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Clinical Policy Bulletin:
Ixabepilone (Ixempra)
Number: 0869


Policy

Ixabepilone (Ixempra) is considered medically necessary for members with locally advanced, recurrent or metastatic invasive breast cancer.

Aetna considers ixabepilone experimental and investigational for all other indications.

Selection criteria are presented in the background section.



Background

Ixabepilone was approved by the FDA in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. The FDA labeling indicates Ixabepilone as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

Guidelines on breast cancer from the National Comprehensive Cancer Network (2013) indicate Ixempra as a single agent for recurrent or metastatic disease that is:

  • hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative with visceral crisis
  • HER2-negative and either hormone receptor-negative, or hormone receptor-positive and endocrine therapy refractory
  • progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease [2A].

Appendix

Continued use beyond 3 months (12 weeks) is considered medically necessary for persons with stable disease (tumor size within 25% of baseline). Continued use is considered not medically necessary when there is evidence of disease progression or unacceptable toxicity occurs. 

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96413
+96415
HCPCS codes covered if selection criteria are met:
J9207 Injection, ixabepilone, 1 mg
ICD-9 codes covered if selection criteria are met :
174.0 - 175.9 Malignant neoplasm of breast
198.81 Secondary malignant neoplasm of breast


The above policy is based on the following references:
  1. Ixempra® (ixabepilone) prescribing information.  Bristol-Myers Squibb Company, Oct. 2011. http://packageinserts.bms.com/pi/pi_ixempra.pdf, assessed 4/10/12.
  2. Ixempra®, NCI website:  http://www.cancer.gov/cancertopics/druginfo/fda-ixabepilone, accessed 10/29/07, 2/22/10, 4/12/12.
  3. Ixempra® monograph, Facts and Comparisons online, accessed 10/29/07, 2/22/10.
  4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. V2.2013  Accessed 4/10/2013
  5. National Comprehensive Cancer Network (NCCN). Compendium listing for Ixempra. Accessed 4/12/12.
  6. Ixempra, DrugDex. Micromedex Website. http://www.micromedexsolutions.com/micromedex2/librarian Accessed 4/10/12.
  7. Ixempra. Clinical Pharmacology Website. www.clinicalpharmacology.com. Accessed 4/10/12.


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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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