Subject: Aranesp 1616-A SGM P2020

Drug

ARANESP®  (darbepoetin alfa)

Policy:

1. 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.

1.  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.  Anemia in patients with malignancy

 

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

 

 

 

 

1. Precertification Criteria

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 in Members with Malignancy 
Authorization of 12 weeks may be granted for treatment of anemia in members with malignancies.

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 is < 500 mU/mL.

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

 
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 in Members with Malignancy
Authorization of 12 weeks may be granted for continued treatment of anemia in members with malignancies.
 

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.

Place of Service:

Outpatient

The above policy is based on the following references:

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 1, 2020.
3.  Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed September 1, 2020.
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 1. 2020. http://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Accessed September 1, 2020.
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. NCCN hematopoietic growth factors.  Short-term recommendations specific to issues with COVID-19 (SARS-CoV-2).  National Comprehensive Cancer Network, Inc.  Available at: https://www.nccn.org/covid-19/pdf/HGF_COVID-19.pdf.  Accessed September 9, 2020.  

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.

April 15, 2021