CurrentUnitedHealthcarePolicy IEXD0100.07

Enjaymo (sutimlimab-jome) — coverage criteria

Medical benefit drug policy for use of Enjaymo (sutimlimab-jome) to treat hemolysis in adults with cold agglutinin disease (CAD); applies to UnitedHealthcare members and providers administering the drug.

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (sutimlimab-jome) — coverage criteria

Policy CodePolicy IEXD0100.07

Change TypeRevised — expanded list of contraindicated concomitant complement inhibitors

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization with diagnostic documentation; initial and reauthorization approvals are limited to no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

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

Updated References section to reflect the most current information.

12 monthsmaximum approval period

J1302HCPCS

D59.12ICD-10

titer ≥ 64diagnostic threshold

≤10 g/dLbaseline Hb for initiation

Policy Summary

PayerUnitedHealthcare

PolicyEnjaymo (sutimlimab-jome) — coverage criteria

Policy CodePolicy IEXD0100.07

Change TypeRevised — expanded list of contraindicated concomitant complement inhibitors

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization with diagnostic documentation; initial and reauthorization approvals are limited to no more than 12 months.

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Medical necessity criteria

Covered when ALL of the following are met

Initial therapy: Diagnosis of cold agglutinin disease (CAD) by, or in consultation with, a hematologist with expertise in CAD; confirmation of CAD 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 antiglobulin test (DAT); positive monospecific DAT for C3d; IgG DAT ≤ 1+; cold agglutinin titer ≥ 64 at 4°C; cold agglutinin syndrome secondary causes have been 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; Enjaymo dosing in accordance with FDA-approved labeling; patient is not receiving Enjaymo in combination with a complement inhibitor (e.g., Soliris [eculizumab], Ultomiris [ravulizumab-cwzb], Empaveli [pegcetacoplan], Fabhalta [iptacopan], PiaSky [crovalimab], Zilbrysq [zilucoplan]); initial authorization for no more than 12 months.

See list of complement inhibitors in policy

Continuation of therapy: 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; Enjaymo dosing in accordance with FDA-approved labeling; patient is not receiving Enjaymo in combination with a complement inhibitor (e.g., Soliris [eculizumab], Ultomiris [ravulizumab-cwzb], Empaveli [pegcetacoplan], Fabhalta [iptacopan], PiaSky [crovalimab], Zilbrysq [zilucoplan]); reauthorization for no more than 12 months.

Cold agglutinin syndrome secondary causes must be excluded before Enjaymo is considered. Examples that must be ruled out include infection, rheumatologic disease, systemic lupus erythematosus, overt hematologic malignancy, and other autoimmune disorders. Documentation of exclusion of these secondary causes is required as part of the diagnostic confirmation of cold agglutinin disease.

Enjaymo must not be used in combination with a complement inhibitor. Examples listed in the policy include Soliris (eculizumab), Ultomiris (ravulizumab‑cwzb), Empaveli (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab), and Zilbrysq (zilucoplan). Requests for Enjaymo administered concurrently with any of these agents are inconsistent with coverage criteria and may be denied.

Diagnosis, Procedure, and Biomarker Codes

Applicable HCPCS CodesHCPCS

J1302

Injection, sutimlimab-jome, 10mg

Applicable Diagnosis CodesICD-10

D59.12

Cold autoimmune hemolytic anemia

inv-06: Cold agglutinin titer — ≥ 64 at 4°C

Cold agglutinin titer thresholdCold agglutinin titer ≥ 64 at 4°C

Role in diagnosisRequired as part of CAD confirmation alongside DAT and hemolysis markers

Clinical trial eligibilityUsed as an enrollment criterion in the CARDINAL sutimlimab study (titer ≥ 64 at 4°C)

inv-07: Baseline hemoglobin for initial therapy — ≤ 10 g/dL

Baseline hemoglobin requirement for initial therapyBaseline hemoglobin ≤ 10 g/dL

Clinical trial eligibilityHb ≤ 10 g/dL was an eligibility criterion in the CARDINAL study for sutimlimab

Authorization, Documentation, and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Initial authorization will be for no more than 12 months. Reauthorization (continuation) requests will also be approved for no more than 12 months at a time.

Initial authorization duration: <= 12 months
Reauthorization duration: <= 12 months

Denial Risk

Concomitant Complement Inhibitors — Denial Risk

Requests for Enjaymo will be denied if the patient is receiving Enjaymo in combination with other complement inhibitors. Examples of complement inhibitors that preclude combination therapy include Soliris (eculizumab), Ultomiris (ravulizumab-cwzb), Empaveli (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab), and Zilbrysq (zilucoplan).

Do not combine Enjaymo with listed complement inhibitors; requests may be denied if combined

Laboratory and Diagnostic Thresholds

inv-15: Cold agglutinin titer — ≥ 64 at 4°C

Diagnostic thresholdCold agglutinin titer ≥ 64 at 4°C

Required with DATTiter threshold must be present along with positive polyspecific DAT and C3d monospecific DAT

Referenced in guidanceInternational Consensus diagnostic recommendations specify CA titer ≥ 64 at 4°C

Key Definitions and Clinical Terms

inv-13: Chronic hemolysis — lab evidence (elevated LDH, decreased haptoglobin, indirect bilirubin, reticulocytosis)

Key laboratory markersElevated lactate dehydrogenase (LDH)

Key laboratory markersDecreased haptoglobin

Key laboratory markersIncreased indirect bilirubin

Key laboratory markersIncreased reticulocyte count

inv-14: CAD diagnostic criteria — DAT positive for C3d with IgG DAT ≤ 1+ and cold agglutinin titer ≥ 64 at 4°C

DAT and IgG criteriaPositive polyspecific DAT and positive monospecific DAT for C3d with IgG DAT ≤ 1+

Clinical Background

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which complement activation driven by cold agglutinins causes hemolysis. Diagnostic confirmation requires laboratory evidence of chronic hemolysis (for example, elevated LDH, low haptoglobin, increased indirect bilirubin, and increased reticulocyte count), a positive polyspecific direct antiglobulin test (DAT) with monospecific DAT positive for C3d and IgG DAT ≤ 1+, and a cold agglutinin titer ≥ 64 at 4°C. Treatment goals include increasing hemoglobin, reducing transfusion dependence, and improving anemia‑related symptoms; historically, rituximab‑based regimens have been used, while Enjaymo (sutimlimab‑jome) targets complement-mediated hemolysis in adults with CAD.

Policy Revisions and Update Log

04/01/2025material_revisionLatest

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

04/01/2025references_update

Updated References section to reflect the most current information.