CurrentAetnaPolicy N/A

Enjaymo (sutimlimab-jome) Medication Precertification Request — Coverage Criteria

This document is Aetna's medication precertification request form and clinical checklist for initiating or continuing Enjaymo (sutimlimab-jome) therapy for members; it governs what information providers must submit to request prior authorization. It applies to providers submitting requests to Aetna (Medicare Advantage Part B uses a different form).

Policy Summary

PayerAetna

PolicyEnjaymo (sutimlimab-jome) Medication Precertification Request — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form with required clinical documentation (laboratory evidence of hemolysis and CAD diagnostic testing for initiation; response or progression data for continuation).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

requiredfields required

1-866-752-7021precert phone

1-888-267-3277precert fax

Coverage Criteria for Enjaymo (sutimlimab-jome)

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inv-01: Initial Therapy — Initiation requests — covered when ALL of the following are met

Initiation requests — covered when ALL of the following are met

Initiation criteria for Enjaymo: Diagnosis of primary cold agglutinin disease (CAD) confirmed by evidence of hemolysis

Checkbox on form: 'Was the diagnosis of primary cold agglutinin disease (CAD) confirmed by evidence of hemolysis?'

Laboratory evidence of hemolysis: LDH: Lactate dehydrogenase (LDH) level above the upper limit of normal (enter U/L)

Checkbox and field on form: 'Does the patient have a lactate dehydrogenase (LDH) level above the upper limit of normal? Please indicate level: U/L'

Laboratory evidence of hemolysis: haptoglobin: Haptoglobin level below the lower limit of normal (enter mg/L)

Checkbox and field on form: 'Does the patient have a haptoglobin level below the lower limit of normal? Please indicate level: mg/L'

Direct antiglobulin testing: polyspecific DAT: Positive polyspecific direct antiglobulin test (DAT)

Checkbox on form: 'Does the patient have a positive polyspecific direct antiglobulin test (DAT) result?'

Direct antiglobulin testing: monospecific C3d: Monospecific DAT strongly positive for C3d

Checkbox on form: 'Does the patient have a monospecific direct antiglobulin test (DAT) result strongly positive for C3d?'

Cold agglutinin titer >= 1:64 measured at 4°C>= 1:64 measured at 4°C

Checkbox on form: 'Does the patient have a cold agglutinin titer of 1:64 or higher measured at 4°C?'

DAT IgG level of 1+ or less1+ or less

Checkbox on form: 'Does the patient have a DAT IgG level of 1+ or less?'

Exclusion of secondary causes: Secondary cold agglutinin disease has been ruled out (e.g., secondary to infection, rheumatologic disease, or active hematologic malignancy)

Form requires confirmation: 'Has secondary cold agglutinin disease (CAD) been ruled out for the patient?'

inv-02: Continuation Therapy — Continuation requests — covered when ONE of the following are met

Continuation requests — covered when ONE of the following is met

Clinical response: Patient has demonstrated a positive response to therapy (e.g., improvement in hemoglobin levels, improvement in markers of hemolysis such as bilirubin, haptoglobin, LDH, reticulocyte count, or a reduction in blood transfusions)

Checkbox on form: 'Has the patient demonstrated a positive response to therapy?'

No progression/toxicity: Patient has not experienced disease progression or unacceptable toxicity while on the current regimen

Checkbox on form: 'Has patient experienced disease progression or unacceptable toxicity while on the current regimen?' (answer 'No' supports continuation)

For initiation of Enjaymo, the precertification checklist requires that secondary cold agglutinin disease (CAD) be actively ruled out. The form lists examples of secondary causes that must be considered and excluded, including CAD secondary to infection, rheumatologic disease, or active hematologic malignancy. If secondary CAD has not been ruled out, the initiation criteria are not met.

Initial Therapy Details

inv-13: Initial Therapy — Initial therapy approval requires lab confirmation of CAD and exclusion of secondary causes.

Initial therapy approval requires laboratory confirmation of primary CAD and exclusion of secondary causes.

Diagnostic confirmation of primary CAD: Diagnosis of primary cold agglutinin disease (CAD) confirmed by evidence of hemolysis and meeting the specified laboratory/diagnostic criteria: LDH above upper limit of normal; haptoglobin below lower limit of normal; positive polyspecific DAT; monospecific DAT strongly positive for C3d; cold agglutinin titer >= 1:64 at 4°C; DAT IgG 1+ or less; and secondary causes ruled out.

Each specific laboratory/diagnostic item is a required checkbox on the initiation section of the form.

Provider Actions and Precertification Instructions

Prior Authorization

Prior Authorization Required

Prior authorization (precertification) is required via Aetna. Submit the completed Enjaymo precertification form (all fields must be completed and legible) to Aetna Precertification Notification: Phone: 1-866-752-7021; FAX: 1-888-267-3277. For Medicare Advantage Part B requests, use the Medicare request form.

Complete Enjaymo precertification form and include all required sections: patient, prescriber, dispensing/provider, product, diagnosis (ICD codes), and clinical information.
Incomplete or illegible fields may delay review or result in denial; plan may request additional information.
For Medicare Advantage Part B, submit using the Medicare request form.

Billing Rule

Site of Care and Administration Codes

Place of administration and the appropriate administration (CPT) code(s) must be specified on the precertification request. Indicate the site of care: self-administered, physician's office, outpatient infusion center, home infusion center, or other. Provide the administering center/agency name, phone, address and any applicable billing/TIN/PIN information.

Specify Place of Administration: Self-administered; Physician's Office; Outpatient Infusion Center; Home Infusion Center; Other.
Include Administration code(s) (CPT) on the form.
Provide Dispensing Provider/Pharmacy selection (Physician's Office, Retail Pharmacy, Specialty Pharmacy, Other) and full contact details for the dispensing provider.

Documentation Required

Required Documentation for Precertification

Providers must submit completed patient, insurance, prescriber, dispensing/provider, product (dose and frequency), diagnosis (primary and any secondary ICD codes), and all required clinical documentation. Clinical fields on the form (including initiation and continuation-specific labs and clinical response information) must be completed in full for review.

Include patient demographics, weight/height, and allergy information.
Prescriber information: name, credentials, NPI, license, specialty, and contact details.
Product information: Enjaymo dose and frequency.
Diagnosis: primary ICD code and any additional ICD codes.
Attach required clinical documentation: hemolysis evidence, LDH, haptoglobin, DAT results, cold agglutinin titer, and documentation ruling out secondary CAD for initiation; for continuation include evidence of response or progression/toxicity.

Denial Risk

Incomplete Documentation Triggers Review Delay/Denial

Precertification requests with incomplete or illegible fields may not be accepted for review; Aetna may request additional information or deny the request if required documentation is not provided. Ensure all form fields and attachments are complete to avoid processing delays.

All fields must be completed and legible.
Missing clinical or administrative details (including site of care or CPT administration codes) can trigger delay or denial.
Provide complete contact information for requester and dispensing/provider to facilitate follow-up.

Place of Administration Requirements

Note

Indicate place of administration and complete hospital‑setting questions when applicable

Indicate the exact place of administration; if an outpatient hospital setting is selected, complete the specific questions about adverse events, venous access, behavioral/physical/cognitive impairment, and medical instability that justify that setting.

Check appropriate place of administration box (self‑administered, physician's office, outpatient infusion center, home infusion center).
If outpatient hospital setting: answer questions about prior adverse events, severe venous access issues, behavioral/cognitive impairment, and medical instability.

Background

Enjaymo (sutimlimab-jome) is a specialty medication for primary cold agglutinin disease (CAD). The Aetna precertification form requires laboratory evidence of hemolysis and specific diagnostic testing to confirm primary CAD prior to initiation. For initiation the form requests documentation of: elevated LDH above the upper limit of normal; low haptoglobin below the lower limit of normal; a positive polyspecific direct antiglobulin test (DAT); a monospecific DAT strongly positive for C3d; a cold agglutinin titer ≥ 1:64 measured at 4°C; a DAT IgG level of 1+ or less; and confirmation that secondary CAD has been ruled out (e.g., infection, rheumatologic disease, or active hematologic malignancy).

OpenPayer

Enjaymo (sutimlimab-jome) Medication Precertification Request — Coverage Criteria

Coverage Criteria for Enjaymo (sutimlimab-jome)

Initial Therapy Details

Continuation / Renewal Criteria

Coding and Laboratory Values

Provider Actions and Precertification Instructions

Place of Administration Requirements

Diagnostic Definitions and Criteria

Background