CurrentEmblemHealthPolicy N/A

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

Defines accepted indications, coverage criteria, exclusions, and coding for Enjaymo (sutimlimab-jome) for members; applies to providers submitting medication requests to Evolent for EmblemHealth lines of business.

Policy Summary

PayerEmblemHealth

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

Policy CodePolicy N/A

Change TypeTemplate conversionnon-material edits

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using billing code J1302 and provide documentation of primary CAD with Hgb ≤10 g/dL and recent transfusion history.

SourceLink

POLICY UPDATE CHANGES

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

24maximum treatment duration

≥2 g/dLrequired Hgb rise by 5 weeks

6 morecent transfusion timeframe (initial)

J1302billing code

6.5/7.5single dose max (wt‑based)

Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial Therapy

Covered when ALL of the following are met

Primary CAD coverage criteria: Member has a confirmed diagnosis of primary Cold Agglutinin Disease (CAD).as stated

Diagnosis must be supported by documentation per policy (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature).

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

Transfusion history: Documented recent history of blood transfusion within the prior 6 months.

Policy Summary

PayerEmblemHealth

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

Policy CodePolicy N/A

Change TypeTemplate conversionnon-material edits

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization using billing code J1302 and provide documentation of primary CAD with Hgb ≤10 g/dL and recent transfusion history.

SourceLink

On This Page

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.

Regimen	Indication / Eligibility
Enjaymo (sutimlimab-jome) monotherapy per prescribing information
Primary Cold Agglutinin Disease (CAD) with confirmed diagnosis; hemoglobin (Hgb) ≤ 10 g/dL within the last 4 weeks; recent history of blood transfusion within 6 months.

Enjaymo (sutimlimab-jome) is considered not medically necessary for investigational or off‑label indications that lack sufficient supporting evidence. Sufficient evidence is defined by inclusion in CMS‑recognized compendia or acceptable peer‑reviewed literature; case reports or meeting abstracts alone are inadequate. Evaluation of evidence considers whether the patient population and regimen are represented, whether outcomes are clinically meaningful, and whether study design is appropriate — nonrandomized trials with adequate subject numbers may be supportive, while anecdotal reports are generally insufficient.

Coding and Dosing Information

Covered HCPCS CodesHCPCSCovered

J1302

Injection, sutimlimab-jome, 10 mg

Hemoglobin response — baseline and early response

Baseline hemoglobinHgb <= 10 g/dL within the last 4 weeks

Required hemoglobin response to avoid exclusion>= 2 g/dL rise from baseline by 5 weeks of treatment

Consequence of not meeting responseContinued requirement for blood transfusions or failure to achieve the >=2 g/dL rise are exclusion criteria

Dosing single-dose maximums

Single-dose maximum for weight <75 kg6.5 gm per single dose

Single-dose maximum for weight >=75 kg7.5 gm per single dose

Policy actionDosing above these single-dose limits is an exclusion for coverage

Maximum treatment duration

Maximum authorized treatment duration24 months

Policy consequenceTreatment beyond 24 months is an exclusion and may be denied

Documentation noteDuration limit applies to Enjaymo (sutimlimab-jome) therapy per policy exclusions

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Enjaymo (sutimlimab-jome). Providers must obtain prior authorization from Evolent/EmblemHealth before initiating therapy.

Prior authorization is required for initial and renewal requests for Enjaymo (sutimlimab-jome).
Billing code: HCPCS J1302 — Injection, sutimlimab-jome, 10 mg.

Note

Continuation Request Conditions

Continuation (renewal) requests may be processed without full re-evaluation when all continuation conditions are met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medications are being added to the continuation request.

Documentation Required

Required Clinical Documentation

Supporting clinical documentation must be supplied with the request. Use evidence from FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer-reviewed literature that meets CMS standards.

Documented diagnosis of primary Cold Agglutinin Disease (CAD).
Hemoglobin (Hgb) ≤ 10 g/dL within the last 4 weeks.
Recent history of blood transfusion within the prior 6 months.
Prior treatment history and response, including dates and outcomes of therapies.
Weight and dosing calculation to confirm dose does not exceed single-dose limits (≤6.5 g if weight <75 kg; ≤7.5 g if weight ≥75 kg).
Laboratory results supporting baseline and on-treatment hemoglobin values.
Rationale and citations from FDA labeling, CMS compendia, NCCN/ASCO guidance, or peer‑reviewed literature demonstrating indication and expected benefit.

Denial Risk

Triggers for Denial / Exclusion

Requests should include information that would identify triggers for denial or exclusion — failure to meet response criteria, ongoing transfusion dependence, excluded secondary causes, dosing or duration limits, or investigational/off‑label uses lacking sufficient evidence.

Member continued to require blood transfusions after treatment initiation.
Failure to achieve an increase in Hgb ≥2 g/dL after 5 weeks of Enjaymo (sutimlimab-jome) treatment.
Presence of overt malignancy (excluding primary CAD as specified).
Cold agglutinin disease secondary to infection, rheumatologic disease, or other secondary causes.
Dosing exceeds single-dose limits: >6.5 g for weight <75 kg or >7.5 g for weight ≥75 kg.
Treatment duration exceeds maximum limit of 24 months.
Use for investigational or off‑label indications not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature (insufficient evidence such as only case reports or abstracts without full peer‑reviewed publication).

Criterion	Requirement
Diagnosis
Confirmed primary Cold Agglutinin Disease (CAD).
Baseline hemoglobin
Hemoglobin (Hgb) ≤ 10 g/dL documented within the last 4 weeks.
Transfusion history
Recent history of blood transfusion within the prior 6 months.
Regimen
Enjaymo (sutimlimab-jome) used as monotherapy per prescribing information.

Background on Cold Agglutinin Disease

Cold Agglutinin Disease (CAD) is an immune hemolytic anemia in which autoantibodies (cold agglutinins) trigger complement‑mediated destruction of red blood cells, leading to declining hemoglobin levels and potential transfusion dependence. Primary CAD is characterized as a low‑grade monoclonal B‑cell lymphoproliferative disorder detectable in blood or bone marrow without radiologic evidence of neoplasm. Sutimlimab‑jome (Enjaymo) targets the classical complement pathway to reduce hemolysis and is indicated for patients with primary CAD who meet the policy’s hematologic and transfusion history criteria.

OpenPayer

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

Coverage Criteria for Enjaymo (sutimlimab-jome)

Coding and Dosing Information

Provider Actions, Documentation, and Prior Authorization

Regimens Covered

Key Definitions

Line of Therapy Information

Background on Cold Agglutinin Disease