Erythropoiesis-Stimulating Agents (ESAs)

Restricted Product(s)

• epoetin alfa (Epogen®) intravenous or subcutaneous injection for administration by a healthcare professional 
• epoetin alfa (Procrit®) intravenous or subcutaneous injection for administration by a healthcare professional 
• epoetin alfa-epbx (Retacrit®) intravenous or subcutaneous injection for administration by a healthcare professional 
• darbepoetin alfa (Aranesp®) intravenous or subcutaneous injection for administration by a healthcare professional 
• methoxy polyethylene glycol (PEG) epoetin-beta (Mircera®) for intravenous or subcutaneous injection for administration by a healthcare professional 

FDA Approved Use

• Epoetin alfa (Epogen®) 
  • Treatment of anemia due to 
    • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis 
    •  Zidovudine in patients with HIV-infection 
    • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy 
  • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery 
• Epoetin alfa (Procrit®) 
  • Treatment of anemia due to 
    • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis 
    • Zidovudine in patients with HIV-infection 
    • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy 
  • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery 
• Epoetin alfa (Retacrit®) 
  • Treatment of anemia due to 
    • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis 
    • Zidovudine in patients with HIV-infection 
    • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy 
  • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery 
• Darbepoetin alfa (Aranesp®) 
  • Treatment of anemia due to: 
    • Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis 
    • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy 
• Methoxy polyethylene glycol (PEG) epoetin-beta (Mircera®) 
  • Treatment of anemia associated with chronic kidney disease (CKD) in: 
    • Adult patients on dialysis and adult patients not on dialysis 
    • Pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA

Criteria for Medical Necessity

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

Criteria for Approval of Restricted Product(s)

1. The patient’s transferrin saturation, serum ferritin, and hemoglobin have been evaluated (in the last 4 weeks); AND 
2. For patients with a serum ferritin of < 100 mcg/L or a serum transferrin saturation < 20%, supplemental iron therapy has been initiated; AND 
3. The patient will be using the product to reduce allogeneic transfusions; AND 
   1. The patient is a candidate for elective, noncardiac, nonvascular surgery; AND 
   2. The patient’s hemoglobin is > 10 g/dL and ≤ 13 g/dL; OR 
4. The patient will be using for anemia due to myelosuppressive chemotherapy; AND 
   1. The patient has a non-myeloid malignancy; AND 
   2. The patient’s hemoglobin is < 10 g/dL (in the last 4 weeks); AND 
   3. The patent is currently on or has received chemotherapy in the last 6 months; AND 
   4. Chemotherapy is not intended to be curative; AND 
   5. The requested medication is NOT Mircera; OR 
5. The patient will be using for anemia associated with chronic kidney disease; AND 
   1. The patient has been diagnosed with chronic kidney disease; AND 
   2. The patient is on dialysis with a hemoglobin of < 10 g/dL (in the last 4 weeks); 
   3. The patient is not on dialysis with a hemoglobin of <10 g/dL (in the last 4 weeks) and is steadily decreasing, indicating a high likelihood for RBC transfusion; OR 
6. The patient will be using for anemia due to myelodysplastic syndrome; AND 
   1. The patient has been diagnosed with myelodysplastic syndrome; AND 
   2. The patient's hemoglobin is < 12 g/dL when starting ESA therapy; OR 
   3. The patient's hemoglobin is ≤12 g/dL while receiving and stable on ESA therapy; OR 
7. The patient will be using for anemia related to zidovudine treatment; AND 
   1. The patient has been diagnosed with HIV/AIDS; AND 
   2. The patient is being treated with zidovudine; AND 
   3. The patient's hemoglobin is < 12 g/dL when starting ESA therapy; OR 
   4. The patient's hemoglobin is ≤ 12 g/dL while receiving and stable on ESA therapy; OR 
8. The prescriber has submitted documentation in support of the use of the prescribed ESA for the intended diagnosis which has been reviewed and approved by the Clinical Review pharmacist; AND 
   1. The patient's hemoglobin is < 12 g/dL when starting ESA therapy; OR 
   2. The patient's hemoglobin is ≤ 12 g/dL while receiving and stable on ESA therapy; AND 
9. If the request is for Epogen or Procrit, the patient has tried and had an inadequate response to Retacrit OR has an intolerance, FDA labeled contraindication, or hypersensitivity to Retacrit [medical record documentation required]; AND 
10. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below).

Duration of Approval:

Reduction of allogenic blood transfusion: 180 days
Anemia due to myelosuppressive chemotherapy: 180 days
All other diagnoses: 365 days

NOTE:

Use of Erythropoiesis-Stimulating Agents (ESAs) may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either:

1. In accordance with FDA label (when clinical benefit has been established, and it is not determined to be investigational as defined in the Blue Cross NC Corporate Medical Policy (CMP), “Investigational (Experimental) Services.” [please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia]; OR 
2. In accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. 

References

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

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

November 2024: Criteria update (Mircera): Expanded FDA labeled age to pediatric patients 3 months to 17 years of age on dialysis or not on dialysis, and added associated dosing in FDA label reference table. Other minor updates made throughout policy for clarity with no change to policy intent. 
April: Criteria Update: Added Retacrit dosing for CKD patients not on dialysis to FDA dosing table
March 2022: Criteria change: Removal of code Q5105 from dosing table
June 2021: Criteria change: Added requirement of evaluation of patient’s transferrin saturation, serum ferritin, and hemoglobin; requirement of supplemental iron for low ferritin or transferrin; removal of Omontys; defined surgical candidate for reduce allogeneic transfusions as elective, noncardiac, nonvascular; added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy