Subject: Iclusig 2173-A SGM P2024
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 chronic phase (CP) chronic myeloid leukemia (CML) with resistance
or intolerance to at least two prior kinase inhibitors
2. Adult patients with accelerated phase (AP) or blast phase (BP) chronic myeloid leukemia
(CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for
whom no other kinase inhibitors are indicated
3. Adult patients with newly diagnosed Ph+ ALL, in combination with chemotherapy.
4. Adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast
phase) or T315I-positive Ph+ ALL
Limitation of use: Iclusig is not indicated and is not recommended for the treatment of
patients with newly diagnosed CP-CML.
B. Compendial Uses
1. Additional therapy for CML patients after hematopoietic stem cell transplant (HSCT)
2. Ph+ B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (Ph+ B-ALL/LL)
3. Maintenance therapy for Ph+ B-ALL/LL patients after hematopoietic stem cell transplant
(HSCT)
4. Myeloid/lymphoid neoplasms with eosinophilia and FGFR1 or ABL1 rearrangements in
chronic phase or blast phase
5. Gastrointestinal Stromal Tumors (GIST)
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 or Ph+ ALL/LL: 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 mutation
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 FGFR1 or ABL1 rearrangement
III. CRITERIA FOR INITIAL APPROVAL
A. Chronic Myeloid Leukemia (CML)
Authorization of 12 months may be granted for treatment of CML that has been confirmed
by detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular
testing when any of the following criteria are met:
1. Member has T315I-positive CML
2. Member has CML with no identifiable BCR::ABL1 mutations and resistance to primary
therapy with bosutinib, dasatinib, or nilotinib
3. Member has chronic phase (CP) chronic myeloid leukemia (CML) with resistance or
intolerance to at least two prior kinase inhibitors (e.g., bosutinib, dasatinib, imatinib,
nilotinib)
4. Member has accelerated phase (AP) or blast phase (BP) CML and treatment with any
other kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib) is not indicated
B. Ph+ Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LL)
Authorization of 12 months may be granted for treatment of Ph+ ALL/LL that has been
confirmed by detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or
molecular testing.
C. Myeloid/Lymphoid Neoplasms with Eosinophilia
Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid
neoplasms with eosinophilia and FGFR1 or ABL1 rearrangement in the chronic phase or
blast phase.
D. Gastrointestinal Stromal Tumors (GIST)
Authorization of 12 months may be granted for treatment of GIST as a single agent for
residual, unresectable, recurrent or metastatic/tumor rupture disease after progression on at
least four FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, and ripretinib)
IV. CONTINUATION OF THERAPY
A. CML
Authorization of 12 months may be granted for continued treatment of CML when there is
no evidence of unacceptable toxicity or disease progression while on the current regimen
and either of the following is met:
1. Member has CML that has been confirmed by detection of Ph chromosome or BCR::ABL
gene by cytogenetic and/ or molecular testing
2. Member has received HSCT for CML
B. Ph+ ALL/LL
Authorization of 12 months may be granted for continued treatment of ALL/LL when there is
no evidence of unacceptable toxicity or disease progression while on the current regimen
and either of the following criteria is met:
1. Member has Ph+ ALL/LL that has been confirmed by detection of Ph chromosome or
BCR::ABL gene by cytogenetic and/ or molecular testing
2. Member has received HSCT for ALL/LL
C. Myeloid/Lymphoid Neoplasms with Eosinophilia, GIST
Authorization of 12 months may be granted for continued treatment of myeloid/lymphoid
neoplasms with eosinophilia or GIST 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:
- Iclusig [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; March 2024.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 3, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 2.2024). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 3, 2024.
- NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 4.2023). © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 3, 2024.
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.
November 03, 2024
