CurrentCignaPolicy IP0749

Iron Replacement - Monoferric (ferric derisomaltose) intravenous infusion

Prior authorization and coverage criteria for Monoferric (ferric derisomaltose) IV infusion for treatment of iron deficiency anemia in adults across specified indications, as administered under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyIron Replacement - Monoferric (ferric derisomaltose) intravenous infusion

Policy CodePolicy IP0749

Change TypeNew policy; preferred product step therapy revised

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age ≥18, specialist involvement for CKD non-dialysis, and completion of required preferred product trials before Monoferric is approved.

SourceLink

POLICY UPDATE CHANGES

New policy created for Monoferric.

Preferred product criteria for CKD non-dialysis changed to require trial of both sodium ferric gluconate complex (Ferrlecit, generics) and Venofer (previously one product required); INFeD removed from preferred products; continuation-of-therapy criterion removed.

≥18minimum patient age for indications

1000 mgmaximum dose per 30 days

J1437HCPCS code

PA requiredadmin requirement

Coverage and Medical Necessity Criteria

Iron Deficiency Anemia in Patients with Chronic Kidney Disease who are not on Dialysis

Approve when ALL of the following are met for each numbered FDA-approved indication

CKD non-dialysis (FDA-approved): 1. Patient is ≥ 18 years of age; AND 2. The medication is prescribed by or in consultation with a nephrologist or hematologist; AND 3. Preferred product criteria is met for the product(s) as listed in the below table(s).Up to a maximum dose of 1000 mg IV per 30 days

Approval duration: 1 year

Other Uses with Supportive Evidence

Approve when ALL of the following are met for each listed supportive indication

CKD on dialysis (supportive): Indication: Iron deficiency anemia in patients with chronic kidney disease who are on dialysis.

Policy Summary

PayerCigna

PolicyIron Replacement - Monoferric (ferric derisomaltose) intravenous infusion

Policy CodePolicy IP0749

Change TypeNew policy; preferred product step therapy revised

Effective Date

Next Review Date

Key ActionObtain prior authorization and document age ≥18, specialist involvement for CKD non-dialysis, and completion of required preferred product trials before Monoferric is approved.

SourceLink

On This Page

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Monoferric. All approvals are provided for the durations specified in the policy. Because of the specialized skills required for evaluation and monitoring, Monoferric must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization approvals: follow durations listed under each indication in the policy.
Prescriber requirement: prescribe or consult with a specialist (e.g., nephrologist, hematologist, cardiologist) as specified by indication.

Step Therapy

Preferred Product Step Therapy

For Employer and Individual/Family plans, CKD non-dialysis criteria require trial of at least the listed preferred IV iron products prior to approval, unless the patient has already initiated therapy with the requested medication and requires completion of the current course.

Employer Plans: trial of at least one of INFeD, sodium ferric gluconate complex (Ferrlecit, generics), or Venofer; or patient has initiated therapy and needs to complete current course.
Individual and Family Plans: same preferred product requirements as Employer Plans.

Documentation Required

Required Documentation for CKD Non‑Dialysis

Documentation must support that the patient is ≥ 18 years of age and that the medication is prescribed by or in consultation with the appropriate specialist when required by the indication. For CKD non-dialysis, documentation must also demonstrate that preferred product criteria have been met per the applicable plan (Employer or Individual/Family).

Age documentation: record showing patient is ≥ 18 years of age.
Specialist documentation: note showing prescription by or consultation with a nephrologist, hematologist, or cardiologist as required by indication.
Preferred product documentation: evidence of trial of preferred IV iron products or documentation that patient initiated requested therapy and requires completion of current course.

Documentation Required

Documentation for Other Indications

For other FDA‑approved and supported uses (e.g., CKD on dialysis; iron deficiency associated with heart failure), documentation must show the patient is ≥ 18 years of age and must satisfy the specific subcriteria for that indication (including required specialist involvement where specified).

CKD on dialysis: document indication and clinical justification; approvals provided for 3 years.
Heart failure–associated iron deficiency: document age ≥ 18 and that the medication is prescribed by or in consultation with a cardiologist or hematologist; approvals provided for 1 year.
Other uses: provide clinical notes supporting the FDA‑approved or evidence‑supported indication and any relevant prior therapies or intolerance to oral iron, if applicable.

Denial Risk

Billing/Code Mismatch Denial Risk

Claims submitted without covered diagnosis/procedure codes or without adherence to the applicable Coverage Policy criteria will be denied.

Submit appropriate ICD-10 and procedure/CPT/HCPCS codes that match a covered indication.
Ensure prior authorization approval is on file and matches the billed service dates and dosing limits (maximum 1000 mg IV per 30 days unless otherwise specified).

Denial Risk

Not Medically Necessary for Other Uses

Monoferric for any use not specified in this policy is considered not medically necessary and may be denied.

Examples of not covered uses: indications outside those listed under FDA‑approved indications and other uses with supportive evidence in this policy unless criteria are met.
Criteria will be updated as new published data are available.

Dosing and Clinical Thresholds

Standard dosing

Recommended dose (≥50 kg)1000 mg IV as a single dose per treatment cycle for patients ≥ 50 kg

Recommended dose (<50 kg)20 mg/kg IV as a single dose per treatment cycle for patients < 50 kg

Repeat dosingTreatment may be repeated if iron deficiency anemia recurs

Clinical iron status criteria referenced

KDIGO thresholds (CKD)Initiation suggested: TSAT ≤ 30% and ferritin ≤ 500 ng/mL for dialysis patients; for non-dialysis, TSAT < 40% and ferritin < 100 ng/mL, or TSAT < 25% with ferritin ≥ 100 and < 300 ng/mL

NCCN thresholds (cancer-related anemia)Defines absolute iron deficiency as ferritin < 30 ng/mL and TSAT < 20%; functional deficiency ranges referenced for IV iron consideration

ACC/AHA thresholds (heart failure)Absolute iron deficiency ferritin < 100 ng/mL; functional deficiency ferritin 100–300 ng/mL if TSAT < 20%

Clinical use guidanceGuidelines distinguish absolute vs functional iron deficiency and guide initiation of oral vs IV iron and combination with ESAs

OpenPayer

Iron Replacement - Monoferric (ferric derisomaltose) intravenous infusion

Coverage and Medical Necessity Criteria

Billing and Coding

Provider Requirements and Operational Notes

Background and Drug Description

Dosing and Clinical Thresholds