Document Number: IC-0055

Last Review Date: 03/05/2024

Date of Origin: 03/2012

Dates Reviewed: 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022, 03/2023, 03/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Halaven 1 mg/2 mL solution in a single-dose vial for injection: 8 vials every 21 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 80 billable units every 21 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Breast Cancer † ‡ ^1-3

• Patient has metastatic disease †; AND
  • Used as a single agent for patients who have previously received at least two chemotherapy regimens for the treatment of metastatic disease; AND
  • Prior therapy includes treatment with an anthracycline and a taxane in either the adjuvant or metastatic setting; OR
• Patient has recurrent unresectable or metastatic disease OR inflammatory disease that has not responded to preoperative systemic therapy ‡; AND
  • Patient has HER2-negative disease; AND
    • Used as a single agent; AND

• • • Patient has hormone receptor-positive disease with visceral crisis or is endocrine therapy refractory; AND
    • Used in one of the following treatment settings:
      • First-line therapy if no germline BRCA 1/2 mutation
      • Second-line therapy if not a candidate for fam-trastuzumab deruxtecan-nxki
      • Third-line therapy and beyond; OR

• • Patient has triple negative breast cancer (TNBC); AND
    • Used as a single agent; AND
    • Used in one of the following treatment settings:
      • First-line therapy if PD-L1 CPS <10 and no germline BRCA 1/2 mutation
      • Subsequent therapy; OR
  • Patient has HER2-positive disease; AND
    • Used as fourth-line therapy and beyond in combination with margetuximab-cmkb OR trastuzumab

Liposarcoma † ^1,4

• Used as a single agent; AND
• Patient has unresectable or metastatic or recurrent disease; AND
• Patient has received a prior anthracycline-containing regimen (e.g. doxorubicin, liposomal doxorubicin, etc.)

Soft Tissue Sarcoma (STS) ‡ Ф ^2,5,6

• Used as a single agent for palliative therapy; AND
• Patient has one of the following sub-types of STS:
  • Pleomorphic Rhabdomyosarcoma; AND
    • Used as subsequent therapy for advanced or metastatic disease
  • Retroperitoneal/Intra-Abdominal*; AND
    • Used as alternative systemic therapy for unresectable or progressive disease after initial therapy for unresectable or stage IV disease; OR
    • Used as subsequent therapy for recurrent unresectable or recurrent stage IV disease
  • Extremity/Body Wall, Head/Neck**; AND
    • Used as subsequent therapy for advanced or metastatic disease with disseminated metastases

* For well-differentiated liposarcoma (WDLS-retroperitoneum, paratesticular) with or without evidence of de-differentiation, treat as other soft tissue sarcomas; risk of WDLS progression without de-differentiation is low and therefore single-agent systemic therapy is recommended.

** For atypical lipomatous tumor/well-differentiated liposarcoma (ALT/WDLS) of the extremity, abdominal wall, trunk that was initially diagnosed as ALT and shows evidence of de-differentiation, treat as other soft tissue sarcomas.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based on the following criteria:

• Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: QT-prolongation, severe neutropenia (ANC < 500/mm³), peripheral neuropathy (Grade 3 or 4), etc.

5. Dosage/Administration ^1,6

6. Billing Code/Availability Information

HCPCS Code:

• J9179 – Injection, eribulin mesylate, 0.1 mg; 1 billable unit = 0.1mg

NDC:

• Halaven 1 mg/2 mL solution in a single-dose vial for injection: 62856-0389-xx

7. References

1. Halaven [package insert]. Nutley, NJ; Eisai Inc; September 2022.  Accessed January 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Eribulin. National Comprehensive Cancer Network, 2024.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org.  Accessed January 2024.
3. Cortes J, O’Shaughnessy J, Loesch D, et al; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914-923.
4. Schöffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-1637.
5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Soft Tissue Sarcoma Version 3.2023. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed January 2024.
6. Schöffski P, Ray-Coquard IL, Cioffi A, et al. Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011;12(11):1045-1052.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A