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    Rydapt

    Drug - Rydapt® (midostaurin) [Novartis Pharmaceuticals]

    March 2019

    Therapeutic area - Oral Oncology

    Initial approval criteria

    Acute Myeloid Leukemia (AML)

    • Patient must be at least 18 years old AND
    • Patient must be newly diagnosed with AML (excluding acute promyelocytic leukemia) AND
    • Patient’s disease is FMS-like tyrosine kinase-3 (FLT3) mutation-positive (FLT3+) as detected by an FDA-approved test (e.g., Leukostrat CDx FLT3 Mutation Assay) AND
    • Must be used in combination with standard cytarabine consolidation therapy* AND
    • Provider must provide attestation that standard cytarabine, daunorubicin and Rydapt induction therapy for AML has been successfully completed AND
    • Provider must provide attestation that reproductive health counseling has been provided to patients during treatment of Rydapt and for at least 4 months after the last dose
    • Initial approval is for 6 months

    Systemic Mastocytosis (SM)

    • Patient must be at least 18 years old AND
    • Patient has a diagnosis of one of the following:
      • Aggressive systemic mastocytosis (ASM) OR
      • Systemic mastocytosis with associated hematologic OR neoplasm (SM-AHN)
      • Mast cell leukemia (MCL) AND
    • Provider must provide attestation that reproductive health counseling has been provided to patients during treatment of Rydapt and for at least 4 months after the last dose
    • Initial approval is for 6 months

    Renewal approval criteria

    Acute Myeloid Leukemia (AML)

    • Absence of any of the following unacceptable toxicities: pulmonary toxicity (including interstitial lung disease or pneumonitis), febrile neutropenia, infection, nausea, vomiting, etc. AND
    • Stabilization of disease in clinical findings
    • Renewal approval is for 6 months

    Systemic Mastocytosis (SM)

    • Absence of any of the following unacceptable toxicities: pulmonary toxicity (including interstitial lung disease or pneumonitis), febrile neutropenia, infection, nausea, vomiting, etc. AND
    • Tumor response, stabilization of disease or decrease in clinical findings
    • Renewal approval is for 12 months

    Quantity limits

    • Acute Myeloid Leukemia: 56 capsules per 21 days
    • Systemic Mastocytosis: 112 capsules per 28 days

    Billing

    *When Rydapt is used as part of a standard cytarabine, daunorubicin and midostaurin induction therapy for AML, Rydapt should not be billed separately as an outpatient drug.

    Questions

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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