ModifiedmhnPolicy CP.PHAR.503

Sutimlimab-jome (Enjaymo) for cold agglutinin disease

Defines medical necessity and coverage criteria for sutimlimab-jome (Enjaymo) for treatment of hemolysis in adults with primary cold agglutinin disease, including initial and continued therapy requirements and dosing limits for affected health plan lines of business.

Policy Summary

Payermhn

PolicySutimlimab-jome (Enjaymo) for cold agglutinin disease

Policy CodePolicy CP.PHAR.503

Change TypeMaterial clinical criteria and coding updates

Effective DateFeb 4, 2022

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing diagnosis, DAT/C3d results, cold agglutinin titer, baseline and on-treatment hemoglobin and weight for dosing; use HCPCS J1302 for billing.

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.

Removed requirement for history of at least one documented blood transfusion within 6 months (initial criteria) and revised required hemoglobin increase for continued therapy from 2 to 1.5 g/dL; modified evidence of positive response to require only one of specified response measures.

Added HCPCS code J1302 for sutimlimab-jome.

For Commercial continued approval duration updated to '6 months or to the member's renewal date, whichever is longer.'

Adjusted hemoglobin level criteria for continued therapy from 11 to 12 g/dL per FDA labeling and updated criteria to align with pivotal trial design.

Added HCPCS code J1302 for billing of sutimlimab-jome.

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

Revised required hemoglobin increase for continued therapy from 2 g/dL to 1.5 g/dL and changed evidence-of-response requirement to require only one of listed response criteria per CADENZA data and FDA indication.

For Commercial members, updated continued approval duration from 12 months to '6 months or to the member's renewal date, whichever is longer.'

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Coverage Criteria for Sutimlimab-jome (Enjaymo)

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Cold Agglutinin Disease):

Initial Approval - CAD: 1. Diagnosis of primary cold agglutinin disease (CAD).

Initial Approval - CAD: 2. Prescribed by or in consultation with a hematologist or oncologist.

Initial Approval - CAD: 3. Age ≥ 18 years.

Initial Approval - CAD: 4. Secondary CAD has been ruled out (e.g., cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy).

Initial Approval - CAD: 5. Evidence of active hemolysis with all of the following: (a) elevated total bilirubin; (b) polyspecific direct antiglobulin test (DAT) positive; (c) monospecific DAT showing i) strongly positive C3d and ii) IgG negative or weakly positive; (d) cold agglutinin titer ≥ 64 at 4°C.

Initial Approval - CAD: 6. Hemoglobin ≤ 10 g/dL.

Initial Approval - CAD: 7. Enjaymo (sutimlimab-jome) is not prescribed concurrently with rituximab or rituximab-based regimens (e.g., rituximab with bendamustine or fludarabine).

Initial Approval - CAD: 8. Requested dose does not exceed weight-based limits: a) body weight 39 kg to <75 kg: 6,500 mg (6 vials) on Day 0, Day 7, then every 2 weeks thereafter; b) body weight ≥75 kg: 7,500 mg (7 vials) on Day 0, Day 7, then every 2 weeks thereafter.

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met for Continued Approval (CAD):

Continued Approval - CAD: 1. Member meets one of the following: (a) currently receiving medication via the health plan benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity-of-care regulations.

Continued Approval - CAD: 2. Member is responding positively to therapy as evidenced by ONE of the following since initiation of Enjaymo: (a) increase in hemoglobin ≥ 1.5 g/dL from baseline OR hemoglobin ≥ 12 g/dL; OR (b) transfusion-free status or a decreased number of transfusions/blood units.

Continued Approval - CAD: 3. If the request is for a dose increase, the new dose must not exceed the weight-based maximums: a) 39 kg to <75 kg: 6,500 mg (6 vials) every 2 weeks; b) ≥75 kg: 7,500 mg (7 vials) every 2 weeks.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Initial and Continued Therapy (summary of revisions)

Policy criteria were updated; covered when revised clinical thresholds and response documentation are met.

Initial Therapy Criteria (revisions): Requirement for a history of at least one documented blood transfusion within 6 months was removed from the initial approval criteria; other initial criteria remain as specified in the policy.

See full initial criteria for details

Continued Therapy Criteria (revisions): Continued approval response criteria were revised to require demonstration of only one of the listed response measures. The required increase in hemoglobin for continued approval was changed from 2 g/dL to ≥1.5 g/dL, and the continued-therapy hemoglobin threshold was adjusted to ≥12 g/dL to align with FDA labeling and the CADENZA study.Hb increase ≥1.5 g/dL; continued Hb ≥12 g/dL

Response definitions and Hb thresholds updated per FDA labeling and pivotal trial design

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the request is supported by the applicable off‑label use policy or an evidence of coverage document. See the payer off‑label policies for each line of business (Commercial CP.CPA.09, Health Insurance Marketplace HIM.PA.154, and Medicaid CP.PMN.53) for criteria that might allow coverage of off‑label uses.

Per the updated FDA labeling reflected in this policy, Enjaymo (sutimlimab‑jome) must not be prescribed concurrently with rituximab or rituximab‑based regimens (for example, rituximab with bendamustine or fludarabine). Concurrent use with such regimens is explicitly prohibited and will affect medical necessity determinations.

Requests that do not document that the member meets the required diagnostic or laboratory criteria (for example, primary CAD diagnosis, positive polyspecific DAT and monospecific C3d findings, cold agglutinin titer ≥ 64 at 4°C, and hemoglobin ≤ 10 g/dL for initial therapy) or that fail to show secondary causes of cold agglutinin syndrome have been ruled out are considered not medically necessary and will be denied.

Operationally, documentation of concurrent therapy with rituximab or rituximab‑based regimens will trigger non‑coverage: requests indicating concomitant use should be denied. Providers submitting prior authorization must ensure records clearly show the absence of rituximab‑based therapy during the authorization period; failure to do so may result in denial or delayed adjudication.

Coding and Dosing Information

Covered HCPCS CodesHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Covered HCPCS Codes (updated)HCPCSCovered

J1302

HCPCS code added for sutimlimab-jome / billing

Weight-based dosing — dose by weight group (inv-10)

Weight groups39 kg to <75 kg and ≥75 kg

Dose for 39 kg to <75 kg6,500 mg per dose (6 vials) on Day 0, Day 7, then every 2 weeks

Dose for ≥75 kg7,500 mg per dose (7 vials) on Day 0, Day 7, then every 2 weeks

Hemoglobin change threshold for continued therapy — (inv-11)

Required hemoglobin changeIncrease in hemoglobin ≥ 1.5 g/dL from baseline

Alternative continued-therapy Hb criterionHemoglobin ≥ 12 g/dL may also satisfy response criteria (per continued-therapy criteria)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Providers must submit a prior authorization request and all supporting documentation (office/clinic notes, diagnostic test results, and laboratory data) demonstrating the member meets all initial or continued therapy criteria prior to initiation. Claims submitted without an approved prior authorization may be denied.

HCPCS: J1302 (sutimlimab-jome)

Denial Risk

Continued Therapy — Documentation & Denial Risk

For continued therapy, documentation must show the member meets the updated hemoglobin response criteria and required on‑treatment laboratory monitoring. If the member fails to meet the continued‑therapy hemoglobin criteria or insufficient documentation of response is provided, the request for continuation will be denied.

Updated required increase in hemoglobin for response: ≥ 1.5 g/dL (per 2Q 2023 update)

Background

Cold agglutinin disease (CAD) is an autoimmune hemolytic anemia in which circulating cold‑reactive IgM antibodies bind erythrocytes at lower temperatures and activate the classical complement pathway. Complement deposition (notably C3b/C3d) on red blood cells leads to extravascular hemolysis and anemia. Sutimlimab‑jome (Enjaymo) is a classical complement inhibitor indicated to treat hemolysis in adults with primary CAD by targeting this complement‑mediated mechanism.

Definitions and Diagnostic Tests

DAT / C3d — direct antiglobulin test (inv-22)

DefinitionDirect antiglobulin test (DAT; Coombs test) detects complement (eg, C3d) or IgG bound to red blood cells

C3d positivity significanceStrongly positive C3d on monospecific DAT supports complement-mediated hemolysis typical of CAD

Polyspecific vs monospecificPolyspecific DAT positive with a monospecific DAT showing strongly positive C3d and negative/weak IgG supports primary CAD diagnosis

Cold agglutinins — definition and clinical relevance (inv-23)

DefinitionCold agglutinins are typically IgM antibodies that bind erythrocytes at lower temperatures and can cause agglutination in acral circulation

PathophysiologyBinding of cold agglutinins activates the classical complement pathway, leading to C3b deposition and extravascular hemolysis

Revision History and Policy Updates

2025-02-03continued_approval_duration_updateLatest

Commercial continued approval duration changed to '6 months or to the member's renewal date, whichever is longer.'

2023-05-23criteria_revision

Removed requirement for history of at least one documented blood transfusion within 6 months from initial criteria and revised required hemoglobin increase for continued therapy from 2 g/dL to 1.5 g/dL; response requirement changed to require only one of the listed response measures per CADENZA study and revised FDA indication.

2022-03-08