Print Epoetin Alfa (Procrit®, Epogen®) Darbepoetin Alfa (Aranesp®)

Epoetin Alfa (Procrit®, Epogen®) Darbepoetin Alfa (Aranesp®)

 

DESCRIPTION

Erythropoietin is an endogenous glycoprotein that stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of erythroid progenitors in bone marrow. Epoetin alfa, (Procrit®, Epogen®) and darbepoetin alfa (Aranesp®), both manufactured by recombinant DNA technology, are immunologically and biologically indistinguishable from the renal hormone erythropoietin. Darbepoetin alfa (Aranesp®), a second-generation stimulating protein, is a hyperglycosylated analog with a half-life two to three times longer than epoetin alfa (Procrit®, Epogen®).

FDA APPROVED INDICATIONS

Epoetin alfa (Epogen®, Procrit®) is indicated for the treatment of anemia due to Chronic Kidney Disease, in patients on dialysis and not on dialysis. It is also indicated for the treatment of anemia due to zidovudine in HIV-infected patients and for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy when there is a minimum of two additional months of planned chemotherapy. Epoetin alfa (Epogen®, Procrit®) is also indicated for reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Darbepoetin alfa (Aranesp®) is indicated for the treatment of anemia due to Chronic Kidney Disease in patients on dialysis and patients not on dialysis, and for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy when there is a minimum of two additional months of planned chemotherapy.

Generic Name: Epoetin Alfa 

Brand Name: Epogen®, Procrit®

Generic Name: Darbepoetin Alfa

Brand Name: Aranesp®

 

POLICY

Epoetin alfa (Procrit®, Epogen®) is considered medically necessary for the treatment of anemia related to therapy with zidovudine in HIV-infected patients, the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, for the treatment of anemic patients scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, and for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.

Darbepoetin alfa (Aranesp®) is considered medically necessary for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.

 

POLICY EXCEPTIONS

None

 

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

7/1997: Date originally issued

4/1999: Approved by Pharmacy & Therapeutics (P & T) Oncology Committee

1/17/2001: HCPCS code range Q9920-Q9940 added covered codes 

2/2/2001: ICD-9 diagnosis code 285.21 added covered codes

1/30/2002: Prior authorization deleted

2/15/2002: Investigational definition added

4/26/2002: Type of Service and Place of Service deleted. Code Reference section updated. CPT codes 85007, 85027 and 99204 deleted covered codes. ICD-9 diagnosis code 238.7, 272.7, 280.0, 282.60-282.69, 283.2, 285.29, 285.8, 285.8, 773.0, 776.6, 785.6 added non-covered codes, ICD-9 diagnosis codes 285.9, V78.1 and V72.6 deleted covered codes,  ICD-9 procedure code 99.28 deleted covered codes

3/25/2003: Policy section revised, Code Reference section updated, ICD-9 diagnosis code 238.7 moved to covered codes, ICD-9 diagnosis code 203.00, 203.01, 285.22, V58.1 added covered codes, HCPCS range Q9920-Q9940 listed separately covered codes

12/19/2003: Code Reference section reviewed, CPT code 90782, 90784 deleted covered codes, ICD-9 diagnosis code 99.29 deleted covered codes, ICD-9 diagnosis code range 282.60-282.69 listed separately non-covered codes, ICD-9 diagnosis code 282.60, 282.61, 282.62, 282.63, 282.69 description revised non-covered codes, ICD-9 diagnosis code 282.64, 282.68 added non-covered codes

7/9/2004: Code Reference section updated, ICD-9 diagnosis code 585, 586 added covered codes, ICD-9 diagnosis code 593.9 description revised, HCPCS Q9920-9940 deletion date of 12/31/2003 added, HCPCS Q4055 added covered codes

8/11/2005: Code Reference section updated, ICD-9 diagnosis code 283.0 description revised, ICD-9 diagnosis code 285.29 added covered codes, HCPCS Q4054 with effective date of 1/1/2004 added covered codes, HCPCS Q4055 effective date of 1/1/2004 added, HCPCS Q9920, Q9921, Q9922, Q9923, Q9924, Q9925, Q9926, Q9927, Q9928, Q9929, Q9930, Q9931, Q9932, Q9933, Q9934, Q9935, Q9936, Q9937, Q9938, Q9939, Q9940 deleted covered codes, Non-covered codes table and ICD-9 diagnosis code 272.7, 280.0, 282.60, 282.61, 282.62, 282.63, 282.64, 282.68, 282.69, 283.2, 285.29, 285.8, 285.8, 773.0, 776.6, 785.6 deleted

11/8/2005:  Code Reference section updated, 4th digit added to ICD9 diagnosis codes 585.1-585.9, description revised; 5th digit added to code V58.11, description revised

3/6/2006: Aranesp information added to policy. Rewording of policy section to align with indications.

03/23/2006: Coding updated. 2006 revisions added to policy

4/2006: Approved by Pharmacy & Therapeutics (P&T) Committee

9/13/2006: Coding updated. CPT4/HCPCS and ICD9 2006 revisions added to policy.  

9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied

4/1/2014: Policy description updated regarding FDA Approved Indications for the treatment of anemia due to Chronic Kidney Disease. Removed deleted HCPCS codes Q0136, Q4054, and Q4055 from the Code Reference section.

 

SOURCE(S)

Fact and Comparisons, July 1997

American Hospital Formulary Services, 1998 and 2006

Hayes Directory, July 1996

USPDI, 1998

Procrit® Prescribing Information

Epogen® Prescribing Information

Aranesp® Prescribing Information

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

Code Number

Description

CPT-4

 

 

ICD-9 Procedure

 

 

ICD-9 Diagnosis

203.00

Multiple myeloma, without mention of having achieved  remission

203.01

Multiple myeloma in remission

203.02

Multiple myeloma, in relapse

238.71

Essential thrombocythemia

238.72

Low grade myelodysplastic syndrome lesions

238.73

High grade myelodysplastic syndrome lesions

238.74

Myelodysplastic syndrome with 5q deletion

238.75

Myelodysplastic syndrome, unspecified

238.76

Myelofibrosis with myeloid metaplasia

238.79

Other lymphatic and hematopoietic tissues

283.0

Autoimmune hemolytic anemias (drug-induced)

285.21

Anemia in end-stage renal disease

285.22

Anemia in neoplastic disease

285.29

Anemia of other chronic disease

585.1, 585.2, 585.3, 585.4, 585.5, 585.6, 585.9

Chronic kidney disease code range

586

Unspecified renal failure

593.9

Chronic renal insufficiency (acute) (chronic)

V58.11

Encounter for antineoplastic chemotherapy

HCPCS

J0881

Injection, darbepoetin alfa, 1 microgram (non-ESRD use)

J0882

Injection, darbepoetin alfa, 1 microgram (non-ESRD use)

J0885

Injection epoetin alfa, (for non-ERSD use), 1000 units

J0886

Injection, epoetin alpha, 1000 units (for ESRD on dialysis)

Q4081 

Injection, epoetin alfa, 100 units (for ERSD on dialysis)

 

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