CurrentUnitedHealthcarePolicy 2026D0100G

Enjaymo (sutimlimab-jome) for cold agglutinin disease

Defines UnitedHealthcare coverage criteria for Enjaymo (sutimlimab-jome) for treatment of adults with cold agglutinin disease (CAD) under Commercial and Individual Exchange benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (sutimlimab-jome) for cold agglutinin disease

Policy CodePolicy 2026D0100G

Change TypeClarified examples of prohibited combination therapiestemplate transfer

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization and ensure documentation includes hematologist diagnosis, laboratory confirmation of CAD (including DAT and cold agglutinin titer), baseline hemoglobin ≤ 10 g/dL, and that Enjaymo is not given with another complement inhibitor.

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 indicating plan applicability.

J1302HCPCS

D59.12ICD-10

≤10 g/dLBaseline Hb

12 monthsInitial auth

54% / 73%Trial response rates

Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial therapy criteria: Diagnosis of cold agglutinin disease (CAD) by, or in consultation with, a hematologist with expertise in CAD; confirmation of CAD with 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; cold agglutinin syndrome secondary causes ruled out (e.g., infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, other autoimmune disorders); baseline hemoglobin ≤ 10 g/dL; Enjaymo prescribed by a hematologist; dosing in accordance with FDA-approved labeling; patient is not receiving Enjaymo in combination with another complement inhibitor (examples include eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab-cwzb, zilucoplan); initial authorization will be for no more than 12 months

All listed conditions must be met

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy

Continuation therapy criteria:

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (sutimlimab-jome) for cold agglutinin disease

Policy CodePolicy 2026D0100G

Change TypeClarified examples of prohibited combination therapiestemplate transfer

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Documentation of positive clinical response to therapy (e.g., increase in hemoglobin, decreased transfusion requirements, decreased markers of hemolysis, improvement in anemia-related symptoms); Enjaymo prescribed by, or in consultation with, a hematologist; dosing in accordance with FDA-approved labeling; patient is not receiving Enjaymo in combination with another complement inhibitor (examples include eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab-cwzb, zilucoplan); reauthorization will be for no more than 12 months

All listed conditions must be met

Enjaymo must not be administered in combination with another complement inhibitor. Examples of complement inhibitors listed in the policy include eculizumab, pegcetacoplan (Empaveli), iptacopan (Fabhalta), crovalimab (PiaSky), ravulizumab‑cwzb (Ultomiris), and zilucoplan (Zilbrysq).

Treatment with Enjaymo is covered only when diagnostic confirmation criteria for cold agglutinin disease are met. Required documentation includes a hematologist diagnosis or consultation and laboratory confirmation of CAD with evidence of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count), a positive polyspecific DAT, a positive monospecific DAT for C3d, IgG DAT ≤ 1+, and a cold agglutinin titer ≥ 64 at 4°C. Patients without these diagnostic findings (or with a baseline hemoglobin > 10 g/dL) do not meet medical necessity criteria for Enjaymo.

Coding — Procedure and Diagnosis Codes, Key Clinical Values

HCPCS codesHCPCS

J1302

Injection, sutimlimab-jome, 10 mg

Diagnosis CodesICD-10

D59.12

Cold autoimmune hemolytic anemia

Cold agglutinin titer

ThresholdCold agglutinin titer ≥ 64 at 4°C

Test temperatureMeasured at 4°C (optimum thermal range typically 3–4°C)

Role in diagnosisRequired as part of diagnostic confirmation along with DAT and hemolysis markers

Baseline hemoglobin

ThresholdBaseline hemoglobin ≤ 10 g/dL

TimingBaseline value required for initial therapy decision-making

Coverage implicationHemoglobin > 10 g/dL falls outside criteria for medical necessity

Provider Actions — Authorization, Documentation, and Treatment Sequencing

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Initial authorizations will be for no more than 12 months.

Initial authorization duration: ≤ 12 months
Prior authorization required before initiating therapy

Documentation Required

Documentation: Hematologist Involvement Required

Documentation must include evidence that the diagnosis and treatment decisions involve a hematologist. Medical records should show a hematologist’s diagnosis or consultation and that Enjaymo is prescribed by a hematologist (or in consultation with one for continuation).

Hematologist diagnosis or consultation documented in the chart
Prescription order signed or co-signed by a hematologist when applicable

Denial Risk

Documentation Requirements and Denial Risk for Missing Diagnostic Confirmation

Complete diagnostic documentation confirming CAD is required. Absence of required diagnostic confirmation places the request at high risk for denial.

Laboratory confirmation of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, elevated indirect bilirubin, increased reticulocyte count)
Positive polyspecific DAT and positive monospecific DAT for C3d
IgG DAT ≤ 1+ and cold agglutinin titer ≥ 64 at 4°C
Documentation that secondary causes of cold agglutinin syndrome (infection, rheumatologic disease, overt hematologic malignancy, etc.) have been ruled out
Baseline hemoglobin ≤ 10 g/dL

Step Therapy

Foundational Therapies / Clinical Context

Although not stated as a formal step therapy requirement, established foundational therapies for CAD (for patients requiring chronic treatment) such as rituximab monotherapy or rituximab combined with bendamustine or fludarabine are part of standard clinical context and should be considered prior to initiating Enjaymo where clinically appropriate.

Foundational therapies include rituximab ± bendamustine or fludarabine as recommended by consensus guidance
Consider prior use or appropriateness of these treatments when documenting rationale for Enjaymo

Background — Disease and Treatment Context

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia mediated by cold agglutinins (commonly IgM) that leads to complement‑mediated extravascular hemolysis. Diagnosis relies on clinical and laboratory evidence of chronic hemolysis, a positive direct antiglobulin test with C3d specificity, and a qualifying cold agglutinin titer. Treatment goals include increasing hemoglobin and improving anemia‑related symptoms; Enjaymo (sutimlimab‑jome) is indicated for adults with CAD who meet the specified diagnostic and treatment criteria.

Definitions

Cold agglutinin disease (CAD)

DefinitionA form of autoimmune hemolytic anemia mediated by cold agglutinins (autoantibodies, commonly IgM) without an underlying aggressive lymphoma or other obvious secondary cause

PathophysiologyHemolysis is primarily extravascular and complement-mediated: IgM binds RBCs in cooler sites, activates the classical complement pathway leading to C3b opsonization and hepatic macrophage phagocytosis

Diagnostic featuresDiagnosis requires markers of chronic hemolysis, positive polyspecific DAT, positive monospecific C3d DAT, IgG DAT ≤ 1+, and cold agglutinin titer ≥ 64 at 4°C

Clinical presentationCan cause agglutination of RBCs in cooler body parts with hemolytic anemia and related symptoms