MOZOBIL, Plerixafor Form

Plerixafor (Mozobil®) is a hematopoietic stem cell mobilizer. FDA Approved Indication(s) Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) or multiple myeloma (MM). 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 Mozobil is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Mobilization of Hematopoietic Stem Cells (must meet all):

1. Diagnosis of NHL or MM;
   2. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. If request is for brand Mozobil, member must use generic plerixafor, unless contraindicated or clinically significant adverse effects are experienced;
2. Prescribed in combination with a formulary G-CSF (i.e., Zarxio®); *Prior authorization may be required for G-CSF.
3. Member is scheduled to receive autologous stem cell transplantation;
   7. Mozobil is prescribed to be administered for up to 4 consecutive days;
   8. Dose does not exceed one of the following (a or b): a. Weight ≤ 83 kg: 20 mg/day fixed dose or 0.24 mg/kg per day; b. Weight > 83 kg: 0.24 mg/kg (up to 40 mg per day). Approval duration: 3 months
      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): Page 1 of 5

   CLINICAL POLICY
   Plerixafor 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.
   II. Continued Therapy A. Mobilization of Hematopoietic Stem Cells (must meet all):
6. Re-authorization is not permitted. Members must meet the initial approval criteria. Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
7. 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

8. 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 Page 2 of 5

   MM: multiple myeloma NHL: non-Hodgkin lymphoma CLINICAL POLICY
   Plerixafor G-CSF: granulocyte-colony stimulating factor HSCs: hematopoietic stem cells Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): none reported V. Dosage and Administration
   Indication Dosing Regimen Maximum Dose 40 mg/day NHL or MM The recommended dose of Mozobil by SC injection is based on actual body weight: • ≤ 83 kg: 20 mg fixed dose or 0.24 mg/kg of body weight
   • > 83 kg: 0.24 mg/kg of body weight
   Initiate Mozobil treatment after the patient has received G- CSF once daily for 4 days. Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days. Use actual body weight to calculate the volume of Mozobil to be administered: 0.012 x actual body weight (in kg) = volume to be administered (in mL). Mozobil dose and treatment if weight is more than 175% of ideal body weight have not been investigated. VI. Product Availability
   Single-use vial for injection: 1.2 mL of a 20 mg/mL solution containing 24 mg of plerixafor VII.