RYDAPT (midostaurin)

RYDAPT (midostaurin) 

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

Approval:

• 1 year