CurrentCignaPolicy N/A

Monoferric (ferric derisomaltose) prior authorization

This document is a Cigna prior authorization request form and clinical checklist for Monoferric (ferric derisomaltose) infusion therapy, used to determine medical necessity and coverage for patients across applicable Cigna plans. It affects prescribers, infusion sites, pharmacies, and payers involved in obtaining authorization and billing for the medication.

Policy Summary

PayerCigna

PolicyMonoferric (ferric derisomaltose) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (including indication, prior therapies, total requested dose, J‑code and ICD‑10) via fax (855-840-1678) or online to obtain approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

1,000 mgdose threshold (30 days)

855-840-1678fax

800-882-4462urgent phone

Coverage Criteria

Policy Summary

PayerCigna

PolicyMonoferric (ferric derisomaltose) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (including indication, prior therapies, total requested dose, J‑code and ICD‑10) via fax (855-840-1678) or online to obtain approval.

SourceLink

On This Page

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Primary coverage criteria: Patient has a diagnosis of iron deficiency anemia or iron deficiency associated with heart failure or other indicated condition; prescriber provides clinical justification and specialist consultation where requested (e.g., cardiologist for heart failure, nephrologist for non-dialysis CKD, hematologist when indicated); documentation that oral iron supplementation was ineffective or intolerable OR there is a condition that will interfere with oral iron absorption; for non-dialysis CKD patients, trial of at least one alternative IV iron (INFeD, sodium ferric gluconate complex/Ferrlecit, or Venofer) OR documentation that the patient is continuing an initiated Monoferric course; total requested dose does not exceed 1000 mg over a 30-day timeframe for applicable indications; prescriber attestation and required administrative fields are completed on the prior authorization form.see node text

Form contains branching questions to capture indication-specific specialist consultation, prior therapies, dialysis status, and oral iron trial/intolerance.

The form does not list blanket exclusions; rather, coverage determinations are decision-dependent and hinge on the clinical information provided. Branching questions on the prior authorization form require indication-specific details such as whether the request is for iron deficiency associated with heart failure, chronic kidney disease (with dialysis status), or cancer- or chemotherapy-related anemia, and whether specialist consultation (cardiology, nephrology, hematology) has occurred when indicated. Absent the required clinical answers, the reviewer cannot verify that the request meets the policy’s documented criteria.

Requests may be considered not medically necessary when the form fails to document required clinical findings or prior therapies. Examples captured on the form include missing documentation that oral iron supplementation was ineffective or intolerable (or that a condition interferes with oral iron absorption), lack of required specialist consultation for heart failure or non-dialysis CKD scenarios, failure to show a trial of an alternate IV iron when requested, or when the total requested dose exceeds 1000 mg over a 30-day timeframe where that threshold applies.

Initial Therapy

Initial authorization requirements

Initial therapy: Provider documents the diagnosis and selected indication on the form (e.g., iron deficiency associated with heart failure, iron deficiency anemia, CKD-related or cancer/chemotherapy-related anemia).

See form branching for indication-specific questions.

Specialist consultation when indicated: If requested for iron deficiency associated with heart failure, prescriber is the cardiologist or is in consultation with a cardiologist or hematologist; if non-dialysis CKD, prescriber is the nephrologist or in consultation with a nephrologist or hematologist.

Document consultation on the form.

Oral iron trial or absorption rationale: According to the prescriber, oral iron supplementation was ineffective OR intolerable, OR the patient has a condition expected to interfere with oral iron absorption (examples: inflammatory bowel disease).

Form asks whether oral iron was tried and whether it was ineffective or intolerable.

Step therapy / prior IV iron trial (non-dialysis CKD): For patients with CKD who are NOT on dialysis, patient has tried at least ONE of the following: INFeD, sodium ferric gluconate complex (Ferrlecit or generics), or Venofer; OR the request is for continuation of an initiated Monoferric course to complete therapy.

Form includes checkboxes capturing prior IV iron agents and a continuation checkbox.

Dose threshold: For indicated diagnoses (see form), the total requested dose is no greater than 1000 mg over a 30-day timeframe.<= 1000 mg per 30 days

Form asks the total requested dose and includes this threshold for relevant indications.

Administrative completion and attestation: Required administrative fields are completed on the prior authorization form (dose, quantity, duration, J‑code, ICD‑10, facility/dispensing details, prescriber signature) and prescriber attests accuracy of information.

Incomplete administrative information may delay or prevent approval; submit via fax or online per form instructions.

Continuation / Maintenance Criteria

Continuation Therapy

Continuation/maintenance scenarios captured on form

Continuation therapy allowance: If the patient has initiated therapy with the requested medication and requires further medication to complete the current course of therapy, the form provides a checkbox to indicate continuation of an existing Monoferric course.

Provider must indicate ongoing course on the form; document prior doses/dates as requested (dose/quantity/duration fields).

Requirement	Details
Step therapy requirement	When the patient is not on dialysis, the form requires documentation that the patient has tried at least one alternative IV iron (INFeD, sodium ferric gluconate complex [Ferrlecit, generics], or Venofer) prior to Monoferric unless the request is for continuation of an initiated Monoferric course.

Coding and Dose Limits

Billing Codes to be provided by requesterHCPCS

J-code (specified on form)

J-code to be provided by requester for billing the medication

NDC requirementNDC

NDC	NDC number is required on the medical claims to confirm claim is payable (NDC can be found on drug packaging)

inv-06: Total requested dose — no greater than 1000 mg over a 30-day timeframe

ThresholdTotal requested dose no greater than 1000 mg over a 30-day timeframe

ScopeApplies to iron deficiency anemia indications (except CKD on dialysis where form branches capture dialysis status)

Form questionForm asks prescriber to confirm whether total requested dose is ≤ 1000 mg/30 days

ConsequenceRequests exceeding the 1000 mg/30-day threshold may be considered not medically necessary per form guidance

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Monoferric. Submit requests online at CoverMyMeds or via SureScripts in your EHR, or fax the completed prior authorization form. Include the clinical indication, prior therapies attempted (including oral and IV iron where applicable), dosing, duration, J‑code, ICD‑10 diagnosis code, and facility/dispensing details to allow timely review.

Submit online: www.covermymeds.com/main/prior-authorization-forms/cigna/
Standard response time: 5 business days; call if urgent
Include J‑code and ICD‑10 on the request

Denial Risk

Missing Prior Therapy or Absorption Rationale May Cause Denial

The form requires documentation of prior therapy or a prescriber rationale for why prior therapies are not appropriate. If the patient has not tried an alternate IV iron (INFeD, sodium ferric gluconate complex/Ferrlecit, or Venofer), provide documentation of why an exception applies. If oral iron was used, indicate whether it was ineffective or not tolerated, or document a medical condition that impairs oral iron absorption (for example, inflammatory bowel disease). Lack of this documentation may result in denial.

If no prior IV iron tried, document medical rationale for exception
If oral iron tried, indicate ineffective or intolerable and provide dates/doses
If oral iron not tried, document absorption issue or intolerance

Documentation Required

Required Submission Information

Complete and submit all patient and provider information on the form: physician name, specialty, DEA/NPI/TIN, office contact, patient name, Cigna ID, DOB, patient and office addresses and phone/fax. Include medication requested (Monoferric dose/concentration), directions, dose/quantity, duration, frequency, J‑code, ICD‑10, and facility/dispensing information (facility name, tax ID, address, state). Attach relevant clinical notes, prior therapy records, and the prescriber attestation and signature.

Required: patient identifiers (Cigna ID, DOB), provider credentials (DEA/NPI/TIN)
Required: medication dose, quantity, duration, frequency, J‑code, ICD‑10
Required: facility/dispensing name, Tax ID, address, state
Attach clinical notes showing prior therapies, oral iron trial and response, or absorption rationale

Step Therapy

Step Therapy / Prior IV Iron Requirement

Step therapy applies for non‑CKD/non‑heart‑failure indications: the form asks whether the patient has tried at least one alternate IV iron (INFeD, sodium ferric gluconate/Ferrlecit, or Venofer). If the patient has not, or if an exception is claimed, include documentation supporting the exception. For continuation of therapy, indicate if the patient is completing an initiated course and needs additional doses to finish the regimen.

Step agents listed: INFeD, sodium ferric gluconate complex (Ferrlecit), Venofer
If requesting additional doses to complete an initiated course, document prior administration dates and remaining need

Site of Care / Administration

Note

Document acquisition and administration site; least‑intensive‑site considerations may apply

The form collects where the medication will be obtained and where it will be administered (options include Accredo specialty pharmacy, hospital outpatient, retail pharmacy, home health/home infusion, or physician’s office) and asks whether the drug will be administered in the patient's home, physician office, or hospital outpatient setting.

Acquisition options: Accredo, hospital outpatient, retail, home health/home infusion, physician’s office
Administration site options: Patient’s Home, Physician’s Office, Hospital Outpatient
Note: some Cigna plans require infusion in the least intensive medically appropriate setting and case management may redirect site

Background

Monoferric (ferric derisomaltose) is an intravenous iron product indicated on the prior authorization form for treatment of iron deficiency and iron deficiency anemia across several contexts, including iron deficiency associated with heart failure, chronic kidney disease (with dialysis status captured), and cancer- or chemotherapy-related anemia. The form collects indication-specific clinical details (e.g., specialist consultation, prior oral and IV iron trials, and whether a condition interferes with oral iron absorption) to establish medical necessity for IV therapy.

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