BlueCross BlueShield of Tennessee Medical Policy Manual

Darbepoetin Alfa for ESRD (dialysis)

NDC CODE(S)

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)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Anemia due to CKD on dialysis**

On dialysis & Pediatric patients - Initiate at 0.45 mcg/kg intravenously or subcutaneously every 7 days or 0.75 mcg/kg every 14 days

Conversion from Epoetin alfa to Aranesp in patients with CKD on dialysis

  • Aranesp is administered less frequently than epoetin alfa.

  • Administer Aranesp once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly.

  • Administer Aranesp once every 2 weeks in patients who were receiving epoetin alfa once weekly.

  • Maintain the route of administration (intravenous or subcutaneous injection).

**

  • Dose increases of 25% can be considered if after 4 weeks of initial therapy the hemoglobin has increased less than 1 g/dL and the current hemoglobin level is less than the indication specific level noted above

  • Dose decreases of 25% or more can be considered if the hemoglobin rises rapidly by more than 1 g/dL in any 2 week period

  • Dose and frequency requested are the minimum necessary for the patient to avoid RBC transfusions.

  • Avoid frequent dose adjustments. Do not increase the dose more frequently than once every 4 weeks; decreases can occur more frequently.

  • If patients fail to respond over a 12-week dose escalation period, further doses increases are unlikely to improve response and discontinuation of therapy should be considered.  

LENGTH OF AUTHORIZATION

ESRD: Coverage will be provided for 12 months 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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

SOURCES

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. (2019). AHFS DI. Darbepoetin alfa. Retrieved April 16, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Health Care Series. Drugdex Drug Evaluation. (2019, April) Darbepoetin alfa. Retrieved April 16, 2019 from MICROMEDEX Healthcare Series.

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. (2019, January). Center for Drug Evaluation and Research. Aranesp® (darbepoetin alfa) injection, for intravenous or subcutaneous use. Retrieved April 16, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103951s5374lbl.pdf.

ORIGINAL EFFECTIVE DATE: 1/14/2006

MOST RECENT REVIEW DATE:  8/30/2019

ID_MRx

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.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

1 microgram (for ESRD on dialysis) = 1 billable unit

DIAGNOSIS

MAXIMUM UNITS

Anemia due to CKD on dialysis

200 billable units every 7 days