XOSPATA, Gilteritinib Fumarate Form

Gilteritinib (Xospata®) is a tyrosine kinase inhibitor. FDA Approved Indication(s) Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. 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 Xospata is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Myeloid Leukemia (must meet all):

1. Diagnosis of relapsed or refractory AML;
2. Prescribed by or in consultation with an oncologist or hematologist;
3. Age ≥ 18 years;
4. Documentation of a FLT3 mutation;
5. For Xospata requests, member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   
   6. Request meets one of the following (a or b): a. Dose does not exceed 120 mg (3 tablets) per day; 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 – 12 months or duration of request, whichever is less B. Myeloid/Lymphoid Neoplasm with Eosinophilia (off-label) (must meet all):
   7. Diagnosis of a myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic phase or blast phase;
   8. Prescribed by or in consultation with an oncologist or hematologist;
6. Age ≥ 18 years;

7. Documentation of a FLT3 mutation; Page 1 of 6

   CLINICAL POLICY Gilteritinib

   5. For Xospata requests, member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   6. Dose is within FDA maximum limit for any FDA-approved indication or 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 – 12 months or duration of request, whichever is less C. 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.
      II. Continued Therapy A. All Indications in Section I (must meet all):
   9. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Xospata for a covered indication and has received this medication for at least 30 days;
   10. Member is responding positively to therapy;
8. For Xospata requests, member must use generic gilteritinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

9. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 120 mg (3 tablets) per day; 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 – 12 months or duration of request, whichever is less Page 2 of 6

   CLINICAL POLICY Gilteritinib B. 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.
      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. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AML: acute myeloid leukemia FDA: Food and Drug Administration FLT3: FMS-like tyrosine kinase 3 Appendix B: Therapeutic Alternatives
      Not applicable MLNE: myeloid/lymphoid neoplasm with eosinophilia NCCN: National Comprehensive Cancer Network Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to Xospata or any of the excipients • Boxed warning(s): differentiation syndrome V. Dosage and Administration
      Indication AML Dosing Regimen 120 mg PO QD Maximum Dose 120 mg/day VI. Product Availability
      Tablets: 40 mg Page 3 of 6

   CLINICAL POLICY Gilteritinib VII.