ModifiedmhnPolicy CP.PHAR.318

Eribulin Mesylate (Halaven)

Medical necessity criteria, dosing, and coverage guidance for eribulin (Halaven) for metastatic breast cancer and specified soft tissue sarcoma subtypes for members covered by the payer.

Policy Summary

Payermhn

PolicyEribulin Mesylate (Halaven)

Policy CodePolicy CP.PHAR.318

Change TypeCriteria and approval-duration updates (STS subtype additionsapproval duration extended for HIM/Medicaid)

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating the member meets all approval criteria (diagnosis, prescriber specialty, age, line of therapy, dosing limits, and response for continuation).

SourceLink

POLICY UPDATE CHANGES

For STS, added liposarcoma and epithelioid hemangioendothelioma subtypes per NCCN compendium and guidelines.

Extended initial approval duration from 6 months to 12 months for HIM and Medicaid.

For breast cancer, revised trastuzumab and Margenza combination therapy options with Halaven to be fourth-line therapy or beyond per NCCN update.

For soft tissue sarcoma (STS), liposarcoma and epithelioid hemangioendothelioma subtypes were added per NCCN compendium and guidelines.

4Q 2024 annual review: no significant changes; references reviewed and updated.

2FDA-approved indications listed

1.4 mg/m2Maximum dose per administration

J9179HCPCS code referenced

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Coverage Criteria for Eribulin (Halaven)

Initial Approval — Breast Cancer

Covered when ALL of the following are met for breast cancer:

Breast cancer initial: 1. Diagnosis of breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is metastatic or recurrent; 5. Prescribed in one of the following ways: (a) in combination with trastuzumab for HER2-positive disease as fourth-line therapy or beyond; (b) in combination with Margenza for HER2-positive disease as fourth-line therapy or beyond; or (c) as a single agent for HER2-negative disease; 6. Request meets one of the following: (a) dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; or (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose <= 1.4 mg/m2

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval — Soft Tissue Sarcoma

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

STS initial: 1. Diagnosis of one of the following STS subtypes: extremity/body wall and head/neck; retroperitoneal/intra-abdominal; pleomorphic rhabdomyosarcoma; liposarcoma; or epithelioid hemangioendothelioma; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is advanced, metastatic, recurrent, or unresectable; 5. Prescribed as a single agent; 6. Prescribed as subsequent (later-line) therapy for all listed STS subtypes; 7. Request meets one of the following: (a) dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; or (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose <= 1.4 mg/m2

Prescribed regimen must be FDA-approved or recommended by NCCN

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation: 1. Member is currently receiving Halaven via the Health Plan benefit or documentation supports current receipt for at least one 21-day cycle; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets one of the following: (a) new dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; or (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose <= 1.4 mg/m2

Prescribed regimen must be FDA-approved or recommended by NCCN

Coverage updates (STS)

Documented annual review updates relevant to coverage

STS subtype additions: Policy updated to include liposarcoma and epithelioid hemangioendothelioma subtypes for STS per the NCCN compendium and guidelines; initial approval duration for specified lines of business was extended as noted.

Added in 4Q 2025 review

Requests for use of eribulin (Halaven) for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Coverage under this policy is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, or policy). Requests for services inconsistent with those documents or with applicable state or federal requirements may be denied. Non‑FDA indications not addressed in this policy require documentation as described in the off‑label policies to be considered for coverage.

Off‑label prescribing of eribulin must be supported by clinical documentation. Use for indications that are not FDA‑approved and are not covered by this policy will only be considered when the provider submits adequate supporting evidence of efficacy and safety consistent with the referenced off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53). Absent such documentation, requests for off‑label use are considered not authorized.

This clinical policy is intended as a guide to medical necessity to assist in coverage determinations and benefit administration. It does not constitute a guarantee of payment, a contract, or substitute for professional medical judgment. Explicit not‑medically‑necessary (NMN) conditions are not listed in the excerpt; coverage determinations remain subject to the policy language here and the member's plan documents.

Coding and Dosing

Referenced HCPCSHCPCS

J9179

Injection, eribulin mesylate, 0.1 mg

Dose per administration — dosing schedule and maximum dose per administration

Dosing schedule1.4 mg/m2 IV over 2–5 minutes on Days 1 and 8 of a 21‑day cycle (breast cancer and STS)

Maximum dose per administrationMaximum single dose = 1.4 mg/m2

Alternate dosing allowanceDose exceeding 1.4 mg/m2 may be considered only if supported by practice guidelines or peer‑reviewed literature with prescriber evidence submission

Provider Responsibilities and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Providers must submit documentation including diagnosis, prescriber specialty, age, line of therapy, and dosing to support the request.

Prior authorization required with documentation of diagnosis, prescriber specialty, patient age, line of therapy, and dosing.

Prior Authorization

Prior Authorization Duration

Initial approvals follow the policy criteria and specified durations. For Medicaid and HIM, initial approval duration is 12 months. For Commercial, initial approval is 6 months or to the member's renewal date, whichever is longer.

Initial approval duration: Medicaid/HIM — 12 months; Commercial — 6 months or to member renewal date, whichever is longer.

Step Therapy

Background and Drug Information

Eribulin mesylate (Halaven) is a microtubule dynamics inhibitor used in the management of metastatic breast cancer and in certain soft tissue sarcoma (STS) subtypes after prior therapies. The policy aligns eribulin use with FDA‑approved indications and NCCN recommendations and requires that prescribing or consultation be by an oncologist; dosing is specified as 1.4 mg/m2 IV on days 1 and 8 of a 21‑day cycle unless an alternative dose is supported by practice guidelines or peer‑reviewed literature.

Definitions and Abbreviations

HER2 definition — human epidermal growth factor receptor 2

DefinitionHER2 = human epidermal growth factor receptor 2

Role in policyDetermines use of eribulin in combination (HER2‑positive) versus single‑agent (HER2‑negative) regimens

Testing implicationHER2 status must be established by standard testing per clinical practice/guidelines when determining regimen

STS definition — soft tissue sarcoma

DefinitionSTS = soft tissue sarcoma

Included subtypes (policy)Extremity/body wall and head/neck; retroperitoneal/intra‑abdominal; pleomorphic rhabdomyosarcoma; liposarcoma; epithelioid hemangioendothelioma

Line of Therapy Specifications

second-line

Second-line: For HER2-positive breast cancer, combination with trastuzumab or Margenza is designated for fourth-line therapy or beyond; for HER2-negative breast cancer, single-agent eribulin is indicated after prior chemotherapeutic regimens for metastatic disease (including prior anthracycline and taxane).

Line-of-therapy designations align with FDA/NCCN and policy updates

salvage

Salvage: Eribulin is indicated as subsequent (salvage) therapy for listed STS subtypes after prior anthracycline-containing regimens (liposarcoma per FDA; policy requires subsequent therapy for all listed STS subtypes).

Per FDA for liposarcoma and NCCN for additional STS subtypes

not_specified

Biomarker and Testing Requirements

HER2 biomarker requirement — HER2-positive vs HER2-negative per standard testing

Biomarker requirementHER2 status (positive vs negative) determines whether eribulin is used in combination (HER2‑positive) or as single‑agent (HER2‑negative)

Testing standardHER2 status should be established by standard clinical testing per practice guidelines or NCCN recommendations

DocumentationPrescriber must document HER2 status when it determines regimen selection (combination vs single agent)

Dosing Regimens and Indications

Regimen	Administration	Indication / Notes
Eribulin 1.4 mg/m2	IV over 2-5 minutes on days 1 and 8 of a 21-day cycle	Single-agent or in specified combinations per HER2 status and line of therapy; maximum dose 1.4 mg/m2. For breast cancer: combination with trastuzumab or Margenza for HER2-positive disease as fourth-line therapy or beyond, or single-agent for HER2-negative disease. For STS: single-agent subsequent therapy for listed subtypes.

Agent	STS Subtypes Added	Coverage Note
Eribulin mesylate (Halaven)	Liposarcoma; Epithelioid hemangioendothelioma	STS subtypes added per NCCN compendium and guidelines (added in 4Q 2025). Coverage as single-agent subsequent therapy for listed STS subtypes when criteria met.