Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Epogen-Procrit-Retacrit 1619-A SGM P2023
Drug
EPOGEN(epoetin alfa)
PROCRIT(epoetin alfa)
RETACRIT(epoetin alfa)
Policy:
I. 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.
A. FDA-Approved Indications 1. Epoetin alfa is 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 (RBC) transfusion. 2. Epoetin alfa is indicated for 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. 3. Epoetin alfa is indicated for the 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. 4. Epoetin alfa is indicated 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. Epoetin alfa is not indicated for patients who are willing to donate autologous blood preoperatively.
B. Compendial Uses 1. Symptomatic anemia in patients with myelodysplastic syndromes (MDS) 2. Anemia in rheumatoid arthritis 3. Anemia due to hepatitis C treatment with ribavirin in combination with either interferon alfa or peginterferon alfa 4. Anemia in patients whose religious beliefs forbid blood transfusions 5. Symptomatic anemia in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis 6. Cancer patients who are undergoing palliative treatment
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
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.
A. Anemia Due to Chronic Kidney Disease (CKD) Authorization of 12 weeks may be granted for treatment of anemia due to chronic kidney disease in members with pretreatment hemoglobin < 10 g/dL.
B. Anemia Due to Myelosuppressive Chemotherapy Authorization of 12 weeks may be granted for treatment of anemia due to myelosuppressive chemotherapy in members with non-myeloid malignancy and pretreatment hemoglobin < 10 g/dL.
C. Anemia in Myelodysplastic Syndrome (MDS) Authorization of 12 weeks may be granted for treatment of anemia in myelodysplastic syndrome in members with pretreatment hemoglobin < 10 g/dL.
D. Reduction of Allogeneic Red Blood Cell Transfusion in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery Authorization of 30 days may be granted for reduction of allogenic red blood cell transfusion in members scheduled to have an elective, noncardiac, nonvascular surgery with pretreatment hemoglobin ≤ 13 g/dL.
E. Anemia in Rheumatoid Arthritis (RA) Authorization of 12 weeks may be granted for treatment of anemia in rheumatoid arthritis in members with pretreatment hemoglobin < 10 g/dL.
F. Anemia Due to Hepatitis C Treatment Authorization of 12 weeks may be granted for treatment of anemia due to Hepatitis C treatment in members with pretreatment hemoglobin < 10 g/dL who are receiving ribavirin in combination with either interferon alfa or peginterferon alfa.
G. Anemia Due to Zidovudine in HIV-infected Patients Authorization of 12 weeks may be granted for treatment of anemia due to zidovudine in HIV-infected members currently receiving zidovudine with pretreatment hemoglobin < 10 g/dL whose pretreatment serum EPO level is ≤ 500 mU/mL.
H. Anemia in Members Whose Religious Beliefs Forbid Blood Transfusions Authorization of 12 weeks may be granted for treatment of anemia in members whose religious beliefs forbid blood transfusions with pretreatment hemoglobin < 10 g/dL.
I. Anemia in Primary Myelofibrosis (MF), Post- polycythemia Vera MF, or Post-Essential Thrombocythemia MF Authorization of 12 weeks may be granted for treatment of anemia in primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis in members who meet ALL of the following criteria: 1. Pretreatment hemoglobin < 10 g/dL. 2. Pretreatment serum EPO level < 500 mU/mL.
J. Anemia Due to Cancer Authorization of 12 weeks may be granted for treatment of anemia due to cancer in members who have cancer and are undergoing palliative treatment.
III. 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: All members (including new members) requesting authorization for continuation of therapy after at least 12 weeks of ESA treatment must show a response with a rise in hemoglobin of > 1 g/dL. Members who completed less than 12 weeks of ESA treatment and have not yet responded with a rise in hemoglobin of > 1 g/dL may be granted authorization of up to 12 weeks to allow for sufficient time to demonstrate a response.
A. Anemia Due to CKD Authorization of 12 weeks may be granted for continued treatment of anemia due to chronic kidney disease in members with current hemoglobin < 12 g/dL.
B. Anemia Due to Myelosuppressive Chemotherapy 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 < 12 g/dL.
C. Anemia in Myelodysplastic Syndrome (MDS) Authorization of 12 weeks may be granted for continued treatment of anemia in myelodysplastic syndrome in members with current hemoglobin is < 12 g/dL.
D. Anemia in Rheumatoid Arthritis (RA) Authorization of 12 weeks may be granted for continued treatment of anemia in rheumatoid arthritis with current hemoglobin < 12 g/dL.
E. Anemia Due to Hepatitis C Treatment Authorization of 12 weeks may be granted for continued treatment of anemia due to Hepatitis C treatment in members who meet ALL of the following criteria: 1. The member is receiving ribavirin in combination with either interferon alfa or peginterferon alfa. 2. The current hemoglobin is < 12 g/dL.
F. Anemia Due to Zidovudine in HIV-infected Patients Authorization of 12 weeks may be granted for continued treatment of anemia due to zidovudine in HIV-infected members receiving zidovudine with current hemoglobin < 12 g/dL.
G. Anemia in Members Whose Religious Beliefs Forbid Blood Transfusions Authorization of 12 weeks may be granted for continued treatment of anemia in members whose religious beliefs forbid blood transfusions with current hemoglobin < 12 g/dL.
H. Anemia in Primary Myelofibrosis (MF), Post- polycythemia Vera MF, or Post-Essential Thrombocythemia MF Authorization of 12 weeks may be granted for continued treatment of anemia in primary myelofibrosis, post- polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis with current hemoglobin < 12 g/dL.
I. Anemia Due to Cancer 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:
Epogen [package insert]. Thousand Oaks, CA: Amgen Inc.; July 2018.
Procrit [package insert]. Horsham, PA: Janssen Products, LP; July 2018.
Retacrit [package insert]. New York, NY: Pfizer Labs; April 2023.
National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 8, 2023.
Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 08, 2023.
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.
Rizzo JD, Brouwers M, Hurley P, et al. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol. 2010;28(33):4996-5010.
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.
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.
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.
