Pharmacy Prior Authorization Criteria

Rydapt (midostaurin)

Indications for Prior Authorization

Rydapt (midostaurin) capsules

• For diagnosis of Acute Myeloid Leukemia
  Indicated for the treatment of adult patients with newly diagnosed 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.

  Limitations of Use: Rydapt is not indicated as a single-agent induction therapy for the treatment of patients with AML.

• For diagnosis of Aggressive Systemic Mastocytosis, Systemic Mastocytosis with Associated Hematological Neoplasm, or Mast Cell Leukemia
  Indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Criteria

Rydapt

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month [A]
For diagnosis of Acute Myeloid Leukemia (AML)

• Diagnosis of newly diagnosed acute myeloid leukemia (AML)
AND
• FMS-like tyrosine kinase 3 (FLT3) mutation-positive as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., LeukoStrat CDx FLT3 Mutation Assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [5]
AND
• Used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation

Rydapt

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with Associated Hematological Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL)

• One of the following diagnoses: [4]
• Aggressive systemic mastocytosis (ASM)
• Systemic mastocytosis with associated hematological neoplasm (SM-AHN)
• Mast cell leukemia (MCL)

Rydapt

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications listed above

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-02-14, 2023-07-18, 2023-02-27, 2022-01-07, 2021-09-27, 2021-05-26, 2021-05-25, 2020-12-29, 2019-12-13

References

1. Rydapt Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. May 2023.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia v.1.2019. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed February 27, 2023.
3. Stone RM, Mandrekar S, Sanford BL, et al. The multi-kinase inhibitor midostaurin (M) prolongs survival compared with placebo (P) in combination with daunorubicin (D)/cytarabine (C) induction (ind), high-dose c consolidation (consol), and as maintenance (maint) therapy in newly diagnosed acute myeloid leukemia (AML) patients (pts) age 18-60 with FLT3 Mutations (muts): an international prospective randomized (rand) p-controlled double-blind trial (CALGB 10603/RATIFY [Alliance]). Blood. 2015 Dec;126:6.
4. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Systemic mastocytosis v.2.2019. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/mastocytosis.pdf. Accessed February 27, 2023.
5. U.S. Food and Drug Administration: List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at: https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools. Accessed December13, 2019.

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End Notes

1. Although Rydapt (midostaurin) is not FDA-approved for maintenance therapy, the pivotal trial was designed to include induction, re-induction (if indicated), post-remission (consolidation), and maintenance therapy for a total of 12 months. Therapy significantly improved event free survival and overall survival. [1-3]

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Revision History

• 2024-02-14: 2024 Annual Review - Updated references
• 2023-07-18: Removed Oncology specialist requirement
• 2023-02-27: 2023 Annual Review
• 2022-01-07: 2022 Annual Review.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-12-29: 2021 Annual Review: updated reauthorization criteria, updated references
• 2019-12-13: 2020 Annual Review; updated references only

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