HALAVEN, Eribulin Mesylate Form

Eribulin mesylate (Halaven®) is a microtubule dynamics inhibitor. FDA Approved Indication(s) Halaven is indicated for the treatment of patients with: • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Halaven is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Breast Cancer (must meet all):

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, b, or c): a. In combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive disease as fourth-line therapy or beyond; b. In combination with Margenza™ for HER2-positive disease as fourth-line therapy or beyond; c. As a single agent for HER2-negative disease;

   6. Request meets one of the following (a or b): a. Dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
      Medicaid/HIM – 6 months
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   CLINICAL POLICY
   Eribulin Mesylate Commercial – 6 months or to the member’s renewal date, whichever is longer B. Soft Tissue Sarcoma (must meet all):

   1. Diagnosis of one of the following soft tissue sarcoma (STS) subtypes (a, b, or c): a. Extremity/body wall and head/neck STS; b. Retroperitoneal/intra-abdominal STS; c. Pleomorphic rhabdomyosarcoma;
   2. Prescribed by or in consultation with an oncologist;
6. Age ≥ 18 years;
7. Disease is advanced, metastatic, recurrent, or unresectable;
8. Prescribed as a single agent;
9. Prescribed as subsequent therapy for all STS subtypes;
10. Request meets one of the following (a or b): a. Dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
    Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer C. Other diagnoses/indications (must meet 1 or 2):
    1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
    2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
       II. Continued Therapy A. All Indications in Section I (must meet all):
    3. Currently receiving medication via Centene benefit or documentation supports that member is currently receiving Halaven for a covered indication and has received this medication for at least one 21-day cycle;

11. Member is responding positively to therapy; Page 2 of 6

    CLINICAL POLICY
    Eribulin Mesylate

    3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 1.4 mg/m2 on days 1 and 8 of a 21-day cycle; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
       Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
    4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
    5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
       III. Diagnoses/Indications for which coverage is NOT authorized:
       A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
       IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HER2: human epidermal growth factor receptor 2 Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings None reported NCCN: National Comprehensive Cancer Network STS: soft tissue sarcoma Page 3 of 6

    V. Dosage and Administration
    Indication Breast cancer STS Dosing Regimen 1.4 mg/m2 IV over 2 to 5 minutes on days 1 and 8 of a 21-day cycle 1.4 mg/m2 IV over 2 to 5 minutes on days 1 and 8 of a 21-day cycle Maximum Dose 1.4 mg/m2 1.4 mg/m2 VI. Product Availability
    Injection in a single-use vial: 1 mg/2 mL VII.