MARQIBO, Vincristine Sulfate Liposome Form

Vincristine sulfate liposome injection (Marqibo®) is a vinca alkaloid. FDA Approved Indication(s) Marqibo is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.*
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be continegent upon verification and description of clinical benefit in confirmatory trials.

• On May 2, 2022, the FDA withdrew approval of Marqibo after a postmarking clinical trial failed to verify the clinical benefit of the drug. Updated NCCN guidance (Acute Lymphoblastic Leukemia v2.2023) does not support usage.
  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 Marqibo is medically necessary when the following criteria are met:
  I. Initial Approval Criteria
  A. Acute Lymphoblastic Leukemia (must meet all):

  1. Authorization is not permitted due to lack of FDA and NCCN support. Member may not initiate therapy with Marqibo. If member is currently using Marqibo proceed to Section II. A. Acute Lymphoblastic Leukemia for continued therapy criteria (see Appendix D). Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
  2. 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: Page 1 of 6

  CLINICAL POLICY
  Vincristine Sulfate Liposome Injection 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. Acute Lymphoblastic Leukemia (must meet all):
  3. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Marqibo for acute lymphoblastic leukemia and has received this medication for at least 30 days;
  4. Member is responding positively to therapy;
  5. If request is for a dose increase, request meets one of the following (a or b):
     a. New dose does not exceed 2.25 mg/m2 every 7 days;
     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: 12 months B. Other diagnoses/indications (must meet 1 or 2):
  6. 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
  7. 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.
     Page 2 of 6

  CLINICAL POLICY
  Vincristine Sulfate Liposome Injection 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 policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents; B. Patients with the demyelinating form of Charcot-Marie-Tooth syndrome. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ALL: acute lymphoblastic leukemia FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network Appendix B: Therapeutic Alternatives Not applicable
  Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Patients with demyelinating conditions including Charcot-Marie-Tooth syndrome o Hypersensitivity to vincristine sulfate or any of the other components of Marqibo (vinCRIStine sulfate LIPOSOME injection) o Intrathecal administration • Boxed warning(s): for intravenous use only – fatal if given by other routes; dosage recommendations differ from vincristine sulfate, verify drug name and dose to avoid overdosage Appendix D: General Information
  • On May 2, 2022, the FDA withdrew approval of Marqibo after a postmarking clinical trial failed to verify the clinical benefit of the drug. The manufacturer voluntarily withdrew its new drug application and drug approval was subsequently withdrawn.
  • The NCCN no longer recommends Marqibo per its Acute Lymphoblastic Leukemia Guidelines Version 2.2023. V. Dosage and Administration
  Indication ALL
  (off-label) Dosing Regimen 2.25 mg/m2 IV over 1 hour once every 7 days Maximum Dose See dosing regimen VI. Product Availability
  Marqibo Kit containing the following:
  • Vial: vincristine sulfate injection, USP 5 mg/5 mL (1 mg/mL) • Vial: sphingomyelin/cholesterol liposome injection 103 mg/mL • Vial: sodium phosphate injection 355 mg/25 mL (14.2 mg/mL) Page 3 of 6

  CLINICAL POLICY
  Vincristine Sulfate Liposome Injection VII.