ModifiedEmblemHealthPolicy MG.MM.PH.84

Halaven (eribulin) Intravenous

Criteria and requirements for coverage of intravenous eribulin (Halaven) for adults with specific metastatic cancers (breast cancer, liposarcoma, soft tissue sarcoma) including dosing, authorization length, and coding. Applies to EmblemHealth-managed members and providers submitting authorization requests.

Policy Summary

PayerEmblemHealth

PolicyHalaven (eribulin) Intravenous

Policy CodePolicy MG.MM.PH.84

Change TypeAnnual review — revised criteria

Effective Date

Next Review DateApr 3, 2025

Key ActionSubmit clinical evidence that the member meets the policy criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Annual Review updated initial criteria for breast cancer including modifications to lines of therapy, PD-L1 and germline BRCA language, and combination use with HER2-directed agents.

Added palliative therapy language and clarified usage settings for multiple soft tissue sarcoma subtypes including retroperitoneal/intra-abdominal disease.

Removed package insert link and several prior-stated disease- and receptor-specific criteria for breast cancer and soft tissue sarcoma.

6 monthsinitial length of authorization

80max billable units/21d

1.4 mg/m2standard dose

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Coverage Criteria for Eribulin (Halaven)

Initial Therapy - Breast Cancer

Covered when ALL of the following are met for initial approval (Adults):

Age: Patient is 18 or older

Breast cancer indications

General breast prerequisites: Used as a single agent for patients who have previously received at least TWO chemotherapy regimens for treatment of metastatic disease; prior therapy includes treatment with an anthracycline and a taxane in either the adjuvant or metastatic setting
Applies where specified in nested settings
HER2-negative / HR+ setting: Hormone receptor–positive disease with visceral crisis or endocrine therapy refractory; used as a single agent in one of the following settings: 1) First-line therapy if no germline BRCA1/2 mutation; 2) Second-line therapy if not a candidate for fam-trastuzumab-nxki; 3) Third-line therapy and beyond
Triple negative breast cancer (TNBC) setting: TNBC: used as a single agent in one of the following settings: 1) First-line therapy if PD-L1 CPS <10 and no germline BRCA1/2 mutation; 2) Subsequent therapyPD-L1 CPS <10 (when specifying first-line)
Also requires absence of germline BRCA1/2 mutation for first-line TNBC per policy language
HER2-positive setting: HER2‑positive disease: used in combination with margetuximab-cmkb OR trastuzumab as fourth-line therapy and beyond
Combination use limited to fourth-line and beyond per policy

ref

Initial Therapy - Liposarcoma

Covered when ALL of the following are met for liposarcoma:

Disease state: Patient has unresectable, metastatic, or recurrent liposarcoma

Prior therapy: Patient received prior anthracycline-based therapy

Agent use: Eribulin must be used as a single agent

Initial Therapy - Soft Tissue Sarcoma

Covered when ALL of the following are met for soft tissue sarcoma (STS):

Intent: Used as a single agent for palliative therapy

STS subtypes and usage settings: Patient has one of the listed STS subtypes and meets the specified usage context

Usage contexts include subsequent therapy for advanced/metastatic disease; alternative systemic therapy for unresectable/progressive disease after initial therapy; or palliative subsequent therapy for recurrent unresectable or stage IV disease

Renewal Therapy

Renewal Criteria - Authorizations can be renewed when ALL of the following are met:

Continued eligibility: Patient continues to meet the applicable initial criteria

Disease response: No disease progression as defined by lack of disease progression or improvement in tumor size and/or improvement in patient symptoms

Toxicity: Absence of unacceptable toxicity from the drug (examples include severe QT prolongation; severe neutropenia, ANC < 500/mm3; peripheral neuropathy)ANC < 500/mm3

Examples only; clinical judgment required

Coverage criteria (breast cancer and soft tissue sarcoma) - summaries

Policy contains multiple and revised criteria sets for breast cancer and soft tissue sarcoma, including settings for first-line, subsequent, and palliative use.

Breast cancer criteria (summary of revisions): Initial breast cancer criteria were modified to define use in first-line, subsequent, and third-line settings depending on PD-L1 and germline BRCA1/2 status, and to clarify combination use with HER2-directed agents (margetuximab or trastuzumab).See full policy text

Detailed conditional logic and exact placement by biomarker and prior therapies are in the full policy

Soft tissue sarcoma criteria (summary of revisions): STS criteria were updated to add palliative therapy language, specify single-agent use for certain subtypes, and permit alternative systemic therapy for unresectable or progressive disease after initial therapy for unresectable or stage IV disease.See full policy text

Detailed subtype-specific logic appears elsewhere in the policy

Halaven (eribulin mesylate) is considered investigational when it is used for any indication that is not specifically listed as covered in this policy.

Recent revisions removed prior language that limited eribulin use to specific hormone receptor statuses or to narrow prior‑therapy sequences; the policy excerpts do not provide explicit new exclusion statements describing those prior restrictions.

Portions of earlier policy text describing use tied to receptor‑negative or receptor‑positive states were removed during revision; the available excerpts do not include explicit replacement language stating that such uses are now 'not medically necessary.'

Covered Regimens and Dosing Configurations

Regimen	Indication / Line of therapy	Coverage status
Eribulin in combination with margetuximab-cmkb OR trastuzumab
HER2-positive disease — used as fourth-line therapy and beyond
Used in combination with an anti-HER2 agent for HER2-positive metastatic breast cancer per revised initial criteria

Dose	Schedule	Max billable units per 21 days
1.4 mg/m2 (intravenous)
Administer on Days 1 and 8 of a 21-day cycle
80 billable units per 21 days

Regimen	Applicable disease setting	Coverage status / Notes
Eribulin monotherapy
Breast cancer — used as a single agent for specified HER2-negative, HR+, and TNBC settings depending on biomarker status and line of therapy
Covered when policy criteria for prior lines, biomarker (germline BRCA1/2, PD-L1) and other conditions are met

Regimen	STS subtypes / Setting	Coverage status / Notes
Eribulin monotherapy
Soft tissue sarcoma — single agent use for specified subtypes (e.g., pleomorphic rhabdomyosarcoma, retroperitoneal/intra-abdominal, extremity/body wall/head/neck with disseminated metastases) and for palliative or subsequent therapy in advanced/metastatic disease
Covered when used as single agent for palliative therapy or as subsequent/alternative systemic therapy for unresectable or progressive disease per policy criteria

Billing and Diagnosis Codes

Max billable units per cycle

Max Units80 billable units every 21 days

Prior chemotherapy exposure

Prior chemotherapy exposureReferences prior anthracycline and taxane or at least two prior chemotherapy regimens for metastatic disease.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for eribulin. Coverage will be provided for an initial duration of 6 months and may be renewed upon review.

Prior authorization required
Initial authorization duration: 6 months; may be renewed

Documentation Required

Documentation Required for Review

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria for review. Without submission of diagnosis-coded clinical records and prior treatment documentation, EmblemHealth will be unable to properly review the preauthorization request and the request may be denied.

Submit diagnosis-coded clinical records matching the member's ICD-10 breast cancer code(s) (see ICD-10 Diagnoses list)
Provide prior treatment records documenting prior chemotherapy regimens, anthracycline and taxane exposure, BRCA status, PD-L1 CPS if relevant, and other line-of-therapy details

Line-of-Therapy Rules and Settings

second-line | third-line | later (varies by subtype and biomarker)

Line placement: Used as a single agent for patients who have previously received at least TWO chemotherapy regimens for metastatic breast cancer and prior anthracycline and taxane exposure

Line placement may vary by HER2/HR/TNBC status as detailed in policy

subsequent therapy

Subsequent therapy: For applicable STS subtypes, eribulin is used as subsequent therapy for advanced or metastatic disease or as palliative subsequent therapy for recurrent unresectable or stage IV disease

first-line | second-line | third-line

First/Second/Third-line settings:

Biomarker and Companion Diagnostic Requirements

germline BRCA1/2

germline BRCA1/2 — presence vs absenceFirst-line use in certain breast cancer settings is allowed only if NO germline BRCA1/2 mutation is present

Role in line selectionGermline BRCA1/2 status is used to determine eligibility for first-line versus subsequent therapy in revised breast cancer criteria

DocumentationProviders must document germline BRCA1/2 mutation status when it affects line-of-therapy decisions

PD-L1 CPS

PD-L1 CPS thresholdPD-L1 CPS <10 referenced for first-line use in TNBC

Impact on first-line eligibilityTNBC patients with PD-L1 CPS <10 and no germline BRCA1/2 mutation may be eligible for first-line eribulin as single agent

Definitions and Reference Sources

Eribulin (Halaven) is an intravenous microtubule inhibitor indicated in this policy for certain previously treated advanced malignancies. The policy defines dosing and administration (standard dose: 1.4 mg/m2 IV on days 1 and 8 of a 21‑day cycle), references compendia guidance (NCCN), and sets coverage rules for select metastatic breast cancers and specified sarcomas.

Standard dosing

Standard dosing per administrationAdminister 1.4 mg/m2 IV on days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity

Cycle scheduleRepeat every 21 days (days 1 and 8 dosing)

Maximum per-cycle unitsEnsure total does not exceed 80 billable units per 21-day cycle

Reference source

Primary reference sourcesNCCN Drugs & Biologics Compendium (eribulin) and Eisai Halaven package insert cited in policy references

Policy Revision History

2025-04-03annual_reviewLatest

Annual review updated initial criteria: soft tissue sarcoma criteria added palliative therapy language and clarified alternative systemic therapy for unresectable/progressive disease; breast cancer criteria language modified in prior updates referenced here.

2024-02-29annual_review

Annual review removed package insert link, added dosing chart, and revised breast cancer initial criteria to refine line-of-therapy placement (first-line, second-line, third-line) and PD-L1/germline BRCA language and modified HER2 combination statements.