CurrentCignaPolicy N/A

Enjaymo (sutimlimab) prior authorization for Cold Agglutinin Disease

Form and criteria for prior authorization of Enjaymo (sutimlimab) for treatment of Cold Agglutinin Disease (CAD); intended for prescribers and billing/authorization staff submitting requests to Cigna.

Policy Summary

PayerCigna

PolicyEnjaymo (sutimlimab) prior authorization for Cold Agglutinin Disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach patient-specific documentation (C3d positivity, IgG status, cold agglutinin titer, baseline hemoglobin and bilirubin, exclusion of secondary causes, and hematology consultation as applicable).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5standard response time for drug coverage requests

>=39minimum patient weight queried on form

<=10baseline hemoglobin threshold for documentation

>=64titer threshold at 4°C requested

Authorization criteria for Enjaymo (sutimlimab) in Cold Agglutinin Disease

Policy Summary

PayerCigna

PolicyEnjaymo (sutimlimab) prior authorization for Cold Agglutinin Disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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ALL of the following

Patient diagnosis is Cold Agglutinin Disease (CAD) or indication specified on form
form explicitly asks this as an eligibility question
Patient weight is greater than or equal to 39 kg
There is history of at least one sign or symptom associated with CAD
examples listed: symptomatic anemia (fatigue, weakness, dyspnea, palpitations, lightheadedness, chest pain), acrocyanosis, Raynaud's syndrome, hemoglobinuria, disabling circulatory symptoms, or a major adverse vascular event (eg, thrombosis)
Evidence of chronic hemolysis according to prescriber
form asks prescriber to indicate presence of chronic hemolysis
Laboratory/serologic documentation required
- Direct antiglobulin (direct antibody) test is strongly positive for C3d
  Medical documentation must be attached (lab results, chart notes, etc.)
- Direct antiglobulin (direct antibody) test is negative or only weakly positive for immunoglobulin G (IgG)
  Documentation required
- Cold agglutinin antibody titer is greater than or equal to 64 at 4°C (approximately 40°F)>= 64 at 4°C
  Documentation required
Baseline hemoglobin (prior to initiation of Enjaymo) is less than or equal to 10 g/dL<= 10 g/dL
Documentation required
Baseline total bilirubin is above the laboratory upper limit of normal
Documentation required; use reference range for reporting lab
Secondary causes of cold agglutinin syndrome have been excluded (eg, infection, rheumatologic disease, active hematologic malignancy)
Prescriber must attest
Medication is prescribed by, or in consultation with, a hematologist
Dosing regimen documentation (weight-based)
- If patient weight >= 75 kg, requested dosing regimen is 7,500 mg IV not more frequently than once weekly
- If patient weight < 75 kg, requested dosing regimen is 6,500 mg IV not more frequently than once weekly

Administration and site of care considerations

Operational notes collected on the form that may affect authorization or routing:

ALL of the following

Where medication will be obtained and where it will be administered must be specified (options include CVS Caremark, hospital outpatient, prescriber's office stock, retail pharmacy, home healthcare, etc.)
Per some Cigna plans, infusion MUST occur in the least intensive, medically appropriate setting; prescriber asked if candidate for redirection to alternate setting
Prescriber asked if candidate for redirection to alternate setting; provide medical necessity rationale if applicable

Prior Authorization

Specify site of acquisition and administration

Specify where the medication will be obtained and where it will be administered on the prior authorization form; some Cigna plans require infusion in the least intensive, medically appropriate setting and redirection to an alternate site may be considered.

CVS Caremark
Hospital Outpatient
Prescriber's office stock (billing on a medical claim form)
Retail pharmacy
Home Healthcare
Patient's Home
Physician's Office
Other (as specified)

Documentation required for continued therapy

Continuation therapy documentation

For continued therapy requests, ALL of the following are requested:

ALL of the following

Indicate that request is for continuation of therapy
Provide documentation of beneficial response to medication; if no documentation, provide clinical support for continued use
If no documentation of benefit is provided on the form, prescriber must supply clinical rationale

Documentation Required

Attach laboratory and clinical evidence

Attach medical documentation that includes patient-specific identifiers for all required laboratory and clinical evidence; missing attachments may lead to denial.

Documentation of direct antiglobulin (direct antibody) test strongly positive for C3d
Documentation that direct antibody test is negative or only weakly positive for IgG
Cold agglutinin antibody titer result (≥ 64 at 4°C)
Baseline hemoglobin value (prior to initiation)
Baseline total bilirubin with laboratory reference range
Documentation excluding secondary causes (infection, rheumatologic disease, active hematologic malignancy)
Patient identifiers on all attachments (name, DOB, Cigna ID, etc.)

Prior authorization and documentation requirements

Prior Authorization

Submit prior authorization form with required documentation

Complete and submit the Enjaymo prior authorization form and attach patient-specific documentation (lab results, chart notes, test results) supporting C3d positivity, IgG negativity/weak positivity, cold agglutinin titer ≥64, baseline hemoglobin and bilirubin, exclusion of secondary causes, and hematologist prescribing/consultation as applicable.

Complete form fields: medication, dose, ICD-10, start date, new vs continuation
Attach chart notes and laboratory results showing C3d positivity and IgG status
Attach cold agglutinin titer report showing ≥ 64 at 4°C
Attach baseline hemoglobin (≤ 10 g/dL) and baseline total bilirubin (above lab ULN)
Document exclusion of secondary causes and hematologist involvement

Denial Risk

Risk of denial for missing lab evidence

Requests lacking the required serologic and laboratory documentation (C3d positivity, IgG status, cold agglutinin titer, baseline hemoglobin and bilirubin) may be denied if supporting medical documentation with patient identifiers is not attached.

Clinical background

Enjaymo (sutimlimab) is a targeted monoclonal antibody indicated for treatment of Cold Agglutinin Disease (CAD), an autoimmune hemolytic anemia driven by cold‑reactive autoantibodies that activate complement and produce complement‑mediated hemolysis. The disease manifests with symptoms related to hemolysis (for example, fatigue, weakness, dyspnea, palpitations, lightheadedness, chest pain) and with circulatory phenomena such as acrocyanosis, Raynaud’s, hemoglobinuria, or thrombotic events. The form requires documentation that the patient’s diagnosis is CAD and that treatment is being requested specifically for this indication.

To confirm the serologic and laboratory profile associated with CAD, the prior authorization form requests evidence that the direct antiglobulin (direct antibody) test is strongly positive for C3d and is negative or only weakly positive for immunoglobulin G (IgG). The form also requires documentation of a cold agglutinin antibody titer ≥ 64 at 4°C, and baseline laboratory values including hemoglobin ≤ 10 g/dL (prior to initiation of Enjaymo) and total bilirubin above the reporting laboratory’s upper limit of normal. The form notes that medical documentation (laboratory results, chart notes, test reports) must be attached and include patient identifiers.

The form directs prescribers to exclude secondary causes of cold agglutinin syndrome (for example, infection, rheumatologic disease, or active hematologic malignancy) and to ensure the medication is prescribed by, or in consultation with, a hematologist. Patient weight is queried (minimum documented weight on the form is ≥ 39 kg) because dosing is weight‑based: requests document whether the patient is ≥ 75 kg and therefore receiving 7,500 mg IV not more frequently than once weekly, or 6,500 mg IV not more frequently than once weekly if weight is < 75 kg.

Operational and administrative items on the form include where the medication will be obtained and where it will be administered; some Cigna plans require infusion in the least intensive, medically appropriate setting. For continuation requests, the prescriber must document a beneficial clinical response to therapy or provide justification for ongoing treatment. Standard review time for drug coverage requests is 5 business days.

OpenPayer

Enjaymo (sutimlimab) prior authorization for Cold Agglutinin Disease

Authorization criteria for Enjaymo (sutimlimab) in Cold Agglutinin Disease

Administration and site of care considerations

Documentation required for continued therapy

Prior authorization and documentation requirements

Indication / Diagnosis choices on form

Clinical thresholds and form queries

Clinical background

Defined terms