliris (eculizumab)' with 'eculizumab'.

Transferred content to shared policy template that applies to both UnitedHealthcare Commercial and Individual Exchange benefit plans and added Application section.

≤12 months

Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial Therapy

Enjaymo is medically necessary for the treatment of CAD when ALL of the following are met for initial therapy:

Initial therapy criteria: 1) Diagnosis of CAD by, or in consultation with, a hematologist with expertise in the diagnosis of CAD; 2) Confirmation of the CAD diagnosis based on all of the following: evidence of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count); positive polyspecific direct antiglobin test (DAT); positive monospecific DAT for C3d; IgG DAT ≤ 1+; cold agglutinin titer ≥ 64 at 4°C; 3) Cold agglutinin syndrome secondary causes have been ruled out (e.g., infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, other autoimmune disorders); 4) Baseline hemoglobin ≤ 10 g/dL; 5) Enjaymo prescribed by a hematologist; 6) Enjaymo dosing in accordance with FDA-approved labeling; 7) Patient is not receiving Enjaymo in combination with a complement inhibitor (examples: eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab-cwzb, zilucoplan); 8) Initial authorization up to 12 months.

Continuation Therapy

Continuation (reauthorization) criteria — all required:

Continuation therapy criteria: 1) Documentation of positive clinical response to therapy (e.g., increase in hemoglobin, decreased transfusion requirements, decreased markers of hemolysis, improvement in anemia-related symptoms); 2) Enjaymo prescribed by, or in consultation with, a hematologist; 3) Enjaymo dosing in accordance with FDA-approved labeling; 4) Patient is not receiving Enjaymo in combination with a complement inhibitor (examples: eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab-cwzb, zilucoplan); 5) Reauthorization up to 12 months.

Enjaymo should not be used in combination with other complement inhibitors. Examples of agents that preclude combination use include eculizumab, pegcetacoplan (Empaveli), iptacopan (Fabhalta), crovalimab (PiaSky), ravulizumab-cwzb (Ultomiris), and zilucoplan (Zilbrysq). Operationally, coverage decisions will align with the policy wording in both the Coverage Rationale and Continuation sections: the patient must not be receiving Enjaymo concurrently with any of these complement inhibitors to meet medical necessity criteria for either initial authorization or reauthorization.

If the documented diagnostic criteria or baseline hemoglobin threshold are not met, the request does not meet medical necessity under this policy. Specifically, initiation requires confirmation of CAD with supporting laboratory evidence (e.g., markers of chronic hemolysis, positive polyspecific DAT, positive monospecific DAT for C3d, IgG DAT ≤ 1+, and cold agglutinin titer ≥ 64 at 4°C) and a baseline hemoglobin ≤ 10 g/dL. For continuation, documentation of a positive clinical response (for example, increased hemoglobin, fewer transfusions, or decreased hemolysis markers) is required. When these criteria are absent, provide clear clinical documentation explaining the discrepancy and any relevant supporting data; without sufficient documentation, coverage may be denied.

Coding and Diagnostic Criteria

HCPCS CodesHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Diagnosis CodesICD-10

D59.12

Cold autoimmune hemolytic anemia

inv-07: Cold agglutinin titer

Diagnostic threshold>= 64 at 4°C

Test contextRequired as part of confirmation of CAD diagnosis (polyspecific DAT, monospecific DAT for C3d, IgG DAT ≤ 1+)

Study enrollment criterionCold agglutinin titer ≥ 64 at 4°C was used for eligibility in the CARDINAL phase 3 study of sutimlimab

inv-08: Baseline hemoglobin

Baseline hemoglobin requirement<= 10 g/dL

Clinical roleUsed as an eligibility criterion for initial therapy and for enrollment in the pivotal CARDINAL study

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required (HCPCS J1302)

Prior authorization is required for Enjaymo (sutimlimab-jome). Requests must document that the patient meets either the initial or continuation coverage criteria and should be billed using HCPCS code J1302 (Injection, sutimlimab-jome, 10 mg).

Prior authorization must include documentation that all applicable coverage criteria are met (initial or continuation).
Bill using HCPCS code J1302 for sutimlimab-jome (10 mg).

Note

Prior therapies referenced (informational)

The policy cites other therapeutic options in the Background/Clinical Evidence (for informational context) — for example, rituximab monotherapy and rituximab-based combinations (rituximab plus bendamustine or fludarabine) — but it does not require a trial of these therapies as a formal step prior to coverage of Enjaymo.

Rituximab monotherapy and rituximab plus bendamustine or fludarabine are discussed as treatment options and response data are summarized.

Background and Clinical Context

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which cold agglutinins (typically IgM) activate complement and lead predominantly to extravascular hemolysis. Diagnosis is established by a hematologist and typically requires evidence of chronic hemolysis (for example, elevated LDH, low haptoglobin, increased indirect bilirubin, increased reticulocyte count), a positive polyspecific direct antiglobulin test (DAT), a positive monospecific DAT for C3d, and a cold agglutinin titer ≥ 64 at 4°C. Enjaymo (sutimlimab-jome) is indicated for treatment of CAD when these diagnostic criteria are met, treatment is prescribed by a hematologist, dosing follows FDA labeling, and the patient is not receiving another complement inhibitor.

Definitions

inv-14: CAD definition

DefinitionCold agglutinin disease (CAD) is an autoimmune hemolytic anemia mediated by cold agglutinins (autoantibodies, typically IgM) that bind red blood cells at low temperatures and trigger complement activation leading primarily to extravascular hemolysis.

PathophysiologyBound IgM recruits classical complement components (C1, C4, C2) leading to C3 convertase formation and C3b opsonization of RBCs followed by macrophage-mediated extravascular hemolysis in the liver.

Diagnostic featuresDiagnosis is based on markers of chronic hemolysis and positive direct antiglobulin testing (polyspecific DAT, monospecific DAT for C3d) often with cold agglutinin titer ≥ 64 at 4°C and IgG DAT ≤ 1+.