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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCountyCare Enjaymo Prior Auth Coverage | OpenPayer
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    CurrentCountyCarePolicy 5074.CC

    Enjaymo (sutimlimab-jome) Coverage Criteria

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    This policy governs prior authorization for Enjaymo under the Health Plan medical benefit for adults with primary cold agglutinin disease. It applies to practitioners requesting or providing the drug and establishes initial and annual continuation criteria.

    Policy Summary
    PayerCountyCare
    PolicyEnjaymo (sutimlimab-jome) Coverage Criteria
    Policy CodePolicy 5074.CC
    Change TypeAnnual reviewno material clinical or coverage changes
    Effective DateJune 1, 2026
    Last ReviewMar 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with all required clinical, laboratory, vaccination, transfusion-history, prescriber, and dosing documentation.
    SourceLink
    POLICY UPDATE CHANGES

    The policy history identifies a March 2026 annual review.

    ≥18 yearsMinimum age for initial authorization
    ≤10.0 g/dLMaximum hemoglobin for initial authorization
    1 transfusionRequired transfusion history
    12 monthsMaximum reauthorization period

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    J1302
    HCPCS code

    Coverage Criteria

    Initial Therapy

    Covered when ALL of the following initial criteria are met:

    Initial therapy

    • Eligibility and diagnosis: The member is age 18 or older, Enjaymo is prescribed by or in consultation with a hematologist, and the member has primary cold agglutinin disease.Age ≥18 years
    • Secondary disease excluded: Secondary cold agglutinin disease has been ruled out, including infection, rheumatologic disease, systemic lupus erythematosus, and overt hematologic malignancy.
    • Laboratory findings: The member has a hemoglobin level of 10.0 g/dL or less and a bilirubin level above the normal reference range.Hgb ≤10.0 g/dL; bilirubin above normal
    • Transfusion history: The member has at least one documented blood transfusion before starting Enjaymo.≥1 transfusion before therapy
    • Vaccination: Documentation or provider attestation confirms vaccination against encapsulated bacteria, such as pneumococcal and meningococcal vaccination, according to the most current ACIP recommendations for patients with persistent complement deficiencies.Current ACIP recommendations
    • Dosing: Enjaymo is prescribed at a dose within the manufacturer’s dosing guidelines based on diagnosis, weight, and other FDA-approved labeling requirements.FDA-approved manufacturer dosing

    Continuation Therapy

    Covered for reauthorization when ALL of the following criteria are met:

    Continuation therapy

    • Response to therapy

      • Reduced transfusion requirement: The number of transfusions or blood units required has decreased.Decrease
      • Hemoglobin increase: The member’s hemoglobin has increased by more than 2 g/dL.>2 g/dL increase
      • Hemoglobin target: The member’s hemoglobin level is at least 12 g/dL.≥12 g/dL

    For reauthorization, concurrent treatment with rituximab and Enjaymo is excluded. The member must not be taking rituximab with Enjaymo.

    Applicable Coding and Clinical Thresholds

    Applicable HCPCS CodeHCPCS
    J1302Injection, sutimlimuab-jome, 10mg
    Hemoglobin
    Initial authorization hemoglobin thresholdHemoglobin (Hgb) level ≤ 10.0 g/dL
    Bilirubin
    Required bilirubin resultBilirubin level above normal reference range
    Hemoglobin response
    Continuation response thresholdHemoglobin increase by >2 g/dL or hemoglobin level ≥12 g/dL

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Prior Authorization Required

    Prior authorization is required before initial Enjaymo therapy. The request must meet all applicable medical-necessity criteria and be prescribed within FDA-approved manufacturer dosing guidelines.

    • Member is age 18 or older.
    • Enjaymo is prescribed by, or in consultation with, a hematologist.
    • Member has primary cold agglutinin disease (CAD).
    • Secondary CAD has been ruled out, including infection, rheumatologic disease, systemic lupus erythematosus, and overt hematologic malignancy.
    • Hemoglobin is ≤ 10.0 g/dL and bilirubin is above the normal reference range.
    • Member has at least one documented blood transfusion before starting Enjaymo.
    Prior Authorization

    Annual Reauthorization Required

    Reauthorization is reviewed annually to establish medical necessity for continued therapy. Approval is limited to up to one year and requires that all continuation criteria are met.

    Policy and Product Background

    Enjaymo (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). This policy establishes coverage requirements for Enjaymo, including annual reauthorization based on documented response to therapy, absence of concurrent rituximab treatment, and dosing within the manufacturer’s FDA-approved guidelines.

    Definitions and Abbreviations

    Definition
    CADCold agglutinin disease
    Definition
    HgbHemoglobin

    Initial Therapy Criteria

    Initial Therapy

    Initial coverage requires ALL of the following criteria:

    Initial therapy

    • Age: The member is age 18 or older.≥18 years
    • Prescriber specialty: Enjaymo is prescribed by, or in consultation with, a hematologist.
    • Diagnosis: The member has primary cold agglutinin disease (CAD).
    • Exclusion of secondary disease:

    Annual Continuation Therapy Criteria

    Annual Continuation Therapy

    Annual reauthorization requires ALL of the following criteria:

    Annual continuation therapy

    • Documented response to therapy

      • Reduced transfusion requirement: The number of transfusions or blood units required has decreased.Decrease
      • Hemoglobin increase: The member’s hemoglobin has increased by more than 2 g/dL.>2 g/dL increase
      • Hemoglobin target:
    Policy Summary
    PayerCountyCare
    PolicyEnjaymo (sutimlimab-jome) Coverage Criteria
    Policy CodePolicy 5074.CC
    Change TypeAnnual reviewno material clinical or coverage changes
    Effective DateJune 1, 2026
    Last ReviewMar 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with all required clinical, laboratory, vaccination, transfusion-history, prescriber, and dosing documentation.
    SourceLink
    On This Page
    Coverage CriteriaApplicable Coding and Clinical ThresholdsAuthorization and Documentation RequirementsPolicy and Product BackgroundDefinitions and AbbreviationsInitial Therapy CriteriaAnnual Continuation Therapy Criteria
  1. Concomitant therapy restriction: The member is not taking rituximab with Enjaymo.No concurrent rituximab
  2. Dosing: Enjaymo remains prescribed at a dose within the manufacturer’s dosing guidelines based on diagnosis, weight, and FDA-approved labeling.FDA-approved manufacturer dosing
    • Member is responding to therapy, demonstrated by at least one of the following: fewer transfusions or blood units required; hemoglobin increased by >2 g/dL; or hemoglobin is ≥ 12 g/dL.
    • Member is not receiving rituximab concomitantly with Enjaymo.
    • Enjaymo remains prescribed within manufacturer dosing guidelines based on diagnosis, weight, and FDA-approved labeling.
    Documentation Required

    Initial Authorization Documentation

    Submit documentation supporting each initial-authorization criterion, or a provider attestation where permitted. Vaccination documentation or attestation must reflect vaccination against encapsulated bacteria according to current ACIP recommendations for patients with persistent complement deficiencies.

    • Hematologist prescription or consultation documentation.
    • Confirmed diagnosis of primary CAD and documentation that secondary causes have been ruled out.
    • Current laboratory results showing hemoglobin ≤ 10.0 g/dL and bilirubin above the normal reference range.
    • Records documenting at least one blood transfusion before Enjaymo therapy.
    • Vaccination records or provider attestation for applicable pneumococcal and meningococcal vaccinations.
    • Requested dose and regimen consistent with FDA-approved manufacturer dosing guidelines.
    Documentation Required

    Reauthorization Documentation

    For annual renewal, submit clinical documentation demonstrating response to Enjaymo and confirming that ongoing treatment remains appropriate. The renewal request must also document the current regimen and relevant concomitant therapy.

    • Transfusion or blood-unit records showing a decrease in transfusion requirements, or laboratory results showing hemoglobin increased by >2 g/dL, or hemoglobin ≥ 12 g/dL.
    • Current Enjaymo dose and regimen within manufacturer guidelines.
    • Medication review confirming the member is not taking rituximab with Enjaymo.
    • Renewal request submitted for a maximum approval period of up to one year.
    Denial Risk

    Initial Criteria Not Met

    Initial authorization may be denied when any required criterion is not met or the requested use is not supported by the submitted documentation. Requests that do not meet established criteria may be referred to a Medical Director when required by the plan and request level.

    • Member is younger than 18.
    • No hematologist prescription or consultation.
    • Diagnosis is not primary CAD or secondary CAD has not been ruled out.
    • Required hemoglobin, bilirubin, or prior-transfusion criteria are not documented.
    • Required vaccination documentation or attestation is absent.
    • Requested dose falls outside FDA-approved manufacturer dosing guidelines.
    Denial Risk

    Continuation Criteria Not Met

    Continuation may be denied at annual review when medical necessity for ongoing Enjaymo therapy is not demonstrated or a continuation requirement is not met.

    • No documented clinical response, including no qualifying reduction in transfusions or blood units and no qualifying hemoglobin improvement or level.
    • Member is taking rituximab with Enjaymo.
    • Requested dose is outside manufacturer dosing guidelines.
    • Required annual renewal documentation is incomplete or does not support continued medical necessity.
    Documentation confirms that secondary cold agglutinin disease has been ruled out, including infection, rheumatologic disease, systemic lupus erythematosus, and overt hematologic malignancy.

  3. Laboratory criteria

    • Hemoglobin is 10.0 g/dL or less.Hgb ≤10.0 g/dL
    • Bilirubin is above the normal reference range.Above normal reference range
  4. Transfusion history: There is documentation of at least one blood transfusion before Enjaymo therapy.≥1 documented transfusion before therapy
  5. Vaccination: Documentation or provider attestation confirms vaccination against encapsulated bacteria, such as pneumococcal and meningococcal vaccination, according to the most current ACIP recommendations for patients with persistent complement deficiencies.Current ACIP recommendations
  6. Dosing: Enjaymo is prescribed at a dose within the manufacturer’s dosing guidelines based on diagnosis, weight, and the FDA-approved labeling.FDA-approved manufacturer dosing
    7. The member’s hemoglobin level is at least 12 g/dL.
    ≥12 g/dL
  7. Concurrent rituximab exclusion: The member is not taking rituximab with Enjaymo.No concurrent rituximab
  8. FDA-approved dosing: Enjaymo is prescribed at a dose within the manufacturer’s dosing guidelines based on diagnosis, weight, and the FDA-approved labeling.FDA-approved manufacturer dosing