Darbepoetin Alfa (Aranesp®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 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
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 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 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 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 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 < 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
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Aranesp [package insert]. Thousand Oaks, CA: Amgen Inc.; January 2019.
2. National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed September 7, 2023.
3. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 7, 2023.
4. 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.
5. 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.
6. 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.
7. 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.
ORIGINAL EFFECTIVE DATE: 1/14/2006
MOST RECENT REVIEW DATE: 4/30/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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