Clinical Policy: Midostaurin (Rydapt)
Defines medical necessity criteria, initial and continued therapy approval conditions, dosing limits, covered indications (FDA-approved AML and systemic mastocytosis indications) and select off-label uses (myeloid/lymphoid neoplasm with eosinophilia and FGFR1 or FLT3 rearrangements; ISM and SSM), approval durations by line of business, and documentation/prior authorization expectations for midostaurin (Rydapt).
2Q 2025 annual review: for AML added use as maintenance therapy for those who have previously received a FLT3 inhibitor and do not have an allogeneic hematopoietic cell transplantation planned per NCCN; for systemic mastocytosis, revised to include off-label use in ISM and SSM per NCCN.
2Q 2024 annual review: per NCCN for AML, added that Rydapt may also be prescribed with idarubicin for induction therapy and added off-label use for maintenance therapy; for systemic mastocytosis, added that Rydapt must be prescribed as a single agent.
2Q 2022 annual review: modified commercial approval duration to 12 months or duration of request and consolidated approval durations to 6 months initial and 12 months for continuation of therapy; added post-induction use in AML and chronic phase option for myeloid/lymphoid neoplasm.
02.21.21 annual review: added standard oncology generic redirection language and off-label indication for myeloid/lymphoid neoplasm with eosinophilia and FGFR1 or FLT3 rearrangements in blast phase.
2Q 2023 annual review: no significant changes; references reviewed and updated.