CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rydapt (midostaurin) coverage and authorization criteria

Defines covered indications, documentation and authorization durations for Rydapt (midostaurin) including FDA-approved AML and systemic mastocytosis indications and specified compendial uses; specifies prior authorization documentation requirements and reauthorization conditions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRydapt (midostaurin) coverage and authorization criteria

Policy CodePolicy N/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; for reauthorization provide evidence of no unacceptable toxicity and no disease progression.

POLICY UPDATE CHANGES

No material clinical/coverage changes

3Primary covered indications listed (FDA + mastocytosis + neoplasms)

12 monthsStandard authorization duration

Coverage Summary

Rydapt (midostaurin) is covered with criteria. It is covered for FDA-approved FLT3 mutation-positive newly diagnosed acute myeloid leukemia (AML) when given in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, and is not indicated as single-agent induction therapy. Rydapt is also covered for adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Selected compendial hematologic neoplasm uses (including myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements, and relapsed/refractory AML post-induction) are covered when criteria are met. All covered uses require that listed approval criteria are met and the member has no exclusions to the prescribed therapy; other indications are considered investigational and not medically necessary.

Covered Indications / Authorization Criteria

Rydapt is covered for the following indications when ALL listed criteria are met and member has no exclusions to therapy:

Covered Indications (ANY of the following)

Acute myeloid leukemia (AML): Rydapt 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.
Not indicated as single-agent induction therapy.
Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL): Rydapt for treatment of adult patients with these diagnoses.
Can be authorized as single agent for these indications.
Myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements (chronic phase or blast phase): Rydapt for treatment of these neoplasms (compendial use).
Relapsed/refractory AML, post-induction therapy, re-induction of residual disease (compendial use).

Required documentation and conditions

Medical record documentation of FLT3 mutation or FGFR1 rearrangement where applicable.
Member must have no exclusions to the prescribed therapy (plan-specific).

Initial and Continuation Therapy Criteria

Authorization Duration and Reauthorization

Authorization rules for initial and continued therapy:

ANY of the following

Initial and continued authorization of up to 12 months may be granted for treatment of FLT3 mutation-positive AML when not used as a single-agent for induction therapy.
Authorization of up to 12 months may be granted for ASM, SM-AHN, or MCL as a single agent.
Authorization of up to 12 months may be granted for myeloid/lymphoid neoplasms with eosinophilia with FGFR1 or FLT3 rearrangement in chronic or blast phase.
Reauthorization (continued treatment) may be granted for additional 12-month periods when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Prior Authorization & Documentation

Prior Authorization

Prior authorization required

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

Affected codes: NDC groups (if any) - none provided

Documentation Required

Documentation for reauthorization

For reauthorization, provide evidence of no unacceptable toxicity and no disease progression while on the current regimen.

Reauthorization interval: up to 12 months

Background and Definitions

Rydapt (midostaurin) is FDA-approved for two primary indications: (1) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by an FDA-approved test; and (2) for treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Compendial uses considered covered when criteria are met include treatment of myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or FLT3 rearrangements (chronic or blast phase) and certain relapsed/refractory AML post-induction (re-induction of residual disease).

Authorization of therapy is typically for up to 12 months for initial and continued treatment across the listed indications, with reauthorization possible for additional 12-month periods when there is no evidence of unacceptable toxicity or disease progression. Prior authorization requires submission of medical record documentation of FLT3 mutation or FGFR1 rearrangement where applicable.

FLT3 mutation-positive: Presence of a FLT3 mutation as detected by an FDA-approved test; medical record documentation is required.

FGFR1 rearrangement: Cytogenetic or molecular rearrangement of FGFR1 as documented in the medical record (required where applicable).