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Eribulin mesylate (Halaven)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020
Last Reviewed: January 22, 2020

Description

Eribulin mesylate (Halaven®) is a potent antimitotic agent with a distinct mechanism from other known antimitotic agents, such as taxanes, vinca alkaloids, and epothilones. Eribulin mesylate (Halaven) blocks cell cycle progression in the G2-M phase. It inhibits the growth phase of microtubules and sequesters tubulin in nonproductive aggregates, ultimately leading to disruption of mitotic spindles and apoptotic cell death after prolonged mitotic blockage. It accomplishes this primarily by disrupting the complex growth and shortening events of microtubules known as dynamic stability.

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 for ANY of the following indications:

Food and Drug Administration (FDA) Indication

Breast Cancer:

  • Individuals with metastatic breast cancer who have previously received at least two (2) chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting:
    • Individuals who are ineligible for an anthracycline agent due to cardiac dysfunction are excluded from this stipulation; or

Soft Tissue Sarcoma:

  • Individuals with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen; or

National Comprehensive Cancer Network (NCCN) Indications

Invasive Breast Cancer:

  • Single agent (preferred regimen) for recurrent or stage IV (M1) human epidermal growth factor receptor 2 (HER-2)-negative with EITHER of the following:
    • 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 ANY of the following:
    • For stage IV or recurrent soft tissue sarcoma of the extremity/superficial trunk, head/neck with disseminated metastases; or
    • For pleomorphic rhabdomyosarcoma; or
    • For unresectable or progressive retroperitoneal/intra-abdominal soft tissue sarcoma; or
    • For soft tissue angiosarcoma; or

Uterine Neoplasms-Uterine Sarcoma:

  • 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

J9179

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J9179

C47.0 C47.10 C47.11 C47.12 C47.20 C47.21 C47.22
C47.3 C47.4 C47.5 C47.6 C47.8 C47.9 C48.0
C48.1 C48.2 C48.8 C49.0 C49.10 C49.11 C49.12
C49.20 C49.21 C49.22 C49.3 C49.4 C49.5 C49.6
C49.8 C49.9 C50.011 C50.012 C50.019 C50.021 C50.022
C50.029 C50.111 C50.112 C50.119 C50.121 C50.122 C50.129
C50.211 C50.212 C50.219 C50.221 C50.222 C50.229 C50.311
C50.312 C50.319 C50.321 C50.322 C50.329 C50.411 C50.412
C50.419 C50.421 C50.422 C50.429 C50.511 C50.512 C50.519
C50.521 C50.522 C50.529 C50.611 C50.612 C50.619 C50.621
C50.622 C50.629 C50.811 C50.812 C50.819 C50.821 C50.822
C50.829 C50.911 C50.912 C50.919 C50.921 C50.922 C50.929
C53.0 C54.0 C54.1 C54.2 C54.3 C54.8 C54.9
C55 C78.00 C78.01 C78.02 Z80.49 Z85.3 Z85.831

Professional Statements and Societal Positions Guidelines

NA

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