State and School Employees' Health Insurance Plan - Erythropoiesis-Stimulating Agents

POLICY NUMBER

S.5.01.423

Aranesp (darbepoetin alfa)

Epogen (epoetin alfa)

Procrit (epoetin alfa)

Retacrit (epoetin alfa-epbx)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Erythropoietin is an endogenous glycoprotein hormone 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 and darbepoetin alfa are both manufactured by recombinant DNA technology and are immunologically and biologically indistinguishable from the renal hormone erythropoietin. Darbepoetin alfa, a second-generation stimulating protein, is a hyperglycosylated analog with a half-life two to three times longer than epoetin alfa.

Epogen (epoetin alfa), Procrit (epoetin alfa), and Retacrit (epoetin alfa-epbx)are indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell transfusions, the treatment of anemia due to zidovudine administered at ≤4200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤500 mUnits/mL, the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy when there is a minimum of two additional months of planned chemotherapy, and to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin >10 to ≤13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.

Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to CKD, 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 concomitant myelosuppressive chemotherapy when there is a minimum of two additional months of planned chemotherapy.

POLICY

Epogen (epoetin alfa), Procrit (epoetin alfa), and Retacrit (epoetin alfa-epbx) are considered medically necessary for the following:

• Treatment of anemia related to therapy with zidovudine in HIV-infected individuals;

• Treatment of anemia in individuals with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy;

• Treatment of anemic individuals scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions; AND

• Treatment of anemia associated with chronic kidney disease, including individuals on dialysis and individuals not on dialysis.

Aranesp (darbepoetin alfa) is considered medically necessary for the following:

• Treatment of anemia associated with chronic kidney disease, including individuals on dialysis and individuals not on dialysis; AND

• Treatment of anemia in individuals with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): Self-administered drugs may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a self-administered drug are not covered under the medical benefit.

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

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 Participant’s illness, injury or Mental Health Disorders, 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 Participant’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 Participant, his or her Provider; and

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

For the definition of medical necessity, “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

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated to change "patients" to "individuals." Policy statements unchanged. Sources updated.

10/02/2024: Code Reference section updated to add new ICD-10 diagnosis codes C81.0A, C81.1A, C81.2A, C81.3A, C81.4A, C81.7A, C81.9A, C82.0A, C82.1A, C82.2A, C82.3A, C82.4A, C82.5A, C82.6A, C82.8A, C82.9A, C83.0A, C83.1A, C83.390, C83.398, C83.3A, C83.5A, C83.7A, C83.8A, C83.9A, C84.0A, C84.1A, C84.4A, C84.6A, C84.7B, C84.AA, C84.ZA, C84.9A, C85.1A, C85.2A, C85.8A, C85.9A, C86.11, C86.61, C88.01, C88.21, C88.31, C88.41, C88.80, C88.81, and C88.91. Effective 10/01/2024.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Epogen (epoetin alfa), Procrit (epoetin alfa), Retacrit (epoetin alfa-epbx), and Aranesp (darbepoetin alfa). Minor revisions made to medically necessary statements. Sources updated.

SOURCE(S)

1. Aranesp prescribing information. Amgen Inc. May 2024. Last accessed June 2025.

2. Epogen prescribing information. Amgen Inc. April 2025. Last accessed June 2025.

3. Procrit prescribing information. Janssen Products, LP. April 2025. Last accessed June 2025.

4. Retacrit prescribing information. Pfizer Laboratories Div Pfizer Inc. June 2024. Last accessed June 2025.

5. Schoener B, Borger J. Erythropoietin Stimulating Agents. [Updated 2024 Jul 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishin; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK536997/ Accessed June 2025.

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.

Medically Necessary Codes        

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.