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Erythropoiesis-Stimulating Agents

The use of epoetin alfa, darbepoetin, or pegylated epoetin beta may be considered medically necessary for:
treatment of anemia associated with chronic kidney disease.a,b,c

The use of pegylated epoetin beta is investigational for all other indications.

The use of epoetin alfa or darbepoetin may be considered medically necessary for:

treatment of anemia in cancer patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapya,b;

treatment of anemia related to therapy with AZT (zidovudine) in HIV-infected patientsa;

reduction of allogeneic blood transfusion in surgery patientsa;

treatment of patients after allogeneic bone marrow transplantation; and

treatment of patients with myelodysplastic syndromes to reduce transfusion dependency.

The use of epoetin alfa or darbepoetin may be considered medically necessary for:

treatment of patients with hepatitis C and anemia related to ribavirin treatment.

For medically necessary conditions noted above, the following criteria also apply:

The lowest dose of erythropoiesis-stimulating agents should be usedto avoid red blood cell transfusions;

Erythropoiesis-stimulating agents should not be used to raise the hemoglobin level above 12 g/dL; and

Erythropoiesis-stimulating agent therapy should not be administered without adequate iron stores.

For medically necessary use in cancer patients, these additional U.S. Food and Drug Administration criteria apply:

Epoetin alfa or darbepoetin treatment should not be initiated at hemoglobin levels of 10 g/dL or higher; and

Epoetin alfa or darbepoetin treatment should be discontinued after completion of a myelosuppressive chemotherapy course.

The use of epoetin alfa or darbepoetin is investigational for:

treatment of patients after high-dose chemotherapy with autologous stem cell support;

treatment of noniatrogenic chronic anemia of cancer; and

other cancer-associated anemia except as noted above.

aFDA-approved label for epoetin alfa (Epogen, Procrit).

bFDA-approved label for darbepoetin alfa (Aranesp).

c FDA-approved label for pegylated epoetin beta (Mircera).

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