Is Ferrlecit (Ferric Gluconate) medically necessary for a patient with iron deficiency anemia (E61.1)?

Medical Necessity Determination for Ferrlecit (Ferric Gluconate) in Iron Deficiency Anemia

The requested Ferrlecit therapy is NOT medically necessary based on the submitted documentation, as it fails to meet the fundamental criteria established by the FDA and clinical guidelines: there is no documented evidence of iron deficiency anemia parameters (ferritin <30 ng/mL or TSAT <20%), no documentation of failed oral iron therapy or contraindications to oral iron, and no documentation of any qualifying clinical scenario that would justify intravenous iron administration. 1

Critical Missing Documentation

The case lacks essential elements required for medical necessity approval:

Laboratory Values Not Documented

• No baseline ferritin level documented - The FDA-approved indication and clinical guidelines require documented iron deficiency anemia, typically defined as ferritin <30 ng/mL or TSAT <20% for non-CKD patients 1, 2
• No transferrin saturation (TSAT) documented - This is a fundamental parameter for determining iron deficiency and monitoring therapy 2
• No hemoglobin level documented - Essential for confirming anemia severity and monitoring response 2

Oral Iron Trial Not Documented

• No evidence of oral iron failure, intolerance, or contraindication - This is a prerequisite for IV iron therapy in non-CKD patients according to standard medical practice and the Aetna criteria correctly applied in this case 1
• The FDA label for Ferrlecit specifically indicates use "in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy" 1

Clinical Context Missing

The documentation fails to establish any of the qualifying scenarios:

• No chronic kidney disease (CKD) on hemodialysis documented - This is the FDA-approved primary indication 1
• No erythropoiesis-stimulating agent (ESA) therapy documented - Required for the FDA-approved CKD indication 1
• No gastrointestinal disorder documented (inflammatory bowel disease, post-gastric bypass) that would preclude oral iron absorption 2
• No rapid blood loss documented (heavy uterine bleeding, blood donation programs) 2
• No cancer or chemotherapy-induced anemia documented - which would have different criteria (ferritin 30-800 ng/mL, TSAT 20-50%) 2

FDA-Approved Indication Analysis

Ferrlecit is FDA-approved specifically for: "treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy" 1

The patient in question:

• Has diagnosis codes E61.1 (iron deficiency) and D50.9 (iron deficiency anemia, unspecified)
• Does NOT have documented CKD
• Does NOT have documented hemodialysis
• Does NOT have documented ESA therapy

This represents off-label use without adequate justification.

Dosing Concerns

The ordered regimen (250 mg IV over 2 hours weekly × 4 doses = 1000 mg total) exceeds FDA-recommended dosing:

• FDA-approved adult dose: 125 mg per dialysis session (not to exceed 125 mg per dose based on postmarketing data showing higher doses associated with increased adverse events) 1
• The 250 mg dose, while studied in research settings, showed a 5% adverse event rate and is not the FDA-approved dosing 3, 4
• Individual doses exceeding 125 mg "may be associated with a higher incidence and/or severity of adverse events" per FDA labeling 1

Alternative Approaches Required Before IV Iron

Before approving IV iron therapy, the following must be documented:

Mandatory Prerequisites

• Confirmed iron deficiency anemia with laboratory values (ferritin <30 ng/mL or TSAT <20% for non-CKD patients) 2
• Trial of oral iron therapy with documented failure, intolerance (specific gastrointestinal symptoms), or contraindication 2
• Specific clinical scenario justifying IV route (malabsorption, rapid blood loss, inflammatory bowel disease, post-gastric bypass) 2

For Cancer-Related Anemia (if applicable)

• If cancer-related, different criteria apply: ferritin 30-800 ng/mL and TSAT 20-50% with concurrent ESA therapy for functional iron deficiency 2
• IV iron monotherapy (without ESA) in cancer patients has limited evidence and cannot be routinely recommended 2

Safety Considerations

Ferrlecit carries significant risks that necessitate careful patient selection:

• Serious hypersensitivity reactions including anaphylaxis (some life-threatening and fatal) have been reported in postmarketing experience 1
• Monitoring required for at least 30 minutes after administration until clinically stable 1
• Emergency equipment and personnel must be immediately available 1
• Contraindicated in patients with known hypersensitivity to sodium ferric gluconate 1

Recommendation

DENY the request for medical necessity pending submission of:

1. Complete laboratory documentation: baseline ferritin, TSAT, hemoglobin, and complete blood count
2. Documentation of oral iron trial: specific oral iron preparation used, duration, dosage, and reason for failure (intolerance symptoms or lack of response with follow-up labs)
3. Clinical justification: specific medical condition requiring IV iron (CKD on hemodialysis with ESA therapy, malabsorption disorder, rapid blood loss, etc.)
4. If CKD: documentation of hemodialysis and concurrent ESA therapy per FDA indication 1
5. Dosing justification: if doses >125 mg are planned, specific rationale given FDA warnings about increased adverse events 1

The diagnosis codes alone (E61.1, D50.9) are insufficient without supporting laboratory values and clinical documentation demonstrating why IV iron is medically necessary over oral supplementation.