Medical Necessity Determination: NOT APPROVED
Based on the provided clinical information and Aetna's CPB 0575 criteria, ferumoxytol is NOT medically necessary for this patient because there is no documentation of an unsatisfactory response to, intolerance of, or contraindication to oral iron therapy. 1
Rationale for Denial
Missing Required Documentation
The Aetna policy explicitly requires one of the following conditions be met before ferumoxytol is considered medically necessary 1:
- Documented failure of oral iron therapy - No evidence provided that oral iron was attempted or failed
- Documented intolerance to oral iron - No gastrointestinal side effects or adverse reactions documented
- Documented contraindication to oral iron - No medical contraindications identified
- Specific clinical scenarios - Patient does not meet any of the four enumerated scenarios in the policy
Laboratory Values Do Not Support IV Iron as First-Line
The patient's laboratory values, while indicating iron deficiency, do not represent a clinical emergency requiring immediate IV therapy 1:
- Hemoglobin 11.9 g/dL (not severely anemic; above 10 g/dL threshold typically used for urgent intervention) 2
- Ferritin 20 ng/mL (low but within the reference range of 15-150) 1
- Iron saturation 9% (low, confirming iron deficiency) 1
Oral Iron Should Be First-Line Treatment
Current evidence-based guidelines recommend oral iron as initial therapy for uncomplicated iron deficiency anemia 1:
- No single oral iron formulation has advantages over another; ferrous sulfate is preferred as the least expensive option 1
- Once-daily or every-other-day dosing improves tolerability with similar absorption rates 1
- Adding vitamin C to oral iron supplementation improves absorption 1
When IV Iron Becomes Appropriate
The American Gastroenterological Association guidelines specify that IV iron should be used only if the patient does not tolerate oral iron, ferritin levels do not improve with a trial of oral iron, or the patient has a condition in which oral iron is not likely to be absorbed 1. None of these conditions are documented in this case.
Required Next Steps Before Approval
Documentation Needed for Reconsideration
To meet medical necessity criteria, the following must be documented:
- Trial of oral iron therapy - Minimum 4-8 weeks of appropriate oral iron supplementation (ferrous sulfate 325 mg daily or every other day) 1
- Response assessment - Repeat hemoglobin and iron studies after oral iron trial to demonstrate lack of response (defined as <1 g/dL hemoglobin increase or failure to improve ferritin levels) 1, 3
- Documentation of intolerance - If oral iron causes significant gastrointestinal side effects preventing compliance, this must be documented 1
- Identification of specific clinical scenario - Documentation that patient meets one of the four Aetna-specified scenarios (heavy uterine bleeding with rapid iron loss, inflammatory bowel disease, non-compliance/inability to follow instructions, or post-gastric bypass malabsorption) 1
Alternative Considerations
If the patient has heavy menstrual bleeding (common in young women with chronic anemia since age 15), this should be specifically documented as it would meet Aetna's criterion #1 for members "losing iron at a rate too rapid for oral intake to compensate" 1. However, this information is not currently provided in the clinical documentation.
Cost Considerations
Even if IV iron becomes medically necessary after failed oral therapy, Aetna's policy requires step therapy with lower-cost IV iron formulations (iron dextran/INFeD, iron sucrose/Venofer, or ferric gluconate/Ferrlecit) before ferumoxytol 4. Ferumoxytol costs approximately $1,963 per typical dose compared to $405 for low molecular weight iron dextran 4.
Clinical Stability
The patient is described as "clinically stable" with a hemoglobin of 11.9 g/dL, which does not represent severe anemia requiring urgent intervention 1. This clinical stability supports a trial of oral iron therapy as the appropriate initial management strategy.