Subject: Scemblix 5042-A SGM P2023b
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Adult patients with Philadelphia chromosome-positive
chronic myeloid leukemia in chronic phase (Ph+ CML-CP),
previously treated with two or more tyrosine kinase
inhibitors (TKIs)
2. Adult patients with Philadelphia chromosome-positive
chronic myeloid leukemia in chronic phase (Ph+ CML-CP)
with the T315I mutation
B. Compendial Use
Myeloid/lymphoid neoplasms with eosinophilia and ABL1
rearrangement in chronic or blast phase
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
The following information is necessary to initiate the prior
authorization review:
A. Prior to initiation of therapy for treatment of CML: results of
cytogenetic and/or molecular testing for detection of the Ph
chromosome or the BCR::ABL gene
B. For members requesting initiation of therapy with the
requested medication for treatment of T315I-positive CML:
results of BCR::ABL1 mutation testing for T315I, A337T and
P465S mutations
C. For members requesting initiation of therapy with the
requested medication for treatment of myeloid and/or
lymphoid neoplasms with eosinophilia: results of testing or
analysis confirming ABL1 rearrangement
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Myeloid Leukemia (CML)
Authorization of 12 months may be granted for treatment of
Philadelphia chromosome positive (Ph+) CML in chronic
phase (CP) when either of the following criteria are met:
1. Member has T315I mutation positive CML and results of
BCR::ABL1 mutation testing are negative for the
following: A337T, P465S, or
2. Member has been previously treated with at least two
kinase inhibitors (e.g., bosutinib, dasatinib, imatinib,
nilotinib) and has not tested positive for the following
mutations: A337T, P465S
B. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of
myeloid and/or lymphoid neoplasms with eosinophilia and
ABL1 rearrangement in the chronic phase or blast phase.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III 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:
- Scemblix [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed May 24, 2023.
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.
December 09, 2023
