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.

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.