Is IV Feraheme (ferumoxytol) medically necessary for a patient with iron deficiency anemia secondary to chronic blood loss without current iron studies, given a history of constipation and potential intolerance to oral iron?

IV Feraheme is NOT Medically Necessary Without Current Iron Studies

Based on the Aetna policy criteria provided and FDA labeling, IV Feraheme cannot be approved without documented iron studies (ferritin <30 ng/mL or TSAT <20%) to confirm iron deficiency anemia, regardless of constipation concerns or anticipated oral iron intolerance.

Critical Missing Documentation

The request fails to meet the fundamental requirement for IV iron therapy:

• No current iron studies provided: The policy explicitly requires documented iron deficiency anemia defined as serum ferritin <30 ng/mL or TSAT <20% for non-CKD patients 1
• Labs were ordered on a specific date but results were never submitted despite being requested 1
• Without these values, iron deficiency cannot be confirmed per policy definition 1

Policy Requirements Not Met

The Aetna CPB #0575 policy requires ALL of the following for IV ferumoxytol approval:

1. Documented Iron Deficiency (NOT MET)

• Must have laboratory confirmation: ferritin <30 ng/mL OR TSAT <20% 1
• This is the foundational criterion - without it, no other criteria matter 1

2. Oral Iron Trial Status (INSUFFICIENT DOCUMENTATION)

The policy requires one of these scenarios for patients ≥18 years 1:

• Scenario A: Rapid blood loss exceeding oral replacement capacity (e.g., heavy uterine bleeding) - NOT DOCUMENTED as "rapid" or quantified 1
• Scenario B: GI disorder where oral iron aggravates symptoms (IBD, etc.) - NOT APPLICABLE (constipation alone does not qualify) 1
• Scenario C: Repeated failure to follow oral iron instructions - NOT DOCUMENTED 1
• Scenario D: Post-gastric bypass with demonstrated decreased absorption - NOT APPLICABLE 1

3. Constipation as Sole Justification is Inadequate

• Constipation is a potential side effect of oral iron, not an absolute contraindication 2
• The physician's statement that the patient "would not probably tolerate oral iron tabs well" is speculative, not evidence-based 1
• No documented trial of oral iron showing actual intolerance has been provided 1

FDA Labeling Requirements

Feraheme is FDA-approved for adult IDA patients who 3:

• Have intolerance to oral iron OR
• Have had unsatisfactory response to oral iron OR
• Have chronic kidney disease

Key point: The FDA label requires documented intolerance or unsatisfactory response - not anticipated intolerance 3

Clinical Context Considerations

While the clinical scenario describes legitimate concerns, they do not override policy requirements:

Patient's Clinical Picture:

• History of fetal demise with subsequent condition
• Actively trying to conceive
• Pre-existing constipation
• Diagnosis: D50.0 Iron deficiency anemia secondary to chronic blood loss

What Would Make This Approvable:

1. Submit the pending iron studies showing ferritin <30 ng/mL or TSAT <20% 1
2. Document an actual trial of oral iron (even brief) with specific intolerance (e.g., worsening constipation, GI distress, non-compliance) 1
3. OR quantify blood loss rate as exceeding oral replacement capacity 1

Alternative Oral Iron Strategies Not Explored

Before proceeding to IV therapy, several oral options could minimize constipation risk 2:

• Alternate-day dosing (reduces hepcidin elevation and improves absorption while decreasing GI side effects) 2
• Lower elemental iron doses (25-50 mg daily rather than standard 65 mg) 2
• Ferrous bisglycinate or polysaccharide-iron complex (better GI tolerability) 2
• Liquid formulations 2

Recommendation for Approval Pathway

To obtain authorization, the requesting physician must:

1. Provide the ordered iron studies (ferritin and TSAT) to document iron deficiency per policy definition 1
2. Document one of the following:
   • An actual trial of oral iron (even 1-2 weeks) with documented intolerance/worsening constipation 1
   • OR quantification that blood loss rate exceeds oral replacement capacity 1
   • OR evidence of malabsorption (though gastric bypass is not documented here) 1

Rationale for Denial

The request should be DENIED based on:

• Criterion not met: No documented iron deficiency per policy definition (ferritin <30 ng/mL or TSAT <20%) 1
• Criterion not met: No documented unsatisfactory response or actual intolerance to oral iron 1, 3
• Criterion not met: Blood loss not documented as "rapid" or exceeding oral replacement capacity 1
• Anticipated intolerance is not equivalent to documented intolerance per FDA labeling and policy requirements 3

The clinical scenario may ultimately warrant IV iron, but authorization cannot proceed without the fundamental documentation required by both the insurance policy and FDA labeling standards 1, 3.