CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

This Utilization Management Medical Policy defines prior-authorization recommendations, coverage criteria, dosing limits, prescriber qualifications, approved indications (FDA-approved and other supported uses), and non-covered conditions for Venofer (iron sucrose) administered IV for iron deficiency/iron deficiency anemia across CKD, cancer, heart failure, and other indications.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified / Revised (non-material)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; approve only for members meeting the policy Criteria and Dosing, with case-by-case review for doses outside established dosing.

SourceLink

POLICY UPDATE CHANGES

Annual Revision, Summary of Changes = No criteria changes.

Verbiage updated regarding conditions that interfere with oral iron absorption and moved examples to a Note.

3FDA-Approved Indications Listed

3Other Supported Indications Listed

1000Dosing Limit (mg/30 days)

Coverage Summary

Scope: This policy covers Venofer (iron sucrose) intravenous iron replacement and defines prior-authorization recommendations, coverage criteria, dosing limits, prescriber qualifications, approved indications (FDA-approved and other supported uses), and non-covered conditions across chronic kidney disease (CKD), cancer/chemotherapy-related anemia, heart failure, and other supported indications. Coverage stance: covered with criteria.

Overview: Venofer is indicated for treatment of iron deficiency anemia, particularly in patients with CKD (on and not on dialysis). Coverage is recommended when patients meet the specified authorization criteria for CKD (on dialysis — approved for 3 years; not on dialysis — approved for 1 year if prescribed by or in consultation with a nephrologist or hematologist), cancer- or chemotherapy-related anemia (approve 1 year), heart failure-associated iron deficiency (approve 1 year if prescribed by or in consultation with a cardiologist or hematologist), or other supported iron deficiency indications with documentation of oral iron trial/intolerance or other listed conditions. A dosing limit of maximum cumulative total dose 1000 mg IV per 30 dosing days applies to all approvals. Prior authorization is recommended, and prescriber specialty or documented consultation is required for certain indications; requests for doses outside established dosing will be reviewed case-by-case by a clinician.

Key thresholds and quick facts

Maximum cumulative dose1000 mg per 30 dosing days

FDA-approved indications listed3

Other supported indications listed3

Recommended Authorization Criteria

Coverage of Venofer is recommended in those who meet one of the following criteria:

ANY of the following

FDA-Approved Indication: CKD on dialysis: Iron Deficiency Anemia in patients with chronic kidney disease who are on dialysis
Approve for 3 years; prescriber must meet general policy prescriber requirement
FDA-Approved Indication: CKD not on dialysis: Iron Deficiency Anemia in patients with chronic kidney disease who are not on dialysis
Approve for 1 year if the medication is prescribed by or in consultation with a nephrologist or hematologist
Other Uses with Supportive Evidence: Iron Deficiency Anemia, Other
- ONE of (A, B, C, D)
  - A — Oral iron tried plus effectiveness/intolerance OR current ESA: Patient has tried oral iron supplementation AND (according to the prescriber, oral iron supplementation was ineffective or intolerable) OR Patient is currently receiving an erythropoiesis-stimulating agent (ESA)
    Documentation required: oral iron trial ineffective or intolerable OR current ESA use; examples of ESAs noted in policy
  - B — Condition interfering with oral absorption: According to the prescriber, patient has a condition that will interfere with oral iron absorption
    Examples of conditions that may interfere with oral iron absorption (moved to Note) include inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  - C — Placeholder (not detailed in body): C — (Not explicitly detailed in the policy body)
    Policy lists A, B, C, or D but content for C not provided in source document
  - D — Cancer- or chemotherapy-related anemia:
Iron Deficiency Associated with Heart Failure
Approve for 1 year if prescribed by or in consultation with a cardiologist or hematologist

Dosing Limit for all approvals: Maximum cumulative total dose of 1000 mg given intravenously per 30 dosing days<= 1000 mg per 30 days

Applies to all approvals; requests for doses outside established dosing considered case-by-case

Provider Actions & Requirements

Prior Authorization

Prior authorization required/recommended

Prior Authorization is recommended for medical benefit coverage of Venofer; approval is granted only for members meeting the policy Criteria and Dosing. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Documentation Required

Prescriber specialty or consultation requirement

For CKD patients not on dialysis, prescriber must be or consult with a nephrologist or hematologist (approvals for 1 year). For heart failure use, prescriber must be or consult with a cardiologist or hematologist (approvals for 1 year).

Documentation Required

Oral iron trial or intolerance documentation

For the 'Iron Deficiency Anemia, Other' indication, documentation must show oral iron supplementation was tried and was ineffective or intolerable, or documentation of a condition that will interfere with oral iron absorption, or documentation that the patient is currently receiving an erythropoiesis-stimulating agent, or that the indication is cancer- or chemotherapy-related.

Billing Rule

Dosing limit enforcement

Claims exceeding a cumulative total of 1000 mg IV within any 30-day period may not meet the policy dosing limits and will require case-by-case review.

Background & Evidence

Background: Venofer is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia, particularly in patients with chronic kidney disease. It is administered by IV infusion or slow injection and dosing varies by patient age, dialysis status, and dialysis type (hemodialysis or peritoneal dialysis). The recommended maximum total course dose is 1000 mg per treatment dosing cycle (per 30 dosing days).

Guideline influences: KDIGO guidance informs initiation thresholds for IV iron in CKD and supports switching from oral to IV if response to an optimal oral regimen is insufficient after 1–3 months. NCCN guidance defines iron status categories and supports IV iron for absolute and functional iron deficiency in oncology settings. ACC/AHA heart failure guidance states IV iron is reasonable in HFrEF with iron deficiency to improve functional status and quality of life (Class 2a).

Guideline/Source	Summary
ACC/AHA HF Guideline (2022)
States that in patients with HFrEF (LVEF < 40%) and iron deficiency (absolute ferritin < 100 ng/mL or functional ferritin 100–300 ng/mL with TSAT ≤ 20%), IV iron replacement is reasonable to improve functional status and quality of life (Class 2a recommendation).

Revision History

01/10/2024revision

Verbiage updated: language around conditions that interfere with oral iron absorption changed to 'according to the prescriber; patient has a condition that will interfere with oral iron absorption' and examples were moved to a Note; terminology 'erythroid-stimulating agents' updated to 'erythropoiesis-stimulating agents'.

01/15/2025reviewLatest

Annual review completed; no criteria changes.