Iron Therapy

Accrufer^® (Ferric Maltol) Approval Criteria:

• Diagnosis of iron deficiency anemia (IDA); and
• Lab results verifying IDA must be submitted; and
• Member must be 18 years of age or older; and
• Member must have a documented diagnosis of chronic kidney disease (CKD) or inflammatory bowel disease (IBD) (e.g., Crohn’s disease, ulcerative colitis); and
• Documentation of intolerance or inadequate response to over-the-counter (OTC) oral iron therapy after at least 3 months at recommended dosing; and
• A recent, failed trial of Feraheme^® (ferumoxytol), Infed^® (iron dextran), or Venofer^® (iron sucrose) or a patient-specific, clinically significant reason why the member cannot utilize Feraheme^®, Infed^®, and Venofer^® must be provided; and
• A patient-specific clinically significant reason why the member cannot utilize all other forms of intravenous (IV) iron must be provided; and
• Initial approvals will be for the duration of 3 months of treatment. Subsequent approvals (for 3 months of treatment) will require updated recent laboratory results documenting continued IDA.

Injectafer^® (Ferric Carboxymaltose) Approval Criteria [Iron Deficiency Anemia (IDA) Diagnosis]: 

• An FDA approved indication of 1 of the following:
  • Iron deficiency anemia (IDA); or
  • IDA in patients with non-dialysis dependent chronic kidney disease (CKD); and
• Documented lab results verifying IDA; and
• Documentation of intolerance or inadequate response to oral iron therapy after at least 3 months at recommended dosing; and
• A recent, failed trial of Feraheme^® (ferumoxytol), Infed^® (iron dextran) or Venofer^® (iron sucrose) or a patient-specific, clinically significant reason why the member cannot utilize Feraheme^®, Infed^® , and Venofer^® must be provided.

Injectafer^® (Ferric Carboxymaltose) Approval Criteria [Iron Deficiency Diagnosis]:

• An FDA approved indication of iron deficiency in adult members with New York Heart Association (NYHA) class II-III heart failure (HF) to improve exercise capacity; and
• Member must be 18 years of age or older; and
• Documented lab results verifying iron deficiency; and
• Prescriber must verify member is already receiving optimal background therapy for HF; and
• Member must have left ventricular ejection fraction (LVEF) <45%; and
• Member’s current weight (kg) and hemoglobin (Hb) (g/dL) must be provided to ensure appropriate dosing according to package labeling; and
• A recent trial of Feraheme^® (ferumoxytol), Infed^® (iron dextran) or Venofer^® (iron sucrose) or a patient-specific, clinically significant reason why the member cannot utilize Feraheme^®, Infed^® and Venofer^® must be provided; and
• Initial approvals will be for 1 or 2 doses only (depending on member’s weight and Hb) according to package labeling; and
• Subsequent requests for maintenance doses at weeks 12, 24, and 36 will require submission of updated lab results verifying continued iron deficiency for each dose and will be approved for (1) 500mg dose at a time.

Monoferric^® (Ferric Derisomaltose) Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Iron deficiency anemia (IDA); or
  • IDA in patients with non-dialysis dependent chronic kidney disease (CKD); and
• Documented lab results verifying IDA; and
• Documentation of intolerance or inadequate response to oral iron therapy after at least 3 months at recommended dosing; and
• A recent, failed trial of Feraheme^® (ferumoxytol), Infed^® (iron dextran) or Venofer^® (iron sucrose) or a patient-specific, clinically significant reason why the member cannot utilize Feraheme^® , Infed^® , and Venofer^® must be provided; and
• A patient-specific, clinically significant reason why the member cannot utilize all other forms of intravenous (IV) iron must be provided.