Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Eribulin mesylate (Halaven) may be considered medically necessary when used for ANY of the following:
Food and Drug Administration (FDA) Indication
Breast Cancer
- Metastatic breast cancer in individuals who have previously received at least two (2) chemotherapeutic regimens for the treatment of metastatic disease including an anthracycline and a taxane in either the adjuvant or metastatic setting; or
Soft Tissue Sarcoma
- Unresectable or metastatic liposarcoma in individuals who have received a prior anthracycline-containing regimen; or
National Comprehensive Cancer Network (NCCN) Recommendations
Invasive Breast Cancer
- Single agent for recurrent or stage IV (M1) human epidermal growth factor receptor 2 (HER-2)-negative disease that is:
- Hormone receptor-negative; or
- Hormone receptor-positive with visceral crisis or endocrine therapy refractory: or
- Combination therapy with trastuzumab for recurrent or stage IV (M1) HER2-positive disease that is:
- Hormone receptor-negative; or
- Hormone receptor-positive with or without endocrine therapy; or
Soft Tissue Sarcoma
- Single agent palliative therapy as subsequent lines of therapy for advanced/metastatic soft tissue sarcoma of the extremity/superficial trunk, head/neck with disseminated metastases; or
- Subsequent lines of therapy for advanced/metastatic pleomorphic rhabdomyosarcoma as a single agent; or
- Single-agent palliative treatment as subsequent lines of therapy for recurrent unresectable or stage IV retroperitoneal/intra-abdominal soft tissue sarcoma; or
- Single agent palliative therapy for soft tissue angiosarcoma; or
- Single agent therapy for the treatment of solitary fibrous tumor; or
- Single agent therapy for the treatment of undifferentiated pleomorphic sarcoma (UPS); or
Uterine Neoplasms-Uterine Sarcoma - High-grade endometrial stromal sarcoma (ESS), Undifferentiated uterine sarcoma (UUS), Uterine leiomyosarcoma (uLMS)
- Used as single-agent therapy for recurrent or metastatic disease which has progressed following prior cytotoxic chemotherapy.
The use of eribulin mesylate (Halaven) for any other indication is considered experimental/investigational, and therefore, non-covered. The safety and efficacy for any other indications has not been established by the peer-reviewed literature.
Procedure Codes
