CurrentUnitedHealthcarePolicy N/A

Rydapt (midostaurin) prior authorization

Prior authorization and notification requirements for midostaurin (Rydapt) for UnitedHealthcare members, including covered indications and reauthorization rules; applies to pharmacy benefit review processes and prescribers seeking coverage.

Policy Summary

PayerUnitedHealthcare

PolicyRydapt (midostaurin) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Rydapt for covered indications; prescriptions for members under 19 auto-process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

Age <19Pediatric auto-process

NCCN recognizedGuidance source

Coverage Criteria for Rydapt (midostaurin)

Initial Therapy — AML (adults)

Initial authorization for AML (adult) is covered when ALL of the following are met

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Initial Therapy — Mast Cell Diseases

Initial authorization for mast cell disease indications

Mast cell disease initial authorization: Diagnosis of one of: Aggressive systemic mastocytosis (ASM); Mast cell leukemia (MCL); Systemic mastocytosis with associated hematologic neoplasm (SM-AHN)

Authorization will be issued for 12 months

Initial Therapy — Myeloid/Lymphoid Neoplasms with Eosinophilia

Initial authorization for myeloid/lymphoid neoplasms with eosinophilia

Eosinophilia neoplasm initial authorization: Diagnosis of lymphoid, myeloid, or mixed lineage neoplasms with eosinophilia

Genetic rearrangement requirement: One of the following: Presence of an FGFR1 rearrangement; Presence of an FLT3 rearrangement

Authorization will be issued for 12 months when criteria met

Rydapt (midostaurin) is not indicated as a single-agent induction therapy for the treatment of patients with acute myeloid leukemia (AML). This policy requires Rydapt to be used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for the approved FLT3 mutation–positive, newly diagnosed AML indication; single‑agent use for induction is not an approved indication.

Coverage determinations may be affected by member-specific benefit design, state mandates, and the availability of supporting documentation. Prescriptions for members under 19 years of age will automatically process without a coverage review per benefit rules. Some states may mandate coverage for off‑label uses or require use of alternative compendia; where state mandates apply they supersede the benefit or notification criteria in this document.

UnitedHealthcare may also approve initial or reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic. Use of automated approval and re‑approval processes varies by program; supply limits or other utilization management controls may apply and could impact coverage.

Initial Therapy Criteria by Indication

Initial Therapy — Drug-specific

Initial authorization criteria by indication

AML initial: Diagnosis of AML AND AML is FLT3 mutation-positive AND used in combination with standard induction and consolidation therapy

Authorization for 12 months

Mast cell disease initial: Diagnosis of ASM or MCL or SM-AHN

Authorization for 12 months

Eosinophilia neoplasm initial: Diagnosis of lymphoid/myeloid/mixed neoplasms with eosinophilia AND presence of FGFR1 or FLT3 rearrangement

Authorization for 12 months

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rydapt for most members. Members under 19 years of age have prescriptions that will automatically process without a coverage review. Initial authorization criteria (see policy) apply; authorizations are typically issued for 12 months when criteria are met.

Prior authorization required except for members <19 (automatic processing)
Typical initial authorization term: 12 months

Documentation Required

Required Documentation Sources

Documentation to support coverage decisions may include prior claim and medication history, relevant diagnosis codes (ICD-10), and other claim-level logic. State mandates and member-specific benefit plan language (including state-required compendia) may supersede or expand coverage; verify applicable mandates for the member.

Acceptable documentation: prior claims / medication history, ICD-10 diagnosis codes, prior authorization forms as applicable
Check state mandates and member-specific benefit plan for mandated coverage or compendia requirements

Denial Risk

Automated Approval / Denial Risk

Use of automated approval and re-approval processes varies by program and therapeutic class. Approvals may be issued based solely on prior claim/medication history, diagnosis codes, and/or claim logic; conversely, claims or authorizations can be denied if submitted documentation, claim history, diagnosis coding, or program logic do not support coverage. Supply limits and utilization management programs may apply and can affect approval.

Automated approval/re-approval possible based on claim/medication history and diagnosis codes
Denial risk if claim logic, history, or diagnosis codes do not support coverage
Supply limits/utilization management programs may apply

Step	Requirement
1	No explicit step therapy requirements defined in this policy; supply limits and utilization management programs may apply.

Quantity Limits and Utilization Constraints

Rydapt (midostaurin) — Supply limits may be in place

Quantity limits noteSupply limits may be in place for Rydapt (midostaurin)

Utilization managementUtilization management programs may apply though no specific step therapy sequence is defined in this document

Approval exceptionsUnitedHealthcare may approve based on previous claim/medication history and claim logic which can interact with supply limits

Key Definitions

FLT3 mutation-positive acute myeloid leukemia — Definition / key term

DefinitionAcute myeloid leukemia (AML) that is FLT3 mutation-positive — AML with a documented FLT3 mutation; indication for Rydapt in newly diagnosed adult patients when given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

Treatment contextRydapt is indicated for FLT3 mutation-positive newly diagnosed AML in adults when used with standard induction and consolidation chemotherapy.

LimitationRydapt is not indicated as a single-agent induction therapy for the treatment of patients with AML.

Myeloid/lymphoid neoplasms with eosinophilia — Definition / key term

DefinitionMyeloid/lymphoid neoplasms with eosinophilia — lymphoid, myeloid, or mixed-lineage neoplasms characterized by eosinophilia and associated with FGFR1 or FLT3 rearrangements.

Genetic requirementAuthorization requires presence of an FGFR1 rearrangement or an FLT3 rearrangement when used for these neoplasms.

Guidance sourceNCCN recommends Rydapt for myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements.

Background

Midostaurin is a kinase inhibitor indicated for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation‑positive when given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Midostaurin is also indicated for aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematologic neoplasm (SM‑AHN), and mast cell leukemia (MCL); the NCCN additionally recommends it for myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements.

Policy Revision History

2025-09-01Effective DateLatest

Policy effective date updated to 2025-09-01 (program effective date).

6/2025Annual review

Annual review with revised wording in criteria for myeloid/lymphoid neoplasms; updated references.

6/2024Annual review

Annual review with no changes to clinical criteria; updated references.

6/2023Annual review

Annual review with no changes to clinical criteria; updated references and added state mandate footnote.

6/2022Annual review

Annual review with revised grammar in criteria with no changes to clinical intent; updated references.

6/2021Annual review

Annual review adding myeloid/lymphoid neoplasms criteria per NCCN.

6/2020Annual review

Annual review with no changes to criteria; updated references.

6/2019Annual review

Annual review with no changes to criteria; updated references.

6/2018New program

Prior Authorization/Notification program for Rydapt (midostaurin) initiated.

6/2017Change control

Change control entry recorded for Prior Authorization/Notification Rydapt (midostaurin).

Policy Summary

PayerUnitedHealthcare

PolicyRydapt (midostaurin) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Rydapt for covered indications; prescriptions for members under 19 auto-process without coverage review.

SourceLink

On This Page

OpenPayer

Rydapt (midostaurin) prior authorization

Coverage Criteria for Rydapt (midostaurin)

Initial Therapy Criteria by Indication

Reauthorization and Continuation Criteria

Coding and Age Thresholds

Provider Actions, Prior Authorization, and Documentation

Step Therapy and Related Rules

Quantity Limits and Utilization Constraints

Site of Care Considerations

Key Definitions

Background

Policy Revision History