Subject: Aranesp 1616-A SGM P2023
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ARANESP
(darbepoetin 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. Anemia Due to Chronic Kidney Disease
Treatment of anemia due to chronic kidney disease
(CKD), including patients on dialysis and patients not on
dialysis.
2. Anemia Due to Chemotherapy in Patients with Cancer
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.
B. Compendial Uses
1. Symptomatic anemia in patients with myelodysplastic
syndromes (MDS)
2. Anemia in patients whose religious beliefs forbid blood
transfusions
3. Symptomatic anemia in patients with primary
myelofibrosis, post-polycythemia vera myelofibrosis, or
post-essential thrombocythemia myelofibrosis
4. 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 Aranesp. Members may
not use Aranesp 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 a
pretreatment hemoglobin < 10 g/dL.
D. 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.
E. 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 erythropoietin (EPO) level < 500
mU/mL.
F. 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
Aranesp. Members may not use Aranesp 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 Chronic Kidney Disease (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 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 < 12 g/dL.
D. 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.
E. 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 in members with current
hemoglobin < 12 g/dL.
F. 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:
- Aranesp [package insert]. Thousand Oaks, CA: Amgen Inc.; January 2019.
- National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 7, 2023.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 7, 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.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms. Version 2.2023. http://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed September 7, 2023.
- Gabrilove J, Paquette R, Lyons R, Mushtaq C, Sekeres M, et al. 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.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed September 7, 2023.
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 11, 2024
