CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Midostaurin (Rydapt) coverage criteria — FLT3‑positive AML and selected compendial indications

Criteria and prior authorization requirements for coverage of Rydapt (midostaurin) for FDA-approved and selected compendial hematologic oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMidostaurin (Rydapt) coverage criteria — FLT3‑positive AML and selected compendial indications

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit medical record documentation of FLT3 mutation or FGFR1 rearrangement when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FLT3required mutation for FDA-approved AML indication

ASM, SM-AHN, MCLlisted mast cell disease indications

FGFR1/FLT3compendial biomarker requirement

Coverage Criteria

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FDA‑Approved AML indication

Covered when ALL of the following are met for the FDA-approved AML indication

FLT3‑positive newly diagnosed AML (FDA‑approved): Patient is an adult with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation‑positive as detected by an FDA‑approved test; midostaurin will be given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy; midostaurin is not being used as single‑agent induction therapy.

Submit medical record documentation of FLT3 mutation for prior authorization; authorization may be granted for up to 12 months when criteria are met.

Mast cell disease indications

Covered when ALL of the following are met for mast cell disease indications

ASM / SM‑AHN / MCL: Patient is an adult with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM‑AHN), or mast cell leukemia (MCL); midostaurin is being used as single‑agent therapy for these indications.

Authorization may be granted for up to 12 months; submit relevant clinical documentation for prior authorization.

Compendial indications

Covered compendial uses when documentation supports diagnosis/genetics

Compendial hematologic indications: Uses such as relapsed/refractory AML (including post‑induction or re‑induction of residual disease) and myeloid/lymphoid neoplasms with eosinophilia associated with FGFR1 or FLT3 rearrangements (chronic or blast phase) are covered when supported by appropriate compendial references and documentation (e.g., laboratory evidence of FGFR1 or FLT3 rearrangement where applicable).

Submit medical record documentation of FGFR1 or FLT3 rearrangement when applicable; authorization may be granted for up to 12 months.

Exclusions / Not medically necessary

Not medically necessary when

Experimental/Investigational exclusions: Indications that are not listed as either an FDA‑approved indication or a listed compendial use are considered experimental/investigational and are not medically necessary.

Requests for non‑listed indications may be denied.

All indications for midostaurin (Rydapt) that are not specifically listed in this policy as FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary. Requests for coverage for such unlisted indications may be denied.

Uses of midostaurin that fall outside the FDA‑approved indications and the compendial indications enumerated in this policy are considered not medically necessary. Providers should submit requests only when the indication matches an FDA‑approved or listed compendial use and must include supporting documentation.

Covered Regimens

Regimen	Indication	Coverage status
Midostaurin + cytarabine + daunorubicin induction; midostaurin during cytarabine consolidation
Newly diagnosed FLT3 mutation-positive acute myeloid leukemia (AML); midostaurin given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation (FLT3 mutation detected by an FDA-approved test)
Covered when used in the described combination for newly diagnosed FLT3 mutation-positive AML; Rydapt is not indicated as single-agent induction therapy.

Regimen	Indication	Coverage status
Midostaurin as single-agent therapy
Aggressive systemic mastocytosis (ASM); systemic mastocytosis with associated hematological neoplasm (SM-AHN); mast cell leukemia (MCL)
Covered as single-agent therapy for ASM, SM-AHN, or MCL; authorization of up to 12 months may be granted.

Coding

No explicit billing codes providedmixed

No codes listed

inv-08: Authorization duration

Authorization period12 months

Applies toInitial and continuation authorizations when coverage criteria are met

Documented in sourceAuthorization of 12 months may be granted for the treatment of FLT3 mutation-positive AML

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation authorizations may be granted for up to 12 months when criteria are met.

Authorization of up to 12 months may be granted for AML when Rydapt is used in combination with standard cytarabine/daunorubicin (not as single‑agent induction).
Authorization of up to 12 months may be granted for ASM, SM‑AHN, MCL, and myeloid/lymphoid neoplasms with eosinophilia (FGFR1 or FLT3 rearrangement) per criteria.
Reauthorization (continuation) may be granted for up to 12 months when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Denial Risk

Induction Therapy Usage Constraint

Rydapt must not be used as single‑agent induction therapy for newly diagnosed AML. For FDA‑approved AML indication, Rydapt is indicated only in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy.

Documentation Required

Submit medical record documentation of FLT3 mutation or FGFR1 rearrangement (where applicable) to initiate prior authorization review.

Document positive FLT3 mutation testing for newly diagnosed AML requests.
Document FGFR1 or FLT3 rearrangement testing for myeloid/lymphoid neoplasm requests when applicable.

Denial Risk

Non‑Covered Indications

Requests for indications not listed as FDA‑approved or compendial uses are considered experimental/investigational and are not covered.

Non‑covered examples: any use outside the FDA‑approved indications and the compendial uses listed in policy.
Denials for experimental/investigational indications may be issued when submitted documentation does not support an FDA‑approved or compendial use.

Line of Therapy

first-line | subsequent (per compendial use)

Line of therapy: Used in combination with standard induction and consolidation chemotherapy for newly diagnosed FLT3‑mutated AML (first‑line); compendial uses may include subsequent lines such as relapsed/refractory disease, post‑induction, or re‑induction per compendial guidance.

Midostaurin must not be used as single‑agent induction for newly diagnosed AML; single‑agent use is acceptable for listed mast cell disease indications.

Biomarker Requirements

inv-17: FLT3 — detected by an FDA-approved test

Required biomarkerFLT3 mutation

Detection methodDetected by an FDA‑approved test

Documentation requirementSubmit medical record documentation of FLT3 mutation to initiate prior authorization review

inv-18: FGFR1 or FLT3 rearrangements — biomarker requirement for certain compendial myeloid/lymphoid neoplasms with eosinophilia

Required rearrangementsFGFR1 or FLT3 rearrangements

Applicable diagnosesMyeloid/lymphoid neoplasms with eosinophilia (chronic or blast phase)

Documentation requirementSubmit medical record documentation of FGFR1 or FLT3 rearrangement to initiate prior authorization review

Definitions

inv-14: FLT3 mutation-positive

DefinitionPresence of a FLT3 mutation as detected by an FDA‑approved test

Clinical relevanceRequired for the FDA‑approved newly diagnosed AML indication (midostaurin + standard induction/consolidation)

DocumentationMedical record documentation of FLT3 mutation must be submitted for prior authorization

inv-15: FGFR1/FLT3 rearrangement–positive neoplasms

DefinitionMyeloid/lymphoid neoplasms with eosinophilia and documented FGFR1 or FLT3 gene rearrangements

Disease phasesApplies to chronic phase or blast phase presentations

Coverage noteConsidered a compendial indication when FGFR1 or FLT3 rearrangement documentation is present

Background

Midostaurin (Rydapt) is a targeted kinase inhibitor used in hematologic malignancies. Compendial listings for midostaurin include relapsed/refractory AML and myeloid/lymphoid neoplasms with eosinophilia and documented FGFR1 or FLT3 rearrangements (chronic or blast phase). Coverage for these compendial indications requires documentation supporting the diagnosis and relevant genetic findings.

Revision History

2022policy publicationLatest

Document references Rydapt package insert (Nov 2021) and NCCN compendium (2022); authorization language and indications established in the policy document.