ModifiedHealth NetPolicy CP PHAR.503

Sutimlimab-jome (Enjaymo)

Policy governing medical necessity criteria, dosing, and coverage for sutimlimab-jome (Enjaymo) for treatment of hemolysis in adults with primary cold agglutinin disease for Health Net-affiliated plans.

Policy Summary

PayerHealth Net

PolicySutimlimab-jome (Enjaymo)

Policy CodePolicy CP PHAR.503

Change TypeMaterial clinical criteria revisions and coding additions

Effective Date02.04.22

Next Review Date

Key ActionSubmit prior authorization with diagnosis, labs (hemoglobin and DAT), weight-based dosing, and include HCPCS J1302 when applicable.

SourceLink

POLICY UPDATE CHANGES

Adjusted hemoglobin level criteria for continued therapy from 11 to 12 g/dL.

Added criterion that Enjaymo is not prescribed concurrently with rituximab or rituximab-based regimens.

Adjusted dosing weight cut-off and weight-based dosing regimen.

Removed requirement for history of at least one documented blood transfusion within 6 months from initial criteria.

Revised required increase in hemoglobin level for continued therapy from 2 g/dL to 1.5 g/dL.

Added HCPCS code J1302 for sutimlimab-jome.

Age ≥ 18Minimum age

<10 g/dLInitial Hb threshold

12 g/dLContinued Hb threshold

Required Hb increase

6,500 / 7,500 mgPer-dose amounts

Coverage Criteria for Sutimlimab-jome (Enjaymo)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1. Diagnosis of primary cold agglutinin disease (CAD). 2. Prescribed by or in consultation with a hematologist or oncologist. 3. Age ≥ 18 years. 4. Secondary CAD (cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy) has been ruled out. 5. Evidence of active hemolysis as evidenced by elevated total bilirubin. 6. Polyspecific direct antiglobulin test (DAT/Coombs) is positive. 7. Monospecific DAT demonstrates C3d strongly positive and IgG negative or weakly positive. 8. Cold agglutinin titer ≥ 64 at 4°C. 9. Hemoglobin < 10 g/dL. 10. Enjaymo (sutimlimab-jome) is not prescribed concurrently with rituximab or rituximab-based regimens. 11. Requested dose does not exceed approved weight-based dosing: for body weight 39 kg to <75 kg: 6,500 mg per dose; for body weight ≥75 kg: 7,500 mg per dose.

Approval duration: 6 months

Continuation Therapy

Continued therapy covered when ONE of the following (a or b) is met and member is responding:

Continued Therapy Response: a. Member is transfusion-free or has a decreased number of transfusions/blood units since initiation of Enjaymo; b. Increase in hemoglobin ≥ 1.5 g/dL since initiation of Enjaymo or hemoglobin level ≥ 12 g/dL since initiation.Hb increase ≥ 1.5 g/dL; Hb ≥ 12 g/dL

Member must have previously met initial approval criteria or be currently receiving medication under continuity of care rules.

Continued Dosing: If request is for a dose increase, the new dose must not exceed approved weight-based dosing: 39 kg to <75 kg: 6,500 mg every 2 weeks; ≥75 kg: 7,500 mg every 2 weeks.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date.

Continued Therapy (updated)

Continued therapy and initiation criteria updated per FDA labeling and CADENZA trial

Continued Therapy Requirements (Updated): Member meets revised hemoglobin criteria and demonstrates evidence of positive response defined as at least one of the specified responses per the revised FDA indication and CADENZA study; the prior requirement for a 2 g/dL increase was revised to 1.5 g/dL for continued approval.Hb ≥ 12 g/dL; Hb increase ≥ 1.5 g/dL

Requirement for prior transfusion history removed for initiation per 2Q2023 update

Initial Therapy (updated)

Initial therapy criteria

Initial Therapy Requirements (Updated): Prior documented history of at least one blood transfusion within 6 months is no longer required for initiation; initiation should follow FDA labeling and supporting clinical documentation (diagnosis, relevant DAT and titer results, baseline hemoglobin and bilirubin, and weight-based dosing within approved limits).none

Per 2Q2023 annual review the transfusion history requirement was removed

Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient supporting documentation consistent with the applicable off‑label use policy for the member's line of business (see related policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid). If the requested use falls under formulary/non‑formulary review pathways, refer to the relevant no‑coverage or non‑formulary policies listed in the policy references.

Per the policy update aligned with FDA labeling and the RT4 revision, Enjaymo (sutimlimab‑jome) must not be prescribed concurrently with rituximab or rituximab‑based regimens. Requests for Enjaymo that indicate concurrent use with rituximab should not meet approval criteria unless documentation demonstrates the rituximab therapy has been discontinued and the member otherwise meets the policy's initiation or continuation requirements.

Uses that are not listed as covered in this policy and that are not eligible for coverage under the formulary/non‑formulary processes or an off‑label exception are considered not medically necessary and will be denied per the applicable line‑of‑business policies. Refer providers to the referenced formulary/no‑coverage and off‑label policies for guidance on documentation and exceptions prior to submitting a coverage request.

If the member does not meet the revised continued therapy thresholds or does not demonstrate evidence of positive response as defined in this policy (for example, failure to achieve an increase in hemoglobin of ≥ 1.5 g/dL or to reach a hemoglobin level of ≥ 12 g/dL, or lack of decreased transfusion requirement), ongoing therapy may be considered not medically necessary and requests for continued coverage may be denied. Providers should submit clinical documentation (office notes, lab results) showing the member's hemoglobin trend and transfusion history to support continued use.

Billing and Coding

HCPCS CodesHCPCS

J1302

Injection, sutimlimab-jome; 10 mg

Covered HCPCS CodesHCPCSCovered

J1302

Injection, sutimlimab-jome; 10 mg

Cold agglutinin titer — threshold

Cold agglutinin titer≥ 64 at 4°C

Test temperatureMeasured at 4 degrees Celsius per policy requirement

Role in initial approvalRequired as part of initial CAD diagnostic criteria (monospecific DAT and cold agglutinin titer)

Hemoglobin (initial) — threshold

Initial hemoglobin thresholdHemoglobin < 10 g/dL

ApplicabilityRequired for initial approval of sutimlimab-jome (Enjaymo) for CAD in adults

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization & Coding

Prior authorization is required for sutimlimab-jome (Enjaymo). Submit prior authorization requests to the Health Net medical policy/prior authorization process before initiating therapy. Use HCPCS code J1302 when billing for sutimlimab-jome.

Prior authorization required
Bill using HCPCS J1302 (Injection, sutimlimab-jome; 10 mg)

Documentation Required

Documentation Requirement

Providers must submit complete clinical documentation with the prior authorization request. Failure to provide required documentation may result in delay or denial of the request.

Submit office/clinic notes documenting diagnosis and treatment plan

Background

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia mediated by IgM autoantibodies that activate the classical complement pathway, leading to C3b opsonization of red blood cells and primarily extravascular hemolysis. Sutimlimab‑jome (Enjaymo) is a targeted classical complement (C1s) inhibitor indicated to treat hemolysis in adults with primary CAD; the agent reduces complement‑mediated hemolysis and thereby can improve hemoglobin and reduce transfusion needs in affected patients.

Definitions and Response Criteria

CAD — definition

AbbreviationCAD = cold agglutinin disease

Clinical contextAutoimmune hemolytic anemia mediated by cold-reacting IgM autoantibodies (policy applies to primary CAD)

Appendix referenceDefined in Appendix A: Abbreviation/Acronym Key

DAT — definition

AbbreviationDAT = direct antiglobulin test

Also known asCoombs test (polyspecific and monospecific DAT referenced in criteria)

Role in criteria

Policy Revision History

2022-03-08material_revision

Criteria updated per FDA labeling: adjusted continued therapy hemoglobin threshold from 11 to 12 g/dL, added restriction that Enjaymo not be prescribed concurrently with rituximab or rituximab-based regimens, and adjusted dosing weight cut-off; reflected in P&T approval.

2022-09-09coding_addition

Added HCPCS code J1302 (Injection, sutimlimab-jome; 10 mg) to coding section for billing documentation.

2023-01-26material_revision

2Q 2023 annual review removed requirement for a documented blood transfusion within 6 months from initial criteria, revised required hemoglobin increase for continued therapy from 2.0 g/dL to 1.5 g/dL, and modified evidence-of-response requirement to require only one of the specified responses per revised FDA indication and CADENZA data; inactive HCPCS codes were removed.

Policy Summary

PayerHealth Net

PolicySutimlimab-jome (Enjaymo)

Policy CodePolicy CP PHAR.503

Change TypeMaterial clinical criteria revisions and coding additions

Effective Date02.04.22

Next Review Date

Key ActionSubmit prior authorization with diagnosis, labs (hemoglobin and DAT), weight-based dosing, and include HCPCS J1302 when applicable.

SourceLink

On This Page

DocumentationMust be supported by lab results submitted with prior authorization request

Hemoglobin continued therapy threshold

Continued therapy hemoglobin thresholdHemoglobin ≥ 12 g/dL

Source of changeAdjusted per FDA labeling update and RT4/P&T approval to 12 g/dL for continued therapy

Use in continued approval logicMeeting this threshold is one pathway for continued coverage per policy

Required hemoglobin increase for continued therapy

Required hemoglobin increase for continued therapyIncrease in hemoglobin ≥ 1.5 g/dL since initiation

Revision noteRequirement revised from 2 g/dL to 1.5 g/dL per 2Q2023 annual review and CADENZA data

Continued therapy optionsAn increase ≥1.5 g/dL is an alternative to achieving Hb ≥12 g/dL for continued coverage

Include laboratory results and relevant imaging or consultant notes as applicable

Documentation Required

Required Documentation

Supporting documentation must include office chart notes and pertinent laboratory results demonstrating the member meets all approval criteria. Documentation should directly support diagnosis, evidence of active hemolysis, direct antiglobulin test (DAT) results, cold agglutinin titer, and current hemoglobin values.

Office/clinic progress notes
Relevant lab results (bilirubin, hemoglobin, DAT, cold agglutinin titer)
Consultation notes from hematologist/oncologist if applicable

Documentation Required

Required Clinical Documentation

Clinical documentation should reflect the revised clinical criteria: the updated hemoglobin thresholds for initiation/continuation and that prior transfusion history is no longer required for initiation. For continuation requests, document hemoglobin response consistent with the current threshold (increase ≥1.5 g/dL) or other evidence of clinical benefit per updated guidance.

Document current hemoglobin and trend
Document evidence of response (hemoglobin increase ≥1.5 g/dL or other clinical benefit)
Do not include prior transfusion history as a required element for initiation

Note

Formulary / Off‑Label Referral

Requests for uses not listed on the formulary or not covered by this policy require referral to the applicable formulary/non-formulary or off‑label use policy for the member's line of business.

For formulary drugs follow the commercial/Marketplace/Medicaid formulary policies referenced
For non‑formulary or off‑label uses, follow the off‑label and non‑formulary policies referenced

Billing Rule

Concurrent Therapy Restriction

Enjaymo must not be prescribed concurrently with rituximab or rituximab‑based regimens (for example rituximab with bendamustine or fludarabine). Prior authorization requests that indicate concurrent use with rituximab regimens will be considered not medically necessary.

Concurrent use with rituximab or rituximab‑based regimens is disallowed

Denial Risk

Denial Triggers

Denial may be triggered if submitted documentation does not demonstrate that the member meets the revised hemoglobin criteria or other clinical requirements, if required documentation is missing, or if there is evidence of disallowed concurrent therapy.

Failure to meet hemoglobin criteria or lack of evidence of response (per current thresholds)
Missing office notes or laboratory data
Concurrent rituximab or rituximab‑based therapy

Polyspecific DAT positive and monospecific C3d strongly positive required for initial approval

Evidence of positive response — continued therapy

Definition of evidence of positive responseMember demonstrates at least one of the following: transfusion-free or decreased transfusions since initiation, OR increase in hemoglobin ≥ 1.5 g/dL, OR hemoglobin ≥ 12 g/dL

Source of criteria changeModified per revised FDA indication and CADENZA trial data (2Q2023 update) — only one of the responses is required

Implication for continued therapyDocumentation of one listed response is required for continued coverage; prior requirement for both responses removed

2024-02-08administrative_review

2Q 2024 annual review: no significant clinical changes; references reviewed and updated.

2025-02-03administrative_revisionLatest

2Q 2025 annual review updated Commercial continued approval duration from 12 months to 6 months or to the member's renewal date, whichever is longer (template standard injectable approval duration).