CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Enjaymo (sutimlimab-jome) — Coverage Criteria for Primary Cold Agglutinin Disease

Defines accepted indications, contraindications, exclusions, coding, and use criteria for Enjaymo (sutimlimab-jome) for members and network providers; applies to medication authorization and reimbursement decisions processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnjaymo (sutimlimab-jome) — Coverage Criteria for Primary Cold Agglutinin Disease

Policy CodePolicy N/A

Change TypeExclusion wording revisedtemplate converted

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using billing code J1302 and supply documentation of confirmed primary CAD, recent Hgb ≤10 g/dL, and transfusion history within 6 months.

SourceLink

POLICY UPDATE CHANGES

Under exclusion criteria, removed 'Patient with clinically relevant infection'.

Converted to new Evolent guideline template and replaced UM ONC_1458 Enjaymo (sutimlimab-jome).

24 monthsmaximum treatment duration

≤10 g/dLHgb threshold

6 monthstransfusion window

J1302HCPCS code

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Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial therapy — primary Cold Agglutinin Disease

Covered when ALL of the following are met

Primary CAD indication criteria: Confirmed diagnosis of primary Cold Agglutinin Disease (CAD)

Diagnosis must be documented in the medical record.

Hemoglobin criterion: Hemoglobin (Hgb) less than or equal to 10 g/dL within the last 4 weeksHgb <= 10 g/dL within 4 weeks

Recent laboratory results must be provided.

Transfusion history: Recent history of blood transfusion within the prior 6 months6 months

Transfusion records or documentation of transfusion event required.

Monotherapy requirement: Enjaymo (sutimlimab-jome) prescribed as monotherapy

Use should align with FDA labeling or accepted compendia/peer-reviewed literature.

Continuation therapy

Continuation is allowed when ALL of the following are met

No disease progression: The member has not experienced disease progression on the requested medication

Clinical documentation must show no progression since prior authorization.

Recent prior use with no lapse: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationwithin 12 months; lapse <=30 days

Active authorization history should be verifiable in prior authorization records.

No additional medications added: No additional medication(s) are being added to the continuation request

Continuation requests that add therapies require full policy review.

The following conditions are exclusions to coverage for Enjaymo (sutimlimab-jome): continued requirement for blood transfusions or failure to achieve a hemoglobin (Hgb) rise of ≥2 g/dL after 5 weeks of treatment; presence of any overt malignancy (note: low‑grade monoclonal B‑cell lymphoproliferative disorder confined to blood or bone marrow without radiologic neoplasm is not excluded); Cold agglutinin disease that is secondary to infection, rheumatologic disease, or other autoimmune disorders (e.g., systemic lupus erythematosus); dosing that exceeds the single‑dose limits of 6.5 g for weight <75 kg or 7.5 g for weight ≥75 kg; and treatment duration exceeding the maximum of 24 months.

Coverage does not extend to investigational or off‑label uses of Enjaymo (sutimlimab-jome) that lack sufficient supporting evidence. Evidence considered insufficient includes uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Abstracts or meeting presentations without full published articles are specifically excluded as adequate evidence. Assessment of sufficiency considers whether the patient and disease characteristics, the therapy regimen, and clinically meaningful outcomes are adequately represented in the published evidence, with randomized and nonrandomized trials and study design elements weighed appropriately.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Hemoglobin and dose limits - inv-06

Hemoglobin thresholdHgb ≤ 10 g/dL within the last 4 weeks

Single-dose weight-based limit (<75 kg)6.5 g per single dose

Single-dose weight-based limit (≥75 kg)7.5 g per single dose

Maximum treatment durationTreatment must not exceed 24 months (see exclusion criteria)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enjaymo (sutimlimab-jome). Submit requests to Evolent for processing; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required
Applicable billing code: J1302 - Injection, sutimlimab-jome, 10 mg

Documentation Required

Continuation Request Conditions

Renewal (continuation) requests may be approved without a full reapplication when ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse >30 days of an active authorization; and no additional medications are being added to the continuation request.

Background

Enjaymo (sutimlimab-jome) is a monoclonal antibody therapy indicated for treatment of primary Cold Agglutinin Disease (CAD) as monotherapy in patients who meet specified hematologic and transfusion history criteria. The policy’s coverage pathway requires confirmation of primary CAD, recent hemoglobin ≤ 10 g/dL, and a qualifying history of blood transfusion, with use aligned to FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature.

Definitions

Cold Agglutinin Disease (CAD) — definition and scope (inv-12)

DefinitionPrimary Cold Agglutinin Disease (CAD) — immune‑mediated hemolytic anemia characterized by cold agglutinins; policy applies to confirmed primary CAD

Coverage scopeEnjaymo (sutimlimab‑jome) may be used as monotherapy for members with confirmed primary CAD

Key clinical entry requirementMember must have recent history of blood transfusion within 6 months in addition to Hgb ≤10 g/dL

Exclusions (related)CAD secondary to infection, rheumatologic disease, or other autoimmune disorders is excluded (see exclusion criteria)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnjaymo (sutimlimab-jome) — Coverage Criteria for Primary Cold Agglutinin Disease

Policy CodePolicy N/A

Change TypeExclusion wording revisedtemplate converted

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using billing code J1302 and supply documentation of confirmed primary CAD, recent Hgb ≤10 g/dL, and transfusion history within 6 months.

SourceLink

On This Page

Dose and duration limits respected: Treatment has not exceeded a cumulative duration of 24 months and single-dose limits (6.5 g for weight <75 kg; 7.5 g for weight ≥75 kg) are not exceeded24 months; single-dose limits 6.5 g (<75 kg) / 7.5 g (>=75 kg)

Requests exceeding these limits are excluded and may be denied.

Documentation Required

Required Documentation

Documentation required to support approval includes a confirmed diagnosis of primary Cold Agglutinin Disease (CAD); recent hemoglobin (Hgb) ≤ 10 g/dL within the last 4 weeks; and history of blood transfusion within the prior 6 months. Requests must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per Evolent policy.

Denial Risk

Triggers for Denial / Exclusion

Requests may be denied or excluded for the following triggers: evidence of secondary CAD (due to infection, rheumatologic disease, or other autoimmune disorders); presence of low‑grade monoclonal B‑cell lymphoproliferative disorder without radiologic neoplasm exclusion wording as specified; dosing that exceeds single‑dose limits (6.5 g for weight <75 kg; 7.5 g for weight ≥75 kg); treatment duration beyond 24 months; investigational or off‑label uses lacking sufficient evidence or not supported by CMS compendia or acceptable peer‑reviewed literature. Providers should ensure submitted evidence adequately represents the patient population, regimen, and clinically meaningful outcomes.

Single‑dose limits: 6.5 g (<75 kg) or 7.5 g (≥75 kg)
Maximum treatment duration: 24 months
Exclusions: secondary CAD (infection, rheumatologic or other autoimmune causes), insufficient evidence for off‑label indications