CurrentUnitedHealthcarePolicy 2025D0100F

Medical Benefit Drug Policy - Enjaymo (Sutimlimab-Jome)

Defines UnitedHealthcare medical benefit drug coverage criteria for Enjaymo (sutimlimab-jome) for treatment of hemolysis in adults with cold agglutinin disease, including initial and continuation authorization requirements, applicable codes, and related clinical evidence/background.

Policy Summary

PayerUnitedHealthcare

PolicyMedical Benefit Drug Policy - Enjaymo (Sutimlimab-Jome)

Policy CodePolicy 2025D0100F

Change TypeCoverage rationale revisedtemplate updatearchival

Effective DateApr 1, 2025

Next Review Date

Key ActionPrior authorization required; document diagnosis confirmation, hematologist involvement, FDA-consistent dosing, absence of concomitant complement inhibitors, and evidence of clinical response for continuation (approvals limited to 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 Benefit Considerations section via template update.

Archived previous policy version 2024D0100E.

1FDA Indication (adults with CAD)

12 monthsInitial authorization max duration

12 monthsReauthorization max duration

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Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines UnitedHealthcare medical benefit drug coverage criteria for Enjaymo (sutimlimab-jome) for treatment of hemolysis in adults with cold agglutinin disease (CAD), including initial and continuation authorization requirements, applicable codes, and related clinical evidence/background. Policy number: 2025D0100F. Effective date: April 1, 2025. Last review: July 1, 2025. FDA indication: Enjaymo is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

Quick thresholds & limits

Cold agglutinin titer>= 64 at 4°C

IgG DAT<= 1 +

Baseline hemoglobin<= 10 g/dL

Initial authorization max duration12 months

Reauthorization max duration12 months

Primary billing codeJ1302

Initial Therapy - Medically Necessary Criteria

Continuation Therapy - Medically Necessary Criteria

Medically Necessary - Continuation of Therapy

For continuation of therapy, ALL of the following must be documented:

ALL of the following

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 is prescribed by, or in consultation with, a hematologist
Enjaymo dosing is in accordance with the United States Food and Drug Administration approved labeling
ALL of the following
- Examples of complement inhibitors: Empaveli (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab), Soliris (eculizumab), Ultomiris (ravulizumab-cwzb), Zilbrysq (zilucoplan)

Concomitant Complement Inhibitor Exclusion

Exclusion: Patients must not receive Enjaymo in combination with a complement inhibitor. Examples listed in the policy include: Empaveli (pegcetacoplan), Fabhalta (iptacopan), PiaSky (crovalimab), Soliris (eculizumab), Ultomiris (ravulizumab-cwzb), Zilbrysq (zilucoplan). Note: the policy was updated effective 04/01/2025 to expand the examples of excluded concomitant complement inhibitors to include PiaSky (crovalimab).

Denial Risk

Concomitant complement inhibitor exclusion

Claims may be denied if patient is receiving Enjaymo in combination with listed complement inhibitors (e.g., pegcetacoplan, iptacopan, crovalimab, eculizumab, ravulizumab-cwzb, zilucoplan).

Empaveli (pegcetacoplan)
Fabhalta (iptacopan)
PiaSky (crovalimab)
Soliris (eculizumab)
Ultomiris (ravulizumab-cwzb)
Zilbrysq (zilucoplan)

Applicable Codes

Drug HCPCS (J-code)HCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Diagnosis Codes Related to IndicationICD-10Covered

D59.12

Cold autoimmune hemolytic anemia

Provider Requirements & Billing Rules

Prior Authorization

Prior authorization required for initial and continuation therapy

Initial and reauthorization approvals are limited to no more than 12 months. Documentation must show diagnosis confirmation, hematologist involvement, FDA-consistent dosing, absence of concomitant complement inhibitors, and for continuation evidence of clinical response.

J1302
D59.12

Documentation Required

Diagnostic confirmation and specialist involvement required

Require documentation of chronic hemolysis markers, positive polyspecific DAT, positive monospecific DAT for C3d, IgG DAT ≤ 1+, cold agglutinin titer ≥ 64 at 4°C, and that diagnosis was by or in consultation with a hematologist.

Polyspecific DAT
Monospecific C3d DAT

Clinical Evidence Supporting Use

Background evidence: Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which cold agglutinins bind red blood cells and activate the classical complement pathway leading to primarily complement-mediated extravascular hemolysis. Sutimlimab (Enjaymo) is a classical complement C1s inhibitor given IV (loading doses on Days 0 and 7, then biweekly) that blocks classical pathway activation. Phase 3 evidence includes the single-arm CARDINAL study (n=24) showing a primary composite response in 54.2% of patients with a mean hemoglobin increase of 3.2 g/dL, rapid Hb rises of 1.2 g/dL by Week 1 and 2.3 g/dL by Week 3, and transfusion avoidance in 70.8% of patients from Weeks 5–26. The randomized placebo-controlled CADENZA trial demonstrated a responder rate of 72.7% with Enjaymo vs 15% with placebo (treatment difference 58.78, 95% CI: 34.6, 82.96; p = 0.0004).

Background & Definitions

Additional background/context: CAD is mediated by cold agglutinins that agglutinate RBCs at low temperatures and recruit classical complement components (C1, C4, C2) leading to C3b deposition and extravascular hemolysis by hepatic macrophages. Diagnosis relies on markers of chronic hemolysis, a positive polyspecific DAT with monospecific C3d, and cold agglutinin titer thresholds; treatment goals include improvement in hemoglobin and symptom relief.

Term	Definition
CAD	Cold agglutinin disease, a form of autoimmune hemolytic anemia mediated by cold agglutinins and complement.
DAT	Direct antiglobin test (Coombs test); polyspecific and monospecific for C3d are required as diagnostic criteria.

Revision History

2024D0100Earchived_policy_version

Archived previous policy version 2024D0100E.

2025-04-01material_change

Coverage rationale updated to expand examples of excluded concomitant complement inhibitors; PiaSky (crovalimab) was added to the list of complement inhibitors patients must not be receiving in combination with Enjaymo.

2025-07-01template_clarificationLatest