Erythropoiesis-stimulating Agents - NC Standard

Restricted Product(s)

• Aranesp^® (darbepoetin alfa) 
• Epogen^® (epoetin alfa) 
• Mircera^® (methoxy polyethylene glycol–epoetin beta) 
• Procrit^® (epoetin alfa) 
• Retacrit^® (epoetin alfa-epbx)

FDA Approved Use

• Epoetin alfa (Epogen®, Procrit®, 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 Approval of Restricted Product(s)

Initial Coverage Criteria:

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 requested 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 the requested product 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 the requested product 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; OR 
   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 the requested product 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 stable on ESA therapy; OR 
7. The patient will be using the requested product 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 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 stable on ESA therapy; AND 
9. If the request is for Epogen or Procrit, the patient has tried and failed Retacrit; OR 
   1. The patient has a clinical contraindication/intolerance to Retacrit (medical record documentation required); AND 
10. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    

Duration of Approval: determined by indication (see below)

Reduction of allogenic blood transfusion: 180 days (6 months)
Anemia due to myelosuppressive chemotherapy: 180 days (6 months)
All other diagnoses: 365 days (1 year)

Continuation Coverage Criteria

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has experienced clinical benefit from treatment with the requested agent; AND 
3. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

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 Q2 annually.

May 2024: Criteria update: Criteria was updated for expanded indication for Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic kidney disease in adults on dialysis and not on dialysis and in pediatric patients 3 months to 17 years of age on dialysis or not on dialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.
October 2023: Criteria update: Criteria reviewed and formatting changes. Addition of continuation criteria.
October 2021: Criteria change: Requests for Epogen or Procrit required to step through Retacrit.
Jun 2018: Retacrit added to policy
Apr 2017: Original utilization management criteria issued.