PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Epogen (epoetin alfa) BILLING CODE For Medical-J0885 (Non-ESRD) For Pharmacy-Must use valid NDC code BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office, Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT vary per diagnosis LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Epogen (epoetin alfa) is a preferred product and will only be con sidered for coverage under the medical or pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. ANEMIA For initial authorization: 1. Medication must be prescribed by an oncologist, a nephrologist, an immunologist or infectious disease specialist; AND 2. Member has documented diagnosis of anemia due to one of the following: a) Myelodysplastic syndrome; b) Chronic Kidney Disease ( GFR below 60 mL/min/1.73 m2) ; c) Concomitant Zidovudine treatment in member with HIV-infection; d) The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a min imum of two additional months of planned chemotherapy; AND 3. Members individual iron status reveals both of the following: a) Transfe rrin saturation is at least 20%; b) Fer ritin is at least 100 mc g/L; AND 4. Member is on supplemental iron therapy (unless serum ferritin level > 800 mcg/L); AND 5. Members labs show hemoglobin 10 g/dL for adults (11 g/dL for children) within the last 14 days for initial therapy, OR 10.5 g/dL for adults (11.5 g/dL for children) current ly receiving therapy. 6. Dosage allowed: Members with CKD-50 to 100 Units/kg 3 times weekly (adults) as initial dose and 50 Units/kg 3 times weekly (pediatric patients). Individualize maintenance dose. Intravenous route recommended for members on hemodialysis. Members on Zidovudine due to HIV-infection-100 Units/kg 3 times weekly. Members with cancer-40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients 5 years) . If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Members hemoglobin increased, stayed the same and not decreased further (baseline labs and current labs required); AND 2. Red blood cel ls transfusions are not required or the number of the transfusions has decreased. If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. REDUCTION OF ALLOGENEIC RBC TRANSFUSIONS For initial authorization: 1. Medication must be prescribed by an oncologist, a nephrologist, an immunologist or infectious disease specialist; AND 2. Medication is being used for reduction of allogeneic RBC transfusions in member undergoing elective, non-cardiac, nonvascular high-risk surgery at increased risk of or intolerant to transfusions ; AND 3. Me mbers labs show hemoglobin 13 g/dL. 4. Dosage allowed: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Medication will not be reauthorized. CareSource considers Epogen (epoetin alfa) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: In members with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy In members with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure In members with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion In members scheduled for surgery who are willing to donate autologous blood In members undergoing cardiac or vascular surgery As a substitute for RBC transfusions in patients who require immediate correction of anemia DATE ACTION/DESCRIPTION 10/04/2018 New policy for Epogen created. Hemoglobin requirement expanded. Endogenous serum erythropoietin level requirement removed. References: 1. Epogen [package insert]. Thousand Oaks, CA: Amgen , Inc.; September, 2017. 2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology; Cancer-and Chemotherapy-Induced Anemia. V.2.2018. Available at https://www.nccn.org/professionals/physician_gls/pdf/anemia.pdf. Accessed January 30, 2018. 3. Wolters Kluwer. Facts & Comparisons. www.factsandcomparisons.com, 2011. (May 11, 2011) . 4. Young. D. CMS Anemia Drugs Proposal: Bad for Amgen, Good for Patients, 17 May 2007. 5. New risk management program for erythropoiesis-stimulating agents. Aranesp, Procrit, and Epogen Article; Pharmacist's Letter; April 2010; Vol: 26 Hematology / Oncology . 6. Singh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease, NEngl j Med. 2006; 355:2085-98. 7. Mueller BU, Jacobsen RN, Jarosinski P, et al. Erythropoietin for zidovudine-associated anemia in children with HIV infection. 8. Pediatr AIDS and HIV Infect: Fetus to Adolesc. 1994;5:169-173. 9. Bohlius J, Wilson J, Seidenfeld J, et al., Recombinant Human Erythropoietins and Cancer Patients: Updated Meta-Analysis of 57 Studies Including 9353 Patients. JNatl Cancer Inst. 2006; 98:708-14. 10. Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. 11. Glaspy J, Crawford J, Vansteenkiste J, Henry D, Rao S, Bowers P, Berlin JA, Tomita D, Bridges K, Ludwig HBr JCancer. 2010;102(2):301. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. 12. Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR, American Society of Clinical Oncology, American Society of Hematology; JClin Oncol. 2010;28(33):4996. National Comprehensive Cancer Network (NCCN) guidelines www.nccn.org. Accessed September 3, 2015. 13. Aliment Pharmacol Ther. 2010 May;31(9):929-37. Epub 2010 Feb 18.Review article: optimizing SVR and management of the haematol ogical side effects of peginterferon/ribavirin antiviral therapy for HCV-the role of epoetin, G-CSF and novel agents . 14. Definition and management of anemia in patients infected with hepatitis Cvirus. McHutchison JG, Manns MP, Longo DL Liver Int. 2006;26(4):389 MCG 20th edition, 2016. Effective date: 10/19/2018 Revised date: 10/04/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Aranesp (darbepoetin alfa) BILLING CODE For Medical-J0881 (non-ESRD) For Pharmacy-Must use valid NDC code BENEFIT TYPE Medical or Pharmacy SITE OF SERVICE ALLOWED Office, Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT vary per diagnosis LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Aranesp (darbepoetin alfa) is a preferred product and will only be con sidered for coverage under the medical or pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. ANEMIA For initial authorization: 1. Medication must be prescribed by an oncologist, a nephrologist, an immunologist or infectious disease specialist; AND 2. Member has documented diagnosis of anemia due to one of the following: a) Myelodysplastic syndrome; b) Chronic Kidney Disease (GFR below 60 mL/min/1.73 m2); c) The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy; AND 3. Members individual iron status reveals both of the following: a) Transferrin saturation is at least 20%; b) Ferritin is at least 100 mcg/L; AND 4. Member is on supplemental iron therapy (unless serum ferritin level > 800 mcg/L); AND 5. Members labs show hemoglobin 10 g/dL for adults (11 g/dL for children) within the last 14 days for initial therapy OR 10.5 g/dL for adults (11.5 g/dL for children) current ly receiving therapy. 6. Dosage allowed: Recommended starting dose for adult members with CKD on dialysis-0.45 mcg/kg IV or SQ weekly, or 0.75 mcg/kg IV or SQ every 2 weeks. I Vroute is recommended for patients on hemodialysis. Recommended starting dose for members with CKD not on dialysis-0.45 mcg/kg IV or SQ at 4 week intervals. Recommended starting dose for pediatric member s with CKD: 0.45 mcg/kg IV or SQ weekly , member s with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks. Recommended starting dose for members with cancer on chemotherapy : 2.25 mcg/kg subcutaneously weekly, or 500 mcg subcutaneously every 3 weeks . If member meets all the requirements listed above, the medication will be approved for 6 months.For reauthorization: 1. Members hemoglobin increased, stayed the same and not decreased further (baseline labs and current labs required); AND 2. Red blood cells transfusions are not required or the number of the transfusions has decreased. If member meets all the reauthorization requirements above, the medication will be app roved for an additional 6 months. CareSource considers Aranesp (darbepoetin alfa ) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: In members with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy In members with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure In members with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion In members scheduled for surgery who are willing to donate autologous blood As a substitute for RBC transfusions in patients who require immediate correction of anemia DATE ACTION/DESCRIPTION 10/04/2018 New policy for Aransep created. Hemoglobin requirement expanded. Endogenous serum erythropoietin level requirement removed. References: 1. Aranesp [package insert]. Thousand Oaks, CA: Amgen ; July, 2015. 2. National comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic syndrome. V.1.2018. Available at https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf on January 30, 2018. 3. Wolters Kluwer. Facts & Comparisons. www.factsandcomparisons.com, 2011. (May 11, 2011) . 4. YOUNG. D. CMS Anemia Drugs Proposal: Bad for Amgen, Good for Patients, 17 May 2007 . 5. New risk management program for erythropoiesis-stimulating agents. Aranesp, Procrit, and Epogen Article; Pharmacist’s Letter; April 2010; Vol: 26 Hematology / Oncology . 6. Singh AK, Szczech L, Tang KL, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease, NEngl j Med. 2006; 355:2085-98. 7. Bohlius J, Wilson J, Seidenfeld J, et al., Rec ombinant Human Erythropoietins and Cancer Patients: Updated Meta-Analysis of 57 Studies Including 9353 Patients. JNatl Cancer Inst. 2006; 98:708-14. 8. Erythropoiesis-stimulating agents in oncology: a study-level meta-analysis of survival and other safety outcomes. 9. Glaspy J, Crawford J, Vansteenkiste J, Henry D, Rao S, Bowers P, Berlin JA, Tomita D, Bridges K, Ludwig HBr JCancer. 2010;102(2):301. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. 10. Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR, American Society of Clinical Oncology, A merican Society of Hematology; JClin Oncol. 2010;28(33):4996. National Comprehensive Cancer Network (NCCN) guidelines www.nccn.org. Accessed September 3, 2015. 11. Aliment Pharmacol Ther. 2010 May;31(9):929-37. Epub 2010 Feb 18.Review article: optimizing SVR and management of the haematological side effects of peginterferon/ribavirin antiviral therapy for HCV-the role of epoetin, G-CSF and novel agents . 12. Definition and management of anemia in patients infected with hepatitis Cvirus. McHutchison JG, Manns MP, Longo DL Liver Int. 2006;26(4):389 MCG 20th edition, 2016. Effective date: 10/19/2018 Revised date: 10/04/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Epidiolex (cannabidiol) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT up to 20 mg/kg/day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Epidiolex (cannabidiol) is a non-preferred product andyndrome. NEngl JMed 2017;376:2011-20. Effective date: 09/14/2018 Revised date: 08/31/2018
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Yescarta (axicabtagene ciloleucel)
© Copyright CareSource 2026. All rights reserved.
System Details