CurrentColorado Rocky Mountain Health PlansPolicy 2026D0100G

Enjaymo (sutimlimab-jome) — cold agglutinin disease coverage criteria

This policy governs medical necessity criteria and coverage guidance for Enjaymo (sutimlimab-jome) to treat hemolysis in adults with cold agglutinin disease (CAD) for UnitedHealthcare Commercial and Individual Exchange benefit plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEnjaymo (sutimlimab-jome) — cold agglutinin disease coverage criteria

Policy CodePolicy 2026D0100G

Change TypeTemplate update — no material clinical changes

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization and document hematologist diagnosis, laboratory confirmation (DAT, cold agglutinin titer ≥64 at 4°C, hemolysis markers), baseline Hb ≤10 g/dL, and dosing per FDA label.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1302billing code

D59.12diagnosis code

≤10 g/dLHb threshold

≥64titer threshold

≤12 moauth duration

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Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy:

Initial therapy criteria: 1) Diagnosis of cold agglutinin disease (CAD) by, or in consultation with, a hematologist with expertise in CAD; 2) Confirmation of CAD diagnosis with evidence of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count); 3) Positive polyspecific direct antiglobin test (DAT); 4) Positive monospecific DAT specific for C3d; 5) Immunoglobulin G (IgG) DAT ≤ 1+; 6) Cold agglutinin titer ≥ 64 at 4°C; 7) Cold agglutinin syndrome secondary causes have been ruled out (e.g., infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, other autoimmune disorders); 8) Baseline hemoglobin ≤ 10 g/dL; 9) Enjaymo prescribed by a hematologist; 10) Enjaymo dosing consistent with FDA‑approved labeling; 11) Patient is not receiving Enjaymo in combination with a complement inhibitor (examples include eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab, zilucoplan); 12) Initial authorization limited to no more than 12 months.

Do not flatten — all listed conditions are required.

Continuation Therapy / Reauthorization — Covered when ALL of the following are met for continuation of therapy

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

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 consistent with FDA‑approved labeling; 4) Patient is not receiving Enjaymo in combination with a complement inhibitor (examples include eculizumab, pegcetacoplan, iptacopan, crovalimab, ravulizumab, zilucoplan); 5) Reauthorization limited to no more than 12 months.

All continuation criteria required for reauthorization.

Use of Enjaymo in combination with other complement inhibitors is specifically excluded. Examples of complement inhibitors that must not be used concurrently with Enjaymo include: eculizumab, pegcetacoplan (Empaveli), iptacopan (Fabhalta), crovalimab (PiaSky), ravulizumab-cwzb (Ultomiris), and zilucoplan (Zilbrysq).

Diagnostic confirmation required for coverage includes documentation by, or in consultation with, a hematologist with expertise in CAD and laboratory evidence of chronic hemolysis (for example, elevated lactate dehydrogenase, decreased haptoglobin, increased indirect bilirubin, or increased reticulocyte count). Testing must include a positive polyspecific direct antiglobulin test (DAT), a positive monospecific DAT for C3d, and an IgG DAT ≤ 1+. The cold agglutinin titer must be reported and meet the policy threshold of ≥ 64 at 4°C.

Coding and Diagnostic Thresholds

Covered HCPCS Codes (reference)HCPCS

J1302

Injection, sutimlimab-jome, 10 mg

Relevant Diagnosis Codes (reference)ICD-10

D59.12

Cold autoimmune hemolytic anemia

inv-07: Cold agglutinin titer — diagnostic laboratory threshold

Diagnostic thresholdCold agglutinin titer ≥ 64 at 4°C

Test contextRequired as part of diagnostic confirmation along with DAT and hemolysis evidence

Trial eligibilityCARDINAL study enrolled patients with cold agglutinin titer ≥ 64 at 4°C

inv-08: Baseline hemoglobin — required hemoglobin threshold for initial therapy

Baseline hemoglobin thresholdBaseline hemoglobin ≤ 10 g/dL

Role in initial coverageRequired for initial therapy eligibility per coverage criteria

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Initial authorizations will be granted for no more than 12 months. Reauthorizations (continuation of therapy) are also issued for periods of up to 12 months and require documentation of ongoing benefit.

Initial authorization duration: ≤ 12 months
Reauthorization duration: ≤ 12 months
Prior authorization required

Documentation Required

Specialist Prescriber and Dosing

Enjaymo should be prescribed by, or in consultation with, a hematologist. For initial therapy, diagnosis must be by or confirmed in consultation with a hematologist experienced in CAD. For continuation of therapy, prescriber must be the treating hematologist or consult with one. Dosing must follow FDA approved labeling.

Background

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which circulating cold agglutinins bind red blood cells at low temperatures and activate the classical complement pathway. Complement activation (notably C3 deposition detectable on DAT) leads primarily to extravascular hemolysis and anemia. Diagnosis is based on clinical and laboratory evidence of chronic hemolysis together with immunohematologic testing (polyspecific DAT and monospecific C3d DAT) and measurement of cold agglutinin titer; secondary causes of cold agglutinin syndrome (for example infection, rheumatologic disease, systemic lupus erythematosus, or overt hematologic malignancy) should be excluded.

Definitions and Administration

inv-14: CAD — definition of Cold agglutinin disease

DefinitionCold agglutinin disease (CAD) is an autoimmune hemolytic anemia mediated by cold agglutinins causing complement-mediated, primarily extravascular hemolysis

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

Diagnostic testingDiagnosis relies on evidence of chronic hemolysis and positive polyspecific and monospecific DAT for C3d, plus cold agglutinin titer

inv-15: Sutimlimab administration — dosing schedule used in trials (Days 0, 7, then every 14 days; weight-based dosing)

Dosing schedule (trial)Intravenous administration on Days 0 and 7, then every 14 days (biweekly)

Weight-based dosing (CARDINAL)

Documentation Required

Required documentation includes specialist diagnosis or consultation and laboratory confirmation of chronic hemolysis and CAD diagnostic testing. For initial requests provide: hematology specialist diagnosis/consultation; evidence of chronic hemolysis (e.g., elevated LDH, decreased haptoglobin, increased indirect bilirubin, increased reticulocyte count); positive polyspecific DAT and positive monospecific DAT for C3d; IgG DAT ≤ 1+; cold agglutinin titer ≥ 64 at 4°C; documentation ruling out secondary causes of cold agglutinin syndrome; and baseline hemoglobin ≤ 10 g/dL. For reauthorization provide documentation of positive clinical response (e.g., increased hemoglobin, reduced transfusion needs, decreased hemolysis markers, improvement in anemia-related symptoms).

Initial documentation: hematology consult/diagnosis
Laboratory: markers of chronic hemolysis (LDH, haptoglobin, bilirubin, reticulocyte count)
DAT: positive polyspecific DAT and positive monospecific C3d DAT; IgG DAT ≤ 1+
Cold agglutinin titer ≥ 64 at 4°C
Rule out secondary causes of cold agglutinin syndrome
Baseline hemoglobin ≤ 10 g/dL
Reauthorization documentation: objective clinical improvement (e.g., hemoglobin increase, fewer transfusions, improved hemolysis markers)