CurrentNeighborhood Health Plan of Rhode IslandPolicy 1817-A

Rydapt Sgm 1817 A P2025

Policy governs prior authorization and coverage criteria for Rydapt (midostaurin) across FDA-approved indications and specified compendial uses, including AML with FLT3 mutation, systemic mastocytosis, myeloid/lymphoid neoplasms with eosinophilia and TK gene fusions. Limits other uses as experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRydapt Sgm 1817 A P2025

Policy CodePolicy 1817-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization review requires submission of medical record documentation of FLT3 mutation or FGFR1 rearrangement (where applicable); authorization typically granted for up to 12 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy has no material change noted.

3FDA-Approved Indications Covered

3Compendial Uses Listed

12 monthsTypical Authorization Duration

Coverage Summary

Policy governs prior authorization and coverage criteria for Rydapt (midostaurin) across FDA-approved indications and specified compendial uses, including newly diagnosed FLT3 mutation-positive AML (in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation), systemic mastocytosis subtypes (ASM, SM-AHN, MCL, and certain ISM/SSSM situations), and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions. Coverage is provided with criteria (prior authorization, documentation of mutation/rearrangement where applicable) and typical authorizations are for up to 12 months; uses that are not FDA-approved or compendia-supported are considered experimental/investigational and not medically necessary.

Initial Therapy Criteria - FDA-Approved AML (newly diagnosed FLT3-positive)

FDA-Approved AML (newly diagnosed FLT3-positive) - Initial Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of newly diagnosed acute myeloid leukemia (AML)
FLT3 mutation-positive status confirmed by an FDA-approved test
Medical record documentation required
Rydapt to be used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy
Not covered as single-agent induction therapy
Member has no exclusions to the prescribed therapy

Authorization and Continuation Criteria (AML)

AML - Authorization and Continuation

Authorization and reauthorization conditions:

Initial authorization may be granted for up to 12 months when Rydapt is used per covered indication above

Reauthorization (continued treatment) may be granted for up to 12 months if there is no evidence of unacceptable toxicity

Systemic Mastocytosis — Initial and Continuation Criteria

Systemic Mastocytosis (ASM, SM-AHN, MCL) - Initial and Continuation

Covered when ALL of the following are met:

Initial

Diagnosis of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)
Rydapt prescribed as single agent
Authorization of 12 months may be granted

Continuation: Reauthorization for up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

Systemic Mastocytosis (ISM, SSSM) - After First-line Therapy

Covered when ALL of the following are met:

Diagnosis of symptomatic indolent systemic mastocytosis (ISM) or smoldering systemic mastocytosis (SSSM)

Rydapt prescribed as single agent after first-line therapy with a clinical trial or avapritinib

Authorization of 12 months may be granted

Myeloid/Lymphoid Neoplasms with Eosinophilia and TK Fusions

Myeloid/Lymphoid Neoplasms with Eosinophilia and TK Gene Fusions

Covered when ALL of the following are met:

Diagnosis of myeloid and/or lymphoid neoplasm with eosinophilia with FGFR1 or FLT3 rearrangement (chronic or blast phase)

Medical record documentation of FGFR1 rearrangement or FLT3 rearrangement where applicable

Documentation required

Authorization of 12 months may be granted

Reauthorization for up to 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen

Compendial Uses

Compendial Uses (AML relapsed/refractory, post-induction, maintenance etc.)

Covered when ALL of the following are met:

Compendial alignment: Use aligns with compendia-supported indications: AML relapsed/refractory disease, post-induction therapy, reinduction of residual disease, maintenance therapy; systemic mastocytosis; myeloid/lymphoid neoplasms with eosinophilia and TK fusions

Member has no exclusions to the prescribed therapy

Medical record documentation provided as required (e.g., mutation/rearrangement testing)

Documentation required

Authorization of 12 months may be granted

Not Medically Necessary / Experimental or Investigational

Not covered when ANY of the following apply:

Indication is not FDA-approved or compendia-supported

All other indications are considered experimental/investigational and are not medically necessary

Rydapt used as single-agent induction therapy for AML

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization review requires submission of medical record documentation of FLT3 mutation or FGFR1 rearrangement (where applicable); authorization typically granted for up to 12 months when criteria are met.

Documentation Required

Mutation/rearrangement documentation

Providers must submit medical record documentation confirming FLT3 mutation (for AML) or FGFR1/FLT3 rearrangement (for relevant neoplasms) to initiate prior authorization review.

Denial Risk

Experimental/Not medically necessary denials

Claims may be denied if Rydapt is prescribed for indications that are not FDA‑approved or compendia‑supported, or if Rydapt is used as single‑agent induction therapy for AML.

Clinical Evidence & Definitions

Rydapt is FDA-indicated for adult patients with newly diagnosed AML who are FLT3 mutation-positive when given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, and for treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Compendial uses include various AML settings (relapsed/refractory, post-induction, reinduction, maintenance), systemic mastocytosis, and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.

Primary FDA source: Rydapt [package insert], Novartis Pharmaceuticals Corporation; May 2023.

Compendia reference: The NCCN Drugs & Biologics Compendium®, 2025.

Term	Definition
FLT3 mutation-positive	Presence of FLT3 mutation as detected by an FDA-approved test; documentation required for AML coverage.
FGFR1 rearrangement	Genetic rearrangement involving FGFR1; documentation required for coverage of myeloid/lymphoid neoplasms with eosinophilia where applicable.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRydapt Sgm 1817 A P2025

Policy CodePolicy 1817-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Rydapt Sgm 1817 A P2025

Coverage Summary

Initial Therapy Criteria - FDA-Approved AML (newly diagnosed FLT3-positive)

Authorization and Continuation Criteria (AML)

Systemic Mastocytosis — Initial and Continuation Criteria

Myeloid/Lymphoid Neoplasms with Eosinophilia and TK Fusions

Compendial Uses

Not Medically Necessary / Experimental or Investigational

Applicable Codes

Provider Actions

Clinical Evidence & Definitions

Revision History