Drug Class Prior Authorization Criteria Erythropoiesis Stimulating Agents (ESAs)

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1 Drug Class Prior Authorization Criteria Erythropoiesis Stimulating Agents (ESAs) Line of Business: Medicaid P & T Approval Date: May 16, 2018 Effective Date: July 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Procrit (epoetin alfa), Aranesp (darbepoetin alfa), Mircera (methoxypolyethlene glycol epoetin beta) Formulary Alternatives: None CRITERIA: EPOGEN (EPOETIN ALFA) Reauthorization Patients undergoing elective, noncardiac, nonvascular surgery who are at high risk for perioperative blood loss, to reduce the need for allogeneic red blood cell transfusions a. Perioperative hemoglobin level is greater than 10 and less than or equal to 13 g/dl b. Patient is unwilling to donate autologous blood preoperatively Anemia associated with myelodysplastic syndrome (MDS) b. Baseline serum erythropoietin level is less than or equal to 500 munits/ml

2 20 percent Reauthorization Reauthorization Diagnosis of anemia due to hepatitis C therapy (e.g. ribavirin and interferon-alfa) a. Documented concurrent use of ribavirin and inferferon alfa, or ribavirin and peginterferon alfa. b. Baseline hemoglobin level is less than 10 g/dl 20 percent Code 1 Treatment of anemia due to: zidovudine therapy, cancer chemotherapy or chronic renal failure

3 PROCRIT (EPOETIN ALFA) Reauthorization Anemia due to chronic kidney disease (CKD) b. Baseline adequate iron store should be demonstrated by all of the b. If hemoglobin level is greater than 11 g/dl, dosage should be reduced or interrupted Reauthorization Anemia due to zidovudine in HIV-infected patients a. Zidovudine administered at less than or equal to 4200 mg per week b. Serum erythropoietin level less than or equal to 500 munits/ml

4 Anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies Reauthorization b. At least two additional months of planned chemotherapy Diagnosis of anemia due to hepatitis C therapy (e.g. ribavirin and interferon-alfa) a. Documented concurrent use of ribavirin and inferferon alfa, or ribavirin and peginterferon alfa. b. Baseline hemoglobin level is less than 10 g/dl

5 Reauthorization Reauthorization Patients undergoing elective, noncardiac, nonvascular surgery who are at high risk for perioperative blood loss, to reduce the need for allogeneic red blood cell transfusions a. Perioperative hemoglobin level is greater than 10 and less than or equal to 13 g/dl b. Patient is unwilling to donate autologous blood preoperatively Anemia associated with myelodysplastic syndrome (MDS) Reauthorization b. Baseline serum erythropoietin level is less than or equal to 500 munits/ml 20 percent

6 Reauthorization Diagnosis of anemia due to hepatitis C therapy (e.g. ribavirin and interferon-alfa) a. Documented concurrent use of ribavirin and inferferon alfa, or ribavirin and peginterferon alfa. b. Baseline hemoglobin level is less than 10 g/dl 20 percent ARANESP (DARBEPOETIN ALFA) Anemia due to chronic kidney disease (CKD) b. Baseline adequate iron store should be demonstrated by all of the

7 Reauthorization b. If hemoglobin level is greater than 11 g/dl, dosage should be reduced or interrupted Reauthorization Anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies b. At least two additional months of planned chemotherapy Anemia associated with myelodysplastic syndrome (MDS) b. Baseline serum erythropoietin level is less than or equal to 500 munits/ml

8 Reauthorization MIRCERA (METHOXYPOLYETHLENE GLYCOL EPOETIN BETA) Reauthorization Anemia due to chronic kidney disease (CKD) b. Baseline adequate iron store should be demonstrated by all of the 1. Serum transferrin saturation is greater than or equal to b. If hemoglobin level is greater than 11 g/dl, dosage should be reduced or interrupted Change Control Date Change RPH 06/29/2018 Changed Format IK 05/16/2018 Reformatted document HC

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