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

Darbepoetin alfa (Aranesp®) is indicated 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.

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

 

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 (added 3-25-2003) (description revised 10-1-2008)

203.01

Multiple myeloma in remission (added 3-25-2003)

203.02Multiple myeloma, in relapse (new 10-1-2008)

238.71

Essential thrombocythemia (New 10-1-2006)
238.72Low grade myelodysplastic syndrome lesions (New 10-1-2006)
238.73High grade myelodysplastic syndrome lesions (New 10-1-2006)
238.74Myelodysplastic syndrome with 5q deletion (New 10-1-2006)
238.75Myelodysplastic syndrome, unspecified (New 10-1-2006)
238.76Myelofibrosis with myeloid metaplasia (New 10-1-2006)
238.79Other lymphatic and hematopoietic tissues (New 10-1-2006)

283.0

Autoimmune hemolytic anemias (drug-induced) (description revised 8-11-2005)

285.21

Anemia in end-stage renal disease (added 2-2-2001)

285.22

Anemia in neoplastic disease (added 3-25-2003)

285.29

Anemia of other chronic disease (added 8-11-2005) (description revised 10-1-2006)

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

Chronic kidney disease code range (description revised 7-9-2004) (4th digits and revised description effective 10/1/2005) (added 11/8/2005)

586

Unspecified renal failure (description revised 7-9-2004)

593.9

Chronic renal insufficiency (acute) (chronic) (description revised 7-9-2004)

V58.11

Encounter for antineoplastic chemotherapy (added 3-25-2003) (description revised 7-9-2004) (5th digit and revised description effective 10/1/2005) (added 11/8/2005)

HCPCS

J0881Injection, darbepoetin alfa, 1 microgram (non-ESRD use) (new 1-1-2006)
J0882Injection, darbepoetin alfa, 1 microgram (non-ESRD use) (new 1-1-2006)
J0885Injection epoetin alfa, (for non-ERSD use), 1000 units (new 1-1-2006)
J0886Injection, epoetin alpha, 1000 units (for ESRD on dialysis) (new 1-1-2006) 

Q0136

Injection, epoetin alfa, (for non ESRD use), per 1,000 units (added 1-17-2001) (deleted 12/31/2005)

Q4054

Injection, darbepoetin alfa (Aranesp), 1 mcg (for ESRD on dialysis) (effective date 1-1-2004) (added 8-11-2005) (deleted 12/31/2005)

Q4055

Injection, epoetin alfa, 1000 units (for ESRD on dialysis) (added 7-9-2004) (effective 1-1-2004 added 8-11-2005) (deleted 12/31/2005)

Q4081 

Injection, epoetin alfa, 100 units (for ERSD on dialysis) (New 1-1-2007)

 

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