55513-0002-XX Aranesp (Albumin Free) 25 MCG/ML SOLN (AMGEN)
55513-0003-XX Aranesp (Albumin Free) 40 MCG/ML SOLN (AMGEN)
55513-0004-XX Aranesp (Albumin Free) 60 MCG/ML SOLN (AMGEN)
55513-0005-XX Aranesp (Albumin Free) 100 MCG/ML SOLN (AMGEN)
55513-0006-XX Aranesp (Albumin Free) 200 MCG/ML SOLN (AMGEN)
55513-0021-XX Aranesp (Albumin Free) 40 MCG/0.4ML SOSY (AMGEN)
55513-0023-XX Aranesp (Albumin Free) 60 MCG/0.3ML SOSY (AMGEN)
55513-0025-XX Aranesp (Albumin Free) 100 MCG/0.5ML SOSY (AMGEN)
55513-0027-XX Aranesp (Albumin Free) 150 MCG/0.3ML SOSY (AMGEN)
55513-0028-XX Aranesp (Albumin Free) 200 MCG/0.4ML SOSY (AMGEN)
55513-0032-XX Aranesp (Albumin Free) 500 MCG/ML SOSY (AMGEN)
55513-0057-XX Aranesp (Albumin Free) 25 MCG/0.42ML SOSY (AMGEN)
55513-0098-XX Aranesp (Albumin Free) 10 MCG/0.4ML SOSY (AMGEN)
55513-0110-XX Aranesp (Albumin Free) 300 MCG/ML SOLN (AMGEN)
55513-0111-XX Aranesp (Albumin Free) 300 MCG/0.6ML SOSY (AMGEN)
Erythropoietin is a glycoprotein produced in the kidneys responsible for the stimulation of red blood cell production. Darbepoetin alfa is produced through recombinant DNA technology and serves as a synthetic form of erythropoietin. With the addition of two additional oligosaccharide chains it remains in systemic circulation approximately three times longer than another synthetic formulation of erythropoietin, epoetin alfa.
Darbepoetin alfa has the same amino acid sequence as endogenous erythropoietin. Like the endogenous hormone, it stimulates increased production of red blood cells in individuals with functioning erythropoiesis and is referred to as an erythropoietin-stimulating agent or an ESA.
Darbepoetin alfa for the treatment of anemia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Darbepoetin alfa for the treatment of other conditions/diseases is considered investigational.
Darbepoetin alfa is considered medically appropriate for the treatment of anemia if ALL of the following criteria are met:
Lab values are obtained within 30 days of administration unless otherwise indicated
Prior to initiation of therapy individual should have adequate iron stores as demonstrated by serum ferritin ≥100 ng/mL (mcg/L) and transferrin saturation (TSAT) ≥20% (Intravenous iron supplementation may be taken into account when evaluating iron status)
Initiation of therapy hemoglobin (Hb)<10g/dL and/or Hematocrit (Hct) <30%
Other causes of anemia (e.g., hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out
Anemia is secondary to ANY ONE of the following:
Myelodysplastic syndrome (MDS) and ALL of the following:
Treatment of lower risk disease associated with symptomatic anemia
Endogenous serum erythropoietin level of ≤500 mUnits/mL
Myeloproliferative Neoplasms (MPN) - Myelofibrosis with endogenous serum erythropoietin level of <500 mUnits/mL
Hepatitis C treatment if individual receiving both interferon AND ribavirin
Chemotherapy treatment if ALL of the following
Individual receiving concurrent myelosuppressive chemotherapy
Chemotherapy is not curative but palliative in intent
Minimum of two additional months of planned chemotherapy
Chronic kidney disease (non-dialysis)
Darbepoetin alfa is considered medically appropriate for renewal if ALL of the following criteria are met:
Last dose less than 60 days ago
Absence of unacceptable toxicity from the drug. Examples include pure red cell aplasia, severe allergic reactions (anaphylaxis, angioedema, bronchospasm, etc), severe cardiovascular events (stroke, myocardial infarction, congestive heart failure, thromboembolism, uncontrolled hypertension), seizures, increased risk of tumor progression/recurrence in patients with cancer, etc.;
Lab values are obtained within 30 days of the date of administration (unless otherwise indicated)
Adequate iron stores as demonstrated by serum ferritin ≥ 100 ng/ml (mcg/L) and transferrin saturation (TSAT) ≥20% measured within the previous 3 months; (Intravenous iron supplementation may be taken into account when evaluating iron status)
Other causes of anemia (e.g. hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out
For anemia secondary to ANY ONE of the following:
Myelodysplastic syndrome (MDS), hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%
Myeloproliferative neoplasms (MF, post-PV myelofibrosis, post-ET myelofibrosis), hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%
Chemotherapy treatment, Hemoglobin (Hb) <10 g/dL and/or Hematocrit (Hct) <30% and individual is receiving concurrent myelosuppressive chemotherapy with a minimum of two additional months of planned chemotherapy
Chronic kidney disease for ANY ONE of the following:
Pediatrics: Hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%
Adults: Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33%
Hepatitis C treatment,Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33% and individual must be receiving interferon AND ribavirin
DOSAGE & ADMINISTRATION
Anemia due to myelosuppressive chemotherapy**
Anemia due to CKD Not on Dialysis**
Anemia due to ribavirin/Interferon therapy for HCV
Anemia due to MDS and myeloproliferative neoplasms
Most common weekly dose
|Up to 200 mcg|
Most common every 2 week dose
|Up to 300 mcg|
Most common every 3 week dose
|Up to 500 mcg|
LENGTH OF AUTHORIZATION
Coverage will be provided for 45 days and may be renewed.
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Kidney Disease: Improving Global Outcomes (KDIGO). Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney inter., Suppl. 2012; 2: 279-335. Retrieved April 20, 2016 from:http://www.kdigo.org/clinical_practice_guidelines/pdf/KDIGO-Anemia%20GL.pdf.
Lexi-Comp Online. (2018). AHFS DI. Darbepoetin alfa. Retrieved September 4, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Health Care Series. Drugdex Drug Evaluation. (2018, February) Darbepoetin alfa. Retrieved September 4, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Darbepoetin alfa. Retrieved September 4, 2018 from the National Comprehensive Cancer Network.
National Kidney Foundation. (2007). Kidney Disease Outcomes Quality Initiative. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Retrieved March 16, 2016 from http://www2.kidney.org/professionals/KDOQI/guidelines_anemiaUP/guide1.htm.
U. S. Food and Drug Administration. (2017, October). Center for Drug Evaluation and Research. Aranesp® (darbepoetin alfa) injection, for intravenous or subcutaneous use. Retrieved September 4, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/14/2006
MOST RECENT REVIEW DATE: 10/9/2018
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information
Maximum billable units per dose and over time by indication as a Medical Benefit
1 microgram (for non-ESRD NOT on dialysis) = 1 billable unit