BlueCross BlueShield of Tennessee Medical Policy Manual

Darbepoetin

NDC CODE(S)

 

 

Aranesp (AMGEN)

 Single-dose Vial

1 Vial/Pack, 4 Packs/Case

200 mcg/1 mL

55513-006-01

300 mcg/1 mL

55513-110-01

4 Vials/Pack, 10 Packs/Case

25 mcg/1 mL

55513-002-04

40 mcg/1 mL

55513-003-04

60 mcg/1 mL

55513-004-04

100 mcg/1 mL

55513-005-04

150 mcg/0.75 mL

55513-053-04

Single-dose Prefilled Syringe

1 Syringe/Pack, 4 Packs/Case

200 mcg/0.4 mL

55513-028-01

300 mcg/0.6 mL

55513-111-01

500 mcg/1 mL

55513-032-01

4 Syringes/Pack, 10 Packs/Case

10 mcg/0.4 mL

55513-098-04

25 mcg/0.42 mL

55513-057-04

40 mcg/0.4 mL

55513-021-04

60 mcg/0.3 mL

55513-023-04

100 mcg/0.5 mL

55513-025-04

150 mcg/0.3 mL

55513-027-04

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.

Darbepoetin should be administered in accordance with current FDA-approved labeling. The product label bears boxed warnings about significant risks and for oncological use requires enrollment by providers and hospitals in the FDA REMs (Risk Evaluation Mitigation) program, ESA APPRISE Oncology Program.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Anemia due to myelosuppressive chemotherapy

·       Initiate at 2.25 mcg/kg every 7 days; may increase up to 4.5 mcg/kg every 7 days for insufficient response

·       Initiate at 500 mcg every 21 days

Anemia due to CKD*

·       Not on dialysis - Initiate at 0.45 mcg/kg every 28 days

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

Anemia due to ribavirin/Interferon therapy for HCV

·       Up to 3 mcg/kg every 14 days

Anemia due to MDS

Up to 300 mcg every 7 days

 

 

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

*Dose is titrated based on response; conversion from epoetin alfa to Aranesp is based on the previous epoetin alfa dose; generally under 200mcg per week

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).

No controlled studies were found in the published literature that validate the use of darbepoetin alfa for the treatment of other conditions and diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2014). Erythropoietin (epoetin alfa) (5.01.04). Retrieved March 23, 2016 from BlueWeb.

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. (2016, March). AHFS DI. Darbepoetin alfa. Retrieved March 23, 2016 from Lexi-Comp Online with AHFS.

Lexi-Comp Online. (2016, March). AHFS DI. Epoetin alfa. Retrieved March 23, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Health Care Series. Drugdex Drug Evaluation. (2016, March) Darbepoetin alfa. Retrieved March 23, 2016 from MICROMEDEX Healthcare Series.

MICROMEDEX Health Care Series. Drugdex Drug Evaluation. (2016, March) Erythropoietin. Retrieved March 23, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Epoetin alfa. Retrieved March 23, 2016 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Darbepoetin alfa. Retrieved March 23, 2016 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. (2013, December). Center for Drug Evaluation and Research. Epogen® (epoetin alfa) injection, for intravenous or subcutaneous use. Retrieved March 23, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103234s5323lbl.pdf.

U. S. Food and Drug Administration. (2015, July). Center for Drug Evaluation and Research. Aranesp® (darbepoetin alfa) injection, for intravenous or subcutaneous use. Retrieved March 23, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103951s5363lbl.pdf.

ORIGINAL EFFECTIVE DATE: 1/14/2006

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Darbepoetin (Aranesp®)

 

1.     Is this the initial request for this agent?

 

If yes, go to question #2

If no, go to question #7

 

2.     Are lab values submitted drawn within 30 days of administration?

 

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

3.     Does the individual have adequate iron stores prior to initiation of therapy as demonstrated by serum ferritin ≥100 ng/mL (mg/L0 and transferrin saturation (TSAT) ≥20%?

 

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

4.     Are initiation of therapy levels of hemoglobin (Hb) <10g/dL and/or Hematocrit (Hct) <30%?

 

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

5.     Does the individual have a diagnosis of anemia secondary to ANY ONE of the following?

 

·       Myelodysplastic syndrome (MDS) with endogenous serum erythropoietin level of ≤500 mUnits/mL

·       Hepatitis C treatment if individual receiving both interferon AND ribavirin

·       Chemotherapy treatment if provider enrolled in REMS program and individual is receiving concurrent myelosuppressive chemotherapy that is NOT curative but palliative in intent with a minimum of two additional months of planned chemotherapy

§  Chronic kidney disease for dialysis and non-dialysis individuals

 

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

6.     Is the request for 900 billable units every 21 days for myelodysplastic syndromes (MDS) only or 600 billable units every 21 days for all other indications for dosages as follow for an authorization period of period of 45 days for non-ESRD (non-end-stage renal disease) indications and for 12 months for ESRD indications?

 

Anemia due to myelosuppressive chemotherapy

·       Initiate at 2.25 mcg/kg every 7 days; may increase up to 4.5 mcg/kg every 7 days for insufficient response

·       Initiate at 500 mcg every 21 days

Anemia due to CKD*

·       Not on dialysis - Initiate at 0.45 mcg/kg every 28 days

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

Anemia due to ribavirin/Interferon therapy for HCV

·       Up to 3 mcg/kg every 14 days

Anemia due to MDS

Up to 300 mcg every 7 days

 

 

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

*Dose is titrated based on response; conversion from epoetin alfa to Aranesp is based on the previous epoetin alfa dose; generally under 200mcg per week

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

7.     Was the last dose of darbepoetin alfa less than 60 days ago?

 

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

8.     Does the individual show disease response from the previous treatment?

 

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

9.     Are submitted lab values obtained within 30 days of the date of administration (unless otherwise indicated)?

 

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

10.  Does the individual have adequate iron stores as demonstrated by serum ferritin ≥ 100 ng/ml (mcg/L) and transferrin saturation (TSAT) ≥20% measured within the previous 3 months?

 

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

11.  Is the anemia secondary to ANY ONE of the following?

 

·       Myelodysplastic syndrome (MDS) with hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%

·       Chemotherapy treatment with 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 with levels of ANY ONE of the following:

o   Pediatrics: Hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%

o   Adults: Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33%

·       Hepatitis C treatment with Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33% and individual must be receiving interferon AND ribavirin

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

 

This document has been classified as public information.