Subject: Epogen-Procrit-Retacrit SGM 1619-A P2024_R

Drug

EPOGEN  (epoetin alfa)

PROCRIT®  (epoetin alfa)

RETACRIT  (epoetin alfa-epbx)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications^1-3

• 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 (RBC) transfusion.
• Treatment of anemia due to zidovudine administered at less than or equal to 4200 milligrams (mg) per week in patients with human immunodeficiency virus (HIV)-infection with endogenous serum erythropoietin levels of less than or equal to 500 milliunits per milliliter (mUnits/mL).
• Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
• To reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin greater than 10 to less than or equal to 13 grams per deciliter (g/dL) who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epoetin alfa is not indicated for patients who are willing to donate autologous blood preoperatively.

Compendial Uses

• Symptomatic anemia in patients with myelodysplastic syndromes (MDS)^4,5,13,14,15
• Anemia in patients who will not/cannot receive blood transfusions^5,6
• Myelofibrosis-associated anemia^4,5,9
• Cancer patients who are undergoing palliative treatment⁴

All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Note: Requirements regarding pretreatment hemoglobin level exclude values due to a recent transfusion. All members must be assessed for iron deficiency anemia and have adequate iron stores (defined as a serum transferrin saturation [TSAT] level greater than or equal to 20% within the prior 3 months) or are receiving iron therapy before starting Epogen/Procrit/Retacrit. Members may not use Epogen/Procrit/Retacrit concomitantly with other erythropoiesis-stimulating agents.

Anemia Due to Chronic Kidney Disease (CKD)^1-3,7

Authorization of 12 weeks may be granted for treatment of anemia due to chronic kidney disease in members with pretreatment hemoglobin less than 10 g/dL.

Anemia Due to Myelosuppressive Chemotherapy^1-3,8

Authorization of 12 weeks may be granted for treatment of anemia due to myelosuppressive chemotherapy in members with non-myeloid malignancy and pretreatment hemoglobin less than 10 g/dL.

Anemia in Myelodysplastic Syndrome (MDS)^4,5,8,12-13

Authorization of 12 weeks may be granted for treatment of anemia in myelodysplastic syndrome in members with pretreatment hemoglobin less than 10 g/dL.

Reduction of Allogeneic Red Blood Cell Transfusion in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery^1-3

Authorization of 8 weeks may be granted for reduction of allogenic red blood cell transfusion in members scheduled to have an elective, noncardiac, nonvascular surgery with pretreatment hemoglobin less than or equal to 13 g/dL.

Anemia Due to Zidovudine in HIV-infected Patients^1-3

Authorization of 12 months may be granted for treatment of anemia due to zidovudine in HIV-infected members currently receiving zidovudine with pretreatment hemoglobin less than 10 g/dL whose pretreatment serum EPO level is less than or equal to 500 mU/mL.

Anemia in Members Who Will Not/Cannot Receive Blood Transfusions⁵

Authorization of 12 weeks may be granted for treatment of anemia in members who will not/cannot receive blood transfusions (e.g., religious beliefs) with pretreatment hemoglobin less than 10 g/dL.

Myelofibrosis-associated Anemia^4,5,9,10

Authorization of 12 weeks may be granted for treatment of myelofibrosis-associated anemia in members who meet both of the following criteria:

• Pretreatment hemoglobin less than 10 g/dL.
• Pretreatment serum EPO level less than 500 mU/mL.

Anemia Due to Cancer^4,8

Authorization of 12 weeks may be granted for treatment of anemia due to cancer in members who have cancer and are undergoing palliative treatment.

Continuation of Therapy

Note: Requirements regarding current hemoglobin level exclude values due to a recent transfusion. All members must be assessed for iron deficiency anemia and have adequate iron stores (defined as a serum transferrin saturation [TSAT] level greater than or equal to 20% within the prior 3 months) or are receiving iron therapy before continuation of treatment with Epogen/Procrit/Retacrit. Members may not use Epogen/Procrit/Retacrit concomitantly with other erythropoiesis stimulating agents.

For all indications below (excluding Anemia due to Zidovudine in HIV infected patients): All members (including new members) requesting authorization for continuation of therapy after at least 12 weeks of erythropoiesis-stimulating agent (ESA) treatment must show a response with a rise in hemoglobin of greater than or equal to 1 g/dL. Members who completed less than 12 weeks of ESA treatment and have not yet responded with a rise in hemoglobin of greater than or equal to 1 g/dL may be granted authorization of up to 12 weeks to allow for sufficient time to demonstrate a response.

Anemia Due to CKD^1-3,7

Authorization of 12 weeks may be granted for continued treatment of anemia due to chronic kidney disease in members with current hemoglobin less than 12 g/dL.

Anemia Due to Myelosuppressive Chemotherapy^1-3,8

Authorization of 12 weeks may be granted for the continued treatment of anemia due to myelosuppressive chemotherapy in members with non-myeloid malignancy and current hemoglobin less than 12 g/dL.

Anemia in Myelodysplastic Syndrome (MDS)^4,5,8,12,14

Authorization of 12 weeks may be granted for continued treatment of anemia in myelodysplastic syndrome in members with current hemoglobin is less than 12 g/dL.

Reduction of Allogenic Red Blood Cell Transfusion in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery^1-3

All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Anemia Due to Zidovudine in HIV-infected Patients^1-3

Authorization of 12 months may be granted for continued treatment of anemia due to zidovudine in HIV-infected members receiving zidovudine with current hemoglobin less than 12 g/dL.

Anemia in Members Who Will Not/Cannot Receive Blood Transfusions⁵

Authorization of 12 weeks may be granted for continued treatment of anemia in members who will not/cannot receive blood transfusions (e.g., religious beliefs) with current hemoglobin less than 12 g/dL.

Myelofibrosis-associated Anemia^4,5,9,10

Authorization of 12 weeks may be granted for continued treatment of anemia in myelofibrosis-associated anemia with current hemoglobin less than 12 g/dL.

Anemia Due to Cancer⁴

Authorization of 12 weeks may be granted for continued treatment of anemia due to cancer in members who have cancer and are undergoing palliative treatment.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Epogen [package insert]. Thousand Oaks, CA: Amgen Inc.; April 2024.
2. Procrit [package insert]. Horsham, PA: Janssen Products, LP; July 2018.
3. Retacrit [package insert]. New York, NY: Pfizer Labs; June 2024.
4. National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 5, 2024.
5. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 5, 2024.
6. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed September 5, 2024.
7. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int. 2012;Suppl 2:279-335.
8. Bohlius J, Bohlke K, Castelli R, et al. Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update J Clin Oncol. 2019 May 20;37(15):1336-1351.
9. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms. Version 2.2024. http://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed September 07, 2023.
10. Cervantes F, Alvarez-Larran A, Hernandez-Boluda JC, et al. Erythropoietin treatment of the anemia of myelofibrosis with myeloid metaplasia: results in 20 patients and review of the literature. Br J Haematol. 2004;127(4):399-403.
11. Henry DH, Beall GN, Benson CA, Carey J, Cone LA, Eron LJ, et al. Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy: Overview of Four Clinical Trials. Ann Intern Med.; 117:739–748. doi: 10.7326/0003-4819-117-9-739.
12. Gabrilove j, Paquette R, Lyons R, Mushtaq C, Sekeres M, Tomita D, Dreiling L. Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anemia in patients with myelodysplastic syndromes. Br J Haematol. 2008 Aug; 142(3): 379–393.
13. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes. Version 3.2024. https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed September 5, 2024

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

May 06, 2025