Subject: Epogen-Procrit-Retacrit 1619-A SGM P2021
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EPOGEN
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PROCRIT
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RETACRIT
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epoetin alfa
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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 HIV-infected
patients 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 congestive heart failure
3. Anemia in rheumatoid arthritis
4. Anemia due to hepatitis C treatment with ribavirin in
combination with either interferon alfa or peginterferon alfa
5. Anemia in patients whose religious beliefs forbid blood
transfusions
6. Symptomatic anemia in patients with primary myelofibrosis,
post-polycythemia vera myelofibrosis, or post-essential
thrombocythemia myelofibrosis
7. 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 nonmyeloid
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 whose pretreatment serum erythropoietin
(EPO) level < 500 mU/mL.
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 Congestive Heart Failure (CHF)
Authorization of 12 weeks may be granted for treatment of anemia
in congestive heart failure in members with pretreatment
hemoglobin < 9 g/dL.
F. 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.
G. 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.
H. 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.
I. 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.
J. 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
K. 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 nonmyeloid 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 Congestive Heart Failure (CHF) or Rheumatoid
Arthritis (RA)
Authorization of 12 weeks may be granted for continued treatment of
anemia in congestive heart failure or 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.; July 2018.
- Retacrit [package insert]. Lake Forest, IL: Hospira Inc.; June 2020.
- National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 10, 2021.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 10, 2021.
- 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 10,2021.
- 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.
- Qaseem A, Humphrey LL, Fitterman N, Starkey M, Shekelle P, for the Clinical Guidelines Committee of the American College of Physicians. Treatment of Anemia in Patients with Heart Disease: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2013;159:770-779.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms. Version 2.2021. http://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed September 1, 2020.
- 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.
- 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.
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.
February 14, 2022
