Intravenous Iron Replacement Therapy

• ferric carboxymaltose (Injectafer®) intravenous infusion for administration by a healthcare professional
• ferric derisomaltose (Monoferric®) intravenous infusion for administration by a healthcare professional 

• Ferric carboxymaltose (Injectafer®)
  
  
  • For treatment of iron deficiency anemia (IDA) in adults and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron
  • For treatment of iron deficiency anemia (IDA) in adults who have non-dialysis dependent chronic kidney disease
    
    
• Ferric derisomaltose (Monoferric®)
  
  
  • For treatment of iron deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease

NOTE: This policy addresses ferric carboxymaltose (Injectafer) and ferric derisomaltose (Monoferric) intravenous iron therapies only.

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The requested agent is ferric carboxymaltose (Injectafer) or ferric derisomaltose (Monoferric); AND

a. ONE of the following:

i. The patient has tried and had an inadequate response to oral iron therapy used for at least 3 months [medical record documentation required]; OR

ii. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to oral iron therapy [medical record documentation required]; OR

iii. Documentation has been provided supporting the use of the requested agent over oral iron therapy [medical record documentation required]; AND 

b. ONE of the following:

i. The patient is less than 4 years of age AND ONE of the following:

1. The patient has tried and had an inadequate response to iron sucrose (Venofer®) [medical record documentation required]; OR

2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to iron sucrose (Venofer) that is not expected to occur with the requested agent [medical record documentation required]; OR

ii. The patient is at least 4 years of age and less than 6 years of age AND ONE of the following: 

1. The patient has tried and had an inadequate response to ONE of the following [medical record documentation required]:

a. Iron sucrose (Venofer®); OR

b. Iron dextran (INFeD®); OR

2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to iron sucrose (Venofer) AND iron dextran (INFeD) that is not expected to occur with the requested agent [medical record documentation required]; OR 

iii. The patient is at least 6 years of age and less than 18 years of age AND ONE of the following: 

1. The patient has tried and had an inadequate response to ONE of the following [medical record documentation required]:

a. Sodium ferric gluconate complex in sucrose (Ferrlecit®); OR

b. Iron sucrose (Venofer®); OR

c. Iron dextran (INFeD®); OR

2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to sodium ferric gluconate complex in sucrose (Ferrlecit), iron sucrose (Venofer), AND iron dextran (INFeD) that is not expected to occur with the requested agent [medical record documentation required]; OR

iv. The patient is 18 years of age or older AND ONE of the following: 

1. The patient has tried and had an inadequate response to TWO of the following [medical record documentation required]: 

a. Sodium ferric gluconate complex in sucrose (Ferrlecit®); OR

b. Iron sucrose (Venofer®); OR

c. Iron dextran (INFeD®); OR

d. Ferumoxytol (Feraheme®); OR

2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to sodium ferric gluconate complex in sucrose (Ferrlecit), iron sucrose (Venofer), iron dextran (INFeD), AND ferumoxytol (Feraheme) that is not expected to occur with the requested agent [medical record documentation required]; AND

2. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below). 

Duration of Approval: 30 days (one treatment course)

*Maximum units allowed for duration of approval

all information referenced is from FDA package insert unless otherwise noted below.

1. Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013 Jan 15;87(2):98-104. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

April 2023: Criteria change: Removed Feraheme from the restricted product list. Restructured trial and failure requirements by age and added requirement of trial and failure of two products (i.e., Ferrlecit, Venofer, INFeD, Feraheme) for adults. Policy notification given 2/1/2023 for effective date 4/1/2023.

February 2022: Criteria update: Added pediatric Injectafer indication.

October 2021: Criteria change: Changed trial and failure requirement from all preferred products (Ferrlecit, Venofer, and Infed) to one preferred product (Ferrlecit, Venofer, or Infed).

October 2021: Original medical policy criteria issued. Policy notification given 7/1/2021 for effective date 10/1/2021.