Medical Necessity Determination for Injectafer (Ferric Carboxymaltose)

Diagnostic Criteria

• The American Gastroenterological Association (AGA) defines Iron Deficiency Anemia (IDA) as ferritin <30 ng/mL or transferrin saturation (TSAT) <20% 1, 2

Clinical Appropriateness of IV Iron

• The American Gastroenterological Association (AGA) supports IV iron when oral iron is ineffective or not tolerated, with a valid indication for IV iron being intolerance to oral iron supplements 1, 2
• Recurrent IDA suggests ongoing iron loss or absorption issues, supporting the use of IV iron therapy 1, 2

Required Documentation for Approval

• Current serum ferritin level and transferrin saturation are required for IDA diagnosis, with values <30 ng/mL and <20% respectively 1, 2
• Documentation of contraindication, intolerance, or ineffective response to lower-cost IV iron alternatives (iron sucrose, iron dextran, or ferric gluconate) is necessary 4, 5, 6, 3
• Patient weight and specific dosing (750 mg IV × 2 doses, 7 days apart) are required for FDA-approved dosing 5, 6, 3

Important Safety Consideration

• There is a risk of hypophosphatemia with ferric carboxymaltose, particularly with repeated dosing, and phosphate levels should be monitored if multiple courses are needed 7