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 individuals with cancer with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy;a,b
treatment of anemia related to therapy with AZT (zidovudine) in HIV-infected individuals;a
reduction of allogeneic blood transfusion in surgery individuals;a
treatment of individuals after allogeneic bone marrow transplantation; and
treatment of individuals with myelodysplastic syndromes to reduce transfusion dependency.
The use of epoetin alfa or darbepoetin may be considered medically necessary for:
treatment of individuals 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 used to 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 individuals 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.
a FDA-approved label for epoetin alfa (Epogen, Procrit).
b FDA-approved label for darbepoetin alfa (Aranesp).
c FDA-approved label for pegylated epoetin beta (Mircera).
