DAURISMO, Glasdegib Maleate Form

Glasdegib (Daurismo ™) is a Hedgehog (Hh) pathway inhibitor. FDA Approved Indication(s) Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly- diagnosed acute myeloid leukemia (AML) in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
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 Daurismo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acute Myeloid Leukemia (must meet all):

1. Diagnosis of AML;
   2. Prescribed by or in consultation with an oncologist or hematologist;
   3. Age ≥ 18 years;
   4. Member meets one of the following (a, b, or c): a. Age ≥ 75 years;
      b. Medical justification supports inability to use intensive induction chemotherapy (see Appendix D for examples); c. Member responded to, then relapsed or became refractory, after completion of Daurismo induction therapy ≥ 12 months ago, and Daurismo was not initially stopped due to the development of clinical resistance;
2. Prescribed in combination with low-dose cytarabine;
   
   6. For Daurismo requests, member must use generic glasdegib, if available, unless contraindicated or clinically significant adverse effects are experienced;

3. Request meets one of the following (a or b): a. Dose does not exceed 100 mg (1 tablet) 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 Page 1 of 6

   CLINICAL POLICY Glasdegib Commercial – 12 months or duration of request, whichever is less 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.
   II. Continued Therapy A. Acute Myeloid Leukemia (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Daurismo for a covered indication and has received this medication for at least 30 days;
7. Member is responding positively to therapy;
   3. For Daurismo requests, member must use generic glasdegib, if available, unless contraindicated or clinically significant adverse effects are experienced;
8. Prescribed in combination with low-dose cytarabine;
   
   5. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 100 mg (1 tablet) 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 B. Other diagnoses/indications (must meet 1 or 2):

9. 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 Page 2 of 6

   CLINICAL POLICY Glasdegib 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

10. 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 ECOG: Eastern Cooperative Oncology Group Appendix B: Therapeutic Alternatives
    Not applicable
    Appendix C: Contraindications/Boxed Warnings • Contraindication(s): none reported • Boxed warning(s): embryo-fetal toxicity
    FDA: Food and Drug Administration Hh: Hedgehog
    Appendix D: General Information • The management of AML is divided into induction and postremission (consolidation) therapy. Induction usually includes intensive chemotherapy (e.g., standard [100-200 mg/m2] or high [2 g/m2] dose cytarabine, fludarabine), but many adults with AML are unable to undergo intensive chemotherapy due to its toxicities. Some examples of reasons why members may not qualify for intensive induction chemotherapy include, but are not limited to: o Baseline Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
    o Severe cardiac comorbidity (e.g., history of congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) o Baseline creatinine > 1.3 mg/dL o Member is age ≥ 60 years and declines intensive chemotherapy Page 3 of 6

    CLINICAL POLICY Glasdegib V. Dosage and Administration
    Indication AML Dosing Regimen 100 mg PO QD on days 1 to 28 in combination with cytarabine 20 mg SC BID on days 1 to 10 of each 28-day cycle
    Maximum Dose 100 mg/day VI. Product Availability
    Tablets: 25 mg, 100 mg VII.