CurrentNeighborhood Health Plan of Rhode IslandPolicy 1817-A

Rydapt (midostaurin) coverage and prior authorization criteria

Defines coverage and prior authorization criteria for Rydapt (midostaurin) for FDA-approved indications and selected compendial uses, required documentation, authorization durations, and reauthorization conditions for members of the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRydapt (midostaurin) coverage and prior authorization criteria

Policy CodePolicy 1817-A

Change TypeNo material change

Effective Date

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3FDA-Approved Indications Mentioned

3Compendial Uses Listed

12 moTypical Authorization Duration

Coverage Summary & Covered Indications

This policy covers with criteria Rydapt (brand name for midostaurin) for specified FDA-approved indications and selected compendial uses, subject to the plan’s prior authorization requirements and approval criteria. The policy applies to Rydapt (midostaurin) and defines documentation, authorization durations, and reauthorization conditions for covered uses.

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Covered Indications and General Requirement

Rydapt is covered for the indications below provided approval criteria are met and the member has no exclusions to the prescribed therapy.

ANY of the following

Acute Myeloid Leukemia (AML) - FDA-approved: In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for adult patients with newly diagnosed AML who are FLT3 mutation-positive as detected by an FDA-approved test.
Systemic Mastocytosis (SM) - FDA-approved: For treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Compendial Uses: Acute Myeloid Leukemia (AML) - relapsed/refractory disease, post-induction therapy, reinduction of residual disease, and maintenance therapy.
Compendial Uses: Myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions.
Compendial Uses: Systemic mastocytosis (including symptomatic indolent systemic mastocytosis [ISM] or smoldering systemic mastocytosis [SSSM] under conditions described below).

Documentation requirement for applicable indications: Medical record documentation of FLT3 mutation or FGFR1 rearrangement (where applicable) must be submitted to initiate prior authorization review.

Limitations of use (not covered scenarios)

Rydapt is not indicated as a single-agent induction therapy for the treatment of patients with AML.
All other indications not listed as FDA-approved or compendial are considered experimental/investigational and are not medically necessary.

Authorization Durations, Prior Authorization, and Documentation

Authorization Durations and Reauthorization Criteria

Approval durations and conditions for initial and continued therapy vary by indication.

Acute Myeloid Leukemia (AML)

Authorization of 12 months may be granted for the treatment of FLT3 mutation-positive AML when Rydapt is not used as a single-agent for induction therapy.
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity.

Systemic Mastocytosis

Authorization of 12 months may be granted for treatment of ASM, SM-AHN, or MCL as a single agent.
Authorization of 12 months may be granted for treatment of symptomatic ISM or SSSM as a single agent after first-line therapy with a clinical trial or avapritinib.
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene Fusions

Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid neoplasms with eosinophilia with FGFR1 or FLT3 rearrangement in the chronic phase or blast phase.
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Prior Authorization

Prior authorization required with mutation documentation

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

FLT3 mutation documentation
FGFR1 rearrangement documentation

Prior Authorization

Authorization duration

Initial and reauthorization approvals are typically granted for 12 months for covered indications, conditional on no unacceptable toxicity or disease progression.

Clinical Background & Evidence Sources

Rydapt (midostaurin) is an oral kinase inhibitor with FDA approval in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation‑positive. It is also FDA‑approved as a single agent for advanced systemic mastocytosis subtypes including aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematologic neoplasm (SM‑AHN), and mast cell leukemia (MCL). Compendial uses acknowledged by the policy include relapsed/refractory AML (post‑induction, reinduction, maintenance), myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions, and other systemic mastocytosis settings.

Supporting references include the Rydapt [package insert] (Novartis; May 2023) and the NCCN Drugs & Biologics Compendium (cited 2025).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRydapt (midostaurin) coverage and prior authorization criteria

Policy CodePolicy 1817-A

Change TypeNo material change

Effective Date

Next Review Date

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

SourceLink

On This Page

OpenPayer

Rydapt (midostaurin) coverage and prior authorization criteria

Coverage Summary & Covered Indications

Authorization Durations, Prior Authorization, and Documentation

Limitations of Use and Not Covered Scenarios

Applicable Codes

Clinical Background & Evidence Sources

Definitions

Policy Revision History