Is intravenous iron therapy, specifically Ferric Derisomaltose (Monoferric), medically necessary for a 75-year-old female with iron deficiency anemia, history of gastrointestinal (GI) bleed, and unsatisfactory response to oral iron therapy?

Intravenous Iron Therapy is Medically Necessary for This Patient

This 75-year-old female with iron deficiency anemia, history of GI bleed and gastric ulcer, meets clear criteria for intravenous iron therapy (Ferric Derisomaltose/Monoferric) based on her GI disorder that impairs oral iron absorption and her persistent severe anemia despite oral iron therapy.

Rationale for Approval

Patient Meets Multiple Criteria for IV Iron

This patient satisfies both guideline-based and FDA-approved indications for intravenous iron:

Laboratory Evidence of Severe Iron Deficiency:

• Ferritin 5 ng/mL (severely depleted iron stores, well below the 30 ng/mL threshold for IDA) 1
• Transferrin saturation 7% (confirms absolute iron deficiency, below 20% threshold) 1
• Hemoglobin 8.3-8.9 g/dL (moderate-to-severe anemia) 2
• MCV 83.2-86 (microcytic anemia pattern) 2

Clinical Indications per 2024 AGA Guidelines:

• Intravenous iron should be used if 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
• This patient has documented GI malabsorption secondary to gastric ulcer, GERD, and PPI use—all conditions that significantly impair oral iron absorption 1
• History of GI bleed represents a disorder of the gastrointestinal tract where symptoms may be aggravated by oral iron therapy 1

FDA-Approved Indication:

• Monoferric is specifically indicated for adult patients with iron deficiency anemia who have had unsatisfactory response to oral iron therapy 2
• The patient has been taking oral iron daily with minimal hemoglobin improvement (8.3 to 8.9 g/dL over time), demonstrating inadequate response 2

Why Oral Iron Has Failed

Gastrointestinal Factors Preventing Oral Iron Absorption:

• PPI use blocks iron absorption by reducing gastric acid needed for iron solubilization 1
• Gastric ulcer and prior GI bleed indicate mucosal pathology that impairs absorption 1
• GERD with PPI therapy creates a malabsorptive state for oral iron 1
• The patient is currently tolerating oral iron without cramping, but laboratory values show no meaningful improvement in iron stores (ferritin remains critically low at 5 ng/mL) 1

Clinical Evidence Supporting IV Iron Over Oral:

• In patients with GI disorders and malabsorption, oral iron is frequently ineffective even when tolerated 1
• Studies demonstrate that lack of response to oral iron should prompt trial of IV iron, as absorption may be impaired by gut pathology 1

Symptomatic Burden Requiring Rapid Correction

Quality of Life Impact:

• Fatigue and occasional dizziness are classic symptoms of iron deficiency anemia affecting daily function 3
• Hemoglobin 8.3-8.9 g/dL represents moderate-to-severe anemia requiring prompt correction to prevent end-organ complications 1
• At age 75, this degree of anemia increases fall risk, cognitive impairment, and cardiovascular stress 1

Morbidity Considerations:

• Persistent severe anemia (Hb <10 g/dL) in elderly patients is associated with increased mortality and reduced functional capacity 1
• Continued oral iron therapy alone will not adequately replenish iron stores given her malabsorptive state 1

IV Iron Formulation Selection

Ferric Derisomaltose (Monoferric) is Appropriate:

• Single-dose administration of 1000 mg is preferred over formulations requiring multiple infusions 1
• FDA trials demonstrated efficacy in patients with intolerance or unsatisfactory response to oral iron, with mean hemoglobin increase of 2.49 g/dL at 8 weeks 2
• Safety profile is excellent; true anaphylaxis is very rare, with most reactions being complement activation-related pseudo-allergy (infusion reactions) that are manageable 1

Policy Criteria Alignment

The provided policy criteria explicitly state:

• Ferric derisomaltose is medically necessary for members 18 years and older with documented iron deficiency anemia AND unsatisfactory response to oral iron [@policy criteria provided@]
• Members with a disorder of the gastrointestinal tract in which symptoms may be aggravated by oral iron therapy qualify [@policy criteria provided@]

This patient meets BOTH criteria:

1. Unsatisfactory response to oral iron (ferritin remains 5 ng/mL, minimal Hb improvement despite daily oral iron)
2. GI disorder (gastric ulcer, GERD, history of GI bleed) with malabsorption and PPI use

Common Pitfalls to Avoid

Do Not Delay IV Iron Waiting for "Adequate Oral Iron Trial":

• When GI malabsorption is documented (gastric ulcer, PPI use), oral iron is predictably ineffective 1
• Prolonging ineffective oral therapy delays symptom resolution and risks complications from persistent severe anemia 3

Do Not Require Discontinuation of PPI:

• PPIs are medically necessary for this patient's gastric ulcer and GERD 1
• The solution is IV iron, not stopping gastroprotection 1

Ensure Proper Monitoring:

• Recheck hemoglobin, ferritin, and transferrin saturation at 4-8 weeks post-infusion 1
• Investigate ongoing GI blood loss if anemia recurs (colonoscopy is overdue per clinical note) 1

Decision: APPROVE

This request for IV iron (Ferric Derisomaltose/Monoferric) should be approved based on:

• Documented severe iron deficiency anemia (ferritin 5 ng/mL, TSAT 7%, Hb 8.3-8.9 g/dL) 1, 2
• Unsatisfactory response to oral iron therapy (persistent severe iron deficiency despite daily oral iron) 1, 2
• GI disorder causing malabsorption (gastric ulcer, GERD with PPI use, history of GI bleed) 1
• Symptomatic anemia affecting quality of life (fatigue, dizziness) 3
• Meets both AGA guideline criteria and FDA-approved indications 1, 2
• Aligns with provided policy criteria for IV iron in GI disorders with unsatisfactory oral iron response [@policy criteria@]