CurrentUnitedHealthcarePolicy CSINDO1OO.06

Enjaymo (Sutimlimab-Jome) (for Indiana Only)

This Indiana-only UnitedHealthcare Medical Benefit Drug Policy governs coverage criteria and authorization requirements for Enjaymo (sutimlimab-jome) for treatment of cold agglutinin disease (CAD) for Community Plan members in Indiana.

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (Sutimlimab-Jome) (for Indiana Only)

Policy CodePolicy CSINDO1OO.06

Change TypeRevised coverage rationale (added PiaSky/crovalimab to combination exclusions)

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization documenting hematologist-confirmed CAD, required labs (C3d DAT, cold agglutinin titer ≥64, baseline Hb <10 g/dL), and absence of concurrent complement inhibitors.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale updated list of examples of complement inhibitors the patient must not be receiving in combination with Enjaymo; added PiaSky (crovalimab).

J1302HCPCS code (10 mg)

D59.12Diagnosis code (CAD)

<10 g/dLHb threshold

≥64Titer requirement

≤12 mo

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Coverage and Medical Necessity Criteria

Initial therapy (medical necessity criteria)

Covered when ALL of the following are met:

Diagnosis of CAD by, or in consultation with, a hematologist with expertise in the diagnosis of CAD

Confirmation of CAD: Confirmation based on evidence of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count); positive monospecific DAT for C3d; cold agglutinin titer ≥ 64 at 4°C; IgG DAT <1+

Hemoglobin requirement: Baseline hemoglobin level < 10 g/dL<10 g/dL

Secondary causes excluded: Cold agglutinin syndrome secondary to infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, or other autoimmune disorders has been ruled out

Prescriber: Enjaymo is prescribed by a hematologist

No concurrent complement inhibitors: Patient is not receiving Enjaymo in combination with specified complement inhibitors (examples listed: eculizumab, ravulizumab-cwzb, pegcetacoplan, iptacopan, crovalimab, zilucoplan)

Dosing: Enjaymo dosing is in accordance with United States FDA–approved labeling

Authorization duration: Initial authorization will be for no more than 12 months<=12 months

Continuation (reauthorization) therapy

Covered when ALL of the following are met:

Prescriber or consultation: Enjaymo is prescribed by, or in consultation with, a hematologist

Clinical response: Documentation of positive clinical response to therapy (e.g., increase in hemoglobin, decreased transfusion requirements, decreased markers of hemolysis, improvement in anemia-related symptoms)

Dosing: Enjaymo dosing is in accordance with United States FDA–approved labeling

Enjaymo must not be used concurrently with certain other complement inhibitors. Examples of agents that, if the member is receiving them, will exclude coverage of Enjaymo include Soliris (eculizumab), Ultomiris (ravulizumab-cwzb), Empaveli (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab), and Zilbrysq (zilucoplan).

Operational clarification: prior authorization must document that the member is not receiving Enjaymo in combination with any of the listed complement inhibitors. The policy update effective 04/01/2025 expanded the explicitly listed examples to include PiaSky (crovalimab), and the presence of concurrent therapy with any listed complement inhibitor is a basis for denial of coverage.

Enjaymo is considered not medically necessary when the documented diagnostic criteria for cold agglutinin disease (CAD) are not met. Examples that do not meet medical necessity include absence of evidence of chronic hemolysis (e.g., no elevated LDH, no decreased haptoglobin, no increased indirect bilirubin or reticulocyte count), a negative monospecific DAT for C3d, a cold agglutinin titer < 64 at 4°C, or an IgG DAT ≥ 1+.

Additionally, treatment is not supported as medically necessary if the member’s baseline hemoglobin is ≥ 10 g/dL, or if documentation does not show that secondary causes of cold agglutinin syndrome (for example infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, or other autoimmune disorders) have been ruled out.

Billing and Diagnostic Codes

Applicable HCPCS CodesHCPCS

J1302

Injection, sutimlimab-jome, 10 mg

Applicable Diagnosis CodesICD-10

D59.12

Cold autoimmune hemolytic anemia

inv-07: Cold agglutinin titer — diagnostic titer threshold

Diagnostic titer thresholdCold agglutinin titer ≥ 64 at 4°C

Temperature for testingMeasured at 4°C (optimum thermal range 3–4°C referenced in background)

Role in eligibilityRequired as part of confirmation of CAD diagnosis for initial enrollment

inv-08: Baseline hemoglobin — enrollment/therapy threshold

Baseline hemoglobin thresholdBaseline hemoglobin < 10 g/dL

Context of useRequired for eligibility in CARDINAL study and for initial therapy authorization

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Requests must demonstrate the patient meets diagnostic and clinical criteria for cold agglutinin disease (CAD) and include supporting documentation per policy. Initial authorizations are typically for up to 12 months; continuation requests must show ongoing clinical benefit and adherence to FDA dosing.

HCPCS: J1302 (Injection, sutimlimab-jome, 10 mg)
Diagnosis: D59.12 (Cold autoimmune hemolytic anemia)

Denial Risk

Lack of CAD Diagnostic Documentation — Denial Risk

Denial risk if documentation does not confirm the CAD diagnosis or if exclusionary conditions are present. Missing elements that may lead to denial include lack of hematologist involvement, absence of evidence of chronic hemolysis, missing DAT/C3d or cold agglutinin titer results, or failure to rule out secondary causes of cold agglutinin syndrome.

Clinical Background

Cold agglutinin disease (CAD) is a form of autoimmune hemolytic anemia caused by cold agglutinins, most often IgM antibodies, that bind red blood cells at low temperatures and trigger complement-mediated hemolysis. The resulting hemolysis is typically extravascular and driven by activation of the classical complement pathway.

Diagnosis of CAD requires both clinical and laboratory evidence: evidence of chronic hemolysis (for example elevated lactate dehydrogenase, decreased haptoglobin, increased indirect bilirubin, or increased reticulocyte count), a positive monospecific direct antiglobulin test (DAT) for C3d, and a characteristic cold agglutinin titer ≥ 64 at 4°C. Sutimlimab (Enjaymo) targets the classical complement pathway (C1s) to reduce complement-mediated hemolysis in CAD.

Key Definitions and Diagnostic Criteria

inv-14: Cold agglutinin disease (CAD) — succinct definition and key characteristics

DefinitionCold agglutinin disease (CAD) is an autoimmune hemolytic anemia mediated by cold agglutinins (autoantibodies) causing complement‑mediated extravascular hemolysis

Primary vs secondaryDefined as cold agglutinin–mediated AIHA without an obvious underlying disease such as aggressive lymphoma or specific infections

PathophysiologyIgM cold agglutinins bind RBCs in cooler body regions, recruit classical complement (C1, C4, C2) leading to C3b opsonization and hepatic extravascular hemolysis

inv-15: Diagnostic criteria referenced — evidence of chronic hemolysis and essential lab findings

Required evidence of chronic hemolysisElevated LDH, decreased haptoglobin, increased indirect bilirubin, and/or increased reticulocyte count

Direct antiglobulin test (DAT) requirements