Overview

This document addresses the use of Halaven (eribulin). Halaven is a non-taxane microtubule dynamics inhibitor that is a synthetic analogue of halichondrin B, a product isolated from a marine sponge. Although the exact mechanism is unknown, it is believed to work through inhibition of the growth phase of microtubule dynamics, without affecting the shortening phase, sequestering tubulin into nonproductive aggregates. The FDA approved indications for Halaven include metastatic breast cancer or unresectable or metastatic liposarcoma. The National Comprehensive Cancer Network (NCCN) provides additional recommendations with a category 1 and 2A level of evidence for the uses in invasive breast cancer and soft tissue sarcoma.

Definitions and Measures

• Adjuvant therapy: Treatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation, hormone or biological therapy.
• Anthracycline: A type of antibiotic that comes from certain types of Streptomyces bacteria and are used to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing the cells to die.
• Gleason Grading system: A prostate cancer grading system. A primary and secondary pattern, the number range of each is from 1 to 5, are assigned and then summed to yield a total score.
• Human epidermal growth factor 2 (ERBB2) status: A laboratory finding related to the presence or absence of cellular receptors for HER2/neu; also known as ErbB-2 protein family.
• Line of Therapy:
  • First-line therapy: The first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy or a combination of these therapies.
  • Second-line therapy: Treatment given when initial treatment (first-line therapy) is not effective or there is disease progression.
  • Third-line therapy: Treatment given when both initial (first-line therapy) and subsequent treatment (second-line therapy) are not effective or there is disease progression.
• Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.
• Microtubule inhibitors (MTI): A class of drugs including taxanes, vinca alkaloids, and epothilones that stabilize or destabilize microtubules, thereby suppressing microtubule dynamics required for proper mitotic function, effectively blocking cell cycle progression and resulting in cell death.
• Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.
• One line of therapy: Single line of therapy.
• Taxane: A type of mitotic inhibitor and antimicrotubule drug used to treat cancer that blocks cell growth by stopping mitosis (cell division).

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Halaven (eribulin mesylate)

1. Requests for Halaven (eribulin mesylate) may be approved if the following criteria are met:
2. I.
3. II.
4. III.
5. IV.
6. OR
7. V.
8. VI.
9. VII.
10. VIII.
11. OR
12. IX.
13. X.
14. XI.
15. XII.

2. Individual has a diagnosis of locally recurrent or metastatic breast cancer (Label, NCCN 2A); AND
3. Individual is using as monotherapy; AND
4. Individual is using as a single line of therapy; AND
5. Individual has previously received at least two chemotherapeutic regimens for locally recurrent or metastatic disease;

Individual has a diagnosis of locally recurrent or metastatic HER2 positive breast cancer (NCCN 2A); AND

In one of the following ways:

• A. B. Individual is using in combination with trastuzumab (or trastuzumab biosimilars); OR
• Individual is using in combination with Margenza (margetuximab-cmkb) as third line therapy;

AND

Individual has symptomatic visceral disease; OR

9. Individual has a diagnosis of locally recurrent or metastatic soft tissue sarcoma (Label, NCCN 1, 2A); AND
10. Individual is using as a monotherapy; AND
11. Individual is using as a single line of therapy; AND
12. Individual has previously received at least two chemotherapeutic regimens for locally recurrent or metastatic disease.

Requests for Halaven may not be approved for the following criteria:

• Individual has a diagnosis of head and neck cancer; OR
• Individual has a diagnosis of non-small cell lung cancer; OR
• I.
• II.
• III. When the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion
or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement
policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these
services as it applies to an individual member.

HCPCS

J9179

ICD-10 Diagnosis

C48.0-C48.8

Injection, eribulin mesylate, 0.1 mg

Malignant neoplasm of retroperitoneum and peritoneum

C49.0-C49.9

Malignant neoplasm of other connective and soft tissue

C50.011-C50.929

Malignant neoplasm of breast

C79.81

Z17.0

Z17.1

Secondary malignant neoplasm of breast

Estrogen receptor negative status [ER-]

Estrogen receptor positive status [ER+]

Document History

Reviewed: 02/24/2023