CurrentUnitedHealthcarePolicy CS2O25D01001

Enjaymo (Sutimlimab-Jome)

Defines UnitedHealthcare medical benefit drug policy coverage criteria, applicable codes, prescribing and authorization requirements for Enjaymo (sutimlimab-jome) for treatment of cold agglutinin disease (CAD). Excludes certain states where state-specific policies apply.

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (Sutimlimab-Jome)

Policy CodePolicy CS2O25D01001

Change TypeApplication updateAdministrative revision

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization consistent with policy criteria; initial and reauthorization approvals are limited to no more than 12 months and require documentation of diagnostic criteria and clinical response.

SourceLink

POLICY UPDATE CHANGES

Application Arizona: Added language to indicate this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy

Administrative revision recorded 09/01/2025: Archived previous policy version CS2O25DO1OOH

1HCPCS drug code listed

1Diagnosis code listed

12 moAuthorization limit (initial/reauth)

>=64Cold agglutinin titer threshold

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Coverage Summary

Coverage stance: covered_with_criteria for Enjaymo (sutimlimab-jome) for cold agglutinin disease. Scope: Defines UnitedHealthcare medical benefit drug policy coverage criteria, applicable codes (e.g., HCPCS J1302), prescribing and authorization requirements for Enjaymo, and excludes certain states where state-specific policies apply. Effective date: September 1, 2025. Note: Certain states (for example, Arizona) are excluded per policy changes and should refer to the state's Medicaid clinical policy.

Key thresholds & quick facts

Cold agglutinin titer threshold>= 64 at 4°C

Baseline hemoglobin requirement< 10 g/dL

Initial/reauthorization limitAuthorization up to 12 months

HCPCS drug code count1 (J1302: Injection, sutimlimab-jome, 10 mg)

Diagnosis code count1 (D59.12: Cold autoimmune hemolytic anemia)

Initial Therapy Criteria

Medically Necessary (Initial Therapy)

Enjaymo is medically necessary for the treatment of cold agglutinin disease (CAD) in patients who meet ALL of the following criteria:

ALL of the following

Confirmation of CAD diagnosis (all required)
- Diagnosis of CAD by, or in consultation with, a hematologist with expertise in the diagnosis of CAD
- Positive polyspecific direct antiglobin test (DAT)
- Evidence of chronic hemolysis (e.g., elevated lactated dehydrogenase (LDH); decreased haptoglobin; increased indirect bilirubin; increased reticulocyte count)
- Positive monospecific DAT specific for C3d

Continuation / Reauthorization Criteria

Medically Necessary (Continuation / Reauthorization)

For continuation of therapy, ALL of the following must be met:

ALL of the following

Enjaymo is prescribed by, or in consultation with, a hematologist
Patient is not receiving Enjaymo in combination with a complement inhibitor (e.g., eculizumab, ravulizumab-cwzb, pegcetacoplan, iptacopan, crovalimab, zilucoplan)
Enjaymo dosing is in accordance with the United States Food and Drug Administration approved labeling
Documentation of positive clinical response to therapy (e.g., increase in hemoglobin, decreased transfusion requirements, decreased markers of hemolysis, improvement in anemia-related symptoms)

Exceptions / Case-by-case Review

Requests outside of this criteria will be reviewed for medical necessity on a case-by-case basis.

Requests outside of this criteria will be reviewed for medical necessity on a case by case basis

Applicable Codes

Drug HCPCSHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Diagnosis Codes (Indication)ICD-10Covered

D59.12

Cold autoimmune hemolytic anemia

Provider Actions / Requirements

Prior Authorization

Initial authorization limit

Initial authorization for Enjaymo (sutimlimab-jome) is limited to no more than 12 months and must meet all policy criteria for medical necessity.

Affected code: J1302

Prior Authorization

Reauthorization requirements

Reauthorization for Enjaymo is limited to no more than 12 months and requires documentation of a positive clinical response to therapy (e.g., increase in hemoglobin, decreased transfusion requirements, decreased markers of hemolysis, or improvement in anemia‑related symptoms).

Affected code: J1302

Documentation Required

Diagnostic documentation required

Clinical Evidence

54.2%CARDINAL primary endpoint response (13/24 met composite endpoint)

72.7%CADENZA responder rate (proportion meeting hemoglobin + transfusion criteria)

+3.2Mean hemoglobin change at treatment assessment (approx. 3.2 g/dL increase, CARDINAL)

Cold agglutinin disease (CAD) is mediated by cold agglutinins that bind RBCs and recruit the classical complement pathway leading to primarily extravascular hemolysis. Sutimlimab inhibits the classical complement pathway (C1s) to prevent C3b opsonization and subsequent hemolysis. Efficacy was demonstrated in phase 3 trials: CARDINAL (single-arm, showed rapid Hb increases and the prespecified primary endpoint met) and CADENZA (placebo-controlled, with a responder rate of 72.7%).

Background & Definitions

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which cold agglutinins cause RBC agglutination in cooler body parts and hemolytic anemia. Hemolysis is primarily extravascular and mediated by complement: IgM cold agglutinins bind RBC antigens in cooler sites, recruit classical complement components (C1, C4, C2), leading to C3 convertase formation and C3b coating of RBCs with subsequent phagocytosis by hepatic macrophages. Sutimlimab inhibits the classical complement pathway (C1s), preventing C3b formation and reducing extravascular hemolysis.

CAD — an autoimmune hemolytic anemia mediated by cold agglutinins without obvious underlying disease.

Revision History

2025-09-01material_change

Application Arizona: Added language to indicate this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

2025-09-01administrative_revision

Administrative revision: Archived previous policy version CS2O25DO1OOH.

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (Sutimlimab-Jome)

Policy CodePolicy CS2O25D01001

Change TypeApplication updateAdministrative revision

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Cold agglutinin titer ≥ 64 at 4°C>= 64 at 4°C

Immunoglobulin G (IgG) DAT < 1+< 1+

Baseline hemoglobin level < 10 g/dL< 10 g/dL

Cold agglutinin syndrome secondary to other factors has been ruled out (e.g., infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, other autoimmune disorders)

Enjaymo is prescribed by a hematologist

Enjaymo dosing is in accordance with the United States Food and Drug Administration approved labeling

Patient is not receiving Enjaymo in combination with a complement inhibitor (e.g., eculizumab, ravulizumab-cwzb, pegcetacoplan, iptacopan, crovalimab, zilucoplan)

Initial authorization will be for no more than 12 months≤ 12 months

Reauthorization will be for no more than 12 months≤ 12 months

Diagnostic documentation required to support initiation of Enjaymo includes laboratory and clinical evidence consistent with cold agglutinin disease (CAD). Required items: polyspecific direct antiglobulin test (DAT); monospecific DAT specific for C3d; cold agglutinin titer ≥64 at 4°C; evidence of chronic hemolysis (for example, elevated lactate dehydrogenase [LDH], decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count); IgG DAT <1+; and baseline hemoglobin <10 g/dL.

Documentation Required

Specialist prescribing requirement

Enjaymo must be prescribed by, or in consultation with, a hematologist with expertise in the diagnosis and management of cold agglutinin disease (CAD).

Billing Rule

Concomitant therapy exclusion

Use of Enjaymo in combination with other complement inhibitors is a denial risk. Do not co-administer Enjaymo with other complement pathway inhibitors.

Example agents: eculizumab (Soliris), ravulizumab-cwzb (Ultomiris), pegcetacoplan (Empaveli), iptacopan (Fabhalta), crovalimab (PiaSky), zilucoplan (Zilbrysq)
Affected code: J1302