CurrentCignaPolicy IP0405

Enjaymo (sutimlimab-jome) for cold agglutinin disease

Defines medical necessity, dosing, reauthorization, authorization duration, exclusions, and coding for sutimlimab-jome (Enjaymo) for treatment of hemolysis in cold agglutinin disease for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEnjaymo (sutimlimab-jome) for cold agglutinin disease

Policy CodePolicy IP0405

Change TypeClarified documentation languageno criteria changes

Effective DateMay 1, 2025

Next Review Date

Key ActionProvide documentation (chart notes, DAT showing C3d positive and IgG negative/weak, cold agglutinin titer >64 at 4°C, baseline labs, exclusion of secondary causes, weight) to support initial or reauthorization approvals up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added definition of 'documentation' and updated 'documentation' phrasing throughout coverage policy.

Annual Revision performed 5/1/2024 with no criteria changes.

1Covered Indication (Cold agglutinin disease)

1Not Covered Indication (Paroxysmal Cold Hemoglobinuria)

12Approval duration (months)

Coverage Summary

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.

Initial Therapy - Medical Necessity for Cold Agglutinin Disease

Enjaymo is considered medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of cold agglutinin disease (CAD)
Documentation required
Age 18 years or older
Weight ≥ 39 kg≥ 39 kg
History of at least ONE symptom associated with cold agglutinin disease
Documentation of chronic hemolysis
Documentation required
Diagnostic criteria
- Direct antiglobulin test (DAT) strongly positive for C3d and negative or only weakly positive for immunoglobulin G
  Laboratory documentation required
- Cold agglutinin antibody titer > 64 at 4°C (approximately 40°F)> 64 at 4°C
Baseline laboratory criteria (prior to treatment)
- Hemoglobin ≤ 10 g/dL≤ 10 g/dL
  Documentation of most recent pre-treatment hemoglobin required
- Total bilirubin above the upper limit of normal for the reporting laboratory
  Laboratory reference range must be provided
Secondary causes of cold agglutinin syndrome have been excluded
Documentation of evaluation for underlying malignancy, infection, or autoimmune disease as applicable
Medication is prescribed by, or in consultation with, a hematologist
Dosing regimen (one of the following)
- Weight ≥ 75 kg: 7,500 mg intravenously not more frequently than once weekly≥ 75 kg
- Weight ≥ 39 kg to < 75 kg: 6,500 mg intravenously not more frequently than once weekly39–<75 kg

When coverage is available and medically necessary, dosage, frequency, duration of therapy, and site of care should be reasonable and clinically appropriate and supported by evidence-based literature. Receipt of sample product does not satisfy criteria requirements for coverage.

Operational

Reauthorization / Continuation Therapy

Continuation is medically necessary when ALL of the following are met:

ALL of the following

All initial therapy medical necessity criteria are still met (diagnosis, age/weight, baseline labs, exclusion of secondary causes, hematology involvement)
Documentation of beneficial response to therapy
Examples include increase in hemoglobin compared to baseline, reduction in markers of hemolysis (e.g., bilirubin, LDH), decreased transfusion requirement, or documented clinical improvement in circulatory symptoms; documentation required

Authorization durations: Initial approval up to 12 months; reauthorization up to 12 months.

Operational

Not Medically Necessary / Exclusions

Any other use is considered not medically necessary, including:

ANY of the following

Use for paroxysmal cold hemoglobinuria
Insufficient evidence from controlled trials and evidence-based professional organizations for Enjaymo in this condition
Use for indications other than treatment of hemolysis in cold agglutinin disease in adults (e.g., pediatric patients, other autoimmune hemolytic anemias)
Use when baseline diagnostic or laboratory criteria are not met (e.g., absence of chronic hemolysis, DAT not showing strong C3d positivity, cold agglutinin titer ≤ 64 at 4°C, hemoglobin > 10 g/dL, or total bilirubin within laboratory normal range)
Use when secondary causes of cold agglutinin syndrome have not been excluded

Dosing

Cold agglutinin antibody titer> 64 at 4°C (approximately 40°F)

Hemoglobin (Hb)≤ 10 g/dL

Total bilirubinAbove the upper limit of normal for the reporting laboratory

Patient weight for eligibility≥ 39 kg

Applicable Codes

Drug J-code for EnjaymoHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Provider Actions

Prior Authorization

Authorization required

Initial and reauthorization approvals are limited to up to 12 months. Documentation must be provided to demonstrate diagnostic criteria, baseline laboratories, exclusion of secondary causes, and that the medication is prescribed by or in consultation with a hematologist; reauthorization must also include documentation of beneficial response.

J1302
Duration: up to 12 months

Documentation Required

Required supporting documentation

Provide chart notes and relevant medical records including DAT results (strongly positive for C3d and negative or only weakly positive for IgG), cold agglutinin titer greater than 64 at 4°C, evidence of chronic hemolysis, baseline labs (hemoglobin ≤ 10 g/dL and total bilirubin above the laboratory upper limit of normal), documentation that secondary causes have been excluded, and patient weight.

Chart notes and medical records
DAT results: C3d strongly positive; IgG negative or weak
Cold agglutinin titer > 64 at 4°C
Evidence of chronic hemolysis
Baseline labs: hemoglobin ≤ 10 g/dL; total bilirubin above ULN
Exclusion of secondary causes
Patient weight (≥ 39 kg)

Billing Rule

Dosing/billing per 10 mg units

Report HCPCS code J1302 (Injection, sutimlimab-jome, 10 mg) using the number of units that reflect the total dose administered (each unit = 10 mg).

Example: 6,500 mg = 650 units of J1302

Clinical Evidence

n=24CARDINAL Phase III trial enrollment

n=42CADENZA Phase III trial enrollment

Evidence summary: Phase III trials referenced: CARDINAL (n=24) and CADENZA (n=42) supporting efficacy in cold agglutinin disease.

Background

Background: Enjaymo (sutimlimab-jome) is a classical complement inhibitor indicated for treatment of hemolysis in cold agglutinin disease in adults. Cold agglutinin disease is an autoimmune hemolytic anemia defined by chronic hemolysis, typical direct antiglobulin test findings (strong positivity for C3d and negativity or only weak positivity for immunoglobulin G), and a cold agglutinin titer ≥ 64 at 4°C (approximately 40°F); secondary causes (cold agglutinin syndrome) must be excluded.

Documentation: May include chart notes, laboratory tests, medical test results, claims records, prescription receipts, and/or other information.

Revision History

5/1/2024annual_revision

Annual Revision performed with no criteria changes (summary: No criteria changes).

5/1/2025annual_revision (clarified)Latest

Annual Revision added definition of 'Documentation' and updated 'Documentation' phrasing throughout the coverage policy; no clinical criteria changes noted.