Subject: Rydapt 1817-A SGM P2022
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered covered benefits provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Rydapt is indicated, in combination with standard
cytarabine and daunorubicin induction and cytarabine
consolidation chemotherapy, for the treatment of adult
patients with newly diagnosed acute myeloid leukemia
(AML) who are FLT3 mutation-positive, as detected by
an FDA approved test.
Limitations of Use: Rydapt is not indicated as a single-
agent induction therapy for the treatment of patients
with AML.
2. Rydapt is indicated for the treatment of adult patients
with aggressive systemic mastocytosis (ASM), systemic
mastocytosis with associated hematological neoplasm
(SM-AHN), or mast cell leukemia (MCL).
B. Compendial Uses
1. AML: Relapsed/refractory disease, post-induction
therapy, re-induction of residual disease
2. Myeloid/lymphoid neoplasms with eosinophilia and
FGFR1 or FLT3 rearrangements in chronic phase
3. Myeloid, lymphoid, or mixed lineage neoplasms with
eosinophilia and FGFR1 or FLT3 rearrangements in blast
phase
All other indications are considered
experimental/investigational and are not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review: Medical record documentation of
FLT3 mutation or FGFR1 rearrangement (where applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Acute myeloid leukemia (AML)
Authorization of 12 months may be granted for the
treatment of FLT3 mutation-positive AML when it is not
used as a single-agent for induction therapy.
B. Aggressive systemic mastocytosis (ASM), systemic
mastocytosis with associated hematological neoplasm
(SM-AHN), and mast cell leukemia (MCL)
Authorization of 12 months may be granted for the
treatment of ASM, SM-AHN, or MCL as a single agent.
C. Myeloid/Lymphoid Neoplasms with eosinophilia
Authorization of 12 months may be granted for the
treatment of myeloid and/or lymphoid neoplasms with
eosinophilia with a FGFR1 or FLT3 rearrangement in the
chronic phase or blast phase.
IV. CONTINUATION OF THERAPY
A. Acute myeloid leukemia (AML)
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization when there
is no evidence of unacceptable toxicity.
B. Aggressive systemic mastocytosis (ASM), systemic
mastocytosis with associated hematological neoplasm
(SM-AHN), mast cell leukemia (MCL), myeloid/lymphoid
neoplasms with eosinophilia
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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Rydapt [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2021.
- The NCCN Drugs & Biologics Compendium®. © 2022 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 10, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
July 26, 2022
