Midostaurin (Rydapt)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

  • Indicated for the treatment of adults patients with:
    • Newly diagnosis acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. (Rydapt is not indicated as a single-agent induction therapy for the treatment of patients with AML.)
    • Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)

Patients must meet the following criteria for the indiciation(s) above:

  • Prescribed by an oncologist, AND
  • 18 years or older, AND
  • Confirmed diagnosis:
    • Acute Myeloid Leukemia (AML) that is FLT3-mutation positive
    • Aggressive Systemic Mastocytosis (ASM)
    • Systemic Mastocytosis Associated with Acute Hematologic Neoplasm (SM-AHN)
    • Mast Cell Leukemia (MCL), AND
  • For FLT3-mutation positive AML only: member is newly diagnosed, and Rydapt will be used in combination with standard cytarabine + daunorubicin induction and cytarabine consolidation chemotherapy in newly diagnosed FLT3-mutation positive AML.  (Rydapt is not indicated as a single-agent induction therapy for the treatment of patients with AML.)

Dosing:

  • AML: 50 mg orally twice daily with food on days 8 and 21 of each cycle of induction with cytarabine and daurorubicin and on days 8 and 21 of each cycle of consolidation with high-dose cytarabine
  • ASM, SM-AHN, MCL: 100mg orally twice daily with food

Approval:

  • 1 year

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