CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Halaven (eribulin) — Drug Coverage Criteria

Defines authorization, continuation, and exclusion criteria for coverage of Halaven (eribulin) for members; applies to utilization management staff and network providers requesting medication authorization.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHalaven (eribulin) — Drug Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review DateN/A

Key ActionSubmit prior authorization to Evolent/UM with supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO or peer‑reviewed literature) for requested Halaven use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1.4 mg/m2Single dose maximum

Breast cancerIndications listed

LiposarcomaIndication listed

FDA/CMS/NCCN/ASCOEvidence sources required

Coverage Criteria for Halaven (eribulin)

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General evidentiary requirement: Use must be supported by FDA approved product labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Reference CMS Medicare Benefit Policy Manual Chapter 15

Breast cancer indications: Either: (1) member has recurrent or metastatic HER2-negative breast cancer and Halaven (eribulin) is used as a single agent; OR (2) member has recurrent or metastatic HER2-positive breast cancer and Halaven (eribulin) is used in combination with trastuzumab or a trastuzumab biosimilar

Liposarcoma indication: Member has metastatic or unresectable liposarcoma with disease progression on anthracycline-based therapy and Halaven (eribulin) is used as a single agent

Continuation criteria related to covered indications: Continuation requests for previously used Halaven may be considered (see continuation therapy block) provided continuation conditions are met

See continuation therapy criteria

Requests for Halaven (eribulin) will be excluded when any of the policy exclusion criteria are met. Key exclusion triggers include: dosing that exceeds the single dose limit of 1.4 mg/m2; evidence of disease progression on or after receiving Halaven; or use that is investigational or off‑label without sufficient supporting evidence as defined in this policy. The policy’s evidence standard requires support from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature, and the exclusion criteria apply when those standards are not met.

The policy prohibits coverage for investigational or off‑label indications of Halaven (eribulin) when the submitted evidence does not meet the policy’s sufficiency criteria. Sufficient evidence must demonstrate that the patient and disease characteristics and the administered regimen are adequately represented in published studies, that outcomes are clinically meaningful (ASCO‑aligned benchmarks such as a Hazard Ratio < 0.80 or survival benefits of at least 3 months for OS/PFS), and that study design and patient numbers provide valid inference. Case reports, meeting abstracts without full peer‑reviewed articles, and otherwise uncontrolled anecdotal reports are explicitly considered inadequate to establish coverage for investigational or off‑label use.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Approval Authority

Prior authorization is required for all requests for Halaven (eribulin). Evolent (the delegated Utilization Management vendor) is responsible for processing medication requests from network ordering providers; final authorization decisions are made by the Utilization Management Committee as the plan's final approval authority.

All requests must be submitted to Evolent/UM for review prior to initiation of therapy.
Evolent performs the initial review; final approval decisions are made by the Utilization Management Committee.
Requests not authorized by Evolent/UM may be deemed not approvable and not reimbursable.

Documentation Required

Indication-specific Sequencing

Indication-specific sequencing and permitted combinations are required and will be verified at prior authorization. For each covered indication, Halaven must be used in the role described below.

Breast cancer (recurrent or metastatic): single-agent use for HER2-negative disease.
Breast cancer (recurrent or metastatic): may be used in combination with trastuzumab or a trastuzumab biosimilar for HER2-positive disease.
Soft tissue sarcoma (metastatic/unresectable liposarcoma): use as a single agent after disease progression on anthracycline-based therapy.

Documentation Required

Required Supporting Evidence

Supporting clinical evidence must be provided with the authorization request. Acceptable sources include FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer-reviewed literature that meets the standards described below.

Provide FDA product labeling when applicable.
If using off-label indications, include citations from CMS-approved compendia, NCCN/ASCO guidelines, or peer-reviewed literature.
Peer-reviewed literature must adequately represent the patient and disease characteristics, the regimen used, and report clinically meaningful outcomes (e.g., ASCO-recommended thresholds such as HR < 0.80 or ≥3 months survival benefit for OS/PFS).
Case reports and abstracts without full peer-reviewed articles generally are insufficient.
Evolent/UM will assess whether the evidence meets these criteria during review.

Denial Risk

Exclusion Triggers and Denial Risk

Requests meeting any exclusion criteria will be denied. Common exclusion triggers will be verified by UM and should be addressed in the submission.

Dosing that exceeds the single-dose limit of 1.4 mg/m2.
Documented disease progression on or after prior receipt of Halaven (eribulin).
Investigational or off-label uses lacking sufficient supporting evidence per the listed evidentiary standards (see Required Supporting Evidence).

Background

Halaven (eribulin) is identified in this policy as an antineoplastic agent used for specified metastatic or recurrent cancers. The policy context describes its accepted uses (see coverage criteria) and establishes clinical and dosing safeguards — including the single dose limit of 1.4 mg/m2 and exclusion for disease progression — to guide utilization management decisions.

Definitions

inv-10: Continuation exemption definition

DefinitionContinuation requests for a not-approvable medication shall be exempt from this Evolent policy provided all conditions are met

Condition 1The requested medication was used within the last year

Condition 2The member has not experienced disease progression and/or no intolerance to the requested medication

Condition 3Additional medication(s) are not being added to the continuation request

Initial Therapy Criteria

Initial therapy

Initial therapy covered for the following disease-specific circumstances:

Breast cancer initial use: Halaven (eribulin) as a single agent for members with recurrent or metastatic HER2-negative breast cancer OR Halaven in combination with trastuzumab or a trastuzumab biosimilar for members with recurrent or metastatic HER2-positive breast cancer

Liposarcoma initial use: Halaven (eribulin) as a single agent for members with metastatic or unresectable liposarcoma who have disease progression on anthracycline-based therapy

Continuation Therapy Criteria

Continuation therapy

Continuation requests for previously used medication may be exempt from reauthorization when ALL conditions are met:

Continuation exemption conditions: (1) The requested medication was used within the last year; (2) The member has not experienced disease progression and/or has not had intolerance to the requested medication; (3) No additional medication(s) are being added to the continuation request

Requests that meet these conditions may be exempt from reauthorization; exclusion criteria still apply (e.g., dosing limits)