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Clinical Policy Bulletin:
Clofarabine (Clolar)
Number: 0867


Policy

Aetna considers clofarabine injection (Clolar) medically necessary for acute myeloid leukemia (AML) and for relapsed or refractory acute lymphoblastic leukemia (ALL).

Aetna considers clofarabine experimental and investigational for all other indications.



Background

Clolar was approved by the FDA for acute lymphoblastic leukemia: "Clolar (clofarabine) Injection is a purine nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted."

Guidelines from the National Comprehensive Cancer Network (2013) indicate Clolar for the following:

  • Acute Lymphoblastic Leukemia (ALL) - Salvage therapy for relapsed/refractory Philadelphia chromosone-negative pre-B-cell ALL in patients aged ≤21 years as a component of clofarabine-containing regimens [2A]
  • Acute Myeloid Leukemia (AML) - Induction therapy as a single agent for intermediate-intensity therapy for patients age ≥60 years with performance status ≤2 [2B]
  • Acute Myeloid Leukemia (AML) - Used in combination with cytarabine as

    • postinduction therapy in patients age <60 years with induction failure
    • salvage chemotherapy [2A]
 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96413
+96415
HCPCS codes covered if selection criteria are met:
J9027 Injection, clofarabine, 1 mg
ICD-9 codes covered if selection criteria are met:
204.00 - 204.02 Acute lymphoid leukemia
205.00 - 205.02 Acute myeloid leukemia


The above policy is based on the following references:
  1. Fadrel S, Gandhi V, O’Brien S, et.al.  Results of a Phase I – II Study of Clofarabine in Combination with Cytarabine (Ara-C) in Relapsed and Refractory Acute Leukemia.  [prepublished online]  Blood. Oct. 14, 2004; DOI 10.1182/blood-2004-05-1933
  2. Drugdex. Drug Evaluations: Clofarabine.  Thompson Micromedex http://www.thompsonhc.com.  , 2008.  accessed 03/16/2010
  3. Childhood Acute Lymphoblastic Leukemia (PDQ®): Treatment (Health Professional Version). National Cancer Institute.  accessed 1/18/2005
  4. Clolar Prescribing Information. Genzyme Corporation. San Antonio, TX. February, 2008.
  5. Micromedex® Healthcare Series. n.d. Thomson Reuters (Healthcare) Inc. , Greenwood Village, CO. 16th March 2010 http://www.thomsonhc.com.
  6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia. V.2.2013.


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Copyright Aetna Inc. All rights reserved. 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.
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