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

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

 

POLICY NUMBER

L.5.01.423

 

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®).

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.

 

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

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

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

 

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.

09/01/2015: Code Reference section updated for ICD-10. Added ICD-9 diagnosis codes 403.00 - 403.91 and 404.00 – 404.93. Deleted ICD-9 diagnosis code 593.9.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions.

05/26/2016: Policy number L.5.01.423 added.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

 

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

  

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) (Deleted 12/31/2015)

Q4081

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

ICD-9 Procedure

ICD-10 Procedure

  

 

 

ICD-9 Diagnosis

ICD-10 Diagnosis

203.00

Multiple myeloma, without mention of having achieved remission

C90.00

Multiple myeloma, not having achieved remission

203.01

Multiple myeloma in remission

C90.01

Multiple myeloma, in remission

203.02

Multiple myeloma, in relapse

C90.02

Multiple myeloma, in relapse

238.71

Essential thrombocythemia

D47.3

Essential (hemorrhagic) thrombocythemia

238.72

Low grade myelodysplastic syndrome lesions

D46.0

Refractory anemia without ring sideroblasts, so stated

D46.1

Refractory anemia with ring sideroblasts

D46.20

Refractory anemia with excess of blasts, unspecified

D46.21

Refractory anemia with excess of blasts 1

D46.4

Refractory anemia, unspecified

D46.A

Refractory cytopenia with multilineage dysplasia

D46.B

Refractory cytopenia with multilineage dysplasia and ringed sideroblasts

238.73

High grade myelodysplastic syndrome lesions

D46.22

Refractory anemia with excess of blasts 2

238.74

Myelodysplastic syndrome with 5q deletion

D46.C

Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

238.75

Myelodysplastic syndrome, unspecified

D46.9

Myelodysplastic syndrome, unspecified

D46.Z

Other myelodysplastic syndromes

238.76

Myelofibrosis with myeloid metaplasia

D47.1

Chronic myeloproliferative disease

238.79

Other lymphatic and hematopoietic tissues

C94.40-C94.42

Acute panmyelosis with myelofibrosis (code range)

283.0

Autoimmune hemolytic anemias (drug-induced)

D59.0

Drug-induced autoimmune hemolytic anemia

285.21

Anemia in end-stage renal disease

D63.1

Anemia in chronic kidney disease

285.22

Anemia in neoplastic disease

D63.0

Anemia in neoplastic disease

285.29

Anemia of other chronic disease

D63.8

Anemia in other chronic diseases classified elsewhere

403.00 - 403.91

Hypertensive chronic kidney disease, stage I through stage V (code range)

I12.0 - I12.9

Hypertensive chronic kidney disease, stage I through stage V (code range)

404.00 - 404.93

Hypertensive heart and chronic kidney disease, stage I through stage V (code range)

I13.0 - I13.2

Hypertensive heart and chronic kidney disease, stage I through stage V (code range)

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

Chronic kidney disease code range

N18.1 - N18.9

Chronic kidney disease (code range)

586

Unspecified renal failure

N19

Unspecified kidney failure

V58.11

Encounter for antineoplastic chemotherapy

Z51.11

Encounter for antineoplastic chemotherapy


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